MARKET SURVEY CUM

DETAILED TECHNO ECONOMIC

FEASIBILITY REPORT

(PROJECT FEASIBILITY REPORT)

ON

DEXTROSE SALINE (I.V. FLUID)

(FFS TECHNOLOGY) (Cap: 60,000 Bottles/Day)

INDENTIFICATION & EVALUATION DIVISION FOR HI-TECH PROJECTS

EIRI CONSULTANTS & ENGINEERS

* REGD. OFFICE *
4449, NAI SARAK, MAIN ROAD,
NEAR CHANDNI CHOWK,
DELHI - 11 00 06. (INDIA)
(BETWEEN MARWARI KATRA AND ROSHAN PURA),
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E-Mail : eiriprojects@gmail.com, eiribooks@yahoo.com
Web: www.eiriindia.org,
www.eiribooksandprojectreports.com

CODE : EIRI/EDPR/2085
J.C. : 1001(INR), 1002(US$)
 C A U T I O N
This project report has been prepared on the basis of information available
with M/S. ENGINEERS INDIA RESEARCH INSTITUTE. The intention here
is to provide preliminary information to the prospective entrepreneur. Prior to
making a firm decision for investment in the project the entrepreneur must
verify the various feasibility aspects together along with the addresses for the
procurement of plant & machinery and raw materials independently. The
information supplied in this report is obtained from the reliable sources but it
is not guaranteed and the money once paid will not be refunded back in any
case. Claims for incomprehensiveness of the project report will not be
entertained and no legal action in this regard would be entertained in any
case (Subject to Delhi Jurisdiction only). Any matter relating to our standard
points covered in the report may be modified with in 5 days time only from
the date of purchase.

ENGINEERS INDIA RESEARCH INSTITUTE, 4449 NAI SARAK, DELHI-110006.

 DEXTROSE SALINE (I.V. FLUID)
(FFS TECHNOLOGY) (Cap: 60,000 Bottles/Day)
[EIRI/EDPR/2085] J.C.: 1001(INR), 1002(US$)

CONTENTS

INTRODUCTION 6
INTRAVENOUS FLUIDS 12
IV FLUID/ELECTROLYTE THERAPY 13
KEY TERMS 15
DEXTROSE 16
DEXTROSE SALINE INJECTION 17
PROPERTIES 18
REQUIREMENTS OF RAW MATERIALS 20
EXPORT OPPORTUNITY OF INTRAVENOUS SOLUTION 22
INTERNATIONAL MARKET OVERVIEW 29
ECONOMIC PROFILE 30
WORLD MARKET CONSUMPTION 31
SOURCE OF MACHINES TECHNOLOGY 32
OVERVIEW OF THE GLOBAL INTRAVENOUS SOLUTIONS MARKET 33
IV FLUID PRODUCTION CAPACITY AND MARKET DEMAND IN AFGHANISTAN 35
USES AND APPLICATION 44
SOME GENERAL INTRAVENOUS FLUIDS 45
MARKET SURVEY 48
MARKET STRACTURE 55
INDIAN BULK DRUG MARKET SHARE 58
ADDITIONAL MARKET POSITION 64
INDIAN PATENTS LAW, TRADE LAW & TAXATION 68
'TAX'ING INDIAN PHARMA 76
PRESENT MANUFACTURES OF I.V FLUIDS 77
SPECIFICATION OF INDIAN PHARMACOPEIA ON I.V FLUIDS DEXTRAN 40
INJECTION 82
DEXTRAN 110 INJECTIONS 85
B.I.S. SPECIFICATIONS FOR PLASTIC I.V. BOTTLES 86
SODIUM CHLORIDE AND DEXTROSE INJECTION 88
WATER THE EXCELLENT SOLVENT USED IN PHARMACY 90
BASIC RAW MATERIALS 91
REQUIREMENTS OF RAW MATERIALS AND SPECIFICATIONS 92
COMPOSITION OF IV FLUID 94
COMPOSITION OF COMMON IV FLUID (MEQ/L) 95
COMPOSITION OF IV FLUIDS 97
COMPOSITION OF COMMERCIAL I.V. FLUID AVAILABLE 98
MANUFACTURING PROCESS OF I.V. FLUID (FFS TECHNOLOGY) 99
PROCESS FLOW DIAGRAM 101
PROCESS IN DETAILS 102
FLOW DIAGRAM OF MANUFACTURING OF I.V. FLUIDS 108
PLANT LAYOUT 109
SWOT ANALYSIS 110
SCHEMATIC DIAGRAM OF FFS PLANT LAYOUT 111
FORM FILL SEAL TECHNOLOGY 112
CALCULATING INTRAVENOUS FLOW RATES 115
GENERAL PLANT LAYOUT 119
MANPOWER 136
LIST OF MACHINERY IV BAG PRODUCTION FORM FILL AND SEAL MACHINE 137
CIP SYSTEM 142
GUIDE TO GOOD MANUFACTURING PRACTICE (GMP) FOR MEDICINAL PRODUCT
PRINCIPLE 145
CLEAN ROOM AND CLEAN AIR DEVICE CLASSIFICATION 147
CLEAN ROOM AND CLEAN AIR DEVICE MONITORING 148
ISOLATOR TECHNOLOGY 152
TERMINALLY STERILISED PRODUCTS 153
ASEPTIC PREPARATION 154
PERSONNEL 155
PREMISES 157
EQUIPMENT 159
SANITATION 160
PROCESSING 161
STERILISATION 165
STERILISATION BY HEAT 166
MOIST HEAT 167
STERILISATION BY RADIATION 168
STERILISATION WITH ETHYLENE OXIDE 169
FILTRATION OF MEDICINAL PRODUCTS WHICH CANNOT
BE STERILISED IN THEIR FINAL CONTAINER 170
FINISHING OF STERILE PRODUCTS 171
SUPPLIERS OF RAW MATERIALS 172
EMPTY IV BAG MANUFACTURER AND SUPPLIER IN INDIA 191
COMPLETE PLANT SUPPLIERS 192
SUPPLIERS OF PLANT AND MACHINEY 193
CONSULTANT OF TURNKEY PROJECT SUPPLIER
OF THE PLANT AND MACHINERY 194
CLEAN ROOM SUPPLIERS 197
APPENDIX – A :

1. COST OF PLANT ECONOMICS

2. LAND & BUILDING
3. PLANT AND MACHINERY
4. FIXED CAPITAL INVESTMENT
5. RAW MATERIAL
6. SALARY AND WAGES
7. UTILITIES AND OVERHEADS
8. TOTAL WORKING CAPITAL
9. COST OF PRODUCTION
10. PROFITABILITY ANALYSIS
11. BREAK EVEN POINT
12. RESOURCES OF FINANCE
13. INTEREST CHART
14. DEPRECIATION CHART
15. CASH FLOW STATEMENT
16. PROJECTED BALANCE SHEET
 DEXTROSE SALINE (I.V. FLUID)
(FFS TECHNOLOGY) (Cap: 60,000 Bottles/Day)
[EIRI/EDPR/2085] J.C.: 1001(INR), 1002(US$)

INTRODUCTION

Intra venous fluids, in general are used as I.V drips for patients in nursing
homes and hospitals suffering from acute dehydration or considerable debilitating
conditions. These I.V fluids replanish the body fluids. Though a number of I.V
fluids are there, generally three types of I.V fluids are used in hospitals as I.V drips.
They are as follows:-

1. Dextrose injection fluid

2. Dextrose and sodium chloride injection fluid

Types of IV Fluid

Crystalloid: Balanced salt/electrolyte solution; for msa true solution and is capable
of passing through semi permeable membranes. May be isotonic, hypertonic or
hypotonic. Normal Saline (0.9% NaCl), Lactated Ringer’s, Hypertonic saline (3, 5, &
7.5%), Ringer’s solution. However, hypertonic solutions are considered plasma
expanders as they act to increase the circulatory volume via movement of
intracellular and interstitial water into the intravascular space.

Colloid: High-molecular-weight solutions, draw fluid into intravascular

compartment via on cotic pressure (pressure exerted by plasma proteins not
capable of passing through membranes on capillary walls).Plasma expanders, as
they are composed of macromolecules, and are retained in the intravascular space.

Free H2O solutions: provide water that is not bound by macromolecules or

organelles, free to passthrough.D5W (5% dextrose in water), D10W, D20W, D50W,
and Dextrose/crystalloid mixes. Blood products: whole blood, packed RBCs, FFP,
Cryoprecipitate, platelets, albumin. Essentially all colloids.
 IVF can supply 3 things: fluid, electrolytes, & calories. In the non stressed,
fasting state, the 150g per day inD5W at 125ml/h can provide enough carbohydrate
to limit proteolysis. The most common uses for IVF: Acutely expand intravascular
volume in hypovolemic states correct electrolyte imbalances Maintain basal
hydration

Commonly used IV Fluids

Normal Saline (0.9% NaCl): Isotonic salt water.154 mEq/L Na+; 154 mEq/L Cl-;
308mOsm/L.Cheapest and most commonly used resuscitative crystalloid. High [Cl-]
above the normal serum 103mEq/L imposes on the kidneys an appreciable load of
excess Cl- that cannot be rapidly excreted.

When saline is injected intravenously, it compensate the deficiency of

sodium ions when dextrose is injected it gives energy due to glucose content of it
when dextro-saline is given in combination, it replanishes the dehydration as well
as gives energy thereby recouping debility syndrome and also in general take care
of malaise.

Introduction

Intravenous fluids are chemically prepared solutions that are administered to

the patient. They are tailored to the body’s needs and used to replace lost fluid
and/or aid in the delivery of IV medications. For patients that do not require
immediate fluid or drug therapy, the continuous delivery of a small amount of IV
fluid can be used to keep a vein patent (open) for future use. IV fluids come in
different forms and have different impacts on the body. Therefore, it is important to
have an understanding of the different types of IV fluids, along with their
indications for use.
How Intravenous Fluids are created

There are several types of IV fluids that have different effects on the body.
Some IV fluids are designed to stay in the intravascular space (intra, within;
vascular, blood vessels) to increase the intravascular volume, or volume of
circulating blood. Other IV fluids are specifically designed so the fluid leaves the
intravascular space and enters the interstitial and intracellular spaces. Still others
are created to distribute evenly between the intravascular, interstitial, and cellular
spaces. The properties that an IV solution has within the body depends on how it
is created and the specific materials it contains. It also de- termines the best type
of IV solution to use in relation to the patient’s needs.

The majority of an IV solution is sterile water. Chemically, water is referred to

as a “solvent.” A solvent is a substance that dissolves other materials called
“solutes.” Within IV solutions, the solutes can be molecules called electrolytes
(charged particles such as sodium, potassium, and chloride) and/or other larger
compounds such as proteins or molecules.

Today, a growing number of pharmaceutical manufacturers are using

advanced aseptic processing technologies to minimize operator intervention and
contamination risk in the filling and packaging of liquid parenteral drugs. One of
these technologies is form-fill-seal (FFS), in which a polymeric material is formed
and sealed inline to a container of choice, while the container is being filled.
 FFS offers cost savings over conventional aseptic processing in glass.
Traditional parenteral filling and packaging requires 23 steps and individual
machines for filling, stoppering and capping. In contrast, FFS requires one piece of
automated machinery, and takes place in six seconds or less.

The entire FFS process is performed under a class-100 laminar flow,

preventing external contamination. The fully automatic, computer-controlled
technology allows for filling and packaging of up to 3, 00,000 bottles of IV fluid per
day. Nitrogen purging options are available for sensitive formulations such as amino
acids
INTRAVENOUS FLUIDS
 IV FLUID/ELECTROLYTE THERAPY

Three key concepts in consideration of fluid and Three key concepts in

consideration of fluid and electrolyte management: electrolyte management:

Cell membrane permeability cell membrane permeability

Osmolarity osmolarity
Electroneutrality electroneutrality

Cell membrane permeability refers to the ability of a Cell membrane

permeability refers to the ability of a cell membrane to allow certain
substances such as cell membrane to allow certain substances such as water
and urea to pass freely, while charged ions water and urea to pass freely,
while charged ions such as sodium cannot cross the membrane and are such
as sodium cannot cross the membrane and are trapped on one side of it.
trapped on one side of it.

Osmolarity Osmolarity is a property of particles in solution. is a property of

particles in solution. If a substance can dissociate in solution, it may
substance can dissociate in solution, it may contribute more than one
equivalent to the contribute more than one equivalent to the osmolarity
osmolarity of the solution. of the solution. For instance, For instance, NaCl
will dissociate into two dissociate into two osmotically osmotically active ions:
Na and active ions: Na and Cl. One millimolar millimolar NaCl yields a 2
yields a 2 milliosmolar milliosmolar solution.

Electroneutrality Electroneutrality means that the overall number of means

that the overall number of positive and negative charges balances. positive
and negative charges balances. For instance, in conditions like renal tubular
acidosis instance, in conditions like renal tubular acidosis where HCO3 where
HCO3-is lost, chloride is retained leading to a is lost, chloride is retained
leading to a hyperchloremic hyperchloremic state.
Expected Expected osmolarity osmolarity of plasma can be calculated of
plasma can be calculated according to the following formula: according to the
following formula: Osmolarity Osmolarity (mOsm/kg) = 2 /kg) = 2×[mEq/L N
[mEq/L Na+] + glucose+ BUN ] + glucose+ BUN

Concentration of sodium is the major determinant. Concentration of sodium

is the major determinant.

Normal serum Normal serum osmolarity osmolarity ranges from about 280 to
ranges from about 280 to 295 mOsm/kg.

Maintenance fluids must be determined for basic Maintenance fluids must be

determined for basic requirements, then existing volume or electrolyte
requirements, then existing volume or electrolyte deficits must be evaluated
to determine the deficits must be evaluated to determine the appropriate IV
fluid to use and the volume to appropriate IV fluid to use and the volume to
administer.
 KEY TERMS

5% Dextrose in water— A carbohydrate solution that uses glucose (sugar) as the

solute dissolved in sterile water. Five percent dextrose in water is packed as an
isotonic solution but becomes hypotonic oncein the body because the glucose
(solute) dissolved in sterile water is metabolized rapidly by the body’s cells.

Colloid solutions — IV fluids containing large proteins and molecules that tends to
stay within the vascular space (blood vessels).

Crystalloid solutions — IV fluids containing varying concentrations of electrolytes.

D5W — See 5% dextrose in water.

Extracellular space — Space outside the cells consisting of the intravas- cular and
interstitial spaces.

Daily fluid requirements of healthy children and adults can be estimated

(100-50-20/4-2-1 or 35ml/kg/d for adults). This will vary depending on pt’s renal
and cardiac function.These requirements will increase in states of dz/stress as fluid
losses increase.Requirements vary around what is necessary to maintain
homeostasis and euvolemia.
 DEXTROSE

Dextrose (D-glucose, corn sugar, starch sugar, blood sugar, grape sugar) is by
for the most abundant sugar in nature and occurs either in the free state
(monosaccharide form) or chemically linked with other sugar varieties. In the free
state, it occurs in substantial quantities in honey, fruits, and berries. As a polymer
of anhydrodextrose units, it occurs in starch, cellulose, and glycogen. Sucrose is a
disaccharide of dextrose and fructose. Commercial production of dextrose by
hydrolysis of starch yields white crystalline sugars that are either anhydrous
(C6H12O6) or hydrated (C6H12O6H2O). Dextrose hydrate with its one molecule of
water of crystallization per molecule of sugar, separates from concentrated solutions
at <50oC. Anhydrous D-glucose does not contain water of crystallization and
separates at 50-115oC. Another anhydrous form, B-D-glucose separates, if
crystallization is carried out at temperatures >110-115oC.

In one of the first attempts to prepare commercial dextrose, grapes

were used as the starting material. It is generally conceded that kirchoffis work in
1811 was the forerunner of the starch hydrolysate industry. It was first reported in
1815 that acid conversion of starch to sugar is the result of hydrolysis of the starch
rather than dehydration, and that the starch sugar is identical with grape sugar. It
was not until 1842, however, that starch hydrolysis was first practiced
commercially in the United States. Crystalline dextrose become a main industrial
product when methods of crystallization were developed in 1920.
 DEXTROSE SALINE INJECTION

The substance Dextrose, known under the synonym anhydrous dextrose, is

used in the preparation of Dextrose injection.

The name 'Dextrose' is used to preserve a distinction from Glucose syrup, a

preparation made by heating starch with water in presence of a small proportion of
acid until the hydrolysis has reached a suitable stage. Glucose syrup is a very
viscous syrup of approximately the following composition:-

Dextrin 40%
Maltose 20%
D-Glucose 20%
Water 20%

It is an important commercial product, and is used (e.g. in the manufacture of

sweets) chiefly because of the sticky, gum-like dextrin it contains.

The source of likely impurities is sufficiently obvious. Sulphur dioxide (from

its use as a bleaching agent during manufacture) is determined by an application of
the monier- Willilams process. The Sulphur dioxide is expelled by boiling from an
acidified solution in a stream of carbon dioxide (to prevent oxidation) and is then
absorbed in a previously neutralized solution of hydrogen peroxide, which oxidizes
it to non-volatile sulfuric acid is then determined by titration with N/10 sodium
hydroxide. Bromophenol blue is the most satisfactory indicator, although methyl
orange can be used.

It will be noted that the specific rotation of the sugar refers to a solution made
with the addition of a few drops of dilute ammonia solution. This is to ensure that
the solution contains the and forms in equilibrium. The mutation of Glucose is
greatly accelerated by traces of alkalies.

Dextrose monohydrate is the familiar substance known under the synonyms

medical glucose and purified glucose. It contains water of crystallization
corresponding approximately to the monohydrate of D-glucose C6H12O6.H2O.

The test for purity is the same as the Dextrose except that the loss on drying
is not less than 7% and not more than 10%. The pure monohydrate contains 9.2%
of water of crystallization.
 PROPERTIES

TABLE I. PHYSICAL PROPERTIES OF D-GLUCOSE

PROPERTY CD-GLUCOSE CD-GLUCOSEHYDTRATE CD-GLUCOSE

Molecular Formula C6H12O6 C6H12O6H2O C6H12O6

M.P.,oC 146 83 150

Solubility (at 25oC) 62-30.2-51.2a 20.2-51.2a,b 71-51.2a

g/100 g soln.

(a)20 112.2-52.7a 112.2-52.7a,b 18.7-52.7a

heat of soln.(at 25oC) - 59.4 -105.4 - 25.9

J/gc

a Equilibrium Value.

b Anhydrous basis.

c To Convert J to Cal, divide by 4.184

 TABLE 2. SOLUBILITY OF DEXTROSE IN WATER

Temperature oC Dextrose Temperature oC Dextrose

in soln., wt % soln., wt %

0 34.9 30 54.6

5 38.0 40 61.8

10 41.2 50 70.9

15 44.5 60 74.8

20 47.8 70 78.2

25 51.3 80 81.3
 REQUIREMENTS OF RAW MATERIALS

1. The material should be purified and crystallize d-Glucose containing one

molecule of water of crystallization. It shall possess a whiter light cream colour.
The material shall be crystalline or granular., odourless powder readily soluble in
water and with a characteristic sweet taste free from foreign flavour.

2. The material shall be free from added colouring matter.

3. The material shall be free from dirt, other extraneous matter, insects, rodent
or other contamination.

4. When tested by the method prescribed in appendix `A' of IS:874-1975, the

loss on drying the material shall be not less than 7.5 per cent and shall not exceed
9.5 per cent by mass.

5.The specific rotation of a solution containing one gram of the material previously
dried at 105oC for 6 hours, and 0.2 ml of ammonium hydoxide solution in each 10
ml of water shall be not less than + 52.5oC and not more than +53.0oC when
tested by the method prescribed in appendix `B'of IS: 874-975.

6. The material shall also comply with the requirements given table I.
 TABLE I: REQUIREMENT FOR DEXTROSE MONOHYDRATE

SL. NO CHARACTERISTIC REQUIREMENT

i) Ash, sulphated (on dry basis) percent by mass , Max 0.1

ii) Acidity To satisfy the test.

iii) Sulphur dioxide, PPM, Max 70

iv) Arsanic (As), PPM, Max 1.1

v) Copper (as CU), PPM, Max 2

vi) Lead (as PB), PPM, Max 0.5

Dextrose injection is a perfectly colourless solution.

 EXPORT OPPORTUNITY OF INTRAVENOUS SOLUTION

The term IV solutions refer to a homogenous mixture used to supplement for the
loss of fluids or electrolytes in the human body. Also IV solutions are used to
administer medicines to the patients. These kinds of solutions mainly consist of
Dextrose and Sodium Chloride (Saline) which are used together or separately in a
controlled proportion. Dextrose (also known as glucose) is a soluble, sweet-tasting
that is used in the body as the main source of energy for cells. While most body
cells can use fats for energy if necessary, brain cells and red blood cells rely almost
entirely on glucose to fulfill their energy needs. The ingredient can, therefore, be a
life-saving molecule when used as a first-line treatment in emergency situations
that could otherwise lead to dehydration and acute hypoglycemia.

Local Manufacturing Activities

In respect to the above type of IV Solutions, there are currently 3 manufacturers in

KSA which produce the IV Solutions products. From the estimated total installed
capacity, the under utilised capacity available for exports, from these producers,
appears to be in the region of 35% for the IV solutions products.

The following table provides estimates of installed capacity, together with local and
export sales (in Million units) for 2011:-

From the table it can be clearly seen that there is a level of local installed capacity
available for potential export. The KSA producers’ range of IV Solutions products
could utilise the idle capacity to export to countries where a demand exists for these
products.
HS Codes

Primarily, the customs/tariff codes used for the import and export of the IV
Solutions products by local producers is covered by the following 6-digit HS Code:-

In respect to this EOP, it should be noted that the above HS Codes have been used
to identify export opportunities for the KSA’s IV Solutions products. In terms of
import/export statistics, it should be noted that the UN Comtrade data is available
only in 6-digits.

The last full years’ data available on Comtrade is for 2010 and for 2011 (93.6% have
only been received so far). Comtrade data is not available from a number of
Countries (their percentage of world trade is given in brackets) which include:-
Saudi Arabia (1.38%), UAE (1.36%), Viet Nam (0.64%), Iran (0.57%), Kuwait
(0.31%), Angola (0.23%), Libya (0.19%), Morocco (0.18%), Bangladesh (0.15%),
Others (1.40%). In total for 2011, the trade statistical data not received so far by
Comtrade represents 6.4% of world trade.
World Market Trends Imports & Exports

The overall world import/export trends show continues growth in IV Solutions

product sector over the past five years. It should be stressed that the growth
recorded over the period of examination is stable year over another and,
interestingly, did not affect negatively during the economic recession 2009, which
would indicate a stable growth potential for the concerned products. In addition, the
stability in this particular product would mostly be due to its medical applications
where these kinds of products are used regularly upon desires despite the
macroeconomic/microeconomic situation around the world. The last argument
would be supported by the following facts:

The product under evaluation (IV solutions) is more or less an affordable

medical product.

The IV solutions are medically extremely important products, in addition to

the fact that there are almost no substitute products.

IV solution is a daily used product and it consumed intensively for health-

weak patients whatever their medical issues are.

It is also seen that the CAGR of the imports (4.8%) is higher than the exportsí
(3.6%), and hence, it can be understood that over the past five years the imports
market is growing faster than the export market which would indicate the
opportunities for exporting the IV solutions products.
Major International Importing Countries

The identification of the importing/exporting countries for IV Solutions products,

selected for this EOP, has been undertaken using the 6-digit UN Comtrade statistics
available for 2011. Knowing the main importing countries can provide (a) an
indication of the market size in the particular target market, and (b) an indication of
the existing competition from other exporting countries (see Section on Competition
- Major & Regional Exporting Countries). The main international importers and
source countries for those imports are identified in the following table by HS Code:-

In the context of the tables, the data from the main importing countries indicates
the size of the import market in each of the target countries together with details of
the main countries supplying the import demand. For KSA to enter these markets a
concerted effort by local companies to export could enable them, over time, to enter
these overseas markets and establish a market share. This would be subject to their
prices being competitive and their distribution, specifications and after-sales
service/support being able to meet local (wholesale/retail) needs and requirements.
As an example, the after-sales service/support required to deal with product
damages or the return of out-of-date products to distributors/producers.

However, to export IV Solutions products, two major factors need to be considered:-

(a) to export goods of high quality product which meets the requirements of its
intended markets and (b) to transport the product in a manner consistent with
maintaining its quality and texture over a long period of time. The key to export
products overseas is to ensure that an appropriate transportation vehicles and
logistical programmes are in place to transport the products to the export market
quickly and without any damage.
Major Importing Countries - MENA Regional & GCC

The major importing countries for IV Solutions products are located outside MENA
(Middle East & North Africa) and the surrounding Region. Hence, to enter these
international markets, the KSA producers will need time and funds to:- (a) identify
local requirements, (b) investigate the market potential properly, then (c) develop an
export marketing plan that could be successfully implemented - based on the
requirements of the target markets, and finally (d) set-up suitable operations and
appropriate logistical support facilities in the selected countries.

While the exporter is developing his medium to long-terms plans to potentially enter
international markets, a short-term development that can be more easily set-up, is
to expand into markets in the Arab countries and the surrounding Region as a
whole. Though the markets closer to home are relatively small in relation to other
markets, they nonetheless offer the exporter the potential to develop Regional
markets for the KSA’s IV Solutions products, although in some markets there could
be competition from local producers as well as other imports.

Countries in the Middle East, and North African Regions offer potential export
opportunities for the local producers, but the respective market size for the
Countries are, of course, relatively smaller when compared to the major importing
countries. However, this should not deter the local producers from entering
Regional markets as this can:- (a) help to iron out any initial export problems that
the local exporter may experience due to implementation of their export delivery
systems in the nearby market areas, and (b) help the exporters to develop a good,
working export marketing plan that can be tried out in the Regional countries, prior
to being implemented in more distant export locations. Finally, the above indicates
the opportunities that are awaiting KSA exporters in the identified markets,
provided they can supply quality products, on time and at the right price. This will
allow KSA to develop existing markets and enter new ones.
Competition - Major Exporting Countries

On an international basis, export statistics (6-digit) indicated that the top countries
exporting IV Solutions products (potential competition) in the world are the
following:-

As KSA exports develop, it will tend to compete directly with the major producers of
IV Solutions products as well as distributors from a range of other exporting
countries. As exporting countries have usually established their distribution and
sales networks in the respective markets, the local KSA companies should evaluate
and understand how these countries and their respective companies have managed
to carve a market for the respective producers and their products. This evaluation
should assist the KSA exporter to identify what actions need to be undertaken to
establish export markets for their own products. For the KSA exports to compete
effectively and efficiently, a concerted effort by the local companies will need to be
undertaken in a systematic way and possibly an initial start could be made by
developing an effective working export plan.

An initial market size can be estimated from the main importing countries, whose
import statistics provide a rough indication of the market size for imports within
their respective markets. In the same manner, identifying the exporters to those
markets will enable the local KSA producer to identify the countries that will be in
competition with them in their respective export markets.
Estimate of Importer’s Landed Costs

An indication of average landed cost is provided to assist the local producer to

gauge initial exporting costs to a particular country. These costs do not include any
clearance charges, duties/taxes or local distributor mark-ups. It should also be
noted here that many producers make a particular product in various quality
grades and this is reflected in their final price for these products. While these
producers may have a `base’, `medium’ and/or `high’ price and/or quality levels,
these price ranges cannot be easily identified from the trade data as the `product
mix’ varies from country to country and, therefore, all statistical costs are averaged
out within the specific product HS Code. It should also be noted that the variations
in costs are also affected by the cost of the raw materials used for producing the
product. High quality and pure raw materials are obviously more costly than their
cheaper lower quality or synthetic counterparts and, hence, this is also reflected in
the final price of the goods.

It must be stressed here that within the above product ranges there are
considerable costs variations which can be exit due to the `quality grade level’
(high/medium/low) of the products, the raw materials used in the production, the
type of packaging used, the transport, logistical, distribution costs, the `product
mix’ being imported, and the market price acceptable in the target country ñ which
would be based on GDP, available disposable income and demand. As an example,
a third world country is unlikely to import large amounts of high quality products
as the local GDP and income compels the local populace to purchase lower
cost/quality products. The converse would be true in developed western countries.
It is likely for these reasons that there could be considerable landed cost differential
between the countries.

This information should assist local KSA companies to ascertain, in a very general
manner, whether their respective products are likely to be competitive in the above
identified export markets or not. Landed costs, by sea shipments, are normally
based on CIF value - purely as a general guide, it is estimated that the variation
between FOB and CIF costs could be somewhere in the region of 10% to 15% of
FOB.
 INTERNATIONAL MARKET OVERVIEW

Although the U.S. market comprises almost 70% of the total world market for IV
solutions, the market for third world and emerging nations is growing much faster
and presents a tremendous opportunity for the IVPC Facility™. This growth is due
to the building of better and higher quality health care institutions and other health
care infrastructures in areas once deemed dormant.

World market growth is driven by population increases and constant up-scaling and
sophistication of health care delivery. As part of this up-scaling, IV infusion therapy
is becoming increasingly important in overall health care treatment regimens as
new developments in antibiotics and other medications used in areas such as
chemotherapy, burn centers, and renal/peritoneal dialysis centers favor
intravenous use and application.

Many countries continue to rely on imported product, which is often too expensive
for the general population to afford. Frequently, where product is made locally, the
quality is poor and the costs are still high. In addition, the lack of inexpensive and
readily available supplies of IV solutions in many developing nations has lead to a
high incidence of death from non-mortal injuries and non-terminal diseases. The
IVPC Facility™ provides an immediate and inexpensive remedy to this situation.
 ECONOMIC PROFILE

The economic advantages of producing IV solutions locally in emerging and

medically developing nations via EWMA IVPC Facility™ can result in an extremely
short return on initial investment. Profitability can be established at only 50%
production capacity.

• Direct production costs using U.S. cost figures are 45% to 65% lower than current
market pricing for primary product lines. Under the U. S. calculation. direct and
indirect labor costs comprise the largest single cost element. In emerging nations,
where the cost of labor is much less and the cost of IV solutions often is much
higher, the actual production cost figures can be 60% to 90% lower than market
pricing.

• Secondary product lines with significantly higher profit margins can be introduced
at any time to greatly enhance profitability.

• Long distance shipping costs are not incurred with the regional target market
creating significant savings on distribution costs.

• Demand for IV solutions is so great that should production exceed local demand.
opportunities for national and export sales are unlimited in the foreseeable future.

• Local labor is trained in the technology and employed by the facility. The efficiency
of the technology allows for a small staff of personnel to maintain rated production
capacity.

• Most raw materials are available locally.

 WORLD MARKET CONSUMPTION

Population in Avg. Comsumption Total Consumption in

Country/Regieons
Millions Per Capita Liters

China 1,400 1.0 Liter 1,400,000,000

India 1,250 1.0 Liter 1,250,00,000

Indonesia 210 1.0 Liter 210,000,000

Pakistan 200 1.0 Liter 200,000,000

Bangladesh 176 1.0 Liter 176,000,000

Brazil 212 1.5 Liter 318,000,000

Nigeria 161 1.0 Liter 161,000,000

Russia 186 2.0 Liter 372,000,000

Asia 825 1.0 Liter 825,000,000

Africa 713 1.0 Liter 713,000,000

South America 198 1.5 Liter 297,000,000

 SOURCE OF MACHINES TECHNOLOGY

Rao Designs International, Inc.

Telephone - (847) 671-6182
FAX - (847) 671-9276
Postal address - 9451 Ainslie,
Schiller Park, Illinois, 60176
Electronic mail - raodesign@aol.com

Automatic Liquid Packaging Solutions, LLC US Office:

2445 E. Oakton Street
Arlington Heights, IL. 60005 USA
Tel: (001) 847.264.5349
Tel: (001) 847.372.3336
Fax: (001) 847-264-5348
E-mail: ar@alp-solutions.com

Mahanagar Engg. Pvt. Ltd.

Anup Tiwari
C-8, Sec-8 Noida,
Uttar Pradesh 201301, INDIA
Phone : +91 9999054970, +91 9873907980
Email : anup@dairynpack.com Website: http://www.packliquids.com

GENERAL EQUIPMENT INC.

8770 Sunset Drive #191
Miami FL 33173 · USA
Tel: +1 305 468 4650 +33 6 68 96 24 99 ·
Fax: +1 360 937 2965 +33 8 21 46 30 77
Email: info@generalequipment.info
www.generalequipment.info
 OVERVIEW OF THE GLOBAL
INTRAVENOUS SOLUTIONS MARKET

The global intravenous solutions market will grow at a steady CAGR of almost 6%
during the forecast period. Intravenous solutions have a complete mix of essential
nutrients and help people suffering from conditions like diabetes and cancer to get
the required nutrients. These fluids are very effective in treating electrolyte
imbalances and replacing lost fluids. The market demand for these products is on
the rise in the APAC region and is expected to increase over the next few years.
Since all of these products are available in portable packages, it is easy to use them
in a home setting as well.

Products used in intravenous therapy are highly regulated by governments to

ensure quality and constant availability to consumers. A wide variety of products,
including antibiotics and medications, are used during intravenous therapy to treat
patients. Through innovation, vendors can offer premixed products for easy use and
reduce packaging waste. Market size in the APAC region is growing rapidly as
countries like India and China are improving their healthcare infrastructure. The
need for such products is also high due to an increased incidence of chronic
diseases.

Geographical segmentation of the intravenous solutions market

Americas

APAC

Europe

MEA

The American market size for intravenous solutions is the largest on a global scale.
Revenues are expected to touch close to USD 2 billion by the end of 2020. The
availability of multi-chamber bags and other factors generated a lot of demand in
the region. Demand for these products is expected to grow in South America as well
since many of the countries are investing a lot of money to improve healthcare
facilities.
Competitive landscape and key vendors

The market is highly diverse due to the presence of many international and regional
companies. International companies have the finances and a skilled workforce to
manufacture products fast and at reasonable prices. The APAC market is also an
attractive venue for new products and facility investment from vendors.

Key vendors in this market are -

Baxter
B. Braun Melsungen
Fresenius Kabi
Hospira

Other prominent vendors in the market include Bioscrip, Claris Lifesciences,

Grifols, JW Life Science, Sichuan Kelun Pharmaceutical, Terumo, Omnicare, Vifor
Pharma, and Widatra Bhakti.

Growth drivers, challenges, and upcoming trends: Home treatment

The new trend of home treatment and the availability of premixed solutions have led
to early hospital discharges of patients and home recuperation. Since most patients
prefer the convenience and comfort of recuperating at home, portable pumps are
very useful. Portable pumps offer a way to mix medications reliably, making it
easier for patients to get the right dosage. Such changes play a significant role in
reducing errors and lowering waste and disposal costs.
 IV FLUID PRODUCTION CAPACITY
AND MARKET DEMAND IN AFGHANISTAN

The production of IV fluids is estimated to include the following fluid types:

Dextrose, Saline, Ringer, Amino Acids, Glucose, Plasma, Sodium Chloride, Manitol
and Mix. Based on multiple stakeholder interviews with both private sector
representatives and Pharmaceutical Enterprise, the current market demand in
Afghanistan is estimated to be 12,000,000 (500 ml units) annually within the
current population. Total production capacity for the domestic production facility is
as follows:

Year 1 – 5,000,000 (500 ml units)

Year 2 – 7,000,000 (500 ml units)
Year 3 – 9,000,000 (500 ml units)
Year 4 – 12,000,000 (500 ml units)
Years 5-10 – 15,000,000 (500 ml units)

Figure 1 below highlights the assumptions of local production over the 10-year
period based on proportional estimates of population growth and maximum
capacity of the local production plant.
Results

The results of the economic evaluation are organized from both economic and
financial perspectives highlighting both total and unit costs of domestic production.
Table 1 shows the estimated economic costs of the local production of IV Fluids in
Afghanistan over a 10-year period. It should be highlighted that raw materials
generally represent the highest proportion of costs annually, while other cost drivers
include infrastructure, equipment, and human resources. The total economic cost
of operation is estimated as 139,587,661 (Afs) of $2,908,076 USD in year 1 and
242,974,203 (Afs) or $5,061,963 USD in year 10.
Table 2 shows the estimated financial costs of the local production of IV Fluids in
Afghanistan over a 10-year period. It should be highlighted that raw materials
generally represent the highest proportion of costs annually, while other cost drivers
include infrastructure, equipment, and human resources. The total financial cost of
operation is estimated as 115,508,400 (Afs) or $2,406,425 USD in year 1 and
218,894,942 (Afs) or $4,560,311 USD in year 10.
Furthermore, figure 2 shows the estimated progression of financial costs over the
10-year period. Costs seemingly rise in the first 4 years, but then subsequently
stabilize in years 5-10, partly due to production maximizing out at 15,000,000
(500ml units).

Figure 2. Estimated Financial Costs of Production by Year for IV Fluid

Production over 10 years (Afs)
Furthermore, Figure 3 shows the key cost drivers for the cost of local production
costs over the 10-year period. Raw materials and human resources represent the
largest proportion of estimated costs. As noted earlier in this report, we assume that
the cost of raw materials includes customs fees in Afghanistan, although a $0.01
(approx. 0.5 Afs) addition for such fees (per unit) would reflect a 7.5% annual
increase in raw materials costs, still below the cost of importation.

Figure 3. IV Fluid Local Production – Estimated Key Cost Drivers by Category

– 10 Years (Afs)
Figure 4 represents a comparison of the estimated average local production unit
costs (under the economic perspective) with estimated average import prices. It
should be noted that import prices are estimated to be higher each year after year
1. Average import prices are assumed to be 25 Afs in years 1-5 and 27 Afs in years
6-10. Meanwhile, local production unit cost estimates, even when considering
donated resources, are expected to stabilize just above 15 Afs per 500ml in year 5.
This considerable difference appears from qualitative discussions to be largely due
to savings in import transportation costs to Kabul.
 USES AND APPLICATION

1. Aqeuous isotonic injection (5%) of dextrose are given as intravenous injections to

increase the column of circulating blood in the shocks and haemorrhages and to
counteract dehydration. When it is desired to replace excessive salt loss also
glucose is injected along with sodium chloride.

2. Dextrose monohydrate is used as supplement to cow's milk in part of feeding.

3. Hypertonic dextrose solution (25-50%) are in medical treatment partly because

they are believed to strengthen heart muscles. Hypertonic solutions are used in
intravenous injection to relieve intractable pressure in patient with hydrocephalus
and meningitis.
 SOME GENERAL INTRAVENOUS FLUIDS

1. Adrenaline Tartrate (In ampoules)

Each ml contains
Adrenaline Bitertrate 1.8 mg
Sodium Choloride 8.0 mg
Sodium Meta-bi-sulphate 0.1%

2. Atropine Sulphate (In ampoules)

Each ml. contains
Atropine Sulphate 0.6 mg

3. Dextrose (540 ml bottle)

Containing Dextrose 5%

4. Dextrose & Sodium Chloride (540 ml bottle)

contains Dextrose Mono Hydrate 5%
Sodium Chloride 0.9%

5. Diazepam (In ampoules 2 ml)

Each ml contains
Diezepam 10 mg.

6. Diuremide (2 ml ampoules)
Each ml. contains
Deuremide 10 mg.
7. Frusemide (2 ml Ampoules)
Each ml contains
Frusemide 20 mg

8. Lignocanine (30 ml vial)

contains
Lignocaine 2%.

9. Mannitol (350 ml bottle)

Contains
Mannitol 20%.

10. Pethidine (1 ml, 2 ml ampoules)

Each ml contains
Pethidine 50 mg.

11. Phenobarbitone Sodium (1 ml ampoules)

Each ml contains
Phenobarbitone Sod 200 mg.

12. Sodium Bicarbonate (10 ml vial)

Each ml contains
Sodium Bicarbonate 7.5% w/u

13. Sodium Chloride (Normal Saline)

(540 ml bottle)
Contains
Sodium Chloride 0.9% w/c

14. Sodium Lactate (540 ml bottle)

Contains Molar Sodium 1/6
15. Glycerine in D/W (1000 ml bottle)
Contains 1.5% Glycerin Distilled water.

16. Premolyte-m (500 ml bottle)

Contains Maintenance soln. with 5% Dextrose.

17. Premolyte-P (500 ml bottle)

Contains Pediatric solution with 5%
Dextrose.

18. Premolyte-G (500 ml bottle)

Containing Gastric solution with 5%
Dextrose.

19. Premolyte-E (500ml bottle)

Containing Extracellular replacement solution with 5%
Dextrose.

20. Premogyl (100 ml bottle)

Containing Metromidazole 5 mg.

21. Preniezol (540 ml bottle)

Contains Metronidazole 2 mg.
 MARKET SURVEY

INDIAN DRUGS AND PHARMACEUTICALS INDUSTRY

• The pharmaceutical industry in India is among the most highly organized

sectors. This industry plays an important role in promoting and sustaining
development in the field of global medicine.

• Due to the presence of low cost manufacturing facilities, educated and skilled
manpower and cheap labor force among others, the industry is set to scale
new heights in the fields of production, development, manufacturing and
research.

• In 2008, the domestic pharma market in India was expected to be US$ 10.76
billion and this is likely to increase at a compound annual growth rate of 9.9
per cent until 2010 and subsequently at 9.5 per cent till the year 2015.

• Indian pharmaceutical industry has grown over a period of time and has seen
many ups and down during its evolution.

• The architect of the Indian pharmaceutical industry would be Acharya

P.C.Ray. In the year 1901 Acharya P.C.Ray founded Bengal Chemicals and
Pharmaceuticals Works Ltd. It started by making drugs from indigenous
materials and then went on to manufacture quality chemicals, drugs,
pharmaceuticals and employed local technology, skills and resources
Industry Trends

• The pharma industry generally grows at about 1.5-1.6 times the Gross
Domestic Product growth

• Globally, India ranks third in terms of manufacturing pharma products by

volume

• The Indian pharmaceutical industry is expected to grow at a rate of 9.9 % till

2010 and after that 9.5 % till 2015

• In 2011-12, India exported drugs worth US$8.2 billion in to the US and

Europe followed by Central and Eastern Europe, Africa and Latin America

• The Indian vaccine market which was worth US$865 million in 2011-12 is
growing at a rate of more than 20%

• The retail pharmaceutical market in India is expected to cross US$ 15-17

billion by 2014
Market Structure

Industry Type Number of Companies

Indian - Bulk Drugs 113

Gelatin Capsules 4

Indian - Bulk Drugs & Formln Lrg 27

Indian - Bulk Drugs & Formln

M/S 92

Indian - Formulations 118

I V Fluids 9

Multinational 10
MARKET STRACTURE
INDIAN BULK DRUG MARKET SHARE
India in is now recognized as one of the leading global players in pharmaceuticals.
Europe accounts for the highest share of India pharma exports followed by North
America and Asia. The policy initiatives taken by the Government of late have led
to quantitative and qualitative improvements in the R&D activities of the
industry. The National Pharmaceutical Policy, aimed at ensuring availability of
lifesaving drugs at reasonable prices, is being finalized. Taking stock of the
imperative requirement for skilled manpower, the Government has decided to set
up six new National Institutes of Pharmaceutical Education and Research
(NIPERs) in different regions of the country. As a new initiative in the
pharmaceutical sector.

The first comprehensive Drug Policy of 1978 and thereafter the Drug Policy of
1986 together with the application of process patent under the Patent Act of 1970
successfully paved the way for development of indigenous pharmaceutical industry
which went into the production of generic drugs in a big way. During the period
from 1978 to 1990 indigenous industry acquired a respectable status in terms
of product range and market share. R&D was confined to process
development/innovation of existing molecules.

Following are some of the important developments that have taken place in
pharmaceutical sector during the last fifteen years.

Industrial licensing for all kinds of drugs has been abolished (it has
recently been done for the last remaining bulk drugs produced by the use of
recombinant DNA technology, bulk drugs requiring in-vivo use of nucleic acids
and specific cell-tissue targeted formulations). However the need for obtaining
manufacturing license under Drugs and Cosmetics Act, 1940 continues for
all units whether organized or small scale. The State Drug Controllers are
authorized to issue such licenses in most cases.

FDI up to 100% is permitted, subject to stipulations laid down from time in

the Industrial Policy, through the automatic route in the case of all bulk drugs
cleared by the Drug Controller General (India), all their intermediates and
formulations. Recently bulk drugs produced by the use of recombinant DNA
technology, bulk drugs requiring in-vivo use of nucleic acids as the active
principles and special cell/tissue targeted formulations have also been allowed
this facility.
 Automatic approval for Foreign Technology Agreement (FTA) is already available
in the case of all the bulk drugs cleared by Drug Controller General (India), all
their intermediated and formulations. Recently bulk drugs produced by the
use of recombinant DNA technology, bulk drugs requiring in-vivo use of nucleic
acids as the active principles and special cell/tissue targeted formulations have
also been allowed this facility.

Automatic approval for Foreign Technology Agreement (FTA) is already available

in the case of all the bulk drugs cleared by Drug Controller General (India), all
their intermediates and formulations, except bulk drugs produced by the use
of recombinant DNA technology, bulk drugs requiring in-vivo use of nucleic acids
as the active principles, and specific cell/tissue
targeted formulations.

Imports of drugs and pharmaceuticals are regulated through EXIM Policy and
presently all items except those requiring clearance under The Narcotics and
Psychotropic Substances Act, 1985 are allowed under OGL. Further, a
centralized system of registration has been introduced under the Drugs &
Cosmetics Act and Rules made there under, administered by Ministry of Health
and Family Welfare. These arrangements may continue to regulate imports of
Drugs and Pharmaceuticals.

Exports are permitted in accordance with the EXIM Policy and relevant
procedures/rules formulated for the purpose by the Directorate General of
Foreign Trade. Exports are also subject to laws prevalent in importing countries.
Also, the exporters are allowed imports of inputs on duty-free basis for
export production. The Industry has shown commendable export
performance, the trade balance being positive. Over the last few years the
compounded annual growth rate in exports has been 22.7 percent.

Product patent the pharmaceuticals has been introduced in the country with
effect from 1st January, 2005 by amending the Patents Act, 1970 in conformity
with the TRIPS agreement. The physical infrastructure in the four patent offices in
the country (Kolkata, Delhi, Chennai and Mumbai) has been substantially
strengthened and computerization has been introduced. Steps are now being
taken to further augment and improve the software and human resources in these
offices to enable them to deal with the new responsibilities.
 Clinical Trials are essential for drug development. Schedule Y of the Drugs and
Cosmetics Rules, 1945 has been amended to allow for multicentric concurrent
clinical trials in India. Under these rules clinical trials have been defined and it
has been made mandatory to take approval for conducting any type of clinical
trials in the country. Also Good Clinical Practices (GCP) guidelines have been
published and made mandatory. It also addresses the protection of study subjects
(patients/volunteers) and integration and quality of data.

The latest information provided by IBEF on the pharma industry says that
as per a study titled, the globalization of innovation: Pharmaceuticals, Can India
and China cure the Global Pharmaceutical Market, by US-based Ewing Marion
Kauffman Foundation, increasing R&D initiatives in the pharmaceutical sector
has made India a more mature place for drug discovery activities compared to
China. Indian companies are playing an important role in early drug discovery
processes due to their substantial experience in the field of generic drugs. The
study also holds India as a more established venue for chemistry and drug
discovery developments than China.

According to a research report, Booming Pharma Sector in India, released in

August 2008 by RNCOS (an industry research firm), India has been portrayed as
an emerging destination of drug formulation research and exports. As per the
report India exported drugs with US$ 10.2 billion in 20010-11 and the Us and
Europe were the biggest export destinations for Indian generic manufacturers,
followed by emerging markets like Central and Eastern Europe, Latin America
and pharmaceutical exports is expected is expected to grow at a CAGR of 18.5
per cent between 2007-08 and 2011-12. India's pharmaceuticals market is
expected to grow by about 15 per cent in the fiscal year 2010-11, keeping pace with
Brazil, China, Russia, South Korea and Mexico, says a recent study by global
industry consulting firm IMS. According to the study, India's medicine
manufacturers will have some reason to cheer, with expensive patented medicine
falling out of favour and governments leaning towards cheaper medicines, where
Indian companies have a price and quality edge over their competitors in other
countries.

The Government has put in place a new patent regime from the year 2005
keeping in line with the WTO commitments. India is among the few developing
economies to have brought in amendments to the existing patent law.
 ADDITIONAL MARKET POSITION

At present there are about over 92 companies which are manufacturing I.V.
solutions. These include all units in the organized as well as in the unorganized
sector. Another category of manufacturers which account for nearly 100 percent
of the production are hospitals.

The five top companies (A category) which account for nearly 36 per cent of the
total production and their annual production on is given below:-

Manufacturer Annual Production

(lac Bottles)

1. Elys Chemicals Laboratories

P. Ltd. Mumbai 22

2. Laboratories Vifor (India)

P. Ltd. Mumbai 31

3. No-Gar Ravindra Laboratories

P. Ltd., Ahmedabad 77

4. Mount Mettur Ltd., Chennai 26

5. Tablets Ltd., Chennai 27

There are over 44 units (`B' category) whose annual production is

between 2 lacs and 20 Lacs bottles. The total annual production of all these units
is around 220 Lacs bottles. About 35 units are them, producing less than 3
Lacs (`C' category) bottles per year. The annual production of these units is
estimated to about over 35 lacs bottles.

Besides the above mentioned manufacturers, some big hospitals also go

in for manufacture of I.V. Solutions. No hospital manufactures all its needs. On
an average, it can be said that the production is only to the extent of 30% of
the requirement. The remaining 70% is met by purchase from the open market.
Only those hospitals having capacity of 300 or more beds go in for the production of
their own.
GOVERNMENT INITIATIVES

• The government of India has undertaken several including policy initiatives

and tax breaks for the growth of the pharmaceutical business in India. Some
of the measures adoptedare:

• Pharmaceutical units are eligible for weighted tax reduction at 150% for the
research and development expenditure obtained.

• Two new schemes namely, New Millennium Indian Technology Leadership

Initiative and the Drugs and Pharmaceuticals Research Program have been
launched by the Government.

• The Government is contemplating the creation of SRV or special purpose

vehicles with an insurance cover to be used for funding new drug research

• The Department of Pharmaceuticals is mulling the creation of drug research

facilities which can be used by private companies for research work on rent

Pharma Export

• In the recent years, despite the slowdown witnessed in the global economy,
exports from the pharmaceutical industry in India have shown good buoyancy
in growth.

• Export has become an important driving force for growth in this industry with
more than 50 % revenue coming from the overseas markets. For the financial
year 2008-09 the export of drugs is estimated to be $8.25 billion as per the
Pharmaceutical Export Council of India, which is an organization, set up by
the Government of India.

• A survey undertaken by FICCI, the oldest industry chamber in India has

predicted 16% growth in the export of India's pharmaceutical growth during
2012-2013.
Exports

• Over 60 per cent of India’s bulk drug production is exported.

• Domestic pharmaceutical exports, growing at 35 per cent per annum,

touched a new height of US$5.8 billion in the financial year 2012-13.

• The export revenue now contributes almost half of the total revenue for the
top three pharmaceutical majors: Dr Reddy’s, Ranbaxy and Cipla.

• The other major exporters are Wockhardt Limited, Sun Pharmaceutical

Industries Ltd. And Lupin Laboratories.

• The formulations and exports are largely to developing nations in CIS, South
East Asia, Africa and Latin America .

• In the coming years, opening up of US generics market and anti AIDS market
in Africa will boost exports.

SALES AND EXPORTS GROWTH

DEMAND PROJECTION:

With the continuous increase in the number of hospitals and medical facilities
all over the country, the actual market for I.V. fluids is growing at a fast pace.
Increasing awareness of the utility and significance of I.V. therapy, the market,
over a period of time is expected to grow at a faster pace.

As indicated earlier, the demand for I.V. solutions depend mainly on the rate
of growth of beds in the country and the consumption rate.
 INDIAN PATENTS LAW, TRADE LAW & TAXATION

India Patents Act, 1972: Evolution and Impact

• India provided product patent protection in pharmaceuticals till 1972

• This did not have any positive effect because:

– the MNCs, who held the patents were not keen on manufacturing (and
R&D) activities; they preferred imports to local production in India and

– prevented the Indian companies from doing so by using their patent

rights.

– On the one hand, because of lack of competition, drug prices in India

were very high.

– On the other hand, India was dependent on imports for many of the
essential bulk drugs. The import dependence constricted consumption
in a country deficient in foreign exchange and inhibited the growth of
the industry
The India Patents Act, 1970

• The 1970 Act imposed substantial limits on patent rights; these limits
were intended to encourage indigenous inventions and secure their
production in India on a commercial scale (India Patents Act 1970, §
83)

• First, and most importantly, pharmaceutical products could not be

patented

• Second, firms were permitted to patent only a single process for making
a pharmaceutical; a firm could not block competitors by patenting all
possible processes for making a drug

• Third, the term for pharmaceutical process patents shortened to five

years from the grant of the patent or seven years from application filing,
whichever was less, compared to 14 years from application filing for all
other inventions

• And fourth, the Act imposed very broad “compulsory

licensing”provisions for pharmaceutical process patents. Within three
years of the grant, the patents were deemed “licenses of right,” meaning
that anyone could use the process if they paid a royalty
(Chaudhuri 2005, 37-8). In sum, pharmaceutical products had no
protection, and pharmaceutical processes were protected for only
three years if a royalty were paid and five years if no royalty were paid
Post-TRIPS Patent Laws (1995-Present)

• In January of 1995, India became a founding member of the World Trade

Organization (WTO) and agreed to the requirements of the WTO intellectual
property agreement, Trade-Related Aspects of Intellectual Property Rights
(TRIPS).

• Under the Agreements on Trade Related Aspects of Intellectual Rights (TRIPS),

mandatory for all countries to provide product patent protection in all
products including pharmaceuticals

One important argument during TRIPS negotiations

• Developing countries too would benefit from stronger patent protection

because it will stimulate private R&D investment for developing country
diseases e.g., leishmaniasis, sleeping sickness, Dengue fever, which are
neglected by the Western MNCs

• TRIPS has not led to much R&D for developing drugs for necessary for
developing countries and neglected by MNCs as Indian companies are not yet
ready to undertake R&D independently and do not have all the skills and the
resources to do so

GOVT. REGULATIONS AND LEGAL ASPECTS

• The Central Drug Standard Control Organization (CDSCO), which falls under
the purview of the Ministry of Health and Family Welfare, is the primary
regulatory body in India.

• The Drug Controller General of India (DCGI) presides over the CDSCO and is
in charge of the approval of licenses for drugs at both the central and state
levels
• In January 2005, India introduced the product patent regime in accordance
with the TRIPS agreement with an amendment to the Indian Patents Act.
Further, in 2008, the introduction of the Drugs and Cosmetics (Amendment)
Act 2008 put forth stringent penalties and imprisonment

• FDI of up to 100 per cent in drugs and pharmaceuticals is permitted through

the automatic route. For licensable drugs and pharmaceuticals manufactured
by recombinant DNA technology and specific cell/tissue-targeted
formulations, FDI requires prior government approval

• The GoI plans to set up a pharmacopeial commission to support ayurveda,

yoga and naturopathy, unani, siddha and homoeopathy (AYUSH) through
guidelines laid down in the review of the Eleventh Plan

• As stated on the National Pharmaceutical Pricing Authority (NPPA) website,

the NPPA is responsible for fixing and controlling the prices of 76 bulk drugs
under the Essential Commodities Act

• The Department of Pharmaceuticals was formed on July 2, 2008, under the

Ministry of Chemicals and Fertilisers with the objective of focusing on the
development of the pharmaceutical sector in the country and to regulate
various activities related to the pricing and availability of medicines at
affordable prices, R&D, the protection of intellectual property (IP) rights and
international commitments related to the pharmaceutical sector

• The GoI has been actively supporting the industry with various measures. It
is embarking on a major multi-billion dollar initiative, with 50 per cent public
funding through a PPP model, to harness India’s innovation capability.
LAWS PERTAINING TO MANUFACTURE AND SALE OF DRUGS IN INDIA

• The Drugs and Cosmetics Act, 1940

• The Pharmacy Act, 1948

• The Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954

• The Narcotic Drugs and Psychotropic Substances Act, 1985

• The Medicinal and Toilet Preparations (Excise Duties) Act, 1956

• The Drugs (Prices Control) Order 1995 (under the Essential Commodities Act

The Drugs and Cosmetics Act 1940

The object of the Act is to regulate the import, manufacture, distribution and sale of
drugs.

Under the provisions of this Act, the Central Government appoints the Drugs
Technical Advisory Board to advise the Central Government and the State
Governments on technical matters arising out of the administration of this Act. The
board can constitute subcommittees for the consideration of a particular matter
The Pharmacy Act 1948

Under the provisions of this act the Central Government constitutes a Central
Pharmacy Council of India consisting of following members:
a) Six members from the Teachers of pharmacy.
b) Six members from practicing pharmacists or Pharmaceutical Chemists holding
degree of diploma.
c) One member elected by the Medical Council of India.
d) The Director-General of Health Services.
e) The Director of the Central Drugs Laboratory.
f) The Chief Chemist, Central Revenues.
g) One member to represent each state elected by members of State Councils who
shall be a registered pharmacist.
h) One member to represent each State Government who shall be either registered
medical practitioner or a registered pharmacist

Registration of Pharmacists

– The State Government has under the provisions of the Pharmacy Act to
get a register of the State Pharmacists prepared and it is the State
Pharmacy Council which has to maintain the register.

– The register shall contain the name and residential address of

Pharmacist, the date of his first admission to the register, qualifications
for registration, his professional address, the name of his employer and
prescribed particulars
The Drugs and Magic Remedies (Objectionable Advertisements) Act 1954

This Act is meant to control the Advertisements regarding drugs; it prohibits the
advertising of remedies alleged to possess magic qualities and to provide for matters
connected therewith.

The Drugs and Magic Remedies Act prohibits a person from taking part in
publication of any advertisement referring to any drug which suggests use of the
drug for:

a) the procurement of miscarriage in women or prevention of conception in women;

and

b) the maintenance or improvement of the capacity of the human being for sexual
pleasure;

Narcotic Drugs and Psychotropic Substances Act, 1985

– This is an Act to consolidate and amend the law relating to Narcotic

Drugs

– It’s aim is to make stringent provisions for the control and regulation of
operations relating to Narcotic Drugs and Psychotropic Substances and
for matters connected therewith
 'TAX'ING INDIAN PHARMA

Direct taxes

• Governed by the provisions of Income-tax Act, 1961

• Under the provisions of section 35(1) of the Act, a deduction of 100 percent
expenditure, not being expenditure in the nature of cost of any land and
building is available in respect to scientific research related to the business

• Expenditure on developing the SEZ is exempt from all duties of customs,

excise, CST and service tax.

Indirect taxes

• Customs duty consists of Basic Customs Duty (BCD)-12.5 percent

• Additional duty of customs under section 3(1) ('CVD')-16.32 percent and

additional duty of customs under section 3(5) (ADC)-four percent

• Excise duty is levied at 16 percent on the transaction value of goods

manufactured in India

• Drugs and medicines classified under chapter heading 3003.10 and 3003.20
are subject to excise duty on the basis of the MRP
 PRESENT MANUFACTURES OF I.V FLUIDS

(Dextrose, Dextrose Sodium Chloride & Sodium Chloride Solutions)

MR. KARUN R. NARANG

EASTERN MEDIKIT LTD
3, DR. G.C. NARANG MARG,
DELHI-110007
Phone:911127667131/27667734/27667845/27662915/16
Email: prateen@medikit.com,pankaj@medikit.com

MANOHAR KOTHARI, MD
INDO GERMAN PHARMA EQUIPMENT
KOTHARI HOUSE, PLOT A-13,
OFF CROSS ROAD B, STREET NO.5,
MIDC, ANDHERI (E),
MUMBAI-400093, MAHARASHTRA
Phone:+91 22 283 23615, +91 22 283 42338
Email: indogmbh@bom3.vsnl.net.in

MR. KETAN A SHAH

K D ENTERPRISE
DAMODAR BLDG., GROUND FLOOR,
105, PRINCESS STREET,
MUMBAI-400002, MAHARASHTRA
Fax:Phone:912222062364/22003580
VINOD KUMAR GUPTA, MD
PARENTERAL DRUGS (INDIA) LTD
VILLAGE ASRAWAD, P.O. DUDHIA,
NEma: WAR ROAD, INDORE-452001,
MADHYA PRADESH
Phone:+91 731 466308, 466309

MR. AJIT KUMAR

SHIVANO HEALTHCARE
SHIVANO HOUSE, E-5 & 6,
AMBAJI IND. AREA,
ABU ROAD-307026,
RAJASTHAN
Phone:912974226590

Ahlcon Parenterals India Ltd

SP-917 & 918,
Phase - III,RIICO Industrial Area,
Bhiwadi 301 019
Dist. Alwar (Rajasthan),
INDIA
Phone : 91-01493 -305300 (30 Lines)
Fax : 91-01493-221045
Email : info@ahlconindia.com

Regd. Office :

Unit no-201-205,
Second Floor of ND Mall-1
Plot No. 2-4,
Wazirpur District Center,
Netaji Subhash place,
Delhi-110034,
Ph : 91-011- 42344234, 42344218
Fax : 91-011-4234221
Mr. HT Nazare
Sr. G.M. - Operations
Mob : 91-9929095030
Email : hemant.nazare@ahlconindia.com

Mr. Devendra Singh

Sr. G.M. - Marketing
Mob : 91-9810743445
Email : devendra.singh@ahlconindia.com
http://www.ahlconindia.com

AXA Parenteral Ltd

AXA House kishanpur,
Jamalpur, Roorkee - 247667
Uttarakhand (INDIA)
Phone: +91-1332-234041 / 42
Fax: +91-1332-234040
E-mail: axapar@axapar.com
Website: www.axapar.com
www.axaparenterals.com

Denis Chem Lab Limited

Ms Khushbu H. Shah
Compliance Officer and Company Secretary
401, Abhishree Complex
Opp: OM Tower, Beside Bidiwala Park
Satellite Road,Ahmedabad – 380 015
Gujarat, India
Tele :91 - 79 - 2692 5716 / 5719
Fax :91 - 79 - 2692 5710
E-mail :denischem401@gmail.com
cs.denischem@gmail.com
PENTAGON LABS LTD.
An ISO 9001-2000 Company
Reg. Off. : 206, Archana Appartment,
8-B, Ratlam Kothi, INDORE-01(M.P.)
Phone : 0731-4069878, 3255716
Fax : 0731-2518937
Email : pentagonlabsltd@yahoo.co.in

Septy Pharmaceuticals Pvt Ltd (SPL)

Registered Office :
Septy, P.O; Maranjana,
Rangia, -781 354
Assam, India

Corporate Office :
Adams Plaza, G.S. Road
Christian Basti
Guwahati -781 005 .Assam. India
Contact Information:
Tel : +91-361-2341009
Email : info@splcare.com

Aishwarya Lifesciences
127, Swastik Plaza,
Pokhran Road-2, Thane,
Nr-Mumbai, Maharashtra -400601,
India.
Phone: +91 22 32608581 , +91 22 32608581
Mobile: +91 98 330 752 79
E-Mail:healthcare@aishwaryaindia.com
Web:www.aishwaryahealthcare.com
Yogi Drugs
mukeri tola, new colony, niawan road,
Faizabad-224001, Uttar Pradesh, India
Phone:91-5278-223871
Key Personnel
Mr. khem chand (+919696256546,+919305723662)

Life Health Care

C/o. Life Surgical & Vaccines, Ekta Complex,
Above Ekta Medical, Vidhyanagar Main Road,
Rajkot-360002, Gujarat, India
Phone:91-281-2481113
Key Personnel
Dr. Ketan M. Trambadia (+919824300033,+919924800033)
 SPECIFICATION OF INDIAN PHARMACOPEIA
ON I.V FLUIDS DEXTRAN 40 INJECTION

Dextran 40 Injection is sterile solution, in Dextrose Injection, percent w/v,

or in Sodium Chloride Injection, of dextrans of weight average molecular weight
about 40,000 derived from the dextrans of Leuconostc mesenteroides. The solution
may be sterilized by Heating in an Autoclave or by Filtration.

Description- An almost colorless, slightly viscous solution.

Reaction- pH 3.5 to 6.5 for solutions in Dextrose Injects PH 1.6 to 7.0 for solution
in Sodium Chloride Injection I.P..

Content of Dextrans -9.0 to 11.0 prcent w/v for solution in Dextrose Injection
and 9.5 to 10.5 percent w/v for solutions in sodium Chloride Injection when
determined by the following method.

Add a drop of dilute solution of Ammonia and determine the optical

rotation, I.P.. Calculate the content of dextrans from the following expressions.

Content of Dextrose- 4.5 to 5.5 percent w/v for solutions in

Dextrose Injection when determined by the following method:-

Dilute 15 ml with water to 5 ml in a stoppered flask add 25 ml of a buffer

solution containing 14.3 percent w/v of sodium Carbonate and 4.0 percent
w/v of potassium iodide and 45 ml of 0.1 Niodine. Stopper the flask and allow to
stand for exactly thirty minutes at 20o, add 30 ml of dilute hydrochloric acid and
titrate immediately with 0.1N sodium thiosulphate. Repeat the operation using 5
ml of water and commencing with the words "add 25 ml ......", the difference
between the titration represents the amount of of iodine required. Each ml. of
0.1N iodine is equivalent to 0.00901 g of dextrose.
Alcohol :- Distill 100 ml collect the first 15 ml of the distillate and dilute to
50ml of water. Mix 10 ml of 0.1N Potassium dichromate and 10 ml of sulphuric
acid in a stoppered boiling tube, immediately add 5 ml of the distillate, mix stopper
the tube and allow to stand for five minutes. Transfer to 500 ml. flask dilute to
about 300 ml. with calcium dioxide free water, add 2 g of potassium iodide and i
ml of a 10 percent w/v solution of potassium thiosynate, allow to stand for five
minutes and titrate the liberated iodine with 0.1N sodium thiosulphate using
solution of starch towards the end of the titration as indicator. Repeat the
determination commencing with the words " mix 10 ml of 0.1N potassium
dichromate ... " but using 5 ml of water in place of 5 ml of the distillate. The
difference between the titrations is not more than 4.2ml

Nitrogen :- Carryout method B for the determination of nitrogen using 50 ml,

for solutions in Dextrose injection use 30 ml of nitrogen free sulphuric acid and for
solution in sodium chloride injection. 20 ml of nitrogen free sulphuric acid not
more than 0.35 ml of 0.1N sulphuric acid is required.

Foreign Protein :- Inject 0.5 ml on 3 occasions at intervals of two days into the
peritoneal cavity of each of six healthy guinea-pigs weighing not less than 250
g which have not previously been treated with any material which will interfere
with the test. Inject 0.2 ml intravenously into each of three of the guinea pigs
fourteen days after the first intra-peritoneal injection and into each of the other
three guinea pigs twenty-one days after the first intra-peritoneal injection.
Observe the guinea pigs for thirty minutes after each intravenous injection and
again twenty four hours later. The animals exhibit no sign of anaphylaxis, such
as coughing, bristling of hair, or respiratory distress.
Pyrogens :- Complies with the test or pyrogens using not less than 10 ml per Kg
of the rabbit's weight.

Sterility :- Complies with test for sterility.

Storage:- Store Dextran 40 injection in a cool place; temperature fluctuation

should be avoided.

Labelling:- The strength is stated as the percentage w/v of dextrans. The label on
the container also states

(i) the name of the solvent

(ii) the contents should be used if they are hazy or deposit is present.

(iii) the strain of leuconostoc mesentroides used.

Category :- Plasma substitute.

 DEXTRAN 110 INJECTIONS

Description:- An almost colourless, slightly viscous solution.

Reaction :- pH 3.5 to 6.5 for solution in dextrose injection; pH 5.0 to 7.0 for
solution in sodium chloride injection .

Content of dextrans :- 5.5 to 6.5 per cent w/v for determined as described under
Dextran 40 injection.

Content of Dextrose, Acetone, Alcohol, Nitrogen, Heavy Metals, Sulphated ash,

Foreign Protein, Pyrogens, Sterility :-

Complies With the tests described under dextran 40 injection.

Reducing sugars:- For solutions in sodium chloride injection not more than 0.1
per cent w/v, when determined by the test described under Dextran 40 injection.

Storage :- Store dextran 110 injection in Dextran injection in a cool place. Dextran
110 injection in sodium chloride injection may be stored at temperatures not
exceeding 40oC.

Labelling :- The strength is stated as the percentage w/v of Dextrans. The label
on the container also states

(i) The name of the solvent;

(ii) That the contains should not be used if they are hazy or contain any suspended
matter.

Category :- Plasma Substitute.

 B.I.S. SPECIFICATIONS FOR PLASTIC I.V. BOTTLES

IS : 8688 - Polyethylene Bottles for Potable Water.

IS : 6312 - Polyethylene Containers for Transport of Materials.

IS : 8747 - Polyethylene Containers, Blow Moulded, test for environmental

Stress Crack resistance.

IS : 2798 - Polyethylene Containers, testing.

IS : 10141 - Positive list of Constituents of Polyethylene in Contact with

foodstuffs, Pharmaceuticals and drinking water.

IS : 10146 - Polyethene for its safe use in Contact with foodstuffs,

Pharmaceuticals and drinking water.

IS : 2530 - Moulding materials/Compounds, test methods.

For more Information contact at:

Headquarters:

Manak Bhavan, 9 Bahadur Shah Zafar Marg,

New Delhi-110 002
91 11 23238821,23233375,23239402
91 23238821, 23239399 (Fax)
sales@bis.org.intandards Institution.
Sr.No. Sales Outlets Address Telephone No/Fax/e-mail
01. Director (Sales) 91-11-
Manak Bhawan, 23238821,23233375,23239402
9, Bahadur Shah Zafar Marg 91-23238821, 23239399(Fax)
New Delhi-110 002
02. Western Regional Office Phone 022-28329295
Manakalaya, Fax 28374231
Plot No. E-9, MIDC, Road No. Email: saleswro@bis.org.in
8, Behind Telephone
Exchange, Andheri (East),
Mumbai-400 093
03. Eastern Regional Office 033-232053243
5, Chowringhee Approach 91-33-23377459(Fax)
P.O. Princep Street, ero@bis.org.in
Kolkata-700 012
04. Northern Regional Office 91-0172 2665512
SCO 335-336, Sector 34-A 91-0172 2602025 (Fax)
Chandigarh-160 022 910172-2609285,
2664750,2624136(PBX)
nro@bis.org.in
05. Southern Regional Office 91-044-22542315,
C.I.T. Campus, IV Cross Road 22541584,22541470
Chennai-600 013 91-044-22541087 (Fax)
sro@bis.org.in

NOTE :- The use of the ISI Certification Mark is governed by the provisions of the Indian
Standards Institution (Certification Marks) Act and the Rules and Regulations made
thereunder. The ISI Mark on products covered by an Indian Standard conveys the
assurance that they have been produced to comply with the requirements of that standard
under a well-defined system of inspection, testing and quality control which is devised and
supervised by ISI and operated by the producer. ISI marked products are also
continuously checked by ISI for conformity to that standard as a further safeguard.
Details of conditions under which a licence for the use of the ISI Certification Mark may be
granted to manufacturers or processors, may be obtained from the Indian Standards
Institution.
 SODIUM CHLORIDE AND DEXTROSE INJECTION

(Sod. Chlor. and Dextrose Inj.)

Sodium chloride and Dextrose injection is a sterile solution i.e. solution of

sodium chloride and Dextrose in water for injection. The contents of sodium
chloride NaCl and of Dextrose C6H12O6 are not less than 95.0 per cent and not
more than 105.0 per cent of the stated amounts of sodium chloride and Dextrose.
The solution is sterilized immediately after preparation by heating in an
autoclave or by filtration.

Description :- A clear colourless or faintly straw coloured solution.

Identification :- 1. When heated with solution of potassium cupri-tartrate,

yields a copious precipitate of cuprous oxide.

2. Yields the reactions, characteristics of sodium.

3. When treated with solution of silver nitrate, yields a white curdy precipitate
which is insoluble in nitric acid, but soluble after being well washed with water, in
dilute solution of ammonia from which it is re-precipitated by the addition of nitric
acid.

Reaction:- pH, 3.5 to 6.5.

5-Hydroxymethylfurfural and related substances :- Dilute a volume equivalent to

1.0 g of dextrose to 500 ml with water and measure the extinction of a 1 cm layer
of the resulting solution at the maximum about 24 m; extinction not more than
0.50.

Pyrogens:- Complies with the test for pyrogens, using not less than 10 ml per Kg of
the rabbit's weight.

Other Requirements:- Complies with the requirements described under

injections.
Assay:

For Sodium Chloride :- Titrate an accurately measured volume equivalent to

about 0.1 g of sodium chloride with 0.1N silver nitrate, using solution of
potassium chromate indicator. Each ml of 0.1N silver nitrate is equivalent to
0.005844 g of sodium chloride NaCl.

For Dextrose:- Carry out the assay described under Dextrose-Injection

Storage:- Preserve sodium chloride and dextrose injection in a cool place. On

keeping there may be separation of small solid particles stored in Plastic/glass
containers. A solution containing such particles must not be used.

Category:- Fluid, nutrient and electrolyte replihisher.

Usual Strength:- 0.9 per cent w/v of sodium chloride and 5.0 per cent w/v of
Dextrose.
 WATER THE EXCELLENT SOLVENT USED IN PHARMACY

It is important this distinguish between solvents which are acceptable for

injection in the final product and those which are suitable only for use in the
intermediate states of manufacture or in analytical operations. Obviously the
former being administered with drug itself, must be non-toxic and non-irritant and
must not interfere in any way with the normal absorption. In the case of
injectable preparations this is often a severe limitation since the no. of available
solvents is small.

Water has a more extensive range of solubility than any other liquid, and has
the advantage of cheapness. It is therefore the most commonly employed solvent.
One outstanding disadvantage of the use of water as a medium is connected with
its wide range of solubility, it dissolves not only those substances that are
required, such as glycocides, but often those which are not, such as gums,
albunimous, pectinous and the coloming matters, sugars, tannins, vegetable
acids, mineral salts, and in the case of hot water, starch. These substances may
be favourable to the growth of moulds and bacteria or in other ways being
about the decomposition of the preparation. The presence of sugar or other
carbohydrates in a solution may be result in alcoholic fermentation with
evolution of carbon dioxide while the presence of protein matter may lead to the
nitrogenous fermentation with liberation of ammonia. The addition of 0.25 w/v of
chloroform to water prevents the growth of micro organism and is used in
preference to water in pharmaceutical mixtures liable to support bacterial growth.

Pharmacopoeia preparation are directed to be made, with purified water

which is prepared by distillation or by ion-exchange method.

Distillation is the widely adopted technique for preparing water for injection .
Pyrogen must be removed by effective device to prevent entrainment of droplets,
because although the presents of minimal amounts of pyrogen may not always
matter in small volume injections, there virtual absence is very necessary in the
case of infusion fluids given in large volume. Patients are receiving these are
often dangerously ill and danger may be significantly increased if a fever is
induced. After distillation the water is distributed in ampoules bottles and
sterilized by heat. The British pharmacopoeia is also permits filtration but since
the object of sterilization is to deal with odd organism or to which may have
accidentally contaminate the receiver, there would seem to be no point in using
sterilization method involving a further final aseptic transfer which carries a
risk of contamination.
 BASIC RAW MATERIALS

1. Plastic laminates

3. A - 1 caps

4. Hangers

5. Chemicals : Dextrose, Nacl and KMnO4 (I.P.grade)

6. Card Board Boxes

7. Misc. like labels, corks, aluminium seal, gum etc.

 REQUIREMENTS OF RAW MATERIALS AND SPECIFICATIONS

WATER FOR INJECTION

Where water for injection is directly to be used in the preparation of a

prenteral injection, water freshly prepared by the process described under "Aqupro
Injections" may be used, the sterilization at this stage being omitted provided that
the final solution of preparation is immediately sterilized.

HDPE PHARMA GRADE LAMINATE/ PLASTIC ROLL

The HDPE plastic roll are either clear or colorless. with the using this material to
make HDPE pouch for dextrose packing

LABELING

The label on the sealed container must state (1) the name of the injection. (2)
The strength of the injection, stated as the amount of active ingredient in a suitable
close volume (3) batch number (4) date of manufacture and date of expiry, if any,
and (5) The name of the manufacturer.

The label on the sealed container of a powdered drug intended for the
preparation of an injection must state (1) the name of the drug followed by the
work " Pro injection" or "for injection" (2) the amount of solid drug enclosed in a
container.

IDENTIFICATION

Add a few drops to 5 ml hot alkaline solution of Cupric Tartrate. A copious

red precipitate of cuprous oxide isproduced.
HEAVY METALS

Evaporate a volume of injection of Dextrose equivalent to 3 g of dextrose in a

porcelain dish or crucible to dryness on a steambath, then thoroughly char the
residue. Cool, add a mixture of 30 ml of dilute hydrochloric acid and 2 ml of
solution of bromino, cover the dish and boil gently for 10 minutes. Filter and wash
the filter and residue with 25 ml of hot water. Evaporate the filtrate to a
volume of about 15 ml. Cool and add 10 ml of solution of hydrogen sulphide. The
resulting colours of any is not darken then that of a content made in the same
manner with the same quantities of the same reagents and to which 1.5 ml of
standard lead solution has been added, the solutions being compared in matched
messler tubes ( 5 parts per million).

When Injection of dextrose prescribed no strength being stated a solution

containing 5.0 w/v shall be dispensed.
COMPOSITION OF IV FLUID
COMPOSITION OF COMMON IV FLUID (mEq/L)
Composition of IV fluids
Composition of commercial I.V. fluid available
 MANUFACTURING PROCESS
OF I.V. FLUID (FFS TECHNOLOGY)

First the polypropylene granules are heated at 200 ± 30oC to form a tube shaped
known as parison, Parison reaches to the mould forming the container by the
pressure of sterile compressed air, Next, the fill nozzle known as mandrel fills the
liquid into the container followed by sealing the neck and the filled container is
released from the mould. It takes 10-15 second to produce one container, capacity
of the machine depends upon the number of moulds. Labeling of the container is
done outside the machine. FFS machine should be surrounded by class 1,00,000 or
better area.

Container formation, filling and sealing process is done in a class 100 area with the
machine.

In FFS (Form fill seal) Technology, a polymeric material is formed and sealed inline
to a container of choice, while the container is being fitted.

FFS require one piece of automated machinery and takes place in six second or
less.

The entire FFS process is performed under a class 100 laminar flow preventing
external contamination. The fully automatic computer controlled technology allow
for filling and packaging up to 60,000-1,00,000 Bottles/day

A typical FFS process works as follows:

first bulk solution prepared under aseptic condition (as appropriate) is

delivered to the machine through a bacteria retainer filter, pipe work filter
housing and machine parts, that are in contact with the product are steam
sterilized in place.

Filtered compressed air and granules of a plastic material conforming to a

predetermined specification and known to be compatible with the product to be
filled (usually polyethylene, polypropylene, or polyethylene/polypropylene
copolymer) are supplied to the machine.
Within the machine, the plastic granules are extruded downward under pressure
(up to 350 bar) as a hot hollow mouldable plastic tube (or parison). As a result of
the high pressure extrusion process, the parison reaches a temperature of 170o-
230oC. The configuration and internal integrity of the parison are maintained by as
internal downward flow of filtered air under pressure.

The two halves of the mould close around the seal the base. Simultaneously, the top
of the parison is cut free by a hot knife edge. The plastic material is now formed into
a container by vacuum and or sterile air pressure.

The container is immediately filled with a metered volume of the solution displacing
the sterile air.

Both the air and the solution are filtered through bacteria retaining filter
immediately before entry into the forming or formed container.

When the required volume is filled into the container, the filling unit is raised and
the containers are sealed automatically.

The moulds then open releasing a package formed filled and sealed in one
continuous automatic cycle, meanwhile parison extrusion continues and the cycle
repeats. The filled and sealed units usually require some cropping of excess plastic.
 PROCESS FLOW DIAGRAM

Poly Propylene Sodium Chloride

Dextrose
Distilled Water

Injection Blow Moulding Machine Solution Making

Bottle

Filling Sterilization

Sterilization in Auto
Clove using
Saturated Steam

Leak Testing

Packaging in Card
Board Boxes

Storage

Dispatch for Marketing (IV Fluid using FFS Technology)

 PROCESS IN DETAILS

The process of manufacture of Dextrose, sodium chloride and Dextrose sodium -

chloride fluids consist mainly 3 steps.

I. Distilled Water preparation.

II. Solution making by adding proper quality of ingredients.

III. Sterilization and filling of bottles.

1. DISTILLED WATER PREPARATION:-

Water for injection is prepared by a simple process called multiple stage

evaporation. The raw water is first treated with KMnO4 solution (0.5 - 1.90) in
order to remove the odour and micro organism present in the water. Next comes
the main step of the process distillation in 3 repeated times.

Distillation in a method of separation of substances which differ appreciably

their vapour press is a method of separation. There are various types of distillation
methods using different equipments in the pharmaceutical industry.
Fractional distillation is highly effective in the point of view of unity of the
separated liquid. The raw water heated in the reboiler to get vapourised. This
vapour is changed in condenser and transferred to the reboiler of distillation
unit. This repeated distillation makes highly pure water.

Water for injection is to be minimum required quantity of pure NaCl is added

prior to filling and sealing vessels. Sodium chloride injection water contains (0.9
%) weight per volume of Sodium chloride.
2. SOLUTION PREPARATION :-

The method used in the preparation of I.V. fluids is the same except
little modification in certain basis. In most of the cases the method involves
mixing of various ingredients in proper concentration followed by dissolution in
pyrogen free distilled water under controlled conditions of temperature, pH
particulate matter, pyrogenicity and aseptic environment.

Dextrose 5 % injection contains 540 ml. of I.V. solution with Dextrose 27 gr.
in a Plastic/glass bottle.

Dextrose-Sodium chloride injection contains 540 ml. of fluid with Dextrose

27 gr. and Sodium chloride 4.86 gr. in a Plastic/glass bottle.

Sodium chloride injection contains 540 ml. of fluid with sodium chloride 4.86 gr.
in a Plastic/glass bottle.

3. INJECTION BLOW MOULDING

Above step is Injection Blow Moulding of the container from plastic granule. The
parison is closed between the mould, and the container gets formed either by
blowing sterile compressed air or by vacuum or by using vacuum as well as
blowing. Container assumes shape of the cavity in mould. Container thus produced
is open from the top and in its top part, plastic is still hot and in molten state until
the subsequent steps of filling and container sealing.

4. MOULDING PROCESS

The main mould closes and simultaneously seals the bottom. The special mandrel
unit settles onto the neck area and forms the parison into a container, using
compressed air. Small containers are formed by vacuum.
5. Filling Process

Subsequent step is Filling of the formed container from the top which is still
open (and still in hot-molten state!). Filling nozzles enter from the top of
container and filling is done. Filling nozzles are specially designed and
constructed to facilitate automatic cleaning and automatic sterilization.
Additional functions of filling nozzles are to blow the bottles and also to provide
exhaust path for air in the container. Filling process can be carried out under a
shower of sterile filtered air to avoid contamination during filling. The blower on
the sterile air shower can have variable pressure which can be made to change
automatically so as to maintain constant air pressure under various situations.
The air shower is validated at certain air pressure, and an automatic device can
maintain the same pressure by automatically modulating the speed of the
blower.

6.SEALING PROCESS

After the special mandrel unit retracts, the head mould closes and forms the
required seal by vacuum. Next step is Sealing the top of the container which is
still open and in hot molten state. The top gets pressed between head moulds,
and as a consequence, top part of the container gets formed, sealed and at the
same time, gets cooled. The result is a hermetically sealed container. The final
steps are for de-flashing to remove the flash or scrap, trimming the containers
and delivering the containers outside the machine. The whole process of
extrusion-blowing-filling-and sealing and removing scrap takes between 10 to
18 seconds depending upon the type and size of the container. The advantage
of Blow-Fill-Seal process is derived mainly from the fact that container is
formed, quickly filled and sealed under protected environment automatically
without human intervention.

7. MOULD OPENING PROCESS

With the opening of the blow mould, the container exits from the machine and
the cycle repeats itself. Transfer for further processing is achieved by means of
conveying systems.
FILTRATION AND FILLING:-

1. Weighing of various ingredients for dissolution.

2. Pyrogen free distilled water is collected in a reactor and weighed ingredients

are dissolved in appropriate manner. The mixer is set as per the finished product
requirement.

3. The solution from this reactor pumped through serial filtration to retain
organism, particulate matter and other carbonacious matter.

4. The solution is then filled in Plastic/glass bung and sealed.

STERILIZATION:-

1. The bottles are stacked into external crates and are fed into the autoclave for
terminal sterilization.

2. Sterilization process is carried out in presence of thermograph.

3. The operation is completed when the bottles have required 121oC for 20-30
minutes.

4. The bottles are usually checked for any particulate matter and then labeled.

5. The labeled bottles are packed in corrugated box of 12 or 16 bottles.

QUALITY CONTROL :-

1. For the process of quality control distilled water in the storage tank must be
pyrogen free and free from particulate matter.

2. All operations of filling and filtration should be carried out in a particular

controlled atmosphere at temperature 20 - 25oC.

3. Raw material before using should be subjected to quality testing as per

I.P/B.P. and only material passing the test should be used. The finished product
is also subjected to quality control as per I.P.

4. Finally every bottle is screened for any visible particulate matter and only
bottles free from visible matter should be cleared and passed on the packing
department.

It is easy to use Dextrose powder as the raw material in order to make

Dextrose saline injection of any concentration. The advantages of using dextrose as
the basic raw material are :-

1. Raw material, Dextrose monohydrate(C6H12O6H2O) having dextrose

monohydrate of standard and pharmaceutical grade is available.

2. The process is less available.

3. Can be stored on small scale.

4. Investment is less.

5. More easy quality control.

Hence the process of dextrose saline injection from dextrose powder has been
described separately and given below :-

The dextrose monohydrate powder is taken in a stainless steel vessel

provided with a hole at the bottom to supply the live steam. Dextrose is then
mixed with steam condensed water for some time until the required concentration is
obtained.
The whole process consists of the following steps:-

i) Mixing - Purified crystallized dextrose (C6H12O6.H2O) with water.

ii) Passing of steam

iii) Cooling

iv) Injection filling and sealing

v) Packing and Dispatch.

The Dextrose monohydrate for the required batch quantity is initially mixed
with water in a stainless steel tank in which a stirrer is attached from the top
cover. The tank is equipped with live steam let from the bottom. After the stirring is
over and dextrose monohydrate powder is well dispersed, live steam is allowed
to pass through the bottom. The bubbles of the steam passes through the media,
thereby giving :-

i. Heat to the medium.

ii. Agitation to the system and

iii. Better heat transfer.

The concentration of the solution is checked regularly which continuously

rises because of the condensation of the steam into the medium the best way of
controlling the process is to measure the volume of the tank occupied by the
dextrose solution. As the quantity of the dextrose monohydrate which has been
dissolved is already known adjustment of the strength can be done very easily.

The sample of the solution is taken out and tested for the dextrose
monohydrate concentration. Any alteration in the strength can be made at this
stage.
 FLOW DIAGRAM OF MANUFACTURING OF I.V. FLUIDS

Bottles Ingredients in Potable water

Proper proportion (0.05-0.1%)
KMnO4
Bottle Washing Unit Mixing Tank S.S. Mixing Unit

Bottle Sterilizing Unit Setting Tank Distillation

Column 3 Stage

Filter Press
Distilled Water
Storage

Store

Bottle Filling Unit

Quality Control Sealing

Labeling and Packing

Store

I.V. Fluids of Various Grades for Market

 PLANT LAYOUT

Water Tank Tube Well

Distillation Finished
Section Product Storage

Administrative
Processing Area Building

Laboratory Raw Material

Storage

Security Office
GATE

Total Land Area 6,000 sq.mt.

SWOT ANALYSIS
SCHEMATIC DIAGRAM OF FFS PLANT LAYOUT
 FORM FILL SEAL TECHNOLOGY

1. Form-Fill-Seal Technology:-

1.1 Form-Fill-Seal units are specially built automated machines in which through
one continuous operation, containers are formed from thermoplastic granules, filled
and then sealed. Blow, fill-seal units are machines in which containers are moulded
/ blown (pre-formed) in separate clean rooms, by non-continuous operations.

Note:- (i) These shall be installed in at least Grade C environment.

1.2. Form-Fill-Seal/machines used for the manufacture of products for terminal

sterilization shall be installed in at least Grade C environment and the filling zone
within the machine shall fulfill Grade A requirements.

1.3. Terminally sterilized products.-

1.3.1. Preparation of primary packaging material such as glass bottles, ampoules

and rubber stoppers shall be done in at least Grade D environment. Where there is
unusual risk to the product from microbial contamination, the above operation
shall be done in Grade Cenvironment. All the process used for component
preparation shall be validated.

1.3.2. Filling of products requiring terminal sterilization shall be done under Grade
A environment with a Grade C background.

1.4 Preparation of solutions, which are to be sterilized by filtration, shall be done in

Grade Cenvironment, and if not to be filtered, the preparation of materials and
products shall be in a Grade A environment with Grade B in background.
1.5 Filtration (membrane):-

(i) Solutions for Large Volume Parenterals shall be filtered through a non-fibre
releasing, sterilizing grade cartridge/membrane filter of nominal pore size of 0.22 µ
for aseptic filling whereas 0.45 µ porosity shall be used for terminally sterilized
products.

(ii) A second filtration using another 0.22 µ sterilizing grade cartridge / membrane
filter shall be performed immediately prior to filling. Process specifications shall
indicate the maximum time during which a filtration system may be used with a
view to precluding microbial build-up tolevels that may affect the microbiological
quality of the Large Volume Parenterals.

(iii) The integrity of the sterilized filter shall be verified and confirmed immediately
after use by an appropriate method such as Bubble Point, Diffusive Flow or
Pressure Hold Test. 10.6Sterilization (Autoclaving).

1.6.1. Before any sterilization process is adopted, its suitability for the product and
its efficacy in achieving the desired sterilizing conditions in all parts of each type of
load pattern to be processed shall be demonstrated by physical measurements and
by biological indicators, where appropriate.

1.6.2 All the sterilization process shall be appropriately validated. The validity of the
process shall be verified at regular intervals, but at least annually. Whenever
significant modifications have been made to the equipment and product, records
shall be maintained thereof.

1.6.3 The sterilizer shall be double ended to prevent mix-ups.

1.6.4 Periodic bio-burden monitoring of products before terminal sterilization shall

be carried out and controlled to limits specified for the product in the Master
Formula.

1.6.5 The use of biological indicators shall be considered as an additional method of

monitoring the sterilization. These shall be stored and used according to the
manufacturer is instructions. Their quality shall be checked by positive controls. If
biological indicators used, strict precautions shall be taken t avoid transferring
microbial contamination from them.
1.6.6 There shall be clear means of differentiating sterilized and unsterilized
products. Each basket, tray or other carrier of products or components shall be
clearly labeled with the name of the material, its batch number, and sterilization
status. Indicators shall be used, where appropriate, to indicate whether a batch (or
sub-batch) has passed through the sterilization process.

1.6.7 Sterilization records shall be available for each sterilization run and may also
include thermographs and sterilization monitoring strips. They shall be maintained
as part of the batch release procedure.

1.7. Sterilization (by dry heat):-

1.7.1 Each heat sterilization cycle shall be recorded on a time/temperature chart of

a suitable size by appropriate equipment of the required accuracy and precision.
The position of temperature probes used for controlling and/or recording shall be
determined during the validation and, where applicable, shall also be checked
against a second independent temperature probe located in the same position. The
chart shall form a part of the batch record. Container mapping may also be carried
out in the case of Large Volume Parenterals.

1.7.2 Chemical or biological indicators may also be used, but shall take the place of
physical validation.

1.7.3. Sufficient time shall be allowed for the load to reach the required temperature
before measurement of sterilization time commences. This time shall be separately
determined for each type of load to be processed.

1.7.4. After the high temperature phase of a heat sterilization cycle, precautions
shall be taken against contamination of sterilized load during cooling. Any cooling
fluid or gas in contact with the product shall be sterilized unless it can be shown
that any leaking container would not be approved for use. Air inlet and outlets shall
be provided with bacterial retaining filters.
 CALCULATING INTRAVENOUS FLOW RATES

When a provider orders an intravenous infusion, it is your responsibility to make

sure that the fluid will infuse at the prescribed rate. IV fluids may be infused by
gravity using manual control or infused using an infusion pump. Regardless of the
method, you will be responsible for calculating the correct IV flow rate.

Example: The provider has ordered 1,000 mL 0.9% sodium chloride to infuse over 8
hr. You have a macrodrip tubing with a drop factor of 15 gtt/mL available.
Calculate how many gtt/min to set as the IV flow rate.

Step 1: Choose the formula.

Step 2: Use the formula.

Example: The provider has ordered ranitidine (Zantac) 50 mg in 100 mL 0.9%
sodium chloride intravenous piggyback to be infused over 20 min. You have a
macrodrip tubing with a drop factor of 10 gtt/mL. Calculate how many gtt/min to
set as the IV flow rate.

Step 1: Choose the formula.

Step 2: Use the formula.

Example: The provider has ordered 600 mL of 5% dextrose in water to infuse over 8
hr. Determine how many mL/hr to set the IV pump to deliver.

Step 1: Choose the formula.

Step 2: Use the formula.

Example: The provider has ordered amiodarone (Cordarone) 300 mg in 100 mL to be
infused over 30 min. Determine how many mL/hr to set the IV pump to deliver.

Step 1: Choose the formula.

Step 2: Use the formula.

When calculating the flow rate, first determine whether the intravenous tubing you
are using is microdrip or macrodrip, so that you can use the appropriate drop factor
in your calculations. The drop factor, also called the drip factor, is the calibration or
number of drops per mL of solution delivered for a particular drip chamber. Always
check the tubing package to be sure.

Microdrip tubing universally delivers 60 gtt/mL. It is used for infusing small or very
precise amounts of fluids. Macrodrip tubing varies with the manufacturer but
usually delivers between 10 gtt/mL and 15 gtt/mL. It is used to infuse large
volumes or to infuse fluids quickly.
After you’ve completed your calculations and before you start the infusion, it is
important to mark the bag of fluids with adhesive tape or a commercial time tape
next to the volume markings on the bag. Time taping the IV bag helps you check at
a glance that the fluids are infusing over the correct period of time.

Once an intravenous infusion is initiated, monitor the infusion closely to ensure

that it is infusing at the correct rate. Check the IV site for signs of infiltration and
inflammation. How often you must check varies with the facility, so be sure to
become familiar with your facility’s policies and follow them consistently each time
you are caring for a patient who is receiving an IV infusion.
 GENERAL PLANT LAYOUT

GMP/GHP Criteria for (Level 1 Requirement)

1. Scope – The requirements as given in this document apply to the entire

pharma processing industry. They do not apply to the hotel and catering
industry.
2. Design and Facilities
2.1 Location
a) Establishment shall be away from Toxic chemical/odour producing industries,
approach road to the site shall be concreted/cemented, Surrounding areas
shall be clean with no garbage accumulation and stagnant water and not
prone to pest infestation and flooding. There shall be no uncontrolled
vegetation at least 6 feet from building walls.
b) Open drains, garbage dumps, water logging; open spaces, such as yards,
streets, side or rear lanes and roof tops, should not be used for preparation or
storage of product, cleansing or storage of equipment or utensils
2.2 Premises and rooms

Design Layout

a) Basic Infrastructure appropriate to the operations shall be in place. Flow shall

be so designed that there is no criss‐cross movement of men and material.
Entry points for material and personnel shall as far as possible be separate.
product flow should be in one direction, as far as possible.

b) adequate space should be provided for various activities such as raw material
receipt & storage, processing, final product storage, change facilities for
personnel, foot bath facilities as appropriate to the industry, separate eating
area which is located away from process area, toilets/ washrooms, and do not
open directly into the processing/ packing/ storage areas.
c) There shall be adequate separation between storage areas (raw material,
packaging material and finished goods), processing area, packing area, etc
d) There shall be provision of appropriate loading and unloading points which
facilitate movement of material and provide adequate protection from pests,
rain, etc.
e) All requisite “No Objection Certificates (NOC)” from various authorities shall be
obtained.
2.3 Equipment

a) Equipment shall be located so that it permits adequate maintenance and

cleaning; functions in accordance with its intended use; facilitates good
hygienic practices, including monitoring, if required.
b) Equipment and re‐usable containers coming into contact with product
shall be durable, designed and constructed to ensure that they can be
adequately cleaned, disinfected where necessary, and maintained to avoid the
contamination of product. Where necessary, equipment shall be movable
or capable of being disassembled to allow for maintenance, cleaning,
disinfection, monitoring, etc.
c) These shall be made of materials with no toxic effect in intended use and
should not pass on colours.
d) Pharma products contact surfaces of equipment should be free from
unnecessary projections and crevices; and designed and constructed to allow
easy cleaning and maintenance.

e) Equipment used to cook, heat treat, cool, store or freeze product shall be
designed to achieve the required product temperatures (and other parameters
as relevant) as rapidly as necessary for product safety and suitability and to be
effectively maintained and allow parameters to be monitored and controlled.
These shall be periodically calibrated & records maintained. The frequency of
calibration shall be based on the type of equipment, criticality of the
measurement, location & extent of usage.
f) Maintenance programmes shall be in place which shall cover
maintenance schedule, responsibilities, methods, tools and gadgets, etc for
effective functioning of the equipment .

2.4 Containers for waste and inedible substances

a) Containers for waste, by‐products and inedible or dangerous substances
shall be identifiable, suitably constructed and where appropriate made of
impervious material. Those used to hold dangerous substances shall also be
lockable.
2.5 Facilities
Water supply
a) An adequate supply of potable water with appropriate facilities for its storage,
distribution and temperature or any other controls, shall be available as
necessary. Potable water shall comply with Indian standard IS
10500:95.
b) In case water is stored in tanks, these shall be such that they prevent
contamination of water. They shall be suitably covered to prevent the access
by animals, birds, pests and other extraneous matters.
c) Separate non‐potable water systems (eg fire control, steam
production, refrigeration, sanitary conveniences) shall be identified and shall
not connect with or allow reflux into, potable water systems.
d) The potable water pipes run at a higher level than non potable water
pipes and they should not be concealed.

Drainage and waste disposal

a) Drainage systems as relevant to the operations shall be appropriately designed
and constructed. The sewage discharge shall comply with the requirements of
environmental pollution Board (including ETP, rendering plant, etc as
applicable). No manhole shall be situated inside any product processing area.
Rainwater pipes, if inside, shall be constructed of impervious rust‐proofing
materials. These shall not open in the product processing area.
b) Drains, if any, in the processing area shall be made of impervious rust
proofing material and shall be covered. These shall have adequate trapping
devices to avoid entry of pests. Drains shall allow for effective cleaning as
relevant (such as fat trap, pressure cleaning, etc).

Cleaning
a) Adequate facilities, suitable designated, where necessary, should be provided
for cleaning raw materials and ingredients, product, utensils and equipment,
etc. These facilities shall have an adequate supply of hot and cold potable
water where appropriate.
 Personnel hygiene facilities and toilets

a) Adequate means of hygienically washing and drying hands (as relevant),

including wash basins and supply of adequate water of potable quality shall be
provided. Taps shall be non‐hand operated.
b) Hand wash basins/ sanitizers should be situated to enable hand washing prior
to start of operations.
c) Toilets/ lavatories of appropriate hygienic design at suitable location with
adequate natural or mechanical ventilation and natural or artificial lighting
shall be provided.
d) Adequate changing facilities for personnel should be provided, as appropriate
to the operations

Temperature control
a) If operations require heating, cooling, cooking, refrigerating and freezing
product, storing refrigerated or frozen products, monitoring product
temperatures, adequate facilities shall be available for the same.
b) Where necessary, ambient temperatures shall be controlled to ensure the safety
and suitability of product.

Air quality and ventilation

a) Adequate ventilation as appropriate to the product and the operations shall
be provided for minimizing air borne contamination, controlling ambient
temperatures and humidity where necessary which might affect the safety and
suitability of product. These shall be achieved through either natural or
mechanical ventilation.
b) Product processing areas where operations result in release of fumes, smoke,
steam or any vapour shall be equipped with an exhaust system or ventilation
that can efficiently and effectively remove these.
c) Ventilation systems shall ensure that air does not flow from unclean to clean
areas and, where necessary, they can be adequately maintained and cleaned.
 Lighting

a) Natural and / or artificial lighting shall be provided in product premises for

various operations and other activities within the facility (eg sanitary
conveniences). The intensity of lighting shall be adequate on the nature of
operations (eg sorting, cleaning, grading, inspection and testing require greater
intensity of light). Where necessary, lighting should be such that the resulting
colour is not misleading.

b) Lighting fixtures shall especially where product or food contact surface is

exposed to open), be shatter proof or protected with shatter‐proof covers to
ensure that food is not contaminated by breakages. The fixtures shall be
designed to avoid accumulation of dirt and be easy to clean.

a) Suitable power back up facilities e.g generators, invertors etc shall be provided
to ensure uninterrupted supply as necessary for production of safe food.

Storage

a) Adequate facilities for storage of food, ingredients, packaging material and non
food chemicals shall be provided. These shall be suitably designed and
constructed as appropriate to operations .

3. Control of operation
3.1 Time and temperature control
a) Where time and temperature is critical to the safety of a food, define
temperature and time controls for heating, cooling, processing and storage
taking into account the nature of food, its shelf life, the processing method, its
packaging, intended use of the product. These controls shall reduce any food
borne pathogen that may be present in the food to an acceptable level.
3.2 Control of other Specific process steps
a) Define controls over other process steps which contribute to food hygiene
which may include cleaning, sorting, chilling, thermal processing, irradiation,
drying, chemical preservation, vacuum or modified atmospheric packaging, etc.
3.3 Specifications
a) Define specifications for products at various stages of operations as relevant
for ensuring food safety and compliance to regulatory and statutory
requirements. These specifications shall be based on sound scientific
principles. Document monitoring procedures, action limits and analytical
methods. Maintain records.

3.4 Microbiological cross contamination

a) When processing food, adequate steps shall be taken to prevent the same
from microbiological cross contamination.
b) Raw, unprocessed food should be effectively separated either physically or by
time from ready‐to‐eat foods, with effective cleaning and where appropriate
disinfection. Similarly this should also be implemented for vegetarian and non
vegetarian products.
c) Access to processing areas should be restricted or controlled. Personnel
should put on clean protective clothing including footwear and wash their
hands before entering. In case of high risk products, access to processing
areas should be only via a changing facility.
c) All surfaces, utensils, equipment, fixtures and fittings should be thoroughly
cleaned and where necessary, disinfected after raw food, particularly meat,
poultry, fish, etc, has been handled or processed to prevent contamination.

3.5 Physical and chemical contamination

a) Foods shall not be contaminated by foreign bodies such as glass, metal
particles from machinery, dust, harmful fumes and hazardous chemicals.
b) In manufacturing and processing suitable and effective detection or screening
devices (such as filters, sieves, magnets, metal detectors) should be used where
necessary.
b) If needed, a glass/ foreign body control policy may be defined and adopted to
assist in achieving safe food.
3.6 Incoming materials requirements

a) Only sound, suitable raw materials or ingredients shall be used.

b) Where appropriate, specifications for raw materials shall be defined including
Regulatory requirements.
c) This may be achieved though supplier control, certificates of conformity,
incoming inspection and testing etc.

d) Where necessary, laboratory tests (in house or externally conducted) shall be

carried out, at appropriate frequencies, to establish conformity.

e) No raw material (including packing material) or ingredient shall be accepted

by an establishment if it is known to contain parasites, undesirable micro
organisms, pesticides, veterinary drugs, heavy metals or toxic, decomposed
or extraneous substances which would not be reduced to an acceptable level
by normal sorting and/or processing.

f) Imported Foods/ raw materials, if used, shall be as per the applicable

regulations g) Records shall be maintained.

3.7 Packaging
a) Packaging design and materials shall provide adequate protection for
products to minimize contamination, prevent damage and accommodate
proper labeling. The materials should be appropriate for the food to be packed
and sufficiently durable to withstand the conditions of processing, handling,
storage and transportation. Use of staple pins, strings, rubber bands, should
be avoided. Glue if used should not come in contact with the food product.
b) Packaging materials and gases shall be non‐toxic and not pose a threat to the
safety of food. Certificates of conformity or other evidence may be used for
verification.
c) Packaging materials shall be stored and handled under hygienic conditions
away from raw materials and finished products.
d) Re‐usable packaging, if used, shall be suitably durable, easy to clean and
where necessary, disinfect. It shall not have been used for packaging non food
products.
3.8 Water

Water, Ice and steam in contact with food

a) Where used either as an ingredient, for making ice, for washing food, food
contact surfaces or hands only potable water shall be used.
b) Water, Ice and steam shall be produced, handled and stored to protect them
from contamination.
c) Steam used in direct contact with food and or food contact surfaces shall not
contain any agent which is hazardous for food safety.
d) Water that is re‐circulated shall be treated and maintained so that it is safe
for use, and the treatment process shall be effectively monitored. Re‐circulated
water which has received no further treatment and water recovered from
processing of food by evaporation or drying may be used, provided its use does
not constitute a risk to the safety and suitability of food.
Water, Ice and steam not in contact with product
a) For steam production, fire control and other similar purposes not connected
with product may not require the use of potable water. In certain processes
(e.g. chilling) and in product handling areas where water does not constitute a
hazard to the safety of product (e.g. use of clean sea‐water) the use of potable
water may not be required.
Water pipes & Storage tanks
a) Water pipes, either hot or cold, should be maintained in good condition and
order at all times to prevent leakage or defects that would result in
contamination of product. Water storage tanks for potable water should be
regularly cleaned and disinfected to prevent contamination.

3.9 Management and supervision

a) All operations shall be monitored and supervised appropriately. The
type of control and extent of supervision needed will depend on the size of
the business, the nature of its activities and the types of product involved.
3.10 Documentation and records

a) Appropriate records of processing, production and distribution shall be kept

and retained for a period that exceeds the shelf life of the product.
b) At a minimum records for the following processes shall be maintained ;
• Incoming material checks
• Inspection & test
• Temperature & time
• Product recall & traceability
• Storage
• Cleaning and sanitation, as appropriate
• Pest control
• Medical & health
• Training
• Calibration
3.11 Product Recall & Traceability

a) Effective procedures shall be in place to enable a complete and rapid recall of

any implicated lot/ batch of finished product. Where a product has been
withdrawn, other products which are produced under similar conditions, shall
be evaluated for safety and may need to be withdrawn.
b) Recalled products shall be held under supervision until they are destroyed,
used for purposes other than human consumption, determined to be safe for
human consumption or reprocessed in a manner to ensure their safety.
c) Product establishments should, as far as possible and appropriate,
maintain an effective mechanism for identification and traceability of the
incoming materials to the supplier and delivery of finished food product to the
customer (not the ultimate consumer). This would help in implementation of an
effective recall.
d) Records of recalled products shall be maintained.
3.12 Storage

a) Product storage facilities shall be designed and constructed to enable

maintenance of cleanliness, ventilation, avoid pest access and harborage;
prevent contamination and where necessary, provide suitable conditions of
temperature and humidity for minimizing deterioration of product.
b) Adequate facilities for storage of product, ingredients, packaging material and
non food chemicals (eg cleaning materials, lubricants, fuels) shall be provided,
and segregated appropriately.
c) Food products shall be stored under conditions that prevent spoilage,
protect against contamination and minimize damage. Product shall be stored
away from the wall not directly on the floor. It should be stored preferably
either on pallets / racks or any other manner to facilitate cleanliness, avoid
ingress of moisture, etc. Product should be stored in clean areas and stacked
in a manner that facilitates ease of movement. Product that requires specific
storage conditions eg Temperature and humidity, air circulation etc
shall be maintained.
d) All products in storage should be clearly identified.
e) Stocks of raw materials (including packing material) and ingredients shall
be subject to effective stock
rotation.
f) Cleaning materials and hazardous chemical substances should have
restricted access to authorized personnel.
4 Maintenance and sanitation
4.1 Cleaning and sanitation programmes shall be in place which shall cover
cleaning schedule, responsibilities, methods of cleaning, equipment and
cleaning aids, etc to effectively control contamination of product These shall
be continuously monitored for their effectiveness. It shall be ensured that
cleaning chemicals do not contaminate product.
4.2 Pest Control

a) Suitable pest control programme shall be in place and effective to ensure

there are no signs of pest infestation including flies, cockroaches, lizards,
rats, etc. The pest control programme shall identify the pests to be controlled,
the area / locations where control is to be applied, the method of control eg
physical, chemical etc., the dosage in case of usage of chemical, schedule,
responsibilities, etc. These shall include use of insectocutors, traps & baits as
appropriate; maintaining cleanliness, covering exposed products and wastes,
blocking drain pipes etc.
b) The pest control activities shall be performed by trained personnel. These
shall be continuously monitored for their effectiveness. It shall be ensured that
pest control chemicals do not contaminate product.
c) The measures shall be documented and records maintained. .
4.3 Waste management

a) Suitable waste management and waste disposal system shall be in place.

Waste shall not accumulate in food processing, storage areas. Waste bins and
areas must be covered and kept appropriately clean
5 Personal hygiene
a) Personnel working in processing area shall be checked for communicable,
infectious and loathsome diseases at least once/year.
b) Personnel working in processing area shall not have any open cuts or
wound/injury, contagious disease, or sickness such as Jaundice, Diarrhea,
fever, etc. The open cuts or wounds shall not come in direct contact with
food or food contact surface.
b) Personnel while working in a product processing area shall maintain a high
degree of personal cleanliness and shall wear clean uniform, head gear/cap,
no loose or hanging jewellery/ glass bangles. Nails shall be trimmed, kept
clean ad without nail polish. Street shoes shall not be permitted. Appropriate
measure such as passing through a foot bath, using shoe covers, changing to
separate foot wear for internal use etc shall be used.

d) Persons shall always wash hands with soap/ disinfectant at the start of
activities, after use of toilets and after touching any contaminated material
(including raw material, money, files etc) or unclean product / product
contact surface / body parts.
e) No spitting, smoking, eating product and pan chewing shall be permitted in the
processing areas.
f) Visitors shall follow the same norms for protective clothing and personal
hygiene as those working in the unit.
g) Personnel Hygiene practices in simple local language / language understood
by the personnel/pictorial shall be suitably displayed at appropriate places.
6. Quality Control
a) The quality control programme shall include inspection and testing of
incoming, inprocess and finished product. (for Specifications see Cl 3.3 a).
b) Infrastructure shall be available for carrying out testing. In case the same is
not available, a proper system for testing in external laboratories shall be in
place.
7. Transportation

a) IV fluid shall be adequately protected during transport to assure drug safety.

b) The transportation or transport containers should be designed and
constructed so that they do not contaminate product (Including ingredients)
or packaging material. These should be kept clean and disinfected. Drug and
Pharma products should be suitably segregated during transportation. Where
the same conveyance or container is used for transporting different foods or
non‐foods, effective cleaning and where necessary, disinfection shall take place
between loads.
c) The temperature, humidity, atmosphere and other necessary conditions, as
appropriate to the product shall be maintained.
8. Product information and consumer awareness
a) All incoming, inprocess and finished products shall be suitably identified for
product identification, stage of processing, inspection & test status, etc. so as
to avoid inadvertent use. All legal/ statutory requirements shall be clearly
given on the label of the final product as per W&M, PFA, etc. All finished
products shall be given a unique Batch number. Any special requirements of
handling, storage, processing, by customer etc shall be clearly indicated on
labels.

9 Competence & Training

a) Managers and supervisors shall have appropriate knowledge of product
hygiene principles and practices.
Suitable training shall be given to all persons to enable them to have the
required knowledge & skills in GHP and GMP for the tasks to be performed by
them effectively to enable a safe product. Trainings shall be held at required
frequencies but atleast once in 6 months and records of the same maintained.
Trainings can be provided on the job and or through class room sessions.
10. Temporary / mobile premises; vending machines
a) All requirements of design, operations and hygiene as applicable shall
apply to Temporary / mobile premises , vending machines (booths) with a
view to ensuring safety and suitability of use.
UTILITIES

The utilities required for plant includes power, steam and water, refrigeration, air
compressor. Power is required to run the motors of different equipments, for
lighting of factory and for other necessary operation. Mainly steam is required in
processing and packaging. Considerable quantity of water is required as ingredient,
for cooking, cooling and washing, steam generation, and many other purposes.

WATER

Potable water is used in this industry. The process water should be soft, free from
minerals and particles. Its quality should be assured in the same way as any other
raw material or ingredient. A quality assurance program for water should cover its
source, its treatment and its distribution and storage within the factory, and
include regular checks for compliance with internal or legislative standards.

Water is used as ingredient in wine making process, for generating steam, as a heat
exchanger medium, for cleaning and sanitation and for the personal needs of
employees. An adequate supply of potable water is fundamental in plant location.

Quality and quantity of available water must be taken into consideration.

Quality involves dissolved and suspended impurities. Hardness, corrosiveness, pH,
chloride content, susceptibility to foaming, clarity, color, odor and taste are
important factors. Treatment techniques include softener, UV System, clarification,
coagulation, sedimentation, filtration, ion exchange, addition of chelating agents
and break-point chlorination.
High pressure soft water is used for cleaning of equipments & filtered water for
walls and floors. Automatic proportioning equipment will feed liquid chlorine to
ensure chlorine content of 3 of 5 ppm and to ensure protection against
surviving pathogens, and also to retard slime formation on belts and other
equipment. Chlorinated potable water will also be required for drinking
purpose too. This will be made available by water treatment system.

Boiler feed water must be such that the scale formation is avoided, thus soft
water is used to reduce calcium and magnesium salts precipitants. Chelating
agents also may be added to avoid buildup of scale. The process water quality
should be as per standard since it will come in direct contact with the material
to be processed and forms a part of our final product. Therefore, process water
will be obtained from the UV system if required. Water Treatment Plant
comprises of softener, filter, UV system, pumps etc with a flow rate of 3 m3/hr.

Water quality parameters for processed water:

S. No Parameters Unit Value

1 Total Hardness mg/lt < 5.0
2 pH value 8.5 to 9.5
3 Dissolved O2 (max) mg/lt 0.02
4 Silica as SiO2 mg/lt 0.5
5 Total Dissolved Solids mg/lt < 50

.
STEAM

Steam for processing operations is generated by “Boilers”. Steam is applied

directly and indirectly for raising temperatures in cooking and processing. It is
also used for sanitization and to heat the water. To avoid local over-heating,
turbulent flow may be insured by circulating at high velocity in tubular or
plate-type heat exchangers equipped with automatic systems. An automatic
control system assures the use of desired heating temperature on all of the
above mentioned system.

POWER

Electricity is used in processing operations for lighting, welding, heating,

cooling and for operating motors which in turn motivate equipment for
conveying, cooling, evacuating, opening, closing and many other operations.
Fire protection regulatory systems should be present in plant.

.
 MANPOWER

GENERAL

The proposed factory plant involves a considerable number of

operations, which require the services of skilled and un-skilled
personnel. The total manpower required for the project is broadly
classified into the following groups:

a. Production, Laboratory and Maintenance

b. General Administration & Security etc.
c. Finance, Purchase & Marketing.
d. Casual Labour for production.

BASIS OF ESTIMATION

The proposed estimation of manpower required for the smooth and

efficient operation of the plant keeps in view of the following
considerations.

a. Distinct division of the zones of supervision and minimizing the

levels of operations;

b. Classified fields of managerial and executive

activities;

c. Providing adequate working conditions with reference to

Indian environment; and Providing for proper quality control
activities at appropriate points

.
LIST OF MACHINERY IV BAG PRODUCTION FORM FILL AND
SEAL MACHINE

IV BAG PRODUCTION (IV Production and Packing)

As the I.V solution consists mainly of

water, the wa- ter purification and
distilling is a very important step to
guarantee the purity of the water.
(Beside: Water purification)

The FFS machine (forming filling

sealing) can be seen as the heart of the
Production line. PP-foils get formed to
bags, filled with the I.V solution and
sealed. Further a stopper will be
adjusted to avoid any I.V solution lost.

To ensure a contamination free

product which is priority number one
in this business, the filled bags have to
be sterilized after the filling.

During the secondary packaging the

filled I.V. bags get overwrapped with a
plastic bag to ensure con- tamination
free storage. The single bags get packed
into cartons manually or with another
machine.

.
IV BAG EMPTY PRODUCTION LINE

Machine output: e.g. 2500bph

/ 500ml bags
Bag volumes: mainly 500, 1000ml (others on request)
Sealing method: any port system
Processed film: Polyolefin film, double wound PP-
multilayer flat film
Sterilization temp.: 121°C
Printing: machine is equipped with hot
foil printing device Operation: One
operator permanently, second temporary
Bag format
Exchange: approx. one hour,
by the operator
Flexibility: Highest
flexibility regarding
- Various bag volumes
- Bag designs
- Machine output
- Time of operation
- Exchange tools for bag layout
- Processing of various pharmaceutical fluids

Options: - welding devices as exchange parts to

go for different bag volumes

.
Especially, I.V. Solution requires extremely high purity
because it is directly in- jected into human blood. For this
reason, the production know-how and reliability of production
line are essential ones to guarantee the safety of the final
product. In this regard general production standards
concerning the hygiene, the production process, the storage
etc. have to be fulfilled.

The production of I.V. Solution production line consists of 5

main phases:

1. Water purifying

2. Distillation

3. Solution filling

4. Sterilization

5. Packing

.
A typical FFS process works as follows.

First, bulk solution prepared under aseptic conditions (as appropriate) is

delivered to the machine through a bacteria-retaining filter. Pipework, filter
housings and machine parts that are in contact with the product are steam
sterilized in place.

Filtered compressed air and granules of a plastic material conforming to a

predetermined specification and known to be compatible with the product to be
filled (usually polyethylene, polypropylene or polyethylene/polypropylene co-
polymers) are supplied to the machine.

Within the machine, the plastic granules are extruded downwards under
pressure (up to 350 bar) as a hot hollow moldable plastics tube (or “parison”) or
tubes. As a result of the high pressure extrusion process, the parison reaches a
temperature of 170° - 230° C. The configuration and internal integrity of the
parison are maintained by an internal downward flow of filtered air under
pressure.

The two halves of a mold close around the parison to seal the base.
Simultaneously, the top of the parison is cut free by a hot knife-edge. The
plastics material is now formed into a container(s) by vacuum and/or sterile air
pressure.

.
The container(s) is/are immediately filled with a metered volume of the
solution, displacing the sterile air. Both the air and the solution are filtered
through bacteria-retaining filters immediately before entry into the forming, or
formed container(s).

When the required volume is filled into the container(s), the filling unit is raised
and the containers are sealed automatically. The mold then opens, releasing a
package formed, filled and sealed in one continuous, automatic cycle.
Meanwhile, parison-extrusion continues, and the cycle repeats. The filled and
sealed units usually require some cropping of excess plastic

.
 CIP SYSTEM

FULLY AUTOMATIC

CIP is the method used in sanitary processing plants to clean interior surfaces
of pipes, vessels, process equipment, filters and associated fittings, without
disassembly by automatically recirculating detergent and rinse solutions. The
washing process consists of several cycles in which rinsing material is recycled
through the vessels, pumps, valves and other process equipment in the flow
system. The system consists of acid, alkali and rinse water tanks, centrifugal
pump and connection to the system being cleaned for the readymade cleaning
solution. It also includes the acid and alkali dosing tanks. The cleaning
solution is circulated and heated up to the operating temperature through heat
exchanger. Conductivity measurement and in-line concentrate metering ensure
that the required amount of detergent is added. The detergent flow rates are
adjusted by the cleaning program. The benefit to industries that use CIP is that
the cleaning is faster, less labor intensive and more repeatable, and poses less
of a chemical exposure risk to people.

.
CIP System can be configured with the following options to specific needs

1. CIP tanks
2. CIP return pump with low point
3. Drain valve
4. Chemical addition system(s)
5. Steam control valve with condensate drip leg
6. CIP return flow switch
7. Heat exchanger

BOILER (HORIZONTAL SHELL & TUBE TYPE, 3 PASS DESIGN)

SALIENT FEATURES

3-Pass, packaged type design.

Integral Water Cooled Furnace.
Large convective heating surface in the 2nd & 3rd pass tubes ensures
excellent heat transfer.
Large water holding and steam holding space gives quick response to
fluctuating
steam demands. Large steam space results in excellent quality of steam.
Dry
steam reduces the processing time, saves steam and improves quality of
processed goods.
Quick opening / closing hand-wheel operated clamps on the gas-tight
refractory lined
smoke boxes makes the operation of doors smooth & quick during
maintenance and also eliminates
frequent changing of gaskets or ropes in the smoke boxes.
Designed especially to operate on Light oil.
Very high radiant heat transfer due to large furnace.
Horizontal packaged boilers – less site work & quick commissioning.
Large steam space ensures availability of dry saturated steam at peak-loads.
Designed as per latest IBR.

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 TECHNICAL DETAILS

BOILER TYPE Shell & Tube, Three Pass design

STEAMING CAPACITY (f & 1000 Kg/hr
a 1000C)
MAX. WORKING 10.54 Kg/cm2 (G)
PRESSURE
STEAM QUALITY Saturated (98% Dry)
FUEL Light Oil
EFFICIENCY 88% + 2% on NCV
NET CALORIFIC VALUE OF 10,200 Kcal/Kg
FUEL
FUEL CONSUMPTION 60 Kg/hr
FIRING Fully Automatic Burner
DESIGN CODE IBR 1950 with Latest
Amendments

SHELL & TUBE BOILER

Shell & Tube Plate Boiler Quality Materials as per

Materials IBR
Tube Diameter 50.8 mm OD
Tube Thickness 3.66 mm

ONLINE DUPLEX FILTER

Suitable to filter impurities and particles from sugar syrup, liquid, beverages.
Consist of 2 sets of filtration connected in parallel
Can be attached online in the interconnecting pipeline
Complete with 3 way valve to enable user to switch for either of the two
filtration media Capacity 500 LPH

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 ANNEXURE-I

GUIDE TO GOOD MANUFACTURING PRACTICE (GMP)

FOR MEDICINAL PRODUCT PRINCIPLE

The manufacture of sterile products is subject to special requirements in

order to minimise risks of microbiological contamination, and of particulate
and pyrogen contamination. Much depends on the skill, training and
attitudes of the personnel involved. Quality Assurance is particularly important,
and this type of manufacture must strictly follow carefully established and
validated methods of preparation and procedure. Sole reliance for sterility or
other quality aspects must not be placed on any terminal process or finished
product test.

Note: This guidance does not lay down detailed methods for determining the
microbiological and particulate cleanliness of air, surfaces, etc. Reference
should be made to other documents such as the EN/ISO Standards.

GENERAL

1. The manufacture of sterile products should be carried out in clean areas

entry to which should be through airlocks for personnel and/or for
equipment and materials. Clean areas should be maintained to an
appropriate cleanliness standard and supplied with air which has
passed through filters of an appropriate efficiency.

2. The various operations of component preparation, product

preparation and filling should be carried out in separate areas
within the clean area. Manufacturing operations are divided into two
categories; firstly those where the product is terminally sterilised, and
secondly those which are conducted aseptically at some or all stages.

3. Clean areas for the manufacture of sterile products are classified

according to the required characteristics of the environment. Each
manufacturing operation requires an appropriate environmental
cleanliness level in the operational state in order to minimise the risks
of particulate or microbial contamination of the product or materials
being handled.

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 In order to meet “in operation” conditions these areas should be
designed to reach certain specified air-cleanliness levels in the “at rest”
occupancy state. The “at rest” state is the condition where the
installation is installed and operating, complete with production
equipment but with no operating personnel present. The “in operation”
state is the condition where the installation is

functioning in the defined operating mode with the specified

number of personnel working.

The “in operation” and “at rest” states should be defined for each clean
room or suite of clean rooms.

For the manufacture of sterile medicinal products 4 grades

can be distinguished.

Grade A: The local zone for high risk operations, e.g. filling zone,
stopper bowls, open ampoules and vials, making aseptic connections.
Normally such conditions are provided by a laminar air flow work
station. Laminar air flow systems should provide a homogeneous air
speed in a range of 0.36 – 0.54 m/s (guidance value) at the working
position in open clean room applications. The maintenance of laminarity
should be demonstrated and validated.
A uni-directional air flow and lower velocities may be used in closed
isolators and glove boxes.

Grade B: For aseptic preparation and filling, this is the

background environment for the grade A zone.

Grade C and D: Clean areas for carrying out less critical stages in
the manufacture of sterile products

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 CLEAN ROOM AND CLEAN AIR DEVICE CLASSIFICATION

4. Clean rooms and clean air devices should be classified in accordance

with EN ISO 14644-1. Classification should be clearly differentiated
from operational process environmental monitoring. The maximum
permitted airborne particle concentration for each grade is given in the
following table:

Grade Maximum permitted number of particles/m³

equal to or greater than the tabulated size
At rest In operation
0.5µm 5.0µm 0.5µm 5.0µm
A 3,520 20 3,520 20
B 3,520 29 352,000 2,900
C 352,000 2,900 3,520,000 29,000
D 3,520,000 29,000 not defined not defined

5. For classification purposes in Grade A zones, a minimum sample volume of

1m³ should b e taken per sample location. For Grade A the airborne
particle classification is ISO 4.8 dictated by the limit for particles ≥5.0 µm.
For Grade B (at rest) the airborne particle classification is ISO 5 for both
considered particle sizes. For Grade C (at rest & in operation) the airborne
particle classification is ISO 7 and ISO 8 respectively. For Grade D (at
rest) the airborne particle classification is ISO 8. For classification
purposes EN/ISO 14644-1 methodology defines both the minimum
number of sample locations and the sample size based on the class limit
of the largest considered particle size and the method of evaluation of the
data collected.

6. Portable particle counters with a short length of sample tubing should be

used for classification purposes because of the relatively higher rate of
precipitation of particles ≥5.0µm in remote sampling systems with long
lengths of tubing. Isokinetic sample heads should be used in
unidirectional airflow systems.

7. “In operation” classification may be demonstrated during normal

operations, simulated operations or during media fills as worst-case
simulation is required for this. EN ISO 14644-2 provides information
on testing to demonstrate continued compliance with the assigned
cleanliness classifications.

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 CLEAN ROOM AND CLEAN AIR DEVICE MONITORING

8. Clean rooms and clean air devices should be routinely monitored in

operation and the monitoring locations based on a formal risk analysis
study and the results obtained during the classification of rooms and/or
clean air devices.

9. For Grade A zones, particle monitoring should be undertaken for

the full duration of critical processing, including equipment assembly,
except where justified by contaminants in the process that would damage
the particle counter or present a hazard, e.g. live organisms and
radiological hazards. In such cases monitoring during routine equipment
set up operations should be undertaken prior to exposure to the risk.
Monitoring during simulated operations should also be performed. The
Grade A zone should be monitored at such a frequency and with suitable
sample size that all interventions, transient events and any system
deterioration would be captured and alarms triggered if alert
limits are exceeded. It is accepted that it may not always be possible to
demonstrate low levels of ≥5.0 µm particles at the point of fill when
filling is in progress, due to the generation of particles or droplets from
the product itself.

10. It is recommended that a similar system be used for Grade B zones

although the sample frequency may be decreased. The importance
of the particle monitoring system should be determined by the
effectiveness of the segregation between the adjacent Grade A and B
zones. The Grade B zone should be monitored at such a frequency and
with suitable sample size that changes in levels of contamination and
any system deterioration would be captured and alarms triggered if alert
limits are exceeded.

11. Airborne particle monitoring systems may consist of independent

particle counters; a network of sequentially accessed sampling points
connected by manifold to a single particle counter; or a combination of
the two. The system selected must be appropriate for the particle size
considered. Where remote sampling systems are used, the length of
tubing and the radii of any bends in the tubing must be considered in the
context of particle losses in the tubing. The selection of the monitoring
system should take account of any risk presented by the materials used
in the manufacturing operation, for example those involving live
organisms or radiopharmaceuticals.

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 12. The sample sizes taken for monitoring purposes using automated
systems will usually be a function of the sampling rate of the
system used. It is not necessary for the sample volume to be the
same as that used for formal classification of clean rooms and clean air
devices.

13. In Grade A and B zones, the monitoring of the ≥5.0 µm particle

concentration count takes on a particular significance as it is an
important diagnostic tool for early detection of failure. The occasional
indication of ≥5.0 µm particle counts may be false counts due to
electronic noise, stray light, coincidence, etc. However consecutive or
regular counting of low levels is an indicator of a possible
contamination event and should be investigated. Such events may
indicate early failure of the HVAC system, filling equipment failure or
may also be diagnostic of poor practices during machine set-up and
routine operation.

14. The particle limits given in the table for the “at rest” state should be
achieved after a short “clean up” period of 15-20 minutes
(guidance value) in an unmanned state after completion of operations.

15. The monitoring of Grade C and D areas in operation should be

performed in accordance with the principles of quality risk
management. The requirements and alert/action limits will depend on
the nature of the operations carried out, but the recommended “clean
up period” should be attained.

16. Other characteristics such as temperature and relative humidity depend

on the product and nature of the operations carried out. These
parameters should not interfere with the defined cleanliness standard.

17. Examples of operations to be carried out in the various grades are given
in the table below (see also paragraphs 28 to 35):

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 Examples of operations for terminally sterilised
Grade
products
A Filling of products, when(see para. 28-30)
unusually at risk
C Preparation of solutions, when unusually at risk. Filling
D of products of solutions and components for subsequent
Preparation
filling
Examples of operations for aseptic preparations
Grade
(see para. 31-35)
A Aseptic preparation and filling
C Preparation of solutions to be filtered
D Handling of components after washing

18. Where aseptic operations are performed monitoring should be frequent

using methods such as settle plates, volumetric air and surface sampling
(e.g. swabs and contact plates). Sampling methods used in operation
should not interfere with zone protection. Results from monitoring
should be considered when reviewing batch documentation for finished
product release. Surfaces and personnel should be monitored after critical
operations.

Additional microbiological monitoring is also required outside

production operations, e.g. after validation of systems, cleaning and
sanitisation.

19. Recommended limits for microbiological monitoring of clean areas

during operation:

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 Recommended limits for microbial contamination
(a)
Grade Air Settle plates Contact plates Glove
(diam. 90 (diam. 55 print
sample
mm), cfu/4 mm), 5
cfu/m³
A <1 < (b)
1 <1 fingers
<1
B 10 5 5 5
C 100 50 25 -
D 200 100 50 -

Notes: (a) These are average values.

(b) Individual settle plates may be exposed for less than 4 hours.

20. Appropriate alert and action limits should be set for the results of
particulate and microbiological monitoring. If these limits are exceeded
operating procedures should prescribe corrective action.

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 ISOLATOR TECHNOLOGY

21. The utilisation of isolator technology to minimise human

interventions in processing areas may result in a significant
decrease in the risk of microbiological contamination of aseptically
manufactured products from the environment. There are many
possible designs of isolators and transfer devices. The isolator and
the background environment should be designed so that the required
air quality for the respective zones can be realised. Isolators are
constructed of various materials more or less prone to puncture
and leakage. Transfer devices may vary from a single door to double
door designs to fully sealed systems incorporating sterilisation
mechanisms.

22. The transfer of materials into and out of
potential sources of contamination. In
isolator is the local zone for high risk
recognised that laminar air flow may not
such devices.
the unit is one of the greatest
general the area inside the
manipulations, although it is
exist in the working zone of all

23. The air classification required for the background environment depends
on the design of the isolator and its application. It should be controlled
and for aseptic processing it should be at least grade D.

24. Isolators should be introduced only after appropriate validation.

Validation should take into account all critical factors of isolator
technology, for example the quality of the air inside and outside
(background) the isolator, sanitisation of the isolator, the transfer process
and isolator integrity.

25. Monitoring should be carried out routinely and should include frequent
leak testing of the isolator and glove/sleeve system.

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 TERMINALLY STERILISED PRODUCTS

26. Preparation of components and most products should be done in at

least a grade D environment in order to give low risk of microbial
and particulate contamination, suitable for filtration and sterilisation.
Where the product is at a high or unusual risk of microbial
contamination, (for example, because the product actively supports
microbial growth or must be held for a long period before sterilisation
or is necessarily processed not mainly in closed vessels), then
preparation should be carried out in a grade C environment.

27. Filling of products for terminal sterilisation should be carried out in at

least a grade C environment.

28. Where the product is at unusual risk of contamination from the

environment, for example because the filling operation is slow or the
containers are wide-necked or are necessarily exposed for more than a
few seconds before sealing, the filling should be done in a grade A zone
with at least a grade C background. Preparation and filling of ointments,
creams, suspensions and emulsions should generally be carried out in a
grade C environment before terminal sterilisation.

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 ASEPTIC PREPARATION

29. Components after washing should be handled in at least a

grade D environment. Handling of sterile starting materials and
components, unless subjected to sterilisation or filtration through a
micro-organism-retaining filter later in the process, should be done in a
grade A environment with grade B background.

30. Preparation of solutions which are to be sterile filtered during the

process should be done in a grade C environment; if not filtered, the
preparation of materials and products should be done in a grade A
environment with a grade B background.

31. Handling and filling of aseptically prepared products should be done in a

grade. A environment with a grade B background.

32. Prior to the completion of stoppering, transfer of partially closed

containers, as used in freeze drying, should be done either in a grade A
environment with grade B background or in sealed transfer trays in a
grade B environment.

33. Preparation and filling of sterile ointments, creams, suspensions and

emulsions should be done in a grade A environment, with a grade B
background, when the product is exposed and is not subsequently filtered.

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 PERSONNEL

34. Only the minimum number of personnel required should be present in

clean areas; this is particularly important during aseptic processing.
Inspections and controls should be conducted outside the clean areas as
far as possible.

35. All personnel (including those concerned with cleaning and

maintenance) employed in such areas should receive regular training in
disciplines relevant to the correct manufacture of sterile products.
This training should include reference to hygiene and to the basic
elements of microbiology. When outside staff who have not received
such training (e.g. building or maintenance contractors) need to be
brought in, particular care should be taken over their instruction and
supervision.

36. Staff who have been engaged in the processing of animal tissue materials
or of cultures of micro-organisms other than those used in the current
manufacturing process should not enter sterile-product areas unless
rigorous and clearly defined entry procedures have been followed.

37. High standards of personal hygiene and cleanliness are essential.

Personnel involved in the manufacture of sterile preparations should be
instructed to report any condition which may cause the shedding of
abnormal numbers or types of contaminants; periodic health checks for
such conditions are desirable. Actions to be taken about personnel who
could be introducing undue microbiological hazard should be decided by
a designated competent person.

38. Wristwatches, make-up and jewellery should not be worn in clean areas.

39. Changing and washing should follow a written procedure designed to

minimise contamination of clean area clothing or carry-through of
contaminants to the clean areas.

40. The clothing and its quality should be appropriate for the process and the
grade of the working area. It should be worn in such a way as to protect
the product from contamination.

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 41. The description of clothing required for each grade is given below:
• Grade D: Hair and, where relevant, beard should be covered. A
general protective suit and appropriate shoes or overshoes should
be worn. Appropriate measures should be taken to avoid any
contamination coming from outside the clean area.
• Grade C: Hair and where relevant beard and moustache should
be covered. A single or two-piece trouser suit, gathered at the
wrists and with high neck and appropriate shoes or overshoes
should be worn. They should shed virtually no fibres or particulate
matter.
• Grade A/B: Headgear should totally enclose hair and, where
relevant, beard and moustache; it should be tucked into the neck
of the suit; a face mask should be worn to prevent the
shedding of droplets. Appropriate sterilised, non-powdered
rubber or plastic gloves and sterilised or disinfected footwear
should be worn. Trouser-legs should be tucked inside the footwear
and garment sleeves into the gloves. The protective clothing
should shed virtually no fibres or particulate matter and retain
particles shed by the body.

42. Outdoor clothing should not be brought into changing rooms leading to
grade B and C rooms. For every worker in a grade A/B area, clean sterile
(sterilised or adequately sanitised) protective garments should be
provided at each work session. Gloves should be regularly disinfected
during operations. Masks and gloves should be changed at least for every
working session.

43. Clean area clothing should be cleaned and handled in such a way that it
does not gather additional contaminants which can later be shed. These
operations should follow written procedures. Separate laundry facilities
for such clothing are desirable. Inappropriate treatment of clothing will
damage fibres and may increase the risk of shedding of particles.

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 PREMISES

44. In clean areas, all exposed surfaces should be smooth, impervious

and unbroken in order to minimise the shedding or accumulation of
particles or micro-organisms and to permit the repeated application of
cleaning agents, and disinfectants where used.

45. To reduce accumulation of dust and to facilitate cleaning there should

be no uncleanable recesses and a minimum of projecting ledges, shelves,
cupboards and equipment. Doors s h o u l d b e d e s i g n e d t o a v o i d
those uncleanable recesses; sliding doors may be undesirable for this
reason.

46. False ceilings should be sealed to prevent contamination from the space
above them.

47. Pipes and ducts and other utilities should be installed so that they do not
create recesses, unsealed openings and surfaces which are difficult to
clean.

48. Sinks and drains should be prohibited in grade A/B areas used for
aseptic manufacture. In other areas air breaks should be fitted between
the machine or sink and the drains. Floor drains in lower grade clean
rooms should be fitted with traps or water seals to prevent backflow.

49. Changing rooms should be designed as airlocks and used to provide

physical separation of the different stages of changing and so minimise
microbial and particulate contamination of protective clothing. They
should be flushed effectively with filtered air. The final stage of the
changing room should, in the at-rest state, be the same grade as the
area into which it leads. The use of separate changing rooms for
entering and leaving clean areas is sometimes desirable. In general hand
washing facilities should be provided only in the first stage of the
changing rooms.

50. Both airlock doors should not be opened simultaneously. An interlocking

system or a visual and/or audible warning system should be operated to
prevent the opening of more than one door at a time.

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 51. A filtered air supply should maintain a positive pressure and an air flow
relative to surrounding areas of a lower grade under all operational
conditions and should flush the area effectively. Adjacent rooms of
different grades should have a pressure differential of 10-15 pascals
(guidance values). Particular attention should be paid to the protection of
the zone of greatest risk, that is, the immediate environment to which a
product and cleaned components which contact the product are
exposed. The various recommendations regarding air supplies and
pressure differentials may need to be modified where it becomes
necessary to contain some materials, e.g. pathogenic, highly toxic,
radioactive or live viral or bacterial materials or products.
Decontamination of facilities and treatment of air leaving a clean area may
be necessary for some operations.

52. It should be demonstrated that air-flow patterns do not present a

contamination risk, e.g. care should be taken to ensure that air flows do
not distribute particles from a particlegenerating person, operation or
machine to a zone of higher product risk.

53. A warning system should be provided to indicate failure in the air

supply. Indicators of pressure differences should be fitted between areas
where these differences are important. These pressure differences
should be recorded regularly or otherwise documented.

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 EQUIPMENT

54. A conveyor belt should not pass through a partition between a grade A
or B area and a processing area of lower air cleanliness, unless the belt
itself is continually sterilised (e.g. in a sterilising tunnel).

55. As far as practicable equipment, fittings and services should be designed

and installed so that operations, maintenance and repairs can be carried
out outside the clean area. If sterilisation is required, it should be
carried out, wherever possible, after complete reassembly.

56. When equipment maintenance has been carried out within the clean
area, the area should be cleaned, disinfected and/or sterilised where
appropriate, before processing recommences if the required standards
of cleanliness and/or asepsis have not been maintained during the work.

57. Water treatment plants and distribution systems should be

designed, constructed and maintained so as to ensure a reliable source
of water of an appropriate q u a l i t y . They s h o u l d n ot b e op e r a t e d
beyond their designed capacity. Water for injections should be
produced, stored and distributed in a manner which prevents microbial
growth, for example by constant circulation at a temperature above 70°C.

58. All equipment such as sterilisers, air handling and filtration systems,
air vent and gas filters, water treatment, generation, storage and
distribution systems should be subject to validation and planned
maintenance; their return to use should be approved.

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 SANITATION

59. The sanitation of clean areas is particularly important. They should be

cleaned thoroughly in accordance with a written programme. Where
disinfectants are used, more t h a n o n e t y p e s h o u l d b e employed.
Monitoring s h o u l d b e undertaken regularly in order to detect the
development of resistant strains.

60. Disinfectants and detergents should be monitored for microbial

contamination; dilutions should be kept in previously cleaned containers
and should only be stored for defined periods unless sterilised.
Disinfectants and detergents used in Grades A and B areas should be
sterile prior to use.

61. Fumigation of clean areas may be useful for reducing microbiological

contamination in inaccessible places.

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 PROCESSING

62. Precautions to minimise contamination should be taken during all

processing stages including the stages before sterilisation.

63. Preparations of microbiological origin should not be made or filled in areas

used for the processing of other medicinal products; however,
vaccines of dead organisms or of bacterial extracts may be filled, after
inactivation, in the same premises as other sterile medicinal products.

64. Validation of aseptic processing should include a process simulation test

using a nutrient medium (media fill).Selection of the nutrient medium
should be made based on dosage form of the product and selectivity,
clarity, concentration and suitability for sterilisation of the nutrient
medium.

65. The process simulation test should imitate as closely as possible the
routine aseptic manufacturing process and include all the
critical subsequent manufacturing steps. It should also take into
account various interventions known to occur during normal production
as well as worst-case situations.

66. Process simulation tests should be performed as initial validation with

three consecutive satisfactory simulation tests per shift and repeated
at defined intervals and after any significant modification to the HVAC-
system, equipment, process and number of shifts. Normally process
simulation tests should be repeated twice a year per shift and process.

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 67. The number of containers used for media fills should be sufficient to
enable a valid evaluation. For small batches, the number of containers
for media fills should at least equal the size of the product batch. The
target should be zero growth and the following should apply:
• When filling fewer than 5000 units, no contaminated units
should be detected.
• When filling 5,000 to 10,000 units:
a) One (1) contaminated unit should result in an
investigation, including consideration of a repeat media fill;
b) Two (2) contaminated units are considered cause
for revalidation, following investigation.
• When filling more than 10,000 units:
a) One (1) contaminated unit should result in an investigation;
b) Two (2) contaminated units are considered cause
for revalidation, following investigation1.

68. For any run size, intermittent incidents of microbial contamination

may be indicative of low-level contamination that should be
investigated. Investigation of gross failures should include the potential
impact on the sterility assurance of batches manufactured since the last
successful media fill.

69. Care should be taken that any validation does not compromise the
processes.

70. Water sources, water treatment equipment and treated water should be
monitored regularly for chemical and biological contamination
and, as appropriate, for endotoxins. Records should be maintained of the
results of the monitoring and of any action taken.

71. Activities in clean areas and especially when aseptic operations are in
progress should be kept to a minimum and movement of personnel
should be controlled and methodical, to avoid excessive shedding of
particles and organisms due to over-vigorous activity. The ambient
temperature and humidity should not be uncomfortably high because of
the nature of the garments worn.

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 72. Microbiological contamination of starting materials should be minimal.
Specifications should include requirements for microbiological quality
when the need for this has been indicated by monitoring.

73. Containers and materials liable to generate fibres should be minimised in

clean areas.

74. Where appropriate, measures should be taken to minimise the

particulate contamination of the end product.

75. Components, containers and equipment should be handled after the

final cleaning process in such a way that they are not recontaminated.

76. The interval between the washing and drying and the
sterilisation of components, containers and equipment as well as
between their sterilisation and use should be minimised and subject to
a time-limit appropriate to the storage conditions.

77. The time between the start of the preparation of a solution and its
sterilisation or filtration through a micro-organism-retaining filter should
be minimised. There should be a set maximum permissible time for
each product that takes into account its composition and the prescribed
method of storage.

78. The bioburden sh ould be monitored before sterilisation. There

should be working limits on contamination immediately before
sterilisation, which are related to the efficiency of the method to be
used. Bioburden assay should be performed on each batch for both
aseptically filled product and terminally sterilised products. Where
overkill sterilisation parameters are set for terminally sterilised products,
bioburden might be monitored only at suitable scheduled intervals. For
parametric release systems, bioburden assay should be performed
on each batch and considered as an in-process test. Where
appropriate the level of endotoxins should be monitored. All
solutions, in particular large volume infusion fluids, should be
passed through a micro- organism-retaining filter, if possible sited
immediately before filling.

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 79. Components, containers, equipment and any other article required in a
clean area where aseptic work takes place should be sterilised and
passed into the area through double-ended sterilisers sealed into the
wall, or by a procedure which achieves the same objective of not
introducing contamination. Non- combustible gases should be passed
through micro-organism retentive filters.

80. The efficacy of any new procedure should be validated, and the
validation verified at scheduled intervals based on performance
history or when any significant change is made in the process or
equipment

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 STERILISATION
81. All sterilization processes should be validated. Particular attention
should be given when the adopted sterilization method is not described
in the current edition of the European Pharmacopoeia, or when it is used
for a product which is not a simple aqueous or oily solution. Where
possible, heat sterilization is the method of choice. In any case, the
sterilization process must be in accordance with the marketing and
manufacturing authorizations.

82. Before any sterilization process is adopted its suitability for the product
and its efficacy in achieving the desired sterilizing conditions in all parts
of each type of load to be processed should be demonstrated by physical
measurements and by biological indicators where appropriate. The validity
of the process should be verified at scheduled intervals, at least
annually, and whenever significant modifications have been made to the
equipment. Records should be kept of the results.

83. For effective sterilization the whole of the material must be subjected to
the required treatment and the process should be designed to ensure
that this is achieved.

84. Validated loading patterns should be established for all sterilization

processes.

85. Biological indicators should be considered as an additional method

for monitoring the sterilization. They should be stored and used according
to the manufacturer’s instructions, and their quality checked by positive
controls. If biological indicators are used, strict precautions should
be taken to avoid transferring microbial contamination from them.

86. There should be a clear means of differentiating products which have not
been sterilized from those which have. Each basket, tray or other carrier
of products or components should be clearly labelled with the material
name, its batch number and an indication of whether or not it has
been sterilized. Indicators such as autoclave tape may be used, where
appropriate, to indicate whether or not a batch (or sub-batch) has passed
through a sterilization process, but they do not give a reliable indication
that the lot is, in fact, sterile.

87. Sterilization records should be available for each sterilization run. They
should be approved as part of the batch release procedure.

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 STERILISATION BY HEAT

88. Each heat sterilization cycle should be recorded on a time/temperature

chart with a sufficiently large scale or by other appropriate equipment
with suitable accuracy and precision. The position of the temperature
probes used for controlling and/or recording should have been
determined during the validation, and where applicable also checked
against a second independent temperature probe located at the same
position.

89. Chemical or biological indicators may also be used, but should not take
the place of physical measurements.

90. Sufficient time must be allowed for the whole of the load to reach the
required temperature before measurement of the sterilizing time-period
is commenced. This time must be determined for each type of load to be
processed.

91. After the high temperature phase of a heat sterilization cycle,

precautions should be taken against contamination of a sterilized load
during cooling. Any cooling fluid or gas in contact with the product
should be sterilized unless it can be shown that any leaking container
would not be approved for use.

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 MOIST HEAT

92. Both temperature and pressure should be used to monitor the process.
Control instrumentation should normally be independent of monitoring
instrumentation and recording charts. Where automated control and
monitoring systems are used for these applications they should be
validated to ensure that critical process requirements are met. System
and cycle faults should be registered by the system and observed by the
operator. The reading of the independent temperature indicator should
be routinely checked against the chart recorder during the sterilization
period. For sterilizers fitted with a drain at the bottom of the chamber,
it may also be necessary to record the temperature at this position,
throughout the sterilization period. There should be frequent leak tests on
the chamber when a vacuum phase is part of the cycle.

93. The items to be sterilized, other than products in sealed containers,

should be wrapped in a material which allows removal of air and
penetration of steam but which prevents recontamination after
sterilization. All parts of the load should be in contact with the sterilizing
agent at the required temperature for the required time.

94. Care should be taken to ensure that steam used for sterilization is of
suitable quality and does not contain additives at a level which
could cause contamination of product or equipment.

DRY HEAT
95. The process used should include air circulation within the chamber
and the maintenance of a positive pressure to prevent the entry of non-
sterile air. Any air admitted should be passed through a HEPA filter.
Where this process is also intended to remove pyrogens, challenge tests
using endotoxins should be used as part of the validation.

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 STERILISATION BY RADIATION
96. Radiation sterilization is used mainly for the sterilization of heat sensitive
materials and products. Many medicinal products and some packaging
materials are radiation-sensitive, so this method is permissible only when
the absence of deleterious effects on the product has been confirmed
experimentally. Ultraviolet irradiation is not normally an acceptable
method of sterilization.

97. During the sterilization procedure the radiation dose should be

measured. For this purpose, dosimetry indicators which are independent
of dose rate should be used, giving a quantitative measurement of the
dose received by the product itself. Dosimeters should be inserted in the
load in sufficient number and close enough together to ensure that there
is always a dosimeter in the irradiator. Where plastic dosimeters are
used they should be used within the time-limit of their calibration.
Dosimeter absorbances should be read within a short period after
exposure to radiation.

98. Biological indicators may be used as an additional control

99. Validation procedures should ensure that the effects of variations in

density of the packages are considered.

100. Materials handling procedures should prevent mix-up between irradiated

and non irradiated materials. Radiation sensitive colour disks should also
be used on each package to differentiate between packages which have
been subjected to irradiation and those which have not.

101. The total radiation dose should be administered within a predetermined

time span.

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 STERILISATION WITH ETHYLENE OXIDE

102. This method should only be used when no other method is practicable.
During process validation it should be shown that there is no damaging
effect on the product and that the conditions and time allowed for
degassing are such as to reduce any residual gas and reaction products
to defined acceptable limits for the type of product or material.

103. Direct contact between gas and microbial cells is essential; precautions
should be taken to avoid the presence of organisms likely to be enclosed
in material such as crystals or dried protein. The nature and
quantity of packaging materials can significantly affect the process.

104. Before exposure to the gas, materials should be brought into

equilibrium with the humidity and temperature required by the process.
The time required for this should be balanced against the opposing need
to minimize the time before sterilization.

105. Each sterilization cycle should be monitored with suitable biological

indicators, using the appropriate number of test pieces distributed
throughout the load. The information so obtained should form part of the
batch record.

106. For each sterilization cycle, records should be made of the time
taken to complete the cycle, of the pressure, temperature and
humidity within the chamber during the process and of the gas
concentration and of the total amount of gas used. The pressure
and temperature should be recorded throughout the cycle on a chart.
The record(s) should form part of the batch record.

107. After sterilization, the load should be stored in a controlled manner

under ventilated conditions to allow residual gas and reaction products
to reduce to the defined level. This process should be validated.

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 FILTRATION OF MEDICINAL PRODUCTS WHICH CANNOT BE
STERILISED IN THEIR FINAL CONTAINER

108. Filtration alone is not considered sufficient when sterilization in

the final container is possible. With regard to methods currently
available, steam sterilization is to be preferred. If the product cannot
be sterilized in the final container, solutions or liquids can be filtered
through a sterile filter of nominal pore size of 0.22 micron (or less), or
with at least equivalent micro-organism retaining properties, into a
previously sterilized container. Such filters can remove most bacteria
and moulds, but not all viruses or mycoplasmas. Consideration
should be given to complementing the filtration process with some
degree of heat treatment.

109. Due to the potential additional risks of the filtration method as

compared with other sterilisation processes, a second filtration via a
further sterilised micro- organism retaining filter, immediately prior to
filling, may be advisable. The final sterile filtration should be carried out
as close as possible to the filling point.

110. Fibre-shedding characteristics of filters should be minimal.

111. The integrity of the sterilised filter should be verified before use and
should be confirmed immediately after use by an appropriate method
such as a bubble point, diffusive flow or pressure hold test. The time
taken to filter a known volume of bulk solution and the pressure
difference to be used across the filter should be determined during
validation and any significant differences from this during routine
manufacturing should be noted and investigated. Results of these
checks should be included in the batch record. The integrity of critical gas
and air vent filters should be confirmed after use. The integrity of other
filters should be confirmed at appropriate intervals.

112. The same filter should not be used for more than one working day unless
such use has been validated.

113. The filter should not affect the product by removal of ingredients from it
or by release of substances into it.

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 FINISHING OF STERILE PRODUCTS

114. Partially stoppered freeze drying vials should be maintained under

Grade A conditions at all times until the stopper is fully inserted.

115. Containers should be closed by appropriately validated methods.

Containers closed by fusion, e.g. glass or plastic ampoules should be
subject to 100%

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 SUPPLIERS OF RAW MATERIALS

POTASSIUM PERMANGANATE

MR. ABHIJIT GHOSH

BASIC & SYNTHETIC CHEMICALS PVT LTD
17D, NORTH ROAD, JADAVPUR,
KOLKATA-700032, WEST BENGAL
Phone:913324123565/3240/4465
Email: basynth@vsnl.net

MR. MITHUN THAKKAR

PRABHAT DYE CHEM INDUSTRIES
GOPMANI CHAMBERS, 34,
DARIYAS THAN STREET, GROUND FLOOR,
MUMBAI-400003, MAHARASHTRA
Phone:912266312745/66312746/23447974
Email: mjthakkar@vsnl.net

SODIUM CHLORIDE (I.P. Grade)

MR. ABHIJIT GHOSH

BASIC & SYNTHETIC CHEMICALS PVT LTD
17D, NORTH ROAD, JADAVPUR,
KOLKATA-700032, WEST BENGAL
Fax:Phone:913324123565/3240/4465
Email: basynth@vsnl.net

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MR. BIPIN MEHTA
BIP CHEMICALS
404, PARTH FLATS,
NR. SANSKAR MANDAL,
BHAVNAGAR-364002, GUJARAT
Phone:912782561275/2445314/2561175/2445315/2448987/2
Email: bipchem@yahoo.co.in

MR. AMIT PATEL, MR. B. N. PATEL

CANTON LABORATORIES PVT LTD
110-A&B, G.I.D.C. ESTATE, MAKARPURA,
VADODARA-390010, GUJARAT
Fax:Phone:912652638084/2638001
Email: canton_inc@yahoo.com,
info@cantonindia.com

MR. HASANABBAS GULAMABBAS KADIWALA

GULKAS PHARMA PVT LTD
914/1, CHHATRAL GIDC,
DIST.- GANDHINAGAR,
KALOL-382729, GUJARAT
Fax:Phone:912764233492
Email: gulkaspharma@rediffmail.com

MR. MUKESH SHAH,

INDIANA CHEM-PORT
349, GIDC, MAKARPURA,
VADODARA-390010, GUJARAT
Fax:Phone:912652638667/2643726
Email: indiana.chemport@rediffmail.com

www.eiribooksandprojectreports.com 173
DEXTROSE

MR. K. B. CHOKSHI,
MR. RAHUL P. JHAVERI, MR. AMUL
SHETH, MR. PRADEEP BORA
ANIL PRODUCTS LTD
ANIL ROAD, NARODA ROAD,
POST BOX NO. 10009,
AHMEDABAD-380025, GUJARAT
Fax:Phone:917922202722/22203222
Email: kamlesh@anil.co.in,
rahul@anil.co.in,
project@anilpr

BIPIN PANCHAL
JAGDISH MACHINERIES PVT LTD
3, SHARADA INDUSTRIAL ESTATE,
NEAR PICKER'S FACTORY,
ANIL STARCH ROAD ,SARASPUR
AHMEDABAD-380018, GUJARAT
Fax:Phone:079-2201455

MR. RATHISAN NAIR

MARINE CHEMICALS
DEEPA BUILDING,
SANTO GOPALAN ROAD, CHULLICKAL,
KOCHI-682005, KERALA
Fax:Phone:914842227241/2223703/2220802
Email: marine@vsnl.com

www.eiribooksandprojectreports.com 174
MR. DIGVIJAY SHARMA
ORIGIN AGROSTAR LTD
BIOTECH CENTRE, 56,
IST MAIN ROAD, WEST CIT NAGAR,
CHENNAI-600035, TAMILNADU
Fax:Phone:914424320554

MR. MUKESH JAIN, MR. NILESH PATEL

RIDDHI SIDDHI GLUCO BIOLS LTD
701, SAKAR-I,
OPP. GANDHIGRAM RAILWAY STATION,
ASHRAM ROAD, AHMEDABAD-380009,
GUJARAT
Fax:Phone:917926581000
Email: ahmd@riddhisiddhi.co.in,
nileshbpatel@hotmail.com

S. V. SHANMUGA VADIVELU, DIRECTOR

RIDDHI-SIDDHI GLUCO-BIOLS LTD
701, SAKAR - I, OFF. ASHRAM ROAD
AHMEDABAD-380006, GUJARAT
Mobile:Fax:Phone:+91 79 658 1000
Email: sdroy_rsgbl@rediffmail.com

MR. ARUN R. HARCHEKAR

S S TECHNO SERVICES PVT LTD
301, POONAM PLAZA,
MARKET YARD ROAD,
PUNE-411037, MAHARASHTRA
Fax:Phone:912024271775/24274360/27111074
Email: sstechno@vsnl.com

www.eiribooksandprojectreports.com 175
HDPE ROLL SHEET FOR PACKAGING

Dhiren Polymers
No. 203, Inrdaprastha, 3rd Dominic Lane,
Orlem, Malad West, Mumbai,
Maharashtra - 400 064, India
Phone: +(91)-(22)-66990590
Mobile: +(91)-9321732615 / 9820588603

AG Poly Packs Private Limited

No. 310, Devika Tower, Chandra Nagar,
Near Anand Vihar, Near Dilshad Garden,
Metro Station, Ghaziabad,
Uttar Pradesh - 201 011, India
Phone: +(91)-(120)-4661900
Fax: +(91)-(120)-4562314
Mobile: +(91)-9811832327 / 9811332327

Track Manufacturing Co. Pvt. Ltd

No. 3, Asia House, KG Marg,
Opposite Bhartiya Vidya Bhawan,
New Delhi, Delhi - 110 001, India
Phone: +(91)-(11)-23070042
Fax: +(91)-(11)-23384131
Mobile: +(91)-9310062508

S. K. Polymers
A-85, Okhla Industrial Phase-2,
New Delhi, Delhi - 110 020, India
Phone: +(91)-(11)-40546066 / 26386065
Mobile: +(91)-9810397657 / 9910252538

www.eiribooksandprojectreports.com 176
Capt. Ebi Moses
Daniel Plastic Dispensers
305, Cape Road, Kottar,
Nagercoil-629002, Tamil Nadu
Phone:914652425263
Email:drmoses2003@yahoo.co.in

Mr. Avinash Datrange

Datsons Plastics
50/9, Wadgaonsheri
Pune-411014, Maharashtra
Fax:Phone:020-27032290

Mg. Director
Himanshu Plastics
D-30, Dsidc Indl. Complex,
Rohtak Road, Nangloi
New Delhi-110041
Phone:011-25476203

Mr. S C Rathi
Innovative Tech Pack Ltd
51,, Roz-Ka-Meo,,
Indl. Area. Sohna,
Gurgaon, Haryana
Phone:0124-2362567, 2363540,

www.eiribooksandprojectreports.com 177
STERILIZING EQUIPMENTS

Mr. Nitin Narang, Mr. Sudhir Narang

Apothecaries Sundries Manufacturing Co
Asco House 13, Community Centre,
Behind Canara Bank, Mayapury Phase-1,
New Delhi-110064
Fax:Phone:911145511541
Email: nn@ascomedical.com

Mr. K Bhaskaran
Filtra Teknopak Cleanroom Systems Ltd
Rishi Tower No. 1,
Off. Western Express Way,
Mumbai-400061, Maharashtra
Phone:912512801233/-91-22-28968931/32/33
Email: teknopak@vsnl.com

Mr. S. K. Narula/ Mr. Prashant Narula

Narula Udyog (I) Pvt Ltd
A-75, Naraina Insustrial Area,
Phase-1, New Delhi-110028
Phone:011-25795757, 25798179,25798179, 51063888

Mr. P. P. Bhardwaj
Speciality Meditech Pvt Ltd
C-23, Raghu Shree,
Jaisingh Highway, Bani Park
Jaipur-302016, Rajasthan
Phone:911415105136/5170725/2302849
Email: speciality_meditech@yahoo.com

Track Manufacturing Co Pvt Ltd

3, Asia House, K.G. Marg,
Connaught Place, New Delhi-110001
Fax:Phone:911123070042
Email: track@trackexports.net

www.eiribooksandprojectreports.com 178
PM METER

MR. RAJAN
ACCUMAX INDIA
C-5A/184, JANAK PURI,
NEW DELHI-110058
Fax:Phone:911165863026
Email: accumax2000@yahoo.com

MR. ANANT D. PADUBIDRE

ACHALA ENGINEERING & ELECTRONICS
MO-15, DARSHAN GAS COMPOUND,
NR. SHIVAJI HOSPITAL, KALWA (WEST),
THANE-400605, MAHARASHTRA
Fax:Phone:912225381146
Email: achalaee@mtnl.net.in

MR. RAJ VIJ, MR. RAJ VIJ

AMBALA ELECTRONICS
3378, GURU NANAK MARG,
AMBALA CANTT., AMBALA-133001,
HARYANA
Phone:911712619216
Email: laboscience@yahoo.co.in,
veetro@satyam.net.in

Mg. Director
DBK INSTRUMENTS
28 INTERLINK INDL. ESTATE,
CAVES ROAD, JOGESHWARI (E)
MUMBAI-400060, MAHARASHTRA
Fax:Phone:022-28375586
Email: dbklab@hotmail.com

www.eiribooksandprojectreports.com 179
LABELING MACHINES

MR. ASHWANI SOODH

BALSONS CORPORATION
BLUE HEAVEN BUILDING,
OLD RAIWAY ROAD,
GURGAON, HARYANA
Fax:Phone:0124-2339065-66,
Email: balsons@hotmail.com;
balsons@id.eth.net

MR. KANTIBHAI GAJJAR, MR. NIPAM P. GAJJAR

BHAGWATI ENGINEERS
7, PANCHWATI ESTATE,
NR. ODHAV FIRE STATION, G.I.D.C,
AHMEDABAD-382415, GUJARAT
Email: nipamgajjar@yahoo.co.in

MS. SHWETA , MR. PALVINDER SINGH

DASH INTERNATIONAL
Z-24, OKHLA INDUSTRIAL AREA,
PHASE-II, NEW DELHI-110020
Fax:Phone:911141616571/41709919/41709929/26053524/260535
Email: dashintl@gmail.com, dashintl_chn@rediffmail.com

MR. VINOD PATEL

KOLDPACK MACHINERIES PVT LTD
PLOT NO.4, SAHJANAND ESTATE,
NEAR GOTA RAILWAY CROSSING, GOTA,
AHMEDABAD-382481, GUJARAT
Fax:Phone:917932942433
Email: info@koldpackindia.com

www.eiribooksandprojectreports.com 180
MR. K ARUMUGAM
MAHALAKSHMI INDUSTRIES
2/374, PILLAYA KOI STREET,
CHENNAI-600074, TAMILNADU
Fax:Phone:914422631334
Email: mahaindus@gmail.com

MR. HARESH PATEL, MR. HARESH PATEL

MARUTI AUTO MAC ENGINEERS
B-23/24, AMBICA NAGAR INDUSTRIAL ESTATE,
OPPOSITE HANUMANJI TEMPLE,
AMBICA NAGAR, ODHAV,
AHMEDABAD-382415, GUJARAT
Fax:Phone:917922975760/22874026
Email: maruti_123@yahoo.com, maruti123@gmail.com

MMM BUXABHOY & CO

140, 1ST FLOOR, SARANG STREET
MUMBAI-400003, MAHARASHTRA
Fax:Phone:022-23442902
Email: mmmb@vsnl.com

SHRINK PACKAGING SYSTEMS PVT LTD

170, FIE, PATPARGANJ,
DELHI-110092
Fax:Phone:911142141646-48
Email: dinesh.chadha@clearpack.com

SPR GROUP
49-1ST FLOOR, RAMA ROAD,
NAJAFGARH ROAD INDUSTRIAL AREA,
NEW DELHI-110015
Fax:Phone:911165458422,25411866
Email: info@sprsales.com

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TANKS

A M POWER EQUIPMENT
Ashok Chambers, 4-6, S D Road,
Secunderabad-500004,
Andhra Pradesh
Fax:Phone:+91 40 27892919, 27893818
Email: skmk_10873@yahoo.com

AERO ENGINEERS
Plot No. 3419, Phase IV, GIDC,
Vatva, Ahmedabad-382445, Gujarat
Fax:Phone:+91 79 584 0720, +91 79 584 1295
Email: aero@icenet.net

AFFAN ENGINEERS
D-222/31, T.T.C. Ind. Area,
MIDC, Shirwane,
Navi Mumbai-400706,
Maharashtra
Fax:Phone:022-27631182/26125388

AIR FLOW PVT LTD

13/1090, Naiwalan,
Karol Bagh, New Delhi-110005
Fax:Phone:011-25721236
Email: airflow@del3.vsnl.net.in

Joitaram S. Patel, Manager

AIRTECH ENGINEERS
32, P.D. Corporation Estate,
Near Revabhai Estaet CTM,
Ahmedabad-380026, Gujarat
Phone:+91 79 585 4303

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BOILER

D. N. Reddy, MD
A P MOTRONIX PVT LTD
3-18-3, Pragathi Nagar,
Ramanthapur, Hyderabad-500013,
Andhra Pradesh
Fax:Phone:040-27038560/27031929
Email: apmotronix@satyam.net.in

K. C. Rana, MD
A V U ENGINEERS PVT LTD
A-15, A.P.I.E., Balanagar
Hyderabad-500037,
Andhra Pradesh
Fax:Phone:+91 40 237 73235, +91 40 237 72343
Email: avuhyderabad@rediffmail.com

J. K. Bhattacharya, Director & CE

ABB ABL PROJECTS LTD
II ACI House, 1 & 3, Brabourne Road,
Kolkata-700001, West Bengal
Fax:Phone:+91 33 222 05401

Mr. M. G. Patel
ACCU TECH ENGINEERING CO
34, P. D. Estate,
Near Revabhai Estate,
C.T.M. Amraiwadi,
Ahmedabad-380026, Gujarat
Fax:Phone:079-5856596
Email: accutech@wilnetonline.net

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M. Sekar, Director
AISHWARYA BOILERS LTD
231, New Tiny Sector,
Ambattur Industrial Estate,
Chennai-600058, Tamil Nadu
Fax:Phone:+91 44 28264935, 28229458

Mr.Subhash Rana
AKSENGNIEERING CO
468, SIDCO Industrial Estate,
Ambattur, Chennai-600098,
Tamil Nadu
Fax:Phone:044-26250052

Mr. Kailash Magolra

ALBATRON FINE CHEM LTD
40, Dlf Industrial Area,
Alishan Building, Kirti Nagar,
New Delhi-110015
Fax:Phone:011-25161151/25114789/25100768
Email: albatross@vsnl.com

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FILTER PRESS

Mr. Vishal Shah

AMAR EQUIPMENTS PVT LTD
6, Parmar Ind. Estate,
Bel Bazar, Kurla(W),
Mumbai-400070, Maharashtra
Fax:Phone:022-25140169/55953029/25109565
Email: amarengg@vsnl.com

Hiten B. Karani, Director

AMULYA INDUSTRIES
10, Maheshwar Deep,
R.B. Mehta Marg, Ghatkopar (E),
Mumbai-400077, Maharashtra
Fax:Phone:+91 22 285 20116
Email: aamulya@vsnl.net

Mg. Director
AZAD ENGG CO
C-83, B S Road Indl. Area
Ghaziabad-201001, Uttar Pradesh
Fax:Phone:0120-2700708
Email: azadengg@satyam.net.in

Ramesh Patel, Director

DINSHAW FILTRATION SYSTEMS PVT LTD
265, Maulana Shaukatali Road,
Nr. Royal Cinema, Grant Road Corner
Mumbai-400008, Maharashtra
Fax:Phone:+91 22 238 64841, +91 22 238 64789
Email: dinshaw@bom3.vsnl.net.in

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Mr. Lalit Vaghista
DIVA ENVITEC
Ajit Industrial Complex,
No. 104, W.E. Highway,
Mira Road, Mumbai-400068, Maharashtra
Fax:Phone:022-28454252
Email: info@aboutfilter.com

Mg. Director
FLUIDTECH BOILERS PVT LTD
Plot No-2703, Phase-IV,
GIDC Vatva-382445, Gujarat
Fax:Phone:079-2583010
Email: info@fluidltd.com

C. J. Patel, MD
FLUIDTECH BOILERS PVT LTD
2703, Phase IV, GIDC, Vatva,
Ahmedabad-382445, Gujarat
Fax:Phone:+91 79 5830105, 5830106
Email: fluidltd@yahoo.com info@fluidltd.com

Mg. Director
GURUKRUPA ENGINEERING WORKS
24/A, P.R. Estate,
Nagarwel Hanuman Road,
Rakhial, Ahmedabad, Gujarat
Phone:079-22748523/22743647

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LABORATORY EQUIPMENTS

Mg. Director
A POPULAR SCIENTIFIC APPARATUS WORKSHOP
3724, Opp. Kali Bari Mandir
Ambala Cantt.-133001, Haryana
Fax:Phone:0171-2641462, 2619578, 2600082
Email: psawindia@satyam.net.in

S. K. Puri, Proprietor
ACADEMIC LAW AND SERIALS
F 22 B/3, Laxmi Nagar
New Delhi-110092
Fax:Phone:+91 11 22413394, 22420827
Email: alsindia@helintinet.com

Mr P Sridhar
B S PYROMATIC (I) PVT LTD
Post Box 6033, 27/1,
Xii Avenue, Ashok Nagar
Chennai-600083, Tamil Nadu
Fax:Phone:044-24890009/24890710

Syed M., Customer Support Executive

BIOMATRIX SYSTEMS & SERVICES
252, Lane No. 3,
Street No. 6, West Marredpally
Secunderabad-500026, Andhra Pradesh
Fax:Phone:+91 40 553 14329
Email: biomatrix25@hotmail.com

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Mr. Saurabh Mehta
FOSS ELECTRIC (I)
Central Camera Bldg.,
D. N. Road, Fort
Mumbai-400001, Maharashtra
Fax:Phone:022-22610682
Email: ccc3@vsnl.com

Mr P K Chowdhury
GANGES TRADE AGENCY
33/1, N. S. Road, Room No. 350
Kolkata-700001, West Bengal
Fax:Phone:033-22214386/22433804
Email: pkganges@cal2.vsnl.net.in

Mr Ashok Gupta
GUPTA AGENCIES
5341, Punjabi Mohalla,
Ambala Cantt
Ambala-133001, Haryana
Fax:Phone:0171-643058/642016
Email: labfab766@hotmail.com

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MIXER

Mg. Director
ALFATECH TECHNOLOGIES INC
PRAKASH MARBLE COMP.
OPP. DHAWANS NURSERY,
UPAVAN THANE-400606, MAHARASHTRA
Fax:Phone:022-25437438
Email: adityachemopharma@hotmail.com

Mg. Director
ANJALI MARKETING & RESEARCH CENTRE
ANJALI HOUSE, LIBERTY GARDEN,
R NO.1, MALAD (W),
MUMBAI-400064, MAHARASHTRA
Fax:Phone:022-8807711
Email: anjali@bom5.vsnl.net.in

MR. ARUN PATEL

ASHISH ENGINEERING WORKS
C-1, SONAL INDUSTRIAL ESTATE,
MUMBAI-400001, MAHARASHTRA
Phone:912228570450
Email: ashishenggworks@rediffmail.com

MR. SAIFEE RAIPURWALA

BIRLA ELECTRICALS LTD
DALAMAL HOUSE, NARIMAN POINT
MUMBAI-400021, MAHARASHTRA
Fax:Phone:91-2281173, 56344137

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MR. SURANI
BOMBAY SALES AGENCY
93/5, DR. MAHESHWARI ROAD,
MARINE HOUSE, MUMBAI-400009,
MAHARASHTRA
Fax:Phone:91-23721670, 23735032

MR. YASHPAL MINOTRA

DEVIK ENGINEERS
G-1/3, SWAMI SMARTHA,
SUS ROAD, PASHAN,
PUNE-411021, MAHARASHTRA
Fax:Phone:912032520012
Email: devik_1@yahoo.com

MR. BAPU NARAYAN SAWANT

ELECTRO-LAB INDUSTRIES
SHANKARBHAI PATEL COMPOUND,
MULUND LINK ROAD, VEET BHATTI,
NEAR ITALIAN TEXTILE MILL,
GOREGOAN (EAST),
MUMBAI-400063, MAHARASHTRA
Fax:Phone:912230936956
Email: electrolab3@hotmail.com

MR. NAVNATH AWTADE

HOMELINK SALES & MARKETING PVT LTD
679/1A/1B, OSTWAL CORNER,
OPP. RJARSHI SHAHU SAHAKARI BANK,
BIBWEWADI, PUNE-411037, MAHARASHTRA
Fax:Phone:020-24217447,24230373,24230372
Email: rupali_2000@operamail.com

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 EMPTY IV BAG MANUFACTURER AND SUPPLIER IN INDIA

Aishwarya Lifesciences
127, Swastik Plaza, Pokhran
Road-2, Thane,Nr-Mumbai,
Maharashtra -400601, India.
Phone: +91 22 32 608581
+91 22 21 731215
Mobile: +91 98 33 075279
+91 93 24 644372
Web: www.aishwaryahealthcare.com

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 COMPLETE PLANT SUPPLIERS

Hunan FE Pharmaceutical Machinery Co., Ltd.

Address: No.5 East Lixiang Road,
Changsha Economic & Technological Development Zone,
Hunan ,China - 410138
China (Mainland)
Telephone: 86-21-58716151
Mobile Phone: 13916119950
Fax: 86-21-58710793-804

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 SUPPLIERS OF PLANT AND MACHINEY

Aguapuro Equipments Pvt. Ltd.

Jitendra Rane (CEO)
416/417, Jogani Industrial Complex,
Building No. 9, V. N. Purav Road,
Chunabhatti, Mumbai, India - 400022
Mobile: +(91) - 9029295544, +(91) - 9970071189

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 CONSULTANT OF TURNKEY PROJECT SUPPLIER
OF THE PLANT AND MACHINERY

Mahanagar Engg. Pvt. Ltd.

Contact Person : Mr. Anup Tiwari
Regd. Office :
C-8, Sector-8 Noida,
Uttar Pradesh PIN 201301, INDIA
Phone : +91 9999054970, +91 9873907980
Email : anup@indiarams.com
Website : www.packliquids.com

SACMI IMOLA S.C.

Via Selice Provinciale, 17/A - C.P. 113 40026
Imola BO - Italy
Tel: +39-0542-607111
Fax: +39-0542-642354
Email: sacmi@sacmi.it
http://www.sacmi.com

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Weiler Engineering, Inc.
1395 Gateway Drive
Elgin, IL 60124 U.S.A.
Phone: 847-697-4900
Fax: 847-697-4915

PFM Packaging Machinery Limited

PFM House,
2 Pilgrim Way, Stanningley,
LEEDS LS28 6LU, United Kingdom
Phone: +44 (0)113 239 3401
Fax: +44 (0)113 239 3402
Website: pfm@pfmuk.com

HAVER & BOECKER

P.O. Box 33 20
D-59282 OELDE, Germany
Phone: +49-25 22-30 0
Telefax: +49-25 22-30 4 03
E-mail: mf@haverboecker.com
Internet: http://www.haverboecker.com

Affiliated Company USA:

HAVER FILLING SYSTEMS, INC.
Phone: +1-770 760-11 30
Telefax: +1-770 760-11 81
E-mail: sales@haverusa.com
Internet: http://www.haverusa.com

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Affiliated Company Brazil:
HAVER & BOECKER Latinoamericana Màqs. Ltda.
Phone: +55-19-3879-91 00
Telefax: +55-19-3879-14 10
E-mail: haverhbl@haverbrasil.com.br
Internet: http://www.haverbrasil.com.br
Affiliated Company France: HAVER FRANCE S.A.R.L.
Phone: +33-1-39 11 80 80
Telefax: +33-1-39 11 80 89
E-mail: contact@haverfrance.fr
Internet: http://www.haverfrance.fr

Rommelag
rommelag ag
P.O. Box
CH-5033 Buchs, Switzerland
http://www.rommelag.com

Ensymm UG (haftungsbeschränkt) & Co. KG

Life Science Center Düsseldorf
Merowingerplatz 1
D-40225 Düsseldorf
Tel: +49 211 3367527
Fax: +49 211 15763212
info@ensymm.com
http://www.ensymm.com

Managing Director: Dr. P.Dehdari

Gericht (Düsseldorf) / Register-Nr.: HRA 15056
Steuer-Nr.: 106/5819/0839
Ust.-IdNr.: DE228785961

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 CLEAN ROOM SUPPLIERS

E- Pack Polymers Private Limited

Narender Singh
(Sales And Marketing Manager)
2584, Rohatagi Mansion,
Hamilton Road, Kashmere Gate
Delhi, India - 110006
Mobile: +(91) - 9650896002, +(91) - 9650896005

Sungreen Ventilation Systems Pvt Ltd.

Dinesh Jai Kumar (Director)
153, SIDCO Industrial Estate,
Ambattur, Sidco Industrial Estate
Chennai - 600098, Tamil Nadu, India
Mobile: +(91)-9677044016, +(91)-9962044014
Telephone: +(91)-(44)-28113146
Fax: +(91)-(44)-42101119

Axenic Systems
Joseph Ignatius (Partner)
Plot No. 16/17, Dr. Ambedkar Road,
Gorai I, Borivali West, Borivali West
Mumbai - 400091, Maharashtra, India
Mobile: +(91)-9821423083
Telephone: +(91)-(22)-28670544, +(91)-(22)-28695614

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 DEXTROSE SALINE (I.V.FLUID) (FFS TECHNOLOGY) [EIRI2085]1001INR,1002US$
J.C. 1001 Page A- 1

PLANT ECONOMICS

Rated Plant capacity = 60000.00 BOTTLES/day

= 18000000.00 BOTTLES/annum
I.V. FLUID (FFS TECHNOLOGY)

Basis

No. of working days = 25 days/month

= 300 days/annum

No. of shifts = 3 per day

One shift = 8 hours

DEXTROSE SALINE & NORMAL SALINE

(I.V. FLUID) (5%) in 100ml &
500ml Bottle

Currency - Rs.

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 DEXTROSE SALINE (I.V.FLUID) (FFS TECHNOLOGY) [EIRI2085]1001INR,1002US$
J.C. 1001 Page A- 2

LAND & BUILDING

1. Land Area reqd. 1.5 Acre

(6000 sq.mt) @ Rs. 50,00,000/- Acre Rs. 75,00,000.00

2. Processing Area (Clean Room) in

1500 sq.mt. @ Rs. 12,000/- sq.mt. Rs. 1,80,00,000.00

3. Raw Material Storage 300 sq.mt.

@ Rs. 10,000/- sq.mt. Rs. 30,00,000.00

4. Finished Product Storage 500 sq.mt.

@ Rs. 10,000/- sq.mt. Rs. 50,00,000.00

5. Testing Lab. 100 sq.mt.

@ Rs. 12,000/- sq.mt. Rs. 12,00,000.00

6. Adm. Building 100 sq.mt.

@ Rs. 10,000/- sq.mt. Rs. 10,00,000.00

7. Misc. Boundary Wall, Gate etc. Rs. 12,00,000.00

------------------------
TOTAL Rs. 3,69,00,000.00
------------------------

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 DEXTROSE SALINE (I.V.FLUID) (FFS TECHNOLOGY) [EIRI2085]1001INR,1002US$
J.C. 1001 Page A- 3

PLANT & MACHINERY

1. Distilled Water making unit

Consisting of Reboiler, Condensor
made of stainless steel - 316
Cap: 6000 Ltr/hr. 1 Set 1 No. Rs. 50,00,000.00

2. Bacteria Retaining Filter

Cap: 4000 Ltr/hr. 1 No. Rs. 2,50,000.00

3. Mixer made of Stainless Steel-316

fitted with agitator and motor
including dosing system for IV
Fluid Preparation 2 No. Rs. 15,00,000.00

4. Storage Vessels made of Stainless

Steel - 316 Rs. 20,00,000.00

5. Auto Clave for Terminal

Sterilization using Saturated
Steam 1 No. Rs. 25,00,000.00

6. FFS Machine (Fully Automatic)

Computer Controlled include Tube
formation Blowing of Parison,
Filling, Sealing or Crimping S.S
Racks Leak Testing etc.
Cap: 60,000 Bottles/Day Rs. 8,00,00,000.00

7. Air Conditioner Plant Rs. 2,00,00,000.00

8. Automatic Bottle Labelling Machine 1 No. Rs. 10,00,000.00

9. Boiler 1.5 Ton/hr. 1 No. Rs. 15,00,000.00

10. Instrumentation and Process Control Rs. 10,00,000.00

11. D.G. Set 750 KVA Rs. 30,00,000.00

12. Card Board Packing Unit Rs. 8,00,000.00

13. Material Handling Equipments Rs. 7,00,000.00

14. Misc. Pipe & Pipe Fitting, Air

Compressor, Tools, Pumps etc. Rs. 7,50,000.00

------------------------
TOTAL Rs. 12,00,00,000.00
------------------------

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 DEXTROSE SALINE (I.V.FLUID) (FFS TECHNOLOGY) [EIRI2085]1001INR,1002US$
J.C. 1001 Page A- 5

OTHER FIXED ASSETS

1. Office equipment, furniture plus

other equipment & accessories Rs. 5,00,000.00

2. Erection, Installation &

Electrification Rs. 10,00,000.00

3. Pre-operative & Preliminary Exp. Rs. 7,00,000.00

4. Consultancy & Technical Know-How Rs. 10,00,000.00

5. Misc. Rs. 5,00,000.00

------------------------
TOTAL Rs. 37,00,000.00
------------------------

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 DEXTROSE SALINE (I.V.FLUID) (FFS TECHNOLOGY) [EIRI2085]1001INR,1002US$
J.C. 1001 Page A- 6

FIXED CAPITAL

1. LAND & BUILDING Rs. 3,69,00,000.00

2. PLANT & MACHINERY Rs. 12,00,00,000.00

3. OTHER FIXED ASSETS Rs. 37,00,000.00

------------------------
TOTAL Rs. 16,06,00,000.00
------------------------

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 DEXTROSE SALINE (I.V.FLUID) (FFS TECHNOLOGY) [EIRI2085]1001INR,1002US$
J.C. 1001 Page A- 7

WORKING CAPITAL REQUIREMENT/MONTH

RAW MATERIALS

1. Dextrose (IP Grade) 51 MT.

@ Rs. 65,000/-Ton Rs. 33,15,000.00

2. Sodium Chloride (IP Grade) 18 MT.

@ Rs. 20,000/-Ton Rs. 3,60,000.00

3. PP Granules (Pharma Grade) 15,000

Kgs. @ Rs. 200/- Kg. Rs. 30,00,000.00

4. Labels 15,00,000 Nos.

@ Rs. 0.20/- each Rs. 3,00,000.00

5. Corrugated Boxes, Hanger & Misc.

Consumables Rs. 6,00,000.00

------------------------
TOTAL Rs. 75,75,000.00
------------------------

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 DEXTROSE SALINE (I.V.FLUID) (FFS TECHNOLOGY) [EIRI2085]1001INR,1002US$
J.C. 1001 Page A- 8

SALARY & WAGES / MONTH

1. Manager Cum technologist 1 No. Rs. 70,000.00

2. Shift Supervisor 3 No. Rs. 60,000.00

3. Chemist 2 No. Rs. 60,000.00

4. Skilled Workers 10 No. Rs. 1,20,000.00

5. Unskilled Workers 10 No. Rs. 1,00,000.00

6. Marketing Personnel 4 No. Rs. 1,00,000.00

7. Accountant 1 No. Rs. 20,000.00

8. Computer Operator/Clerk 2 No. Rs. 30,000.00

9. Peon/Security Guard 6 No. Rs. 60,000.00

------------------------
TOTAL Rs. 6,20,000.00
------------------------

Plus perks @ 33% p.a.

Rs. 2,04,600.00

------------------------
TOTAL Rs. 8,24,600.00
------------------------

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 DEXTROSE SALINE (I.V.FLUID) (FFS TECHNOLOGY) [EIRI2085]1001INR,1002US$
J.C. 1001 Page A- 9

UTILITIES AND OVERHEADS

1. Power Consumption of 35000

Kwatt hrs @ Rs. 8.00 per Kwatt hr. Rs. 2,80,000.00

2. Water Consumption of 1500

KLs @ Rs. 5.00 per KL Rs. 7,500.00

3. Conveyance & Transportation Rs. 2,50,000.00

4. Advertisement & Publicity Rs. 5,00,000.00

5. Repair & Maintenance Rs. 2,00,000.00

6. Adm. Expenses Rs. 2,00,000.00

7. Fuel (LDO) for Boiler 8000 Ltrs.

@ Rs. 60/-Ltr. Rs. 4,80,000.00

------------------------
TOTAL Rs. 19,17,500.00
------------------------

Total load is 64 Kwatts

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 DEXTROSE SALINE (I.V.FLUID) (FFS TECHNOLOGY) [EIRI2085]1001INR,1002US$
J.C. 1001 Page A- 10

TOTAL WORKING CAPITAL/MONTH

1. RAW MATERIAL Rs. 75,75,000.00

2. SALARY & WAGES Rs. 8,24,600.00

3. UTILITIES & OVERHEADS Rs. 19,17,500.00

------------------------
TOTAL Rs. 1,03,17,100.00
------------------------

1. WORKING CAPITAL FOR 2 MONTHS Rs. 2,06,34,200.00

2. MARGIN MONEY FOR W/C LOAN Rs. 51,58,550.00

COST OF PROJECT

TOTAL FIXED CAPITAL Rs. 16,06,00,000.00

MARGIN MONEY
Rs. 51,58,550.00

------------------------
TOTAL Rs. 16,57,58,550.00

------------------------

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 DEXTROSE SALINE (I.V.FLUID) (FFS TECHNOLOGY) [EIRI2085]1001INR,1002US$
J.C. 1001 Page A- 11

TOTAL CAPITAL INVESTMENT

TOTAL FIXED CAPITAL Rs.16,06,00,000.00

TOTAL WORKING CAPITAL FOR 2 MONTHS

Rs. 2,06,34,200.00

------------------------
TOTAL Rs.18,12,34,200.00

------------------------

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 DEXTROSE SALINE (I.V.FLUID) (FFS TECHNOLOGY) [EIRI2085]1001INR,1002US$
J.C. 1001 Page A- 12

COST OF PRODUCTION/ANNUM

1. Working Capital for 1 year Rs.12,38,05,200.00

2. Interest @ 13.50% on T.C.I Rs. 2,44,66,617.00

3. Depreciation @ 10.00% on buildings Rs. 29,40,000.00

4. Depreciation @ 20.00% on Plant

and Machinery Rs. 2,40,00,000.00

5. Depreciation @ 20.00% on office

equipment & furnitures Rs. 1,00,000.00
------------------------
TOTAL Rs.17,53,11,817.00
------------------------

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 DEXTROSE SALINE (I.V.FLUID) (FFS TECHNOLOGY) [EIRI2085]1001INR,1002US$
J.C. 1001 Page A- 13

TURN OVER/ANNUM

1. By sale of IV Fluid (Dextrose

Saline & Normal Saline) 5% in 100ml
& 500ml Bottles (FFS Technology)
1,80,00,000 Nos.
@ Rs. 12/- each (Avg.) Ex-Factory Rs.21,60,00,000.00

------------------------
TOTAL Rs.21,60,00,000.00
------------------------

PROFIT = RECEIPTS - COST OF PRODUCTION

= 21,60,00,000.00 - 17,53,11,817.00

= 4,06,88,183.00

PROFIT SALES RATIO = Profit / Sales x 100

4,06,88,183.00
= ------------------------------ X 100
21,60,00,000.00

= 18.84 %

RATE OF RETURN = Operating profit / T.C.I x 100

4,06,88,183.00
= ------------------------------ X 100
18,12,34,200.00

= 22.45 %

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 DEXTROSE SALINE (I.V.FLUID) (FFS TECHNOLOGY) [EIRI2085]1001INR,1002US$
J.C. 1001 Page A- 14

BREAK EVEN POINT (B.E.P)

Fixed Costs of the plant are as under -

1. Interests Rs. 2,44,66,617.00

2. Depreciation Rs. 2,70,40,000.00

3. 40.00% of salaries Rs. 39,58,080.00

4. 40.00% of overheads Rs. 92,04,000.00

------------------------
TOTAL Rs. 6,46,68,697.00
------------------------

FIXED COSTS
B.E.P. = ------------------------------ X 100
FIXED COSTS + PROFIT

6,46,68,697.00
= ------------------------------ X 100
6,46,68,697.00 + 4,06,88,183.00

= 61.38 %

LAND MAN RATIO = Total land / Manpower

2 : 39 :: 0 : 1

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 DEXTROSE SALINE (I.V.FLUID) (FFS TECHNOLOGY) [EIRI2085]1001INR,1002US$
J.C. 1001 Page A- 15

RESOURCES FOR FINANCE

1. Term loans from Financial institutions

( 65.00 % of fixed capital )
at @13.50% p.a rate of interest Rs. 10,43,90,000.02

2. Bank loans for 3 months

( 65.00 % of working capital )
at @ 13.50% p.a rate of interest Rs. 1,34,12,230.00

3. Self raised capital from even

funds & loans from close ones to
meet the margin money needs at a
@ 13.50% p.a rate of interest Rs. 6,34,31,970.00

--------------------------
TOTAL Rs. 18,12,34,200.00
--------------------------

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 DEXTROSE SALINE (I.V.FLUID) (FFS TECHNOLOGY) [EIRI2085]1001INR,1002US$
J.C. 1001 Page A- 16

INSTALMENT PAYABLE IN 5 YEARS

================================================================================
Year To Financial To Commercial To others Total
institutions banks
(Rs. 104390000) (Rs. 13412230) (Rs. 63431970)
================================================================================
1 2,08,78,000.00 26,82,446.00 1,26,86,394.00 3,62,46,840.00
2 2,08,78,000.00 26,82,446.00 1,26,86,394.00 3,62,46,840.00
3 2,08,78,000.00 26,82,446.00 1,26,86,394.00 3,62,46,840.00
4 2,08,78,000.00 26,82,446.00 1,26,86,394.00 3,62,46,840.00
5 2,08,78,000.00 26,82,446.00 1,26,86,394.00 3,62,46,840.00
================================================================================

INTEREST PAYABLE IN 5 YEARS

================================================================================
Year On term loans On bank loans On self loans Total
(Rs. 104390000) (Rs. 13412230) (Rs. 63431970)
@ 13.50 % P.A. @ 13.50 % P.A. @ 13.50 % P.A.
================================================================================
1 1,40,92,650.00 18,10,651.05 85,63,315.95 2,44,66,617.00
2 1,12,74,120.00 14,48,520.84 68,50,652.76 1,95,73,293.60
3 84,55,590.00 10,86,390.63 51,37,989.57 1,46,79,970.20
4 56,37,060.00 7,24,260.42 34,25,326.38 97,86,646.80
5 28,18,530.00 3,62,130.21 17,12,663.19 48,93,323.40
================================================================================

TOTAL REPAYMENT SCHEDULE FOR 5 YEARS

================================================================================
Year Interest Instalments Total
================================================================================
1 2,44,66,617.00 3,62,46,840.00 6,07,13,457.00
2 1,95,73,293.60 3,62,46,840.00 5,58,20,133.61
3 1,46,79,970.20 3,62,46,840.00 5,09,26,810.21
4 97,86,646.80 3,62,46,840.00 4,60,33,486.81
5 48,93,323.40 3,62,46,840.00 4,11,40,163.41
================================================================================

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 DEXTROSE SALINE (I.V.FLUID) (FFS TECHNOLOGY) [EIRI2085]1001INR,1002US$
J.C. 1001 Page A- 17

DEPRECIATION CHART FOR 5 YEARS

================================================================================
Year Building costs Plant & Machinery fur. & office equip. Total
( Rs. 29400000.00 )
( Rs. *********** ) ( Rs. 500000.00 )
@ 10.00 % P.A. @ 20.00 % P.A. @ 20.00 % P.A.
================================================================================
1 29,40,000.00 2,40,00,000.00 1,00,000.00 2,70,40,000.00
2 26,46,000.00 1,92,00,000.00 80,000.00 2,19,26,000.00
3 23,81,400.00 1,53,60,000.00 64,000.00 1,78,05,400.00
4 21,43,260.00 1,22,88,000.00 51,200.00 1,44,82,460.00
5 19,28,934.00 98,30,400.00 40,960.00 1,18,00,294.00
================================================================================

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 DEXTROSE SALINE (I.V.FLUID) (FFS TECHNOLOGY) [EIRI2085]1001INR,1002US$
J.C. 1001 Page A- 18

PROFIT ANALYSIS FOR 5 YEARS

================================================================================================
YR CAP. Sales Mfg. Gross Depre- Interest Net profit Net profit
UTIL Expenses Profit ciation before tax after tax
@ 35.00%
================================================================================================
1 70% 151200000 86663640 64536360 27040000 24466617 13029743 8469333
2 80% 172800000 99044160 73755840 21926000 19573294 32256546 20966755
3 80% 172800000 99044160 73755840 17805400 14679970 41270470 26825805
4 90% 194400000 111424680 82975320 14482460 9786647 58706213 38159039
5 100% 216000000 123805200 92194800 11800294 4893323 75501183 49075769
================================================================================================

CASH FLOW STATEMENT FOR 5 YEARS

================================================================================
YR CAP. Net profit Depre- Cash Repayment of Net surplus
UTIL (after tax) ciation in hand Instalment
================================================================================
1 70% 8469333 27040000 35509333 23560446 11948887
2 80% 20966755 21926000 42892755 23560446 19332309
3 80% 26825805 17805400 44631205 23560446 21070759
4 90% 38159039 14482460 52641499 23560446 29081053
5 100% 49075769 11800294 60876063 23560446 37315617
================================================================================

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 DEXTROSE SALINE (I.V.FLUID) (FFS TECHNOLOGY) [EIRI2085]1001INR,1002US$

PROJECTED BALANCE SHEET FOR ( 5 YEARS)

LIABILITIES ASSETS

1. Promoters Capital 6,34,31,970 1. Fixed Assets 14,99,00,000

2. Term loans 10,43,90,000 2. Interest during Construction
period @ 13.50 p.a. 1,11,88,702
3. W/C loan 1,34,12,230 3. Surplus funds 2,01,45,498
-------------------- --------------------
18,12,34,200 18,12,34,200
-------------------- --------------------

1 Year 70 % Capacity

1. Promoters capital 6,34,31,970 1. Depreciated value

2. Net Surplus 1,19,48,887 of Fixed Assets 12,28,60,000
3. Term loans 8,35,12,000 2. Working Capital 1,44,43,940
4. W/C loans 1,07,29,784 3. Surplus funds 3,23,18,701
-------------------- --------------------
16,96,22,641 16,96,22,641
-------------------- --------------------

2 Year 80 % Capacity

1. Promoters capital 7,53,80,857 1. Depreciated value

2. Net Surplus 1,93,32,310 of Fixed Assets 10,09,34,000
3. Term loans 6,26,34,000 2. Working Capital 1,65,07,360
4. W/C loans 80,47,338 3. Surplus funds 4,79,53,145
-------------------- --------------------
16,53,94,505 16,53,94,505
-------------------- --------------------

3 Year 80 % Capacity

1. Promoters capital 9,47,13,167 1. Depreciated value

2. Net Surplus 2,10,70,760 of Fixed Assets 8,31,28,600
3. Term loans 4,17,56,000 2. Working Capital 1,65,07,360
4. W/C loans 53,64,892 3. Surplus funds 6,32,68,859
-------------------- --------------------
16,29,04,819 16,29,04,819
-------------------- --------------------

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 DEXTROSE SALINE (I.V.FLUID) (FFS TECHNOLOGY) [EIRI2085]1001INR,1002US$

4 Year 90 % Capacity

1. Promoters capital 11,57,83,927 1. Depreciated value

2. Net Surplus 2,90,81,053 of Fixed Assets 6,86,46,140
3. Term loans 2,08,78,000 2. Working Capital 1,85,70,780
4. W/C loans 26,82,446 3. Surplus funds 8,12,08,506
-------------------- --------------------
16,84,25,426 16,84,25,426
-------------------- --------------------

5 Year 100 % Capacity

1. Promoters capital 14,48,64,980 1. Depreciated value

2. Net Surplus 3,73,15,616 of Fixed Assets 5,68,45,846
3. Term loans 0 2. Working Capital 2,06,34,200
4. W/C loans 0 3. Surplus funds 10,47,00,550
-------------------- --------------------
18,21,80,596 18,21,80,596
-------------------- --------------------

www.eiribooksandprojectreports.com 216
We hope MARKET SURVEY CUM DETAILED TECHNO ECONOMIC FEASIBILITY REPORT in
your possession at the time, must have conveyed you the elementary idea on process data, market
and economics. We feel you must have now taken a decision to finalize your project plan for
ultimate implementation in a successful manner. Before you go ahead, we suggest you to take our
PRACTICAL PROJECT EXECUTION KNOW HOW REPORT.

"EIRI" offer you PRACTICAL PROJECT EXECUTION KNOW HOW REPORT on this project.

Brief contents of PRACTICAL PROJECT EXECUTION KNOW HOW REPORT are as under :

THIS REPORT SHALL BE FULLY BASE DON CLIENT’S REQUIREMENTS WITH THEIR
PROJECT COST, CAPACITY, PROJECT LOCATION WITH DETAILED MARKET SURVEY,
DELIVERY SHALL BE MADE WITHIN 20 DAYS ON RECEIPT OF 60% AS ADVANCE- EIRI

• Introduction
• Properties
• BIS (Bureau of Indian Standard) Specifications & Requirements
• Uses & Applications
• Present Indian Market Position
• Expected Future Demand
• Export & Import Statistics Data
• Names and Addresses of Existing Units (Present Manufactures)
• List of Plant & Machineries
• Miscellaneous Items and Accessories
• Instruments, Laboratory Equipments and Accessories
• Electrification, Electric Load and Water
• Maintenance, Suppliers/Manufacturers of Plant and Machineries
• Process of Manufacture with formulae if applicable
• Flow Sheet Diagram
• List of Raw Materials
• Availability of Raw Materials
• Requirement of Staff & Labour
• Personnel Management
• Skilled & Unskilled Labour
• Requirement of Land Area
• Built up Area
• Plant Layout.

www.eiribooksandprojectreports.com 217
Along with financial details as under:

Summary of Capital Cost of Project

Land & Side Development Exp.
Buildings
Plant & Machineries
Misc. Fixed Assets
Technical Know how Fees & Exp.
Preliminary Expenses
Pre-operative Expenses
Provision for Contingencies
Below mentioned financial statements (Annexure) will be for 5 to 10 Years

Annexure :: Cost of Project and Means of Finance

Annexure :: Output, Profitability and Cash Flow Chart
Annexure :: Assessment of Working Capital requirements
Annexure :: Sources of Finance
Annexure :: Balance Sheets
Annexure :: Break-Even Analysis and profitability analysis.
Annexure :: Quantitative Details-Output/Sales/Stocks
Annexure :: Sales Realisation
Annexure :: Raw Material Cost
Annexure :: Other Raw Material Cost
Annexure :: Packing Material Cost
Annexure :: Consumables, Store etc.,
Annexure :: Employees Expenses
Annexure :: Fuel Expenses
Annexure :: Power/Electricity Expenses
Annexure :: Repairs & Maintenance Exp.
Annexure :: Other Mfg. Expenses
Annexure :: Administration Expenses
Annexure :: Selling Expenses
Annexure :: Depreciation Charges - Profitability
Annexure :: Depreciation Charges
Annexure :: Interest and Repayment - Term Loans
Annexure :: Tax on Profit
Annexure :: Assumptions for Profitability workings
Annexure :: Assessment of Working Capital

www.eiribooksandprojectreports.com 218
Engineers India Research Institute (EIRI) is a renowned name in the industrial world for
offering technical and financial consultancy services.

EIRI services are:

Detailed Feasibility Reports

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setting up new industrial projects.

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