I.V.

FLUID MANUFACTURING PLANT

[EIRI/EDPR/3752] J.C.: 1634INR,1635US$,1843

INTRODUCTION

Intravenous 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.

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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

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 CONTENTS

INTRODUCTION
TYPES OF IV FLUID
COMMONLY USED IV FLUIDS
HOW INTRAVENOUS FLUIDS ARE CREATED
IV FLUID/ELECTROLYTE THERAPY
KEY TERMS
DEXTROSE
DEXTROSE SALINE INJECTION
PROPERTIES
TABLE I. PHYSICAL PROPERTIES OF D-GLUCOSE
TABLE 2. SOLUBILITY OF DEXTROSE IN WATER
REQUIREMENTS OF RAW MATERIALS
TABLE I: REQUIREMENT FOR DEXTROSE MONOHYDRATE
EXPORT OPPORTUNITY OF INTRAVENOUS SOLUTION
LOCAL MANUFACTURING ACTIVITIES
HS CODES
WORLD MARKET TRENDS IMPORTS & EXPORTS
MAJOR INTERNATIONAL IMPORTING COUNTRIES
MAJOR IMPORTING COUNTRIES - MENA REGIONAL & GCC
COMPETITION - MAJOR EXPORTING COUNTRIES
ESTIMATE OF IMPORTER’S LANDED COSTS
ECONOMIC PROFILE
WORLD MARKET CONSUMPTION
SOURCE OF MACHINES TECHNOLOGY
GLOBAL MARKET OVERVIEW OF IV FLUID
GEOGRAPHICAL SEGMENTATION OF THE INTRAVENOUS SOLUTIONS MARKET
COMPETITIVE LANDSCAPE AND KEY VENDORS
KEY VENDORS IN THIS MARKET ARE -
GROWTH DRIVERS, CHALLENGES, AND UPCOMING TRENDS:
HOME TREATMENT
USES AND APPLICATION
SOME GENERAL INTRAVENOUS FLUIDS
SPECIFICATION OF INDIAN PHARMACOPEIA ON I.V FLUIDS DEXTRAN
INJECTION
DEXTRAN 110 INJECTIONS
B.I.S. SPECIFICATIONS FOR PLASTIC I.V. BOTTLES
SODIUM CHLORIDE AND DEXTROSE INJECTION
IDENTIFICATION:-
ASSAY:

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BASIC RAW MATERIALS
REQUIREMENTS OF RAW MATERIALS AND SPECIFICATIONS
WATER FOR INJECTION
HDPE PHARMA GRADE LAMINATE/ PLASTIC ROLL
LABELING
IDENTIFICATION
HEAVY METALS
COMPOSITION OF IV FLUID
COMPOSITION OF COMMON IV FLUID (MEQ/L)
COMPOSITION OF IV FLUIDS
COMPOSITION OF COMMERCIAL I.V. FLUID AVAILABLE
BASIS OF BFS TECHNOLOGY
BLOW FILL SEAL (BFS) AND FORM FILL SEAL (FFS) TECHNOLOGY
CONCEPT OF BFS
MANUFACTURING PROCESS OF I.V. FLUID (FFS TECHNOLOGY)
PROCESS FLOW DIAGRAM
PROCESS IN DETAILS
1. DISTILLED WATER PREPARATION:-
2. SOLUTION PREPARATION:-
3. INJECTION BLOW MOULDING
4. MOULDING PROCESS
5. FILLING PROCESS
6. SEALING PROCESS
7. MOULD OPENING PROCESS
FILTRATION AND FILLING:-
STERILIZATION:-
QUALITY CONTROL:-
FLOW DIAGRAM OF MANUFACTURING OF I.V. FLUIDS
SWOT ANALYSIS
FORM FILL SEAL TECHNOLOGY
1. FORM-FILL-SEAL TECHNOLOGY:-
1.5 FILTRATION (MEMBRANE):-
LIST OF MACHINERY IV BAG PRODUCTION FORM FILL AND SEAL MACHINE
IV BAG PRODUCTION (IV PRODUCTION AND PACKING)
IV BAG EMPTY PRODUCTION LINE
1. WATER PURIFYING
2. DISTILLATION
3. SOLUTION FILLING
4. STERILIZATION
5. PACKING
A TYPICAL FFS PROCESS WORKS AS FOLLOWS.
SUPPLIERS OF RAW MATERIALS
POTASSIUM PERMANGANATE
SODIUM CHLORIDE (I.P. GRADE)

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DEXTROSE
SUPPLIERS OF PLANT AND MACHINERY
STERILIZING EQUIPMENTS
PM METER
LABELING MACHINES
TANKS
BOILER
FILTER PRESS
LABORATORY EQUIPMENTS
MIXER
EMPTY IV BAG MANUFACTURER AND SUPPLIER IN INDIA
SUPPLIERS OF COMPLETE PLANT AND MACHINERY
CONSULTANT OF TURNKEY PROJECT SUPPLIER OF THE PLANT
AND MACHINERY
CLEAN ROOM SUPPLIERS
MACHINERY CATALOG
PLANT LAYOUT

APPENDIX – A:

01. PLANT ECONOMICS

02. LAND & BUILDING
03. PLANT AND MACHINERY
04. OTHER FIXED ASSESTS
05. FIXED CAPITAL
06. RAW MATERIAL
07. SALARY AND WAGES
08. UTILITIES AND OVERHEADS
09. TOTAL WORKING CAPITAL
10. TOTAL CAPITAL INVESTMENT
11. COST OF PRODUCTION
12. TURN OVER/ANNUM
13. BREAK EVEN POINT
14. RESOURCES FOR FINANCE
15. INSTALMENT PAYABLE IN 5 YEARS
16. DEPRECIATION CHART FOR 5 YEARS
17. PROFIT ANALYSIS FOR 5 YEARS
18. PROJECTED BALANCE SHEET FOR (5 YEARS)

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 COST ESTIMATION
Plant Capacity 50000 Bottles/Day
Land & Building (4000 sq.mt.) Rs. 1.92 Cr
Plant & Machinery Rs. 22.52 Cr
Working Capital for 2 Months Rs. 2.65 Cr
Total Capital Investment Rs. 27.45 Cr
Rate of Return 15%
Break Even Point 48%

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