STUDENTS’ INDUSTRIAL WORK EXPERIENCE SCHEME

(SIWES)

A TECHNICAL REPORT OF INDUSTRIAL WORK EXPERIENCE AT

AGARY INDUSTRIES LIMITED

BY

NWOSU VANESSA CHISOMEBI

COOU/2020/204265
DEPARTMENT: BIOCHEMISTY
COURSE CODE: BCH

IN PARTIAL FULFILMENT FOR THE AWARD OF A BACHELOR OF

SCIENCE (B.Sc.) DEGREE IN BIOCHEMISTRY

DATE: NOVEMBER 2023

i
 DECLARATION

I, NWOSU VANESSA. C, hereby declare that this SIWES report has been carried
out by me under the supervision of MR. IDUBOR ALEXANDER. It has not been
presented for an award of any degree in any institution. All sources of information
are specifically acknowledged by means of reference.

Departmental SIWES Co-ordinator

...................................
SIGN/ DATE

DEDICATION
ii
I, NWOSU VANESSA. C, dedicate this work to Almighty God who saw me
through, from the beginning to the end of the industrial training scheme, to my
sponsor for the financial aids and moral support, and lastly to my loving and caring
parent Mr and Mrs NWOSU for their prayers, and encouragements.

ACKNOWLEDGEMENT

iii
I, NWOSU VANESSA. C, acknowledge my industrial training supervisor, MR.
IDUBOR ALEXANDER and other departmental supervisors for all their
encouragement and fatherly & motherly love from the beginning to the end of the
scheme, and I also want to acknowledge my SIWES supervisor, for his
encouragement and attention all through this period, I say big thank you. May God
bless you?

ABSTRACT

iv
The Student Industrial training Work Experience Scheme (SIWES) was established
due to the increasing need to produce graduate from Nigeria tertiary institution
with sound practical and theoretical background of different discipline. This is a
technical report on six month industrial training carried out in Agary Industrial
Limited under the Quality Assurance and Quality Control department. This report
gives a brief insight on how the pharmaceutical industry operate and summarize
the working experience gained, knowledge learnt during my industrial training at
Agary Industrial Limited.

The Quality Assurance is an essential operation of the Pharmaceutical industry.

Drugs must be marked safe and therapeutically active formations whose
performance is consistent and predictable. The Quality Control department consist
of chemical & microbiology analytical laboratory where analysis of raw materials
before production and finished product are carried out. The requirement involving
quality control of pharmaceutical in accordance with the British pharmacopeia
(B.P) and United State Pharmacopeia (USP) and the current Good Manufacturing
Practices (cGMP) are cited and discussed. The report contains different drugs
produced in Agary, their active pharmaceutical ingredient (APIs) and method of
production. It also explains the various document required in the pharmaceutical
company, the certificate of analysis (COA) for raw material and finished product,
Batch manufacturing record (BMR), site master file (SMF), Quality manual etc.
Water and its essential in pharmaceutical industry as it Is used in production and
other works in the company. The report briefly explains water treatment and its
chemical analysis.

TABLE OF CONTENT

Cover page…………………………..……….……………………................…….1

v
Title page…..............................................................................................................2
Dedication……………………………………………….........................................3
Acknowledgement…………………………………………...............…………….4
Abstract………………………………………………................………………….5
Table of content………………………………………...............………………….6
CHAPTER ONE
1.1 Introduction to SIWES..….………………………............……………………7
1.2 Brief History of SIWES………………........……….…...…….………........…7
1.3 Objectives of SIWES ………………..........………….............….….......…….8
1.4 Importance of SIWES………………………………….……….................…..8
CHAPTER TWO
2.1 History of the company…………………………………..................…..……..9
2.2 Company Vision and Mission…………………………..................…………..9
2.3 Organizational chart………………………………..................…....................11
2.4 Products of the company……………………………….....................………..11
CHAPTER THREE
3.1 Personal experience in the company………………………….........................14
3.2 Active Pharmaceutical Ingredient/Excipient…………...................……..…....14
3.3 Quality control and assurance Department……....……...............…………….17
3.4 Water Treatment………………………………………….…….................…..31
CHAPTER FOUR
4.1 Paracetamol........................................................................................................33
4.2 Garyflox.............................................................................................................
CHAPTER FIVE
5.1 Problem Encountered during the Indusrial Training.........................................37
5.2 Problem Solution...............................................................................................37
CHAPTER SIX
6.1 Conclusion........................................................................................................38
6.2 Recommendation..............................................................................................38

REFERENCE

FIGURES

vi
Figures Pages
1. The Analytic Weighting Balance................................................................. 18

2. The Hardness Tester..................................................................................... 19

3. The Friabilator.............................................................................................. 20

4. The Dissolution Tester.................................................................................. 21

5. Moisture Analyzer......................................................................................... 22

6. The Veineer Calliper..................................................................................... 23

7. The Blending Machine.................................................................................. 26

8. The Fluid Bed Drier and it’s bowl................................................................. 27

9. The Paste Kettle............................................................................................. 28

10. The Compressor............................................................................................ 29

11. The Blistering Machine................................................................................ 30

TABLES

vii
Tables Pages

1. Company organigram chart........................................................................... 4

2. Products, Active Pharmaceutical Ingredient & Uses.................................... 5

3. Assay analysis Dissolution & Disintegration analysis.................................. 9

4. Product Flow Chart....................................................................................... 31

viii
 CHAPTER 1

1.1 INTRODUCTION TO SIWES

SIWES is an acronym for students’ industrial work experience scheme. It is the

accepted skills training program which forms part of the approved minimum
academic standards in the various degree program for all Nigerian universities. It is
aimed at exposing students to machines and equipment’s, professional work
methods and ways of safe guarding the work area and workers in the industries and
other organizations. It is an effort to bridge the gap existing between theory and
practice of engineering and technology, science and other professional educational
program in the Nigerian tertiary institutions.

1.2 BRIEF HISTORY OF SIWES

SIWES was established in the year 1973 to acquaint student skills of handling
industrial machinery and equipments. The Industrial Training Fund (ITF) solely
funded the scheme during its formative years. However, due to financial
constraints, the fund withdrew from the scheme in 1978. The federal Government
noting the significance of the skills training handed the management of the scheme
to the National Universities Commission (NUC) and the National Board for
Technical Education (NBTE) in 1979. In November, 1984 management and
implementation of the scheme was again reverted to the ITF with the funding to be
solely borne by the Federal Government. SIWES (Student’s Industrial Work
Experience Scheme) is a scheme for the duration of 24weeks (six months). SIWES
is done after third year first semester in universities. The effective management of
Student’s Industrial Work Experience Scheme (SIWES) has been as a result of the
cooperation and well played roles of the Federal Government, ITF, Supervising
agencies.
1
 1.3 OBJECTIVES OF SIWES

a) Prepare students for the work situation they are likely to meet after
graduation.
b) Expose students for the work methods and techniques in handling equipment
and machinery that may not be available in the universities.
c) Provide an avenue for students in the Nigerian universities to acquire
industrial skills and experience in their course of study.
d) Enlist and strengthen employers’ involvement in the entire educational
process of preparing university graduates for employments in industry.

1.4 IMPORTANCE OF SIWES

a) The industrial program exposed me to different chemical analysis and

practices thereby putting what I was taught in school to practice.
b) It exposed me to different machineries and equipment which are not
available in school.

2
 CHAPTER 2

2.1 BRIEF HISTORY OF THE COMPANY

Agary pharmaceuticals is a company that is regulated by PCN (Pharmacy Council

of Nigeria) owned by Pharm Ubajoka Calistus. The industry was established in
1992 as a national and regional marketing company that specializes in the
importation and distribution of medical and hospital consumables. Over two
decades the company has partnered with a wide array of customers and consultants
in numerous fields and specialization. The Agary pharmaceutical company is
Nigeria’s number one company in hospital consumables. Overtime the company
also went into the manufacturing of drugs and have 2 other branches in Kano and
Onitsha as well.

2.2 COMPANY VISION AND MISSION

 VISION
To be number one in providing healthcare products that address health and
medical needs
 MISSION
Continuously striving for improvement and innovation in the healthcare
sector
 CORE VALUES
Commitment, Teamwork, Integrity, Innovating, Knowledge, Compliance
 MEMBERSHIP OF ORGANISATION
o PCN
o PMG-MAN
o QMC-PMG-MA
o NALP
3
 2.3 COMPANY’S ORGANOGRAM CHART
OGANIGRAM OF AGARY
PHARMACEUTICAL
MANAGING DIRECTOR
(Pharm. Ubajaka Callistus)

EXECUTIVE DIRECTOR
(Ubajaka Uzoma)

GENERAL MANAGER/SUPRINTENDENT PHARMACY

(Pharm. Iche Victor Mba)

OPERATIONS MANAGER
(Arazu Kenechukwu)

NSM Warehouse head

Production Manager Quality Assurance
(Pharm. David (Nweke Collins)
(Pharm. Nwoko (Idubor Alexandra)
Valentine) Salesman
Production W/H Manager Inventory Officer
Supervisor Microbiologist
(Nkechi Okpala) (Chijioke Gabriel)
Maintenance Manager In-Process (Ihioma Uchedi)
Skilled (Ayitley Michael) Supervisor
Staffs Store Officer
Chemical
Technician Human Resource Manager Analyst
(Jean Chukwura) (Obinna Orji)

General
TABLE 1 4 Operations
2.4 SOME PRODUCTS OF THE COMPANY
S/N PRODUCTS ACTIVE INGREDIENTS USES

1 Garytem – DS Lumefantrine Powder To treat malaria

Artemether Powder

2 Garylyte Glucose Anhydrous B.P For fast

replacement of
lost fluid

3 Paracetamol Paracetamol Powder For pain relief

(headache and
feverish
condition)

4 Garyfol Feltic Acid Powder For pregnant

women to help
form the neural
tube

5 Hamacaplet Paracetamol Powder For pain relief

(headache and
feverish
condition)

6 Hama Extra Cafleine For pain relief

(headache and
Paracetamol Powder
feverish
condition)

5
7 Garytrim Sulphamethoxozole Powder It is used as
antibiotics for
Trimethoprim Powder
cough

8 Garymet Metronidazole For upsetting or

running stomach

9 Garydox Sulphadoxine Powder For developing

signs of malaria
Pyrimethamine Powder

10 Garyfen Ibuprofen Powder For body pains

11 Garyflox Coprofloxacon Powder It is used as

antibiotics for
typhoid and
infection

12 Garyfenac Diclofenac Sodium For body pain

13 Gary-B-Plex Nicotinamide, Vitamin B2, Vitamins for the

Vitamin B, body

TABLE 2

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 CHAPTER 3

3.1 PERSONAL EXPERIENCE OF THE COMPANY

My industrial training was carried in this organization for 5 months and 2

weeks. I was trained on the various activities and processes that are followed
through daily in the pharmaceutical company. As an industrial training student,
I spent most of my time in various department in the company such as: The
Quality Control department, the Quality Assurance department, Production
Unit, Research & Development department.

I was firstly taught GMP (Current Good Manufacturing Practices) which is very
vital in the running of the company and is strictly adhered to in the company. I
was also given the SOPs (Standard Operating Procedures) which are very
detailed on understanding how the various process of analysis are carried out in
various department.

3.2 ACTIVE PHARMACEUTICAL INGREDIENTS

These are ingredients in pharmaceutical drugs that are biologically active

components of a drug product that are responsible for the therapeutic effects.
Drug products can contain more than one active ingredients. The dosage from a
pharmaceutical, contain the active ingredient which is the drug itself and
exports which are substances of the drug. The API is suspended in or other
substances that are pharmaceutically inert.

INACTIVE PHARMACEUTICAL INGREDIENTS EXPERT

Products other than the active ingredients that is intentionally added to the
dosage from to enable processing into patients – friendly medicine to control the
rate at which the active ingredients dissolve form the dosage to aid stability and

7
other reasons. They do not react or affect the therapeutic action of the active
ingredients.

3.3 QUALITY CONTROL AND ASSURANCE DEPARTMENT

Quality control department also known as QC is a unit which inspects the

quality of the drugs. They are focused on process output. The goal of QC is to
identify defects after a product is developed and before it’s released to the
market. The department has various other department; the chemical department
where all chemical analysis is done. Various analysis are carried out in the
Quality Control Department to ensure the integrity of the products. It consists of
3 units: The chemical lab, the microbiology lab and in-process unit

 CHEMICAL DEPARTMENT

The chemical department in the QA/QC is that they design the quality standard
and parameters monitor operations and production output for quality control and
help the facility maintain compliance with regulatory and guiding bodies

Chemical Analysis Include:

 RAW MATERIAL ANALYSIS

This analysis is carried out on raw materials produced by the warehouse

officials for production. Before the raw materials can be used certain analysis
needs to be carried out to ensure the raw materials are up to standard to allow
for smooth manufacturing of drugs. After the analysis is done, if the raw
material passes the required parameters an approval label is pasted on it. Only
materials with approved labels are fit to be used in the production unit. If the
raw material fails, a rejected label is pasted on it which means it is not to be
used for production. Analysis majorly done includes physical tests, solubility
test, acidity or alkalinity, identification and assay etc.

8
Example using Paracetamol

Appearance White or almost white crystalline

powder

Solubility Sparingly soluble in water, freely

soluble in alcohol, very slightly
soluble in methylene chloride

Identification

First identification A, C

Second identification A, B, C, D, E

A. Melting Point: 1680C to 1720C

B. Dissolve 0.1g in methanol R
and dilute to 100.0ml with the
same solvent. To 1.0ml of the
solution add 0.5ml of a 10.3glL
solution of hydrochloric acid R
and dilute to 100.0ml with
methanol R. protect the solution
from bright light and
immediately measure the
absorption maximum at 240nm.
The specific absorbance at the
maximum is 860 to 980
C. Infrared absorption
spectrophotometry

9
 preparation comparison Disc

D. To 0.1g and 1ml of

hydrochloric acid R, heat to 600
long for 3min, add 1ml of water
R and cool in an ice bath. No
precipitate as formed. Add
0.05ml of a 4.9 glL 50 gallon of
potassium dichromate. R.A
violet colour develops which
does not change to red
E. It gives the reaction of a cetyl.
Heat over a naked flame
Assay Dissolve 0.300g in a mixture of
10ml of water and 30ml of
dilute suphuric acid R. Boil
under a reflex condenser for
1hr, cool and dilute to 100.0ml
with water R. To 20.0ml of the
solution add 40ml of water R,
40g Ofec, 15ml of dilute
hydrochloric acid R and 0.1ml
of ferroin R. to treate with 0.1m
cesium sulphate until a
Greenwich yellow colour is
obtained. Carry out a blank
titration.

TABLE 3

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  ASSAY, DISSOLUTION AND DISINTEGRATION

An assay is done to test for the potency of the Active Pharmaceutical

ingredients in a product drug. An ultraviolet spectrophotometer (UV) is usually
used for this process. To run an assay test on any product from the solid
reaction. The product has to be on granules form. The assay or potency of a
drug is between 98.5% - 101.0%

Dissolution test is an in-vitro study to determine how much of the active

ingredients of the product will be made available or released into the body
under a specific amount of time. The medium is heated to 37 oC which is the
main body temperature. Media serves as a buffer in an in vitro study. There are
three common media used for pharmaceutical analysis; the 0.1HCL normal
buffer, Acetale buffer (buffer 4.5), phosphate buffer (6.5 buffer). Comparative
dissolution is a type of dissolution test whereby there’s a comparison of
dissolution time between two company’s products with the same Active
Pharmaceutical ingredients.

Disintegration test is an in vitro study to find out the time it takes for a solid
dosage form to completely break down on the stomach.

Every drug has an active pharmaceutical ingredients (API) which must be

within a specific range in order for the drug to be effective. Assay and
dissolution tests are carried out to determine of the API meets the required
range limit. For every product, specific procedures are followed for both the
assay and dissolution test.

 FINISHED PRODUCT ANALYSIS

The finished product analysis is carried out for reconfirmation of a batch. When
the finished batch passes all the required test, he result is then sent to the
11
Quality Assurance department (Chemical Laboratory) who turns to give
approval for the product to be packaged. The batch has to pass some
requirements such as weight analysis and the assay.

 S.O.P FOR ANALYSIS OF AGARY PARACETAMOL TABLETS

1. Uniformity in weight
Procedure:
2. Weight: twenty (20) tablets each, selected at random and determine their
average weight.
3. Not more than two of the individual tablets weights should deviate from
the average weight by more than ± percent

ASSAY

1. Content of paracetamol
Procedure
 Weight and powder twenty (20) tablets.
 Wight and dissolve as completely as possible a quantity of the powder
equivalent to 0.15g of paracetamol in 250ml volumetric flask
 Add 50ml of 0.1m Sodium Hydroxide, dilute with 100ml of water
 Shake for fifteen (15) minutes and add sufficient water to produce 250ml
 Mix, filter and dilute 10ml of the filtrate to 100ml with water
 Add 10ml of the resulting solution to of 0.1m Sodium Hydroxide, dilute
to 10ml with water
 Measure the absorbance of the resulting solution at the maximum at
about 257nm.

Example

 Weight of sample taken = 0.1778g

 Weight of SPI taken – (0.6220 – 0.4590) g = 0.1630g

12
  Weight of sample II taken = (0.6530 – 0.4901)g = 0.1629g

Absorbance at 257nm

SPI = 0.425

SPI = 0.434

ASSAY IN mg/g

0.425 250 100 100 1.0 1000

SPI = 715 X 0.1630 X 10 X 10 X 100 X 1.0

ASSAY in mg/tab = 911.665 x 0.5554

= 506.338 mg/tab

0.434 250 100 100 1.0 1000

SPII = 715 X 0.1629 X 10 X 10 X 100 X 1.0

ASSAY in mg/tab = 931.542 x 0.5554

= 517.378mg/tab

 WATER ANALYSIS

An important analysis done in the laboratory daily is the analysis of water.

Water is a very key part required for the production of drugs and the condition
of analysis. Water analysis is conducted to check the PH, hardness of the water,
alkalinity, acidity, conductivity and heavy metals in the water. It is done every
morning every day to confirm if the water is safe for the day. These samples
include: sampling point (Treated water).

 MICROBIOLOGY LABORATORY DEPARTMENT

This is the laboratory where microbial analysis are conducted on the drug and
the environment

13
  STERILIZATION:

It is the process of killing all micro-organisms. These are two types of

sterilization (physical & chemical sterilization). The physical sterilization is
using heating autoclave etc, while chemical sterilization is using chemical
substances such as isopropyl alcohol or any alcohol.

 ENVIRONMENTAL MONITORING

Environmental monitoring evaluation is the monitoring of microbial presence in

a controlled dosed environment. After sampling of the room air which lasts for
about 1 hour to 4 hours, the samples are inoculated for 24 hours and microbial
growth is observed. The outcome of the environmental monitoring determines if
the room needs immigration or not. I have carried out this analysis.

Methods of environmental monitoring:

- Open plate: involves the use of sanitized petri-dishes with prepared media
in them to evaluate the microbes.
- Air sampling: simply they use air sampler machine to gathersome
contents in a paper strip.

Media preparation in microbiology:

There are 3 types of media based on the state

- Liquid (brot)
- Semi-olid
- Solid

14
  The liquid has no solidifying agent, while the semi-solid state has a little
amount (¿ 1.5 composition) of solidifying agent/agar, the solid state is
entirely made up of solidifying agent known as agar.

Based on the strength of nutrients:

 Basal media
 Enriched media

The Basal media has no additional nutrients and is used for non-specific
culturing while The Enriched media is used for culturing of gram positive
organism has additional nutrients added to it. For example; glycerol, serum etc.

 IN PROCESS UNIT DEPARTMENT

The in-process unit is the unit to run analysis on compressed tablets, moisture of
granules, disintegration, sample analysis in packaging materials, friability on
caplets: tablets, weight control check and all sub-divisional quality control
check on all lines and unit of operations. The in-process unit controls all the
processes of the individual unit of production processes from start to finish.
Quality check is done from the raw material area, where each raw materials of
different products is checked, i.e the bag, batch no. weight, tar-weight, dirty and
the mode of arrangements, this arrangement shall follow an order of FIFO (First
in first out), to be used in the Dispensary, the temperature, humidity and
cleanliness of the storage room is also guaranteed to standard before acceptance
and usage.

Quality check is done in the dispensary unit, where the materials must have
been approved from the QA/AC unit before use. Here the balance for weighing
is checked, cleared and calibrated, labels, nylons and all provided accumately,
the weighing is done at the right room conditions and at the rights weights for
dispensing the product is well stacked, before leaving for processing
15
(granulation). Here in granulation; approval must have been given after the
quality inspection from dispensary before processing starts. The raw materials is
mixed at the super mixer, taken to the FBD (Fluid Bed Dryer) for drying at
certain time, then taken to the miller for milling into more smaller particles. It is
then taken back into the FBD, for more drying. Sample is taken for moisture
analysis by the Qc (in-process personnel) which after approval of bring okay
(within specification) is taken to the blender, for blending at a certain number of
time. A final moisture is also determined if it is okay for compression. All this
processes from start to finished is supervised by Q.C (in process).

 WEIGHING BALANCE: Twenty tablets are weighed individually and

all together in order to determine its average weight. There is a minimum,
target weight; maximum expected weight of a tablet depending on the
specific product. Each weighed tablets are expected to fall within range.
It is weighed in milligrams.

 HARDNESS TEST: This is a laboratory technique used in the

pharmaceutical industry to test the crushing strength or breaking point of
a tablet. The resistance of a tablet to capping, aberration, or breakage
under conditions of storage, transportation and handling before usage
depends on its hardness. A tablet’s breaking point is dependent on its
shape. There are normally two processes to test tablet hardness but the
one carried out in my place of IT is the compression testing where the
analyst generally aligns the tablet in a repeatable way and the tablet is
squeezed by two jaws until it breaks and the result is recorded. The force
required to break a tablet is measured in kilograms and a crushing
strength of 4kg is usually considered to be the minimum for satisfactory
tablets.

,,

16
 FRIABILITY TEST: Friability is defined as a percentage of weight loss
by tablets due to mechanical action during the test. Tablets are weighed
before and after testing and, friability is expressed as a percentage loss on
pre-test tablet weight. It refers to the ability of compressed tablets to
avoid fracture and breakage during transport. It is designed to evaluate
the ability of the tablet to withstand aberration in packing, handling and
shipping. A number of tablets are weighed and placed in the apparatus
where they are exposed to rolling and repeated shocks as they fall 6
inches in each turn within the apparatus. After 4 min of this treatment or
100 revolutions the tablets are reweighed and the weight compared with
the initial weight. The loss due to abrasion is a measure of tablet
friability. The value is expressed in percentage. A maximum weight loss
should not be more than 1.0%. There should not be any broken tablets.
The equipment used is called a Friabilator.

 DISINTEGRATION TEST: This test is run using a disintegration tester

in which the medium is heated to 37°c (the human body temperature).
Each drug has a time range in which they should disintegrate after being
ingested into the body. If tablet is too hard, it may not disintegrate in the
required period of time. If it is too soft it may not withstand handling
during subsequent processing such as coating or packaging and shipping
operations.

 MOISTURE CONTENT ANALYSIZER: This equipment is used to

check the moisture content in granules.

 VENIER CALLIPER: This equipment is used to check the thickness of

a drug.

17
18
Diagram 1: The Analytical Weighing Balance

19
Diagram 2: The Friabilator

20
Diagram 3: The Disintegration Tester

21
Diagram 4: The calliper

Diagram 5: The calliper

22
23
 Diagram 6: Moisture Analyzer

3.4 PRODUCTION

Manufacturing of drugs takes place in the production section. The production

section is divided into the solid and the liquid area. Various types of drugs
such as tablets, hard gelatine capsules, syrups and suspensions are
manufactured in this section. Tablets and hard gelatine capsules are done in
the solid area while syrups and suspensions are done in the liquid area.

 SOLID SECTION

This section contains the blending area, granulation area, solution paste area,
compression area, tablet inspection area, coating area, blistering area, washing
area.

 BLENDING AREA: this is the place where the blending occurs.

Blending is a granulation process of mixing the already granulated
granules or only the API with other excipients that could react with
liquid used for granulation.

 GRANULATION AREA: Granulation process in which different

machines such as: multimill, Fluid Bed Drier bowl(FBD) , Vibro sifter,
Rapid Mixer Granulator (RMG)are used to transforms fine powders into
free-flowing, dust-free granules that are easy to compress.

 SOLUTION PASTE AREA: The area where the liquids used for
granulation are prepared.

24
 COMPRESSION AREA: this is a room where granules are being turned
to tablets. During the compression stage, the top and bottom punch
(tablet tooling) come together by pressure within the die to form the
tablet. As the punches enter into the compression stage, the top and
bottom punches move between two large wheels called compression
rolls.

 BLISTERING AREA: this is a room whereby a machine is being

used to blister the compressed tablets. Blister packaging has been
adopted as the packaging format by pharmaceutical companies to
protect the product from external factors. Blister packaging allows
access to each individual tablet, offering patient adherence and tamper
resistance.

25
Diagram 7: The Blending Machine

26
Diagram 8: The Fluid Bed Drier and it’s Bowl

27
Diagram 9: The Paste Kettle

28
Diagram 10: The Compressor

29
Diagram 11: The Blistering Machine

30
PRODUCTION FLOW CHART (TABLET)

SOLID AREA

DISPENSING

GRANULATION

COMPRESSION

COATING (depending on the product)

BLISTERING

PACKAGING

TABLE 4
31
 DISPENSING

During the manufacturing processes for pharmaceutical formulation, there is a

paramount requirement to comply with current Good Manufacturing Practices
(cGMP) regulations and maintain absolute quality assurance.

A key part of the secondary pharmaceutical manufacturing process will

involve dispensing: the weighing and transfer of raw materials according to
the batch manufacturing record to the production department.

 GRANULATION

Granulation process transforms fine powders into free-flowing, dust-free

granules that are easy to compress and also to make a homogenized mixture of
all the raw materials. The equipment’s used during granulation process are:

 Vibro sifter: this is use for sifting powder

 Rapid mixer granulation (RMG): use for mixing dry granules and also
after adding paste it is use to mix (wet granules).
 Fluidized bed dryer (FBD): this equipment is use for granulation and
drying.
 Steam jacketed kettle: this is found in the solution preparation room it is
use for binder preparation.
 Multi mill: this is use for size reduction; use for crushing strong granules.
 Cage blender: this is use for blending and during this process lubricant
such as: aerosol, sodium starch glycolate etc. are added during this
process. After the product pass through all this process, it is then being
transferred to the QC department for assay checks.

32
 TYPES OF GRANULATION
 Wet Granulation: This type of granulation use either aqueous or non-
aqueous liquid to form granules.
 Dry Granulation: this type of granulation forms the granules without any
liquid.

 COMPRESSION: Compression is the process of converting granules to tablets using

a compressing machine. The compressor/ compressing machine consist of;
 The Sucker: the sucker takes the granules into the compressor using a
force.
 The Feeder: stores the granules and evenly distribute it to empty dice.
 The Dice: where the granules are compressed in.
 The Punches: gives the shape of the tablets; some have alphabets.
 The Pre-compressor: Is the first stage of compression that removes dust
from the granules.
 The Compressor: Gives a force on the punches that converts the granules
to tablets. The De-duster: Further removes dust from the already
compressed tablets then takes the dust to the eliminator which would be
discarded after each batch.
 After the granules are being transformed to tablets, then In- Process
checks are being observed such as: friability, weight, hardness etc.

 BLISTERING: Blistering is the process of sealing the drug with aluminium strip and
polyvinylchloride (PVC) using a blistering machine. Component of the blistering
machine;
 The Polyvinyl Chloride (PVC) roller: Rolls the PVC to the heating drum.
 Heating Drum: The part of the machine that heats the PVC.
 Forming Drum: It’s the part of the machine that makes holes on the PVC.
 Hopper: where the tablets are poured into.
33
  Linear vibrator: Pushes the tablets gradually into the feeder using
vibration and the sensor in the feeder.
 Feeder/Brush box: brush the tablets into the PVC.
 Sealing Heater: seals the filled PVC with aluminium foil.
 Index Pusher: pushes the sealed drug to the cutter.
 Cutter/cutting station: cuts the drug to its supposed length.
 Embossing: marks the blistered drug with the manufacturing date,
expiring date and batch number.
 Perforator: perforates the sealed drug(not required in some drugs)

The product is then being blistered and sent to the QA for leakage test. It would
be transferred to the QC department for physical parameters (Finished Product),
then packaging follows and kept in the ware house for sales.

3.4 WATER TREATMENT

Water treatment plant to very important in pharmaceutical industries in order to

remove impurities like colour, odour, taste and ions present and also regulate
the PH of the water to make it for production. Water treatment can be chemical
water treatment or reserve osmosis water treatment.

 CHEMICAL TREATMENT ON WATER

The source of raw water is the raw water pumped from the borehole with the aid
of a submersible pumping machine (1.5hp) into the two raw water stainless steel
tank (4,000 Litre) each through aeration shower. The raw pumped is aerated
through the shower and manually dose with calcium hypochlorite of 65% purity
and Lime into the water.

The raw water tank is then manually dosed with 200g of calcium hypochlorite
of 65% purity and 500g LIMBUS as the water is been pumped. It is allowed to
stay for a minimum of 6 hours before transferring to the treated water holding
stainless steel tank (2000 Litre). The essence of the chlorination and lime is to
34
disinfect the water by destroying most of the pathogenic organism and
breakdown the colloidal nature of the iron with lime in the water

 FILTRATION

After 6 hours of chlorination and sedimentation, the chlorinated water is

pumped through the treatment filtration modules with the aid of a surface
pumping machine (1.0hp) through micro filters into the two overhead treated
water storage stainless steel tanks (2000 litres). The first is the graded sand bed,
which consist of granules and fine sand for the removal of sediments and
suspended solids from the water. The second module also houses the same
materials as the first. The third module consist of the activated carbon, which
removes any objectionable odour, taste, colour, and excess chlorine from the
water.

 MICRO FITRATION

At this stage, the treated water is subjected to micro filtration of filter size 5.0
and 1.0 microns before getting into the overhead treated water storage stainless
steel tanks.

 DEMINERALIZATION PROCESS

From the overhead treated water storage stainless steel tanks the water passes
through micro filters of pore sizes of 1.0 and 0.5 microns before passing
through the deionizer or demineralizing plant which consist of Cation column,
Anion column, to remove the cations and anions substances in the treated water,
after which it passes through the ultraviolet sterilizing unit to ensure thorough
treatment of the water for production use for manufacturing. The Ultraviolet
sterilizing stage ensures the denature of the DNA of any pathogen (disease
causing micro-organism) after deionizing stage. The demineralized plant is
regenerated every two months with 15% Hydrochloric Acid for the cation
column and 15% Caustic Soda otherwise known as Sodium Hydroxide for
Anion column.

35
 CHAPTER 4

SELECTED DRUGS

 Paracetamol
 Garylyte (ORS)
 Garyflox
 Garytem
 Folic Acid

4.1 PARACETAMOL

Paracetamol is exactly the same drug as ACETAMINOPHEN (Tylenol), it is a

mild pain reliever that has a history which dates back to 1893. It is an over the
counter drug that is composed of a reaction between p-aminophenol and acetic
anhydride. Acetaminophen is a derivative of acetanitide. It is used to
temporarily reduces or relieve mild headaches, muscle pains, sore throat and
fevers. Acetaminophen can also be used as an anti-inflammatory drug for
osteoarthritis which is caused by the “wear and tear” of the joints due to
incorrect joint allignment.
Although acetaminophen (paracetamol) is typically found as a tablet, it
can also be in form of a solution suspension, chewable tablet, suppository, drops
etc.

CHEMICAL STRUCTURE

36
Its chemical formula is C8H9NO2 and its molecular weight is 151.163g/mol. Is
IUPAC name is N-(4-hydroxyphenyl) acetamide.

Chemical/physical properties

 It is soluble on water, ethanol, acetone.

 It has a melting point of 169-170.50oc.
 It is a white odourless crystalline powder, large monoclinic prisms from
water.
 Its dissociation constant : pka = 9.0 – 9.5.

PHARM KINETICS
Bioaliatlability : 63% - 89%
Protein bonding : negligoble to 10 – 25 % in overdose
Metabolism : predominantly in the liver
Elimination half life: 1.9-2.5 hours
Excretion: Urine

MEDICAL USE
 It is a commonly used medicine that can help treat pain and reduce a high
temperature (fever)
 Acetaminophen is typically used to relieve mild or moderate pain, such as
headaches, tooth ache or sprains, and reduce fevers caused by illness such
as colds and flu.

MECHANISM OF ACTION

Paracetamol has no significant action COX-1 and COX-2 which left its
mode of action a mystery but did explain its lack of anti-inflammatory
action and also, more importantly its freedom from gastro intenstinal side
effects typical of NSAIDs.
Now, recent research has shown the presence of a new previously known
cyclooxygenase enzyme COX-3, found in ther brain and spinal cord,
which is selectively inhabited by paracetamol, and is distinct from the
two already known cyclo oxygenase enzyme COX-1 and COX-2.

37
PRECAUTIONS, CONTRAINDICATION AND WARNINGS.

 Taking too much acetaminophen may cause serious (possibly fatal)

liver disease.
 Before taking acetaminophen tell your doctor or pharmacist of you
are allegic to it or not.

4.2 GARYFLOX (CIPROFLOXACIN)

Ciprofloxacin is a fluoroquinolone antibiotic used to treat a member of

bacterial infections. This includes bone and joint infections,intra abnomal
infections, typhoid fever and uniary tract infections, among others. For some
infections it is used in addition to other antibiotics. It can be taken by mouth, as
eye drops, asear drops or intravenously.

CHEMICAL STRUCTURE

Its chemical formular is C17H18FN3O3 and its molecular weight is 331.4g/mol.

Its IUPAC name is 1-cyclopropy 1-6-fluoro-4-oxo-7-piperazin-1-yloluinoline-
3-carboxylic acid.

38
CHEMICAL/PHYSICAL PROPERTIES.

 It is a white powder with bitter taste.

 Its melting point is at 313-315oc.
 It is freely soluble in acetic acid and slightly soluble in water, methanol,
ethanol or acetone.
 It has a molecular weight of 385.8g/mol.

PHARMKINETICS

Bioavaibility: 70%

Protein binding: 30%

Metabolism:liver

Elimination Half Life: 3.5 hours

Excretion: kidney

MEDICAL USE.

 Ciprofloracin is used totreat or preventcertain infections causd by

bacteria. Eg pneumoia,gonorrhea, typhoid fever
 Ciprofloxacin is also used to treat infections on the skin, bone, joint

MECHANISM OF ACTION

Ciprofloracin is a broad –spectrum antibiotic of the fluoroqianolone class. It is

active against some gram-positive and many gram-negative bacteria. It
functions by inhabiting a type 11 topoisomerase (DNA gyrase) and
topoisomerase iv, necessary to separate bacterial DNA, thereby inhabiting cell
division. Bacterial DNA fragmentalion will occur as a result of inhibition of the
enzymes.
39
PRECAUTIONS, CONTRAINDICATION AND WARNINGS.

 It may cause serious and possibly permanent tendon damae, nerve

problems in the arms and legs.
 It may increase your risk for aortic aneurysm

4.3 GARYLYTE (ORS)

It is a type of third replacement used to prevent and treat dehydration, especially

due to diarrhea. It involves drinking water with modest amounts of sugar and
salts, specifically sodium and potassium. Oral dehydration salt can also be also
given by a nasogastric tube. The use of Oral dehydration, salt has been
estimatedto decrease the riskof death from diarrhea by up to 93%.

CHEMICAL STRUCTURE

Sodium chloride Sodium citrate

Na+ -Cl-

40
Pottassium chloride Glucose Anhydrous

K+-Cl-

Chemical formula of a sodium chloride is NaCl, potassium chloride is KCL,

sodium citrate is C6H5Na3O7 and glucose and hydrous is C6H12O6. The molecular
weight of sodium chloride is approximately 58.44g/mol, potassium chloride is
approximately 74.35g/mol, Sodium citrate is approximately 258.06g/mol and
glucose anmydrouse is approximately 180.16g/mol. The IUPAC name for
soduim chloride is soduim chloride, for potassium chloride is potassium
chloride, for Sodium citrate is Sodium2-hydroxypropane-1,2,3-toicarboxylate
and for glucose is (2R, 3S, 4R, 5R) -2,3,4,5,6-pentahydroxyheranol.

PHARMCINETICS

Sodium Citrate: Protein binding: None available

Metabolism: citrate is metabolised to
bicarbonate in the liver and plays a role as an
intermediate in the citric acid cycle./Sodium
citrate is metabolized to biocarbonate, which is
involved in acid – base regulation

41
 Elimination : it is primarily eliminated through
the kidneys.
Half life : 18-54 min.

Sodium chloride: Protein binding: sodium is not bound by

plasma proteins.
Metabolism: it does not undergo significant
metabolism in the body.
Elimination: it is primarily eliminated through
the kidney.
Half life: 17 minutes.

Potassium chloride: Protein binding: Not available.

Metabolism: Potassium is an essential
electrolyte and does not undergo.
Elimination: it is primarily eliminated through
the kidney
Half life: not available

Glucose Anhydrous: Protein binding: Not available.

Metabolism: Glucose is metabolized in various
tissues to provide energy.
Elimination:Glucose is metabolized and
eliminated through various metabolic pathways,
include glycolysis.
Half life: Approximately 14.3 minutes.

MEDICAL USE
 It is used to cure diarrhea and loss of fluid in the body.
 It is used to cure loss of excess of water due to homeostatis.

MECHANISM OF ACTION

1. Sodium Chloride:

 Absorption: Sodium chloride is rapidly absorbed from the gastrointestinal

tract.
42
  Distribution: It is distributed throughout the extracellular fluid
compartment.
 Metabolism: Sodium chloride does not undergo significant metabolism in
the body. - Elimination: It is primarily eliminated through the kidneys.
2. Sodium Citrate:

 Absorption: Sodium citrate is well absorbed from the gastrointestinal

tract. - Distribution: It is metabolized to bicarbonate in the liver and then
distributed throughout the body. - Metabolism: Sodium citrate is
metabolized to bicarbonate, which is involved in acid-base regulation.
 Elimination: It is primarily eliminated through the kidneys.
3. Potassium Chloride:

 Absorption: Potassium chloride is rapidly absorbed from the

gastrointestinal tract.
 Distribution: It is distributed intracellularly.
 Metabolism: Potassium is an essential electrolyte and does not undergo
significant metabolism.
 Elimination: Potassium is primarily eliminated through the kidneys.
4. Glucose Anhydrous:

 Absorption: Glucose is rapidly absorbed from the gastrointestinal tract.

 Distribution: It is distributed throughout the body, primarily in the
bloodstream.
 Metabolism: Glucose is metabolized in various tissues to provide energy.
 Elimination: Glucose is metabolized and eliminated through various
metabolic pathways, including glycolysis.

PRECAUTIONS, CONTRAINDICATION AND WARNINGS.

 It may lead to nausea and vomitting may occur.

 If you do not take the solution properly, it can cause salt toxicity.

4.4 GARYTEM (ARTEMETHER/LUMEFENTRINE)

43
 Artemether/lumefantrine, are under the trade name caartem among
others, it is a combination of 2 medications artemether and lumefantrine. It is
used to treat malari caused by plasmodium flaeiparum that is not treatable with
chloroquine.it is not typically used to prevent malaria.it is taken by month.

CHEMICAL STRUCTURE

ARTEMETHER LUMEFANTRINE

Its chemical formular is C46H58 Cl3No6 and its molecular weight is 827.3g/mol.
Its IUPAC name is 2-(dibutylamino) -1-1(9Z)-2; 7-dichloro -9-[C4-
chlorophenyl)methylidene]fluoren-4-yTl ethanol, (4S,5R,8S,9R,10S,12R,13R)-
10-methoxy-1,5,9-trimethyl-11,14,15,16-tetraoxatetracydo [10.3.1.0.4.13.08,13]
hexadecane.

CHEMICAL/PHYSICAL PROPERTIES LUMEFANTRINE

 It is a yellow powder with a bitter taste.

 Its melting point is 128-131oc
 its practically insoluble in water

CHEMICAL/PHYSICAL PROPERTIES ARTEMETHER

 it is a white to pale yellow crystals or powder.

 Its melting point is 86oc-90oc.
 its practically insoluble in water.

44
PHARMCINETICS

Artemether: protein binding: 95-4% -99.7

metabolism:its rapidly metabolized to its
active metabolate, dihydroartemisinin.
Half life :1.6 + 0.7 and 2.2 + 1.9 hrs.

Lumefantrine: protein binding: 99.7

Metabolism: liver
Half time: 4.5 days

MEDICAL USE

 It is used to treat a cute, unplicated/modarou in patients

ARTEMETHER MECHANISM OF ACTION

It involves an interaction with ferriprotoporphyrin IX (“heme”), or ferrous ions,

in the acididc parasite food vacuole, which results in the generation of cytotoxic
radical species.

The generally accepted mechanism of action of peroxide anti-malarials,

involves interaction of the peroxide containing drug with heme, a hemoglobin
degradation by product, derived from proteolysis of hemoglobin. This
interaction is believed to result in the formation of a range of potentially toic
oxygen and carbon-centered radicals.

45
 LUMEFANTRINE MECHANISM OF ACTION

The exact mechanism by which lumefantrine exerts iots antimalarial effct is

unknown. However, available data suggests that lumefantrine inhibits the
formation β -hematin by forming a complex with hemin and inhibits nucleic acid
and protein synthesis.

PRECAUTIONS, CONTRAINDICTION AND WARNING

 It may cause serious allergic reactions without following the doctors

instructions.
 Taking ( artermether/lumefantrine )without other antimalarials can be
dangerous for the heart.

4.5 FOLIC ACID

The name “Folic Acid” also called vitamin B9 which is a water soluble essential
vitamin that is converted to tetrahydrofolic acid in the body. It aids in the
production of DNA and RNA, The bodies genetic material, and is especially
important when cells and tissues are growing rapidly such as in infancy,
adolescence and pregnancy. The term “Folic Acid” and “Folate” often are used
interchangeably. However, folate is a general term used to describe the many
different forms of vitamins B9. Folic acid is a B – complex vitamin containing a
pteridina mostly linked by a methylenebridge to para-aminobenzoic acid, which
is joined by a peptide linkage glutamic acid. It is an odourless orange-yellow in
colour with a molecular weight about 441.404glmol. The pH of folic acid is 4.0-
46
4.8 .its melting point is 250 oc and above its temperature, it starts decomposing,
folic acid is slightly soluble in water, ethanol, methanol and botanic solvents.
On the other hands it is insoluble in acetone, chloroform, other and benzene.

SOURCES OF FOLIC ACID

Folic acid or folate are present in a wide variety of foods including vegetables
(especially dark green leafy vegetables) ,fruits and fruits juices, nuts, beaks,
peas, sea-foods, eggs, dietary products, meat and poultry.

Chemical structure

The chemical formula is CiaHia7O6 and molecular weight of 441.4g/mol. Its

lupac name is (25)-2-[C4-amino-4-0x0-1H-pteridin-6-yl) methylamino]
benzoyl] amino] pentanedioic acid

Chemical/physical properties
 A yellow to orange, odorless, tasteless, needless crystalling solid.
 Its melting point is 250oc and above this temperature,
 Its is slightly soluble in water, ethanol, methanol and butane solvents.
 It boiling point is 552.4oc
 Density 1.4704 g/cm3

PHARM KINETICS

Bioaliatlability – rapid and complete

47
Protein bonding – veryhigh to plasma protein

Elimination half-life: It doesn’t have.

Excretion: Kidney (it takes about over 5hrs)

Absorption: it is an active process that occurs primarily in the duodenum &

jejunum (the most extensive part of the small untestine with substantial
mesentery that meets at the top of the abdominal cavity as the root of the
mesentery).

Metabolism: it occurs with the transport of folic acid from the intestinal lumen
to erythrocytes, then into the blood stream to enter the liver.

Common side effect

 Bad taste in your mouth.

 Abdominal smelling.
 Irritability.
 Redness.
 Loss of appetite.
DEFICIENCY

Folate Deficiency also known as folic acid deficiency occurs when there is not
enough folate present in the body. This can lead to a type of anemia called
megalibloiatic anaemia. During pregnancy, folate deficiency increases the risk
of congenital irregularities.

Some group at increased risk of folic acid deficiency include:

 People with alcohol use disorder.

 Pregnant people.
 People at child bearing.
 People with conditions that affect nutrient absorption.

USES OF FOLIC ACIDS

 Folic acid helps your body produce and maintain new cells.
 It also helps prevent changes to DNA that may lead to cancer.
48
 MEDICAL USES
 It protects and treat low level of folate (vitamin B9) in your body.
 Folic acid also support a healthy pregnancy and lowers the risk of birth
defects of the brain and spine.
 Folic acid plays an important role in forming red blood cells and
maintaining brain health

VETERNARY USE
 Folic acid supplementation is used in animals at risk for folate deficiency,
particularly animals with small intestinal disease or mal-absorption.

 Folic acid supplementation, sometimes is used in horses, undergoing

long-term treatment for equine protozoa.

FUNCTIONS

Folic acid performs numerous physiological functions in the human body: the
functions include:

 Immune function: it is involved in tall and mitogen regulation, which is

essential for immunity and growth.
 Collagen: it provides increased hydration by maintaining skin barrier
functions. This can improve moisture retention and alleviate skin dryness.
It is known to significantly reduce the signs of premature ageing by
maintaining adequate collagen production.
 Anti-oxidant: it reduces derivates act both directly and indirectly to
produce autoirdant effects.

MECHANISM OF ACTION

49
 Folic acid is an essential nutrient necessary for protein and nucleic acid
synthesis (DNA and RNA). Folic acid is synthesized by bacteria from the
substrate, para-amino-benzoic acid (PABA), and all cells require folic acid for
growth.

BIOCHEMICAL FUNCTIONS OF FOLIC ACID

 It aids in th production of DNA and RNA, the body’s genetic mateial, and
is especially important when cells and tissues are growing rapidly, such
as in infancy,adolescence, and pregnancy. Folic acid also works closely
with vitamin B12 to help make red blod cells ansd help iron work
properly in the body.
 THF it serves as an acceptor or donor of one carbon units (formyl,
methyl) etc.
 Vitamin B12 deficiency leads to impairment of methiosnine synthase,
resetting on accumulation of homocysteine and trapping folate as
methyltetrahydrofolate known as folate trap.

PRECAUTIONS, CONTRAINDICTION AND WARNINGS

 Large doses are reported to cause redness, accelerating mental

decline in older adults increasing the likelihood of cancer
recurring.
 It is good for patients who have certain allergy reaction to the drug.
 Avoid too rapid intravenous injections.

CHAPTER 5

5.1 PROBLEM ENCOUNTERED DURING THE INDUSTRIAL TRAINING

50
  The inability to integrate immediately especially on the use of
equipment/instruments and also on the various analysis conduct
during my industrial training.

5.2 PROBLEM SOLUTION

 For institution to make available these equipment for use by students on

regular basis in order to adjust properly in various organization we find
ourselves.

CHAPTER 6

6.1 CONCLUSION

51
The SIWES was actually a great opportunity for me to work in a pharmaceutical
industry. The training exposed me to full knowledge and experience of drug
production, social and managerial skills and so much more. With the knowledge and
training acquired from this program and first-hand experience, I can easily work in
any pharmaceutical industry.

6.2 RECOMMENDATION

I recommend that the upcoming student should not just engage in money making
during I.T experience but make use of the opportunity to try hard in observing
their I.T at the right time and at the right attachment.

REFERENCES

British Pharmacopeia (B.P) vol I, II, III, IV,V 2014.

52
British Pharmacopeia (B.P) vol I, II, 1998

United States Pharmacopeia (U.S.P)

53