CHAPTER ONE

INTRODUCTION
1.0 DEFINITION, HISTORY AND BACKGROUND OF SIWES

The Student Industrial Work Experience Scheme (SIWES) also known as industrial
training refers to a program which aims to prepare and expose student for industrial
work situation they are likely to meet after graduation. This scheme serves as a
smooth transition from the classroom to the world of work and further helps in the
applications of knowledge.

This program was introduced into tertiary institution by Industrial Training Fund
(ITF) in the year 1973 to solve the problem of lack of adequate proper skills for
employment of tertiary institution graduates by Nigerian industries.

The scheme was solely funded by Industrial Training Fund (ITF) during its formative
years but as the financial involvement became unbearable to the fund, it withdraws
from the scheme in 1978.

In 1979, the Federal Government handed over the management to the scheme to both
the National University Commission (NUC) and National Board for Technical
education (NBTE).
Later, in November 1984, the Federal Government reverted the management and implementation
of the scheme to ITF.

In July 1985, it was taken over by the Industrial Training Fund (ITF) while the
funding was solely borne by the Federal Government of Nigerian.

1.1 AIMS AND OBJECTIVES OF SIWES

SIWES is strategized for skill acquisition. It is a key factor required to inject and help
keep alive industrialization and economic development in the nation through the
introduction and practical teaching of scientific and technological skills to students.

Specifically, the objective of the Student Industrial Work experiences Scheme

(SIWES) are to:-

1. Provide avenue for students in institutions of higher learning to acquire

industrial skills and experience in their course of study.

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 2. Bridging the gap between theory and practice by providing a platform to apply
knowledge learnt in school to real work.
3. Introduce students to real work atmosphere so that they know what they would
most likely meet once they graduate.
4. Familiarize with various materials, processes, products and their applications
along with relevant aspects of quality control and shop floor management.
5. Understand the social, economic and administration considerations that
influence the working environment of industrial organizations.
6. Expose students to work methods and techniques in handling equipment and
machinery that may not be available in the universities.
7. Understand the psychology of workers and their habits, attitudes and approach
to problem solving.
1.2 BENEFITS OF WORK EXPERIENCE FOR STUDENT
 Development of the key employability skills sought by graduate employers.
 Gives you that edge in seeking employment when graduate.
 An exposure to work place culture and increase career insights.

1.3 BRIEF HISTORY OF GAUZE PHARM AND LAB

Gauze Pharmaceutical and Laboratories Nig Ltd located at Enu-Ifite Village, Awka,
Anambra state was founded in the year 1992. There was no immediate
commencement of productions that same year because it took the company time to
affirm its quality and standard operating procedures. She earnestly commenced
production in the year 2000 with Eight (8) product after approval from NAFDAC and
Pharmacist Council of Nigeria (PCN).

The delay in commencement of production after was neither due to imbalance nor
financial constraints, but resole of the company from inception to manufacture
genuine pharmaceutical products, that will restore the vitality of life, the company
took time to ensure all that is needed to fall in line with the cGMP were in place and
also subjected her products to various Vivo and in Vitro pharmaceutical testing
processes

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The company has maintained a high level of integrity in manufacturing, it is a wholly
indigenous establishment where essence is built on durable quality pharmaceutical
products to meet the customers’ satisfaction, this entails why NAFDAC and PCN in
2003 encouraged the company to register more products and currently having over
fifty (50) products registered with NAFDAC

Gauze Pharmaceutical and Laboratories Nig Ltd maintaining her pace setter status,
has never compromised the quality of her products for whatever reason which has
endeared her products recognition in Nigeria and far beyond. The company's products
had barged so many National awards and currently exports her products to many
African countries

The company manufactures various pharmaceutical products such as Analgesics, Anti

pyretic, Antacids, anti-diarrhea, anti-malaria, antibiotics etc with seven distinct
production lines namely;

 The oral liquid line

 The external liquid line
 The beta-lactam line
 The dry powder/ORS line
 The tablet line
 The water line
 The soap production

1.4 MISSION STATEMENT

In line with the desire to provide effective and affordable pharmaceutical products of
high quality to needy customers, Gauze Pharmaceuticals and Laboratories undertake
to produce and supply good pharmaceutical products to the people.

1.5 VISION STATEMENT: To manufacture genuine pharmaceuticals that will

restore the validity of life.

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1.6 THE COMPANY’S ORGANOGRAM

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1.7 THE COMPANY’S DEPARTMENTS AND THEIR FUNCTIONS

a. Quality Management Department

b. Administrative Department
c. Sales Department
d. Account Department
e. Store Department
f. Technical Department

1. QUALITY MANAGEMENT DEPARTMENT: This is an arm of the

organization that defines the managerial function as it implies to the areas of initiating,
determining and implementing basic quality basics. This department ensures that the
manufacturing processes and the products itself meets the required quality by carrying
out chemical and microbial analysis of raw materials and finished products as well as
qualification and validation of processes, calibration of equipment, documentation and
retention of drug samples.

2. ADMINISTRATIVE DEPARTMENT: This department responsibility for

management of the establishment.it is headed by the Administrative manager. This
was where various work like employment of workers, welfare of workers,
implementing decisions reached by the management, business affairs, supervision of
work.

3. SALES DEPARTMENT: This sales department is an arm that retail products,

goods and services to customers, in other words it is a link between the company
product and customers. It is headed by the sales manager, the aim is to make sales and
gain profit for the company.

4. ACCOUNT DEPARTMENT: This department is headed by the chief accountant

responsible for enforcing and establishing accounting and auditory policymakers to

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enhance the transparency and relevancy of financial reports. They handle the
monetary flow in and out of the company’s income
5. STORE DEPARTMENT: The store manager is in charge of this department. The
jobs here are receiving of raw materials and finished products, storage of raw
materials and finished products, dispensing according to FIFO and FEFO, reconciling
the raw material and finished product dispensing using the ARC No, Non analyzed
chemical raw materials and finished products are kept in quarantine room with yellow
label status on each sample. Analyzed ones are kept in the approved room with green
label status on each sample. Rejected raw materials are kept in the store with red label
as samples that did not pass the analysis carried out.

6. TECHNICAL DEPARTMENT: This is headed by engineering manager. This

department organizes, direct, control and coordinate engineering and technical
operation on equipment/machines in the organization.

1.8 SOME OF THE COMPANY’S PRODUCTS

Oral Liquid Line External Liquid Tablet Line Beta-Lactam/ORS

Line Line

MistMag Calamine Lotion Ibuprofen tablets Zimaclox

Suspension

Vitamin C Syrup Methylated Spirit Paracetamol tablets Zimacillin

Magcid suspension Scabistop Yeast tablets Zimamox

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Koslyn Baby Hydrogen Peroxide Folic acid tablets Oral Rehydration
Cough Syrup Salt (ORS)

Multivitamin Syrup Jamgerm Zimagil tablet

Paracetamol Syrup Iodine Chloroquine

Phosphate tablet

Chloroquine Syrup Eusol solution Ciprofloxacin tablet

1.9 SOME OF THE COMPANY’S PRODUCTS AND THEIR USES

S/N Name of the Active Ingredients Uses
Products
1. Paracetamol syrup Paracetamol powder For the relief of pains and
fever
2. Kosyln Adult Diphenhydramine Relief from cough and nasal
Cough hydrochloride, ammonium Congestion in adults
chloride, sodium citrate and
menthol
3. Multivitamin Vitamin A, B1, B2, B 6, C, Helps make up for any
syrup D3 and nicotinamide. lacking vitamin in children,
and also protect from
nutritional disorders
4. Mist-Mag Magnesium trisilicate, light For relief of hyper-acidity,
suspension magnesium carbonate and heart burns, flatulence and
sodium carbonate indigestion
5. Magcid Magnesium trisilicate, light For relief of hyper-acidity,
Suspension magnesium carbonate and heart burns, flatulence and
sodium carbonate indigestion
6. Zimatrim Cotrimoxazole For relief of stubborn cough

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7. Zimacillin Ampicillin powder For respiratory tract
infections, nose and throat
infections, urinary tract
infections, etc
8. Calamine Lotion Calamine powder Relieves discomfort due to
rashes, sunburn, stings and
insect bites.
9. Methylated Spirit Ethanol and Methanol As first aid for cleansing of
(95%v/v) wound surfaces and also to
clean skin surface when
administering injections.
10. Hydrogen Hydrogen Peroxide Used as mouth wash, first
Peroxide Solution aids, and to remove
dressing from wounds.

11. Jamgerm Chlorohexidine gluconate, An antiseptic, anti-bacterial

Antiseptic and Cetrimide and a cleansing agent

12. Ibuprofen tablet Ibuprofen 400mg Analgesic, Antipyretics and

anti-inflammatory

13. Paracetamol tablet Paracetamol 500mg For relief of headache,fever

and cold

CHAPTER TWO
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 QUALITY MANAGEMENT DEPARTMENT

Quality management department is designed to perform and coordinate quality

management function to ensure that products are of good quality standard. They
control and assure that products pass through series of process like undergoing of
analysis, documenting and retaining. They are the head of ISS in the company.

In pharmaceutical industry, this department cannot be overlooked because of its

importance, if not for this department it is certain that drugs will be contaminated. It
has 2 sections the quality assurance and the quality control.

1. Quality Assurance Management

2. Quality Control Management

2.1 Quality Assurance Department: The Quality assurance department is headed by

the quality assurance manager. The quality assurance manager ensures that products
are acceptable through maintaining and implementing strict order guiding all
production activities. They plan, direct and coordinate Quality Assurance programs
and Formulate Quality Control Policies

2.2 Quality Control Management: This department ensures the quality of raw
materials used and the finished products sold out to the consumers. This is the part of
GMP that is concerned with sampling, testing, documentation and release procedures
which ensure you the necessary and relevant test are actually carried out and the
material are not released for use, sale or supply, until their quality has been judged to
satisfactory according to specification. Those analyses are carried out in two different
laboratories which are:-
 Microbiology laboratory
 Chemistry laboratory

2.2.1 CHEMISTRY LABORATORY

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This is a sub-section of the Quality Control Department where chemical analysis of
water, raw materials and finished products are carried out to ensure that products are
up to standard. This section is faced with the task of calibrating and standardizing
company's equipment before use to ensure adequate capacity and efficiency. All
analysis are performed using the British Pharmacopeia as reference book.
The Chemistry laboratory carries out the following activities using different
equipment’s:
a. They carry out Calibration of weighing balance, PH meter, conductivity meter,
electronic weighing balance, moisture content analyzer.
b. In-process test and chemical analysis of finished products to ensure and
maintain quality.
c. Carrying out analysis on raw materials before issuance for production.
d. Carrying out various test on water used at different production sections of the
company.
e. Carrying out analysis on raw materials before issuance for production.
f. Documentation of analysis performed.
2.2.2 Standard Operating Procedure for Chemistry Laboratory
1. When in the laboratory, always put on your lab coat.
2. When carrying out analysis, always put on your face mask, head gears and
safety goggles.
3. No food or drinks are allowed in the laboratory.
4. All apparatus and bench tops should be kept clean and free of all unnecessary
items always, especially when carrying out analysis
5. Always label and record your samples/results properly.
6. Read the label on any reagent bottle carefully before using.
7. Do not return unused chemicals to the stock bottle (Take only what you need).
Flush unused chemical down the sink.
8. Cover reagent bottles properly with their stoppers.
9. Dispose wastes properly to avoid injury.
10. In case of any injury, inform the chemist.

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2.2.3 Types of Analysis Done in the Chemistry Laboratory
We have basically two types of analysis done in the Chemistry laboratory. These
analysis are utilized in the lab with the aid of the British Pharmacopoeia, which is the
reference book used in the laboratory. These analyses are:-
1. Qualitative Analysis
2. Quantitative Analysis

1. Qualitative Analysis: This type of analysis deals with the identification of the
elements and compounds that are present in a sample of a given substance. It deals
majorly with the chemical constituents of raw materials of drugs used by the
company, also for the finished products. This analysis takes the following parameters
into consideration: colour, pH, odour, specific gravity, melting point, boiling point.

2. Quantitative Analysis: In Quantitative analysis, we calculate the amount or

quantity of an element of compound present in a given sample.. The two methods
employed in quantitative analysis are :- (i) Volumetric Analysis and (ii)Gravimetric
Analysis.
Volumetric Analysis :- is used to determine the volume of a solution using
titration method.
Gravimetric Analysis:-is based on direct mass measurement of the substance.

2.2.4 Chemical Analysis on Water Samples for Drug Production.

Water that is used in different sections of the company must be analyzed by the
Chemist before production is commenced every day, to ensure they are good for
consumption and production. These tests include:
i. Organoleptic Test: This involves test for color, taste, odour and feel.
ii. pH Test: The pH for production water falls between the range of 5.0-7.0. This
pH is tested using the pH meter.
iii. Conductivity Test: Measures the conductive ability of water sample. It is
measured in micro Siemens per centimeter. The standard range for conductivity
is 0-1000us/cm, but the conductivity range for any production water should fall
within the range of 0-10us/cm.

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iv. Total Dissolved Solute (TDS) Test: This is the measure of the combined
content of all inorganic and organic substances contained in the liquid. It is
measured in parts per million (ppm). The standard range for TDS is 0-500ppm,
but the TDS of production water should fall between the range of 0-5ppm. TDS
is usually half the conductivity of the given sample.
v. Test for Presence of Chloride Ions: To indicate the presence of chloride ion,
add two drops of 2M nitric HNO3, followed by the addition of 0.1M AgNO3 in
5ml water sample. Formation of cloudy precipitate indicates the presence of
chlorine.

2.2.5 Chemical Analysis on Raw Materials Used In Drug Production

Raw materials being natural and untransformed reagents or elements that have not
undergone manufacturing process are analyzed in other to ensure the quality and
compliance of it with the stipulated range or with the specification given in the British
pharmacopoeia (BP) and other standard reference book.
Examples of raw materials are; Ascorbic acid, Metronidazole, Zinc oxide, ethanol, 4-
Hydroxyphenyacetamide etc.
In Guaze pharm and lab, raw materials are collected from the Quarantine room in the
store section and analyzed. The parameters considered during chemical analysis
include:
1. Characteristics Test: This involves the physical properties of the substance which
include its color, odour, texture and taste. It also include the solubility of the sample in
water, ethanol, chloroform or any other solvent specified by the British
Pharmacopoeia (BP) or any other reference book being used.
2. Identification Test: This is carried out in other to determine the acidity/alkalinity,
specific gravity, apparent density, melting point and boiling point of a sample.
3. Assay: This is a quantitative test used to determine the percentage purity of raw
materials. This could be determined using titrimetric, spectrophotometric method etc.

Example: Analysis on Vitamin C (Ascorbic acid)

Definition: Vitamin C (Ascorbic Acid) contains not less than 99.0% and not more
than 100.5% of C6H8O6.

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Structural formula:

Physical Characteristics: White or almost white, crystalline powder or colorless

crystal, becoming discolored on exposure to air and moisture.
Identification: To 30ml dissolved of vitamin C, add 20ml of ferroin solution R 1. The
solution remains colorless and not more than 0.2ml of Ammonium Cerium (IV)
sulphate is required to change the colour of the solution to pink.
Solubility: Freely soluble in water, sparingly soluble in ethanol (96%).
Melting Point: About 190°C, with decomposition.
Reducing reaction: A solution of the sample in water immediately reduces potassium
permanganate without heating, producing a brown precipitate.
pH: 2.4 - 2.8
Functional use: Antioxidants, Anticancer, Antiviral

Assay: Ascorbic acid

Aim: To Determine the Percentage Purity of Ascorbic Acid.
Apparatus/Materials: Electronic weighing balance, spatula, conical flask, burette,
pipette, retort stand.
Method of Analysis:Iodimetry
Reagents used: 1M dilute sulfuric acid, carbon dioxide - free water, starch solution,
0.1N Iodine.

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Procedure:
Weigh accurately about 0.1 gm of the sample and dissolve in a mixture of 100 ml
freshly boiled and cooled water and 25 ml of 1M sulfuric acid. Immediately titrate
with 0.1N Iodine, using the starch solution as indicator until a persistent blue-violet
color is obtained. Each ml of 0.1N iodine is equivalent to 8.81mg of ascorbic acid.

Analytical Result:
Weight of Sample used = 97.6mg
Final burette reading = 10.50ml
Initial burette reading= 0.00ml
Titre value = 10.50ml
But, each ml of 0.1N Iodine is equivalent to 8.81mg of Ascorbic Acid
To calculate percentage purity of Ascorbic Acid =
Burette reading × Exact Normality of Iodine × Eq factor ×100
Approximate N of Iodine × weight of sample

= 10.50ml × 0.105 × 8.81mg × 100

0.1 × 97.6mg =99.50%.
Range: 99.0% to 100.5%
Remark: Passed according to British Pharmacopoeia
Example 2:Analysis of Ethanol (96%)H3C-CH2OH
1.Characteristics:colour less clear liquid, which is highly flammable
2.Miscibility:It is miscible with water, chloroform and ether.
3.Identification:
I) To 20ml of ethanol add 0.25ml of phenolphthalein solution R1.The solution remains
colourless and not more than 0.2ml of 0.1M sodium hydroxide VS is required to
change the color of the solution to pink.
ii)Alcoholic content of ethanol is checked using an alcohol meter.
4.Apparent Density (803.8-806.3kg/m3)
Weight of pycnometer=21.565g
Weight of pycnometer +water=49.632g

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Weight of pycnometer +sample=44.128g
Weight of water=28.067g
Weight of sample=22.563g
Apparent density =22.563x997.2kg/m3
28.067. = 801.64kg/m3

2.2.6 Chemical Analysis of Finished Product

Example: Analysis of Vitamin C syrup
Description of the product: It is packaged in a 100ml amber PET bottle corked with
pilfer proof metal cap.
Physical appearance: Yellow syrup with a sweet taste and fine flavor.
Apparatus: Pyconometer, Electronic weighing balance, pH meter.
Specific gravity at 30oc
Weight of pyconometer = 21.563g
Weight of pyconometer + water = 51.187g
Weight of pyconometer + sample = 52.802g
Weight of water = 29.624g
Weight of sample = 31.239g
Specific gravity = weight of sample (g) x 0.99462g/ml
weight of water (g)
= 31.239g x 0.99462g/ml
29.624g
Specific gravity = 1.05g/ml
(Range= 1.00g/ml – 1.10g/ml)
pH = 3.96 (Range= 2.5 - 5.0)
Assay: Ascorbic acid
Aim: To determine the percentage content of Ascorbic Acid powder in Vitamin C
syrup.

Method:Titrimetry

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Apparatus/Material: Conical flask, burette, pipette, distilled water, sulphuric acid,
ammonium cerium (iv) sulfate solution, ferroin solution and sample syrup.
Procedure: 18.75ml of the product containing 0.15g of the active ingredient was
measured out and dissolved in a mixture of 30ml of distilled water and 20ml of 1M
H2SO4. The resulting solution was titrated with 0.1M Ammonium Cerium (IV)
Sulfate solution using ferroin solution as indicator, given that the label claim is
40mg/5ml. Each ml of 0.1M Ammonium Cerium iv Sulfate is equivalent to 8.806mg
of Ascorbic Acid.
Analytical Result:
Volume of Product used = 18.75ml
Final burette reading = 17.10ml
Initial burette reading= 0.00ml
Titre value = 17.10ml
But, each ml of 0.1M Ammonium cerium iv sulfate is equivalent to 8.806mg of
Ascorbic Acid
Therefore, Content of Ascorbic Acid in 5ml of syrup is = (Titre value × mg
equivalence × 5ml) ÷ (Volume of product used)
17.10ml × 8.806mg × 5ml
18.75ml = 40.16mg
% label chain = 40.16mg × 100
40mg = 100.4%
Range: 95% to 107.5%
Remark: Passed according to B.P (1998/2008/2013)
Comment: Conforms to In-house specifications and is fit for consumption.
2.2.7 Carry Over Test of HTH on Washed Bottles
Aim: To determine the presence or absence of HTH on washed bottles.
Reagents: 5-10ml of distilled water, 5-10ml of water from last rinsing bowl, 0.1M
Silver Nitrate(v), 2M Nitric Acid.
Apparatus: 2 test tubes.
Procedure: Two bottles were sampled at random. One filled with water from last
rinsing bowl which 5-10ml is poured in a test tube, and the other empty which 5-10ml

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distilled water is poured in and shaken thoroughly then transferred to the second test
tube. Add a drop of AgNO3 and HNO3 simultaneously into each test tube.
Observation: Formation of cloudy precipitate indicates the presence of HTH while a
clear colorless solution is observed if HTH is absent.

2.2.8 Calibration of Equipment

Calibration is the adjustment or marking of a measuring device to determine the

deviation of a standard so as to ascertain the proper corrections. Calibration in the
chemistry laboratory is done every day before the use of the equipment for analysis.
Equipment calibrated include the pH meter, electronic weighing balance, conductivity
meter etc.

2.2.9 SOME OF THE EQUIPMENTS USED IN THE CHEMISTRY

LABORATORY AND THEIR FUNCTIONS.
1. PH Meter: Used for measuring the degree of alkalinity or acidity of a liquid
sample.

FIG 2.0: PH meter

2. Moisture Analyzer: It is used to analyze the moisture content of drugs.

FIG 2.1: Moisture analyzer

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3. Pycnometer: This is a device made of glace with stopper used to determine the
density of a liquid.
4. Fume Cupboard: It is used for incubating reagents that produce fumes.
5. Volumetric Flasks: They are used to accurately prepare solutions for chemistry.
They come in different volumes, and are used depending on the volume of solution to
be prepared.

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FIG 2.2: Volumetric Flasks
6. Conductivity Meter: Used to check the conductivity of solution, as well as the
Total Dissolved Solvent (TDS).
7. UV Spectrophotometer: It is used for measuring how much a chemical substance
absorbs light by measuring the intensity of light, as a beam of light passes through
sample solution.
8. Electronic Weighing Balance: It is used to determine the weight or mass of
finished products and raw materials.

FIG 2.3: Electronic Weighing Balance

9. Desiccators: This is a short glass jar fitted with an air-tight cover, containing some
desiccating agents such as silica gel dryer, which absorbs the moisture of any
compound placed in it.

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FIG 2.3: Desiccators

2.3 MICROBIOLOGY LABORATORY

Microbiology laboratory section is one of the quality control that handles microbial
analysis of drugs (in-process analysis), finished products, raw materials, water used in
production, bottles for filling drugs and the environment in which the drugs are
produced, to ensure sterility. They carry out researches on observed pathogen to
ensure that adequate measures are put in place to eradicate them. They also ensure
proper cleanliness of the company.

2.3.1 Basic Microbiology Laboratory Rules

1. Once inside the laboratory put on your laboratory coat
2. Do not eat or smoke in the laboratory.
3. Always label and record your samples and results appropriately.
4. Swab the bench before and after work with disinfectants.
5. Avoid breakages and always open cans carefully.
6. Put discarded material in the discard jars.
7. Put unused prepared media in the refrigerator
8. Keep adequate record of every activity carried out.
9. Remove your laboratory cloth at the end of work.
10. Always wash your hands in-between procedure.
11. Always keep records of every activity carried out.
12. Results should be compared at intervals.

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2.3.2 Microbial Analysis of Raw Materials
Example: Microbial Analysis of Sodium Citrate.
AIM: To determine the sterility of Sodium Citrate
MATERIALS/MEDIA USED: Triple beam balance, test tubes, distilled water,
spatula, conical flask, autoclave, masking tape, aluminum foil, oven, pipette,
measuring cylinder, inoculation chamber, culture media (NA, MCA, MSA, SDA).
PROCEDURES:
Glass wares for the analysis were sterilized in the oven at 180 0c for 30 minutes.150ml
of distilled water is used to prepare the various growth media, depending on the label
claim.9ml of distilled water is pipetted into five (5) different test tubes, for the serial
dilution of the test sample. The prepared media and the test tubes containing the
distilled water are sterilized in the autoclave at 1210c/psi for 15 minutes.
Using the sterilized 9ml of water, 9ml of distilled water, fivefold serial dilution is
done for 1g of the sodium citrate sample, and 0.2ml of the 10-5 dilution is pipetted
into the Petri dish, and the growth media is poured on it. Inoculation is fine in the
inoculation chamber, which has been sterilized for 30 minutes.
The Petri dishes are incubated in an inverted position at 25 0c to 300c in a bacterial
incubator and at 220c to 270c in a fungal incubator.

2.3.3 Microbial Analysis of water samples

Aim : To determine the microbial load of water sample.
Material/Media used: triple beam balance, distilled water, foil paper, spatula,
conical flask, hot box, autoclave, test tubes ,measuring cylinder, masking tape,
inoculation chamber, pipette, and growth media (NA,MSC,MCA,SDA)
Procedure: Glass wares for analysis were sterilized in the oven at 180 0c for 30
minutes.150ml of distilled water is used to prepare the various growth media,
depending on the label claim, The prepared media is sterilized in the autoclave at
1210c/psi for 15minutes.
The Petri dishes are incubated in an inverted position at 25 0c to 300c in a bacterial
incubator and at 220c to 270c in a fungal incubator.

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Environmental Check

This is done to ensure that the production environment is free from micro organisms
and other possible contamination. Here, the walls of the production room and tanks
are swabbed with the swab sticks and the stick is on an already prepared gel media on
petri dishes. It also involves exposing the media plate in the open air inside the
production area for about 30minutes, the dishes are then taken to the lab for
incubation for a specific period of time and the result recorded.

2.3.4 Some of the Equipment Used in the Microbiology LABORATORY AND

THEIR FUNCTIONS
1. Triple Beam Balance: It is used to measure the weight of samples in the
laboratory.

FIG 2.4: Triple Beam Balance

2. Deep Freezer: It is used for the preservation of different things used in the
laboratory for a very long period of time. Cultures can be preserved over a long period
of time without any change in the concentration of microorganism.
3. Microscope: It is used for viewing microorganisms and their structural formation.

FIG 2.5: Microscope

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4. Colony Counter: It is used to count the number of colonies of microorganisms
present on a culture plate, to estimate the concentration of microorganisms in liquid
culture.

FIG 2.6 Colony Counter

5. Autoclave: This is a pressurized chamber used for the sterilization of culture

media, glassware and other materials that are not spoilt by moist heat. It operates at
121oc for 15 minutes.

FIG 2.7: Autoclave

6. Incubator: This is an insulated, electrically heated cabinet meant for providing

microorganisms with optimum temperature for growth. The temperature is maintained
at 28-30oc for bacteria, about 25oc for moulds, and 22-27oc for fungi.

FIG 2.8a Bacteria incubator FIG 2.8b: Fungi Incubator

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7. Hot Air Oven: It is used for the sterilization of glassware and materials that are
destroyed by moist heat. It is similar to incubator in make, except that it can operate at
temperatures up to 300oc for 45mins and has a fan for circulating hot air.

FIG 2.9: Hot Air Oven

2.4 DOCUMENTATION
This is an essential part of quality management system and integral part of current
Good Manufacturing Practices (cGMP) responsible for keeping an up-to-date record
of all activities involved in production on daily basis. It is an act of putting down in a
clear manner the processes and activities involved in production. There are four types
of documentation practiced in the company:
I. POLICY DOCUMENTATION: This document what is to be done and who is
accountable for it. Hence, it keeps the duties/responsibilities allocated to individuals
or departments in the factory, and in turn relates the result to the management.
II. STANDARD OPERATING PROCEDURES (SOPS) RECORDS: This
describes the due process to be followed by the respective sections to show that
products are standardized and conforms to cGMP specifications.
III. BATCH MANUFACTURING RECORDS (BMR): These records are generated
from approved master formulae. They define the recipes for the finished product and
the processes involved. A typical BMR contains the following: dispensary records,
manufacturing processes, duration of production, packaging material and finished
product reconciliation, certificate of analysis of the finished product etc.
IV. HISTORY RECORDS: This provides the history of records of each batch of
products, including how it was distributed to the sales representatives and wholesalers.

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2.5 DRUG RETENTION
It is the storage of a sample of fully packaged finished product within the stipulated
temperature and pressure for reference purposes. This is done to create space for
monitoring and retesting of samples collected, for any physiochemical change that
may occur after distribution. Drugs are retained in the retention room.
The Retention room is a room where finished products which has undergone
chemical and microbial analysis are kept under good storage conditions and
surveillance for reference purpose until their expiry dates. Samples of each batch of
every product are kept and monitored by the quality control scientists.

24
 CHAPTER THREE
THE PRODUCTION DEPARTMENTS
This is the largest and the most important department in the company, responsible for
manufacturing the company’s products. It is controlled by the Production Pharmacist,
under the supervision of the superintendent pharmacist. They transform raw materials
to finished products by passing them through various production processes.
This department is made up of two different sections:
 The Pharmaceutical Production Section
 The Non-pharmaceutical Production Section
 The Non-pharmaceutical Production Section

3.1 STANDARD OPERATING PROCEDURES (SOP)FOR THE

PRODUCTION DEPARTMENT
The standard operation procedure is designed to describe a common and constituent
process for production and it is applicable to both the pharmaceutical and non-
pharmaceutical product department. They include
1: All staff working in the product areas must be properly dressed with lab coat, head
gear, factory shoe, hand gloves and face mask.
2: Any staff with a communicable disease or any staff that is sick should not be
allowed into the production area.
3: Hands must be thoroughly washed before handling of production materials.
4: Loitering is prohibited
5: There should be no eating, drinking, or smoking around the production areas.
6: Clean the machines properly after use.
7: All production wears (coats, head gear, factory shoes) must be clean.

3.2Components of drug Formulation

Components of drug formulation are divided into two, the active ingredients and the
excipients.

25
Active ingredients: This is the smallest component of a drug formulation. It performs
proposed function of a drug. E.g ascorbic acid is the active ingredient in vitamin c
syrup

Excipients: They are additives that aid in the manufacturing process, to help stabilize
products, so that they can be taken in various dosage forms. Excipients function as
Binders: They are used to hold ingredients together. They also give weight to small
ingredients.E.g corn starch.
Lubricants: They are used to prevent the clumping of active ingredients and prevent
the sticking of materials to machines in the manufacturing plant.E.g Talc.
Preservatives: They are used to extend the shelf life of products, and prevent bacterial
growth in drugs.E.g methyl paraben, sodium benzoate etc
Colour: These are commonly added to pharmaceutical products for beautification and
identification of drugs.E.g tartrazine yellow etc
Disintegrants: these absorb moisture, expand and dissolve to release
the active ingredient for absorption at the target site.

3.21 THE PHARMACEUTICAL PRODUCTION SECTION

This is the main and largest department where the production of all the drugs take
place, as directed by the production pharmacist in their respective sections. This
department is made up of five production lines:
1. Oral Liquid Line
2. External Liquid Line
3. Oral Rehydration Salt (ORS) Production Line
4. Beta-Lactam Production Line
5. Tablet Production Line
3.2.2 Oral Liquid Line: Oral section line is the line where liquid drugs are produced
and they are taken orally. Drugs produced under this line are in two types. There are
Syrup and suspension.

26
  Syrups are relatively thick solutions of sugar. They usually contain flavour that
helps to mask the task of the medicinal substance. Syrups are taken by both
children and adults but mostly by children. Some examples of syrup drugs
produced at Gauze pharmaceuticals includes; Chloroquine syrup, Paracetamol
syrup, Vitamin C syrup, Cough syrup(Kosylyn baby & Adult), etc.
 A suspension is a two phased system in which a finely divided drug particle is
dispersed in a continuous liquid phase. A well formulated suspension must be
uniformly dispersed, the suspended particles should not settle rapidly and
produce sediment, it should be very easy to pour yet not watery, and it should
have pleasing odour and colour. Examples are the Magcid and Zimatrim
suspension.

3.2.3 External Liquid Line: This line deals with the production of liquid drugs for
external use only. They are administered for skin diseases, wound disinfection, insect
bites, and antiseptics for domestic use. Examples include: Hydrogen Peroxide,
Methylated Spirit, Calamine Lotion, Jamgerm Antiseptic, Scabistop, Iodine tincture
etc.

The Oral liquid line and the External liquid line have the same production flow chart.

The Production flowchart is shown below:

(Active and inactive ingredients)

Compounding
(In the compounding room)

Filling
(Automatic and manual filling)

Packaging
(In the packaging room)
FIG 3.1.3 Production Flowchart for Oral and External Liquid Line

3.1.2.1 Equipment Used in the Oral and External Liquid LINES

i. Automatic Filling Machine: Used for filling drugs into PET bottles.
27
 FIG 3.0
ii. Capping Machine: Used to tighten the caps on the drug bottles.
iii. Compounding Tanks: Used for mixing all raw materials to be used for drug
production.
iv. Shrink Wrap Machine: Used to shrink wrap drugs in nylon bags.

3.1 Oral Rehydration Salt (Ors) Line: 3This line produces oral rehydrated salt that
is in powdered form, and is packaged in sachets with the help of sealing machine. The
drug is used for restoring lost electrolytes in the body during diarrhea, vomiting etc
especially in children.

3.1.4 Beta-Lactam Production Line: This line deals with the production and
packaging of antibiotics drugs, that are in powdered form and highly sensitive. The
Beta-Lactam production line is sited outside the company because of their sensitivity.
Examples include: Zimacillin, Zimaclox, and Zimamox.

3.1.5 Tablet Production Line: This production line deals with the production of
drugs in solid dosage forms as tablets and capsules. Examples include: Ibuprofen
caplets, Yeast tablets etc. They also produces the solid/tablet form of the oral liquid
products e.g. white and orange Vitamin C tablets, Paracetamol tablets, Magcid tablets,
Ciprofloxacin tablets etc.
The Tablet production line is divided into the following subsections:
i. Dispensing room
ii. Granulation room
iii. Compression room
iv. In-process office

28
 v. Coating room
vi. Blistering room
vii. Packaging room
viii. Finished product store room

i. Dispensing Room: This is where all chemical raw materials are weighed and issued
for production. It is dispensed by the Production Pharmacist. The chemical raw
materials may be active or inactive pharmaceutical ingredients. The active ingredients
are the therapeutic agents, while the inactive ingredients are used as adjuncts in
pharmaceutical products.
ii. Granulation Room: This room is where granules are formed, mixed and dried.
These granules are formed by compounding the chemical raw materials. It houses so
many equipments used to produce granules such as paste kettle, rapid mixer
granulator, multi milling machine, fluid bed dryer, vibro sifter etc.
1. Paste Kettle: Used for boiling water used in mixing paste.

FIG 3.1: Paste Kettle

2. Rapid Mixer Granulator (RMG): This is where the raw materials are mixed,
either dry mixing or wet mixing, to form granules.

FIG 3.2: Rapid Mixer

29
3. Fluid Bed Dryer (FBD): This is where the wet granules formed after
granulation is dried. At the point of drying the granules, the moisture content
analysis is done using the moisture analyzer.

FIG 3.3: Fluid Bed Dryer

4. Vibro Sifter: This is a sieving machine where the granules are separated, after
drying, into the fine granules and coarse granules.
5. Multi Mill Machine: This is used for milling granules into finer particles.

FIG 3.4: Multi Mill Machine

6. Cone Blender: This is used for blending all raw materials together, to ensure
that they are well combined. This machine is also used in the Beta-Lactam
production line.

FIG 3.5: Cone Blender

30
iii. Compression Room: This is where the granules are molded into their desired
shapes by the compressing machine which contains punches. Two types of shape are
being given; either tablet (round-shaped drugs), or caplet(oblong-shaped drugs). The
compressing machine is of different types: the 16, 35, 42 and 45 stations; which
produce 16, 35, 42 and 45 tablets in one revolution respectively.

FIG 3.6: Compressing Machine

iv. In-process Office: This is where the analysis of produced drugs is carried out.
Some of the analyses carried out are done at interval during production. Analyses
carried out in the in-process test room includes: hardness test, friability test, weight
variation test, dissolution test, leak test, disintegration test, tablet thickness test, and
moisture content test.
 Hardness Test: This test is carried out to check the breaking point and
crushing point of a tablet under certain conditions of storage, transportation,
and handling before usage. It is carried out using the hardness tester. The range
for tablet hardness is usually 2-6kg/cm.

FIG 3.7: Hardness Tester

 Weight variation Test: This test is done to ensure that each of the tablets
contains the proper amount of drug content uniformly. It is carried out using
the weighing balance, which takes the weight of the drug.
 Disintegration Test: This test, done with the disintegration tester is carried out
to check the time it takes for a tablet to disintegrate in the human body.

31
 FIG 3.8: Disintegration Tester
 Thickness Test: Thickness of a tablet varies with change in weight, due to the
speed or pressure of the compression machine. This test is used to determine
the length (for caplets), width (for caplets) and thickness (for tablets) of a drug.
It is done using the venier caliper.
 Friability Test: This test is carried out to determine the mechanical strength of
the drug, and its ability to retain its shape for a long time before it expires. The
friability of a drug should not be more than 1.0%

FIG 3.9: Friability Tester

 Moisture Content Test: This is the test for the humidity in the dried granules.
It is carried out using the moisture analyzer.
 Leak Test: This test is carried out to check holes and leaks in the tablet. The
leak test apparatus is used for this test.
v. Coating Room: This is where the drugs are coated, using the coating machine.
Coating involves covering of the outer surface ofthe drug product. There are two types
of coating: sugar coating e.g. Ibuprofen; and film coating e.g. Ciprofloxacin.
There are different stages involved in sugar coating: sub coating, smoothening,
colouring and polishing.
32
vi. Blistering Room: This is where the tablets are blistered into finished products,
using PVC and Aluminum foil which is attached in the blistering machine.

FIG 3.10: Blistering Machine

vii. Packaging room: This is where the drugs are packaged with their respective
packaging materials, for easy identification and differentiation.

3.1.5.1 TABLET PRODUCTION FLOWCHART

Dispensing (Active and inactive ingredients)

Granulation (In-process checks)

Compression (In-process checks)

Blistering/Coating (Optional)

Packaging

Quarantine finished product store

Approved Finished Product

33
 CHAPTER FOUR

PRODUCTION DEPARTMENT II

4.1 NON PHARMACEUTICAL PRODUCTION DEPARTMENT

The non-pharmaceutical production department is the various departments of the

company where other products asides pharmaceuticals are produced. They includes: -
Bottle blowing, soap section, bottle washing section.

4.1.1 Bottle Blowing Section

This section is in charge of blowing preform bottles used for the filling of drugs. The
polymer used in manufacturing preform is polyethylene terephthalate commonly
known as PET. These preforms vary in neck finish, weight, shape, colour and size.

4.1.2 Soap Section

In this non-pharmaceutical production line, solid soaps of different sizes are produced.
The soap factory is a separate factory on its own, sited away from the main factory, it
is headed by the manager who oversees the affairs of the factory and reports directly
to the CEO. The solid soap produced in the company is called Trakas soap.
4.1.2.1 Production of soap

Soap is the Sodium (Na) or Potassium (K) salts of long chain fatty acids like palmitic
acid, oleic acid, stearic acid etc. Soap is formed by the combination of oil and lye or
caustic soda in the required proportion to give a mixture of soap and glycerol. This
process is called saponification. Soap is made by heating animal fat or vegetable oil
with concentrated sodium hydroxide (NaOH).

4.1.2.2 Raw Materials Used in the Production of Soap

 Palm kernel oil
 Palm oil
 Hydrogen peroxide
 Caustic soda
 Fatty acid
 Palm stearin
 Sulphuric acid
 Perfume

34
4.1.2.3 Equipment/Machines Used In Soap Production
 Bleaching tank
 Plodder
 Saponification tank
 Amalgamator
 Cutting machine
 Chiller
 Reserve tank
 Reservoir tank
 Boiling pot

4.1.2.4 Processes Involved in the Production of Soap

1. Bleaching: The red oil used is bleached using sulphuric acid and hydrogen
peroxide. This is done in the bleaching tank. The essence of the bleaching is to
remove slugs and debris in the oil which may depend on the source of the oil.
2. Boiling/Saponification: The bleached oil is transferred into the boiling tank, and
then pumped into the mixing tank/saponification tank. During the boiling process,
the palm stearin, palm kernel oil, diluted caustic soda and the fatty acid are mixed
with the bleached oil, and then allowed to boil. The caustic soda reacts with the free
fatty acid of the oil to form soap. After saponification reaction has taken place, the
outlet is opened and the mixture is poured out of the tank and out onto the hardened
soap pit, and left for about 24 hours on the floor to cool and harden.
3. Amalgamating and crushing: The dried soap is put in the amalgamator, where
the soaps are crushed into crumbs. During this process, the perfume is added to give
the soap a good fragrance. The crushed soap is discharged through an outlet.
4. Plodding: The crushed soap is carried with shovel into the plodding machine
where the desired shapes are being formed. There are two types of plodder used in this
process:
 Simplex plodder: It produces one string of soap at a time, and it is fast in
doing this.

35
  Duplex plodder: It produces two strings of soap at a time, but it is more
effective and slow in the process.
5. Cutting and Packaging: The cutting machine cuts the soap into desired sizes,
after which they are packaged.

The processes involved in the production of soap are summarized in the diagram
below:
Quarantine Raw Materials (analysis by the Chemists/Microbiologist)

Bleaching of oil (Bleaching Tank)

Boiling/Saponification (Boiling tank/ Saponification tank)

Cooling (vacuum)

Amalgamating & Crushing (Amalgamator)

Plodding (Plodder)

Cutting (Cutting machine)

Packaging

FIG 3.2.2.3 Flowchart Showing Soap Production Processes and the Machines
Involved

4.1.3 Bottle Washing Section

This section is responsible for washing all the bottles used in the company for filling
products. The process of bottle washing involves soaking of bottles in a solution of
High Tech Hypochlorite (HTH). The reason behind soaking in a solution of HTH is to
get rid of microorganisms and impurities in the bottles. The bottles are washed in

36
three different baths, the first being a solution of HTH with raw water, while the
bottles are rinsed in the second and third bath with production water. Two samples of
the washed bottles are then taken at random to the chemistry laboratory for HTH carry
over test and if it passes the test, the bottles can be used.

In Gauze pharmaceuticals the HTH used is calcium hypochlorite. Calcium

hypochlorite is a bleaching agent with disinfecting and sterilizing properties. It is used
because it destroys a variety of disease causing organisms.

4.1.4 Portable Water Section

This section produces portable bottle and sachet water for drinking. The water is
treated and free from impurities. It has a pH range of 6.5 to 8.5. It is produced and
filled in 50cl and 75cl for the table water and 60cl for the sachet water.

4.1.4.1 Potable Water Treatment

From the collection tank, the water is sent to the reservoir tank with the aid of a
showering cap to enhance aeration. From here, the water is channeled to pass through
a smaller sand bed and two powered activated carbon column filters. It then passes
through a 5 micron, 1 micron and 0.5 micron filters. The water is then sent through a
ultra-violet sterilizer (UV sterilizer).
For sachet water; from the uv sterilizer, the water is sent to the automatic filling and
sealing machine which fills the water into sachets and seals it, after which it is
packaged in sachets.
For table water; from the uv sterilizer, the water enters a big stainless steel tank
called the Dosing tank where a small hose from the ozonator is passed through it. The
water then goes through a 1.0 and 0.5 micron filters after which it passes through a uv
sterilizer, from where it is sent to the bottle automatic filling machine where the water
is filled into bottles, capped and packaged in dozens.

37
Flowchart for Potable Water Treatment
Borehole

Primary treatment plant

Overhead tank

Reverse

Overhead tank

Reverse Osmosis machine

Storage tank

Sand bed column

Activated carbon filter

5 micron filter

1 micron filter

0.5 micron filter

UV sterilizer For bottle water

Automated sacheting
machine Dosing tank

Ozonator

Activated carbon

Micron filters (1.0 & 0.5)

0.1 Micron filter

Uv sterilizer

Automatic bottle filling machine

Packaging

38
4.1.4.2 Water Treatment Line: Water is the most important raw material used in the
pharmaceutical industry. Water, being a universal solvent is the most useful naturally
occurring raw material used on planet earth.
Water treatment describes those industrial processes used to improve the quality of
water to make it more acceptable for a specific end use i.e. production and
consumption.
Water used in pharmaceutical production demands a high degree of purity, and of
course should be free from ions, as these ions can react adversely with the ingredients,
thereby changing the original drug composition. Potable water needs to be colourless,
odourless and tasteless.
There are different categories of water in the company: raw water, table water, de-
mineralized water and distilled water.
i. Raw Water: This is water gotten from the borehole. The area where the borehole is
situated determines the percentage of impurity in the water; it also determines the pH
and conductivity level of the water. This water is used for domestic activities like
cleaning of the working environment, washing of laboratory wears, and cleaning of
laboratory equipment.
ii. De-mineralized/Deionized Water: This is water used for the production of tablets,
syrups, suspensions, lotions. It is prepared by passing potable water through anion and
cation exchange resin beds to remove the ions, so as to prevent further reaction with
the drug’s active ingredient.
iii. Table Water: This is the water produced for consumption. It is either packaged in
sachets or in bottle. The water is free from impurities, but not its entire ion is
extracted, because the human body needs most of the ions in it for certain metabolic
processes. It has a pH of 6.5-8.5
iv. Distilled Water: It is very high quality water collected after condensing water
vapour. It is the purest form of water, because it is free from both microbial and
chemical contamination. Distilled water is used in the Chemistry and Microbiology
laboratories for carrying out analysis.

39
4.1.4.3 Standard Operating Procedures (SOPs) For Water Treatment
1. Ensure all staffs are properly dressed.
2. Backwash and flush sand bed and activated carbon bed daily before work.
3. There should be no eating, drinking or smoking in the production area.
4. Hands must be thoroughly washed before handling production materials.
5. Do not operate the machine when faulty; call the attention of the supervisor.
6. Clean and cover the machine properly after use.
7. All the hoses are to be washed with detergent solution, HTH solution and sponge
every week.
8. Storage tanks, holding tanks and treatment lines are to be washed with HTH every
week and flushed thoroughly with purified water.

4.1.4.3 Water Treatment for Drug Production

Water sourced from the borehole flows into the primary treatment line, where the
acidic nature of the water is taken care of. It then flows into the overhead storage tank,
and to the sand bed filter. The sand bed filter consists of the gravel, semi-gravel,
coarse and fine sand, which is arranged in ascending order from the bottom. It traps
impurities in the water in the form of dirt and debris. From the sand bed filter, water
flows by means of pressure into the activated carbon chamber, where the taste, colour
and odour in water are removed. From here, the water flows to the reverse osmosis
machine which contains semi-permeable membrane, as a means of filtration. Then
water from here moves to the ion-exchange resin, which comprises of anion and
cation columns, that traps the ions in water. From this point, water moves to the
carbon filter (5 micron) and to the micron filters in the order of 1 micron>0.5 micron,
where the left over debris are completely removed. Finally, water passes through the
uv sterilizer that gets rid of any microorganisms that may be present in the water. The
water sample is then taken to the Quality Control Department for analysis, and once
certified, is now ready for production.

40
This whole process is explained diagrammatically in the flow chart below:
Borehole

Charcoal Filter

Sand Bed Column

Overhead Tanks

Aeration chamber

Storage Tank

Sand Bed Filter

Activated Carbon Chamber

Reverse Osmosis

Ion Exchange Resins

Carbon Filter (5 micron)

1 Micron Filter

0.5 Micron Filter

UV sterilizer

Outlet

FIG 3.2.1.2 Water Treatment Flowchart for Drug Production

41
4.1.4.5 Terms Used In Water Treatment
i. Ozonation: This process is carried out by an electric discharge field known as
ozone generators. When a silent discharge of high voltage alternating current passes
through air, ozone is created and is admitted into water through an injector. When
ozone (O3) does its job, it undergoes oxidation by becoming an oxygen molecule (O 2),
the only by-product. Ozone helps to kill microorganisms, precipitates heavy metals,
removes colour and odour present in water, and improves the taste and shelf life of the
water. Only bottle water pass through ozonation, and as a result has a longer shelf life
than sachet water.
ii. Backwashing: This is a method used to remove foreign bodies from production
water. It involves the reversal of the normal flow of water by means of pressure to
flush out germs and debris. It is done for about 15 minutes before the commencement
of daily production.
iii. Flushing: This is another method used in water treatment. After backwashing, the
water is allowed to gush out through its normal flow for fifteen minutes before the
commencement of daily production.
iv. Reverse Osmosis: This is the process of separating pure water from a solution
through a semi-permeable membrane, where the applied pressure overcomes the
Osmotic pressure. It differentiates pure water from impure water.
v. Demineralization Plant: This is used for the removal of ions from water. It
consists of the cations and anions exchange-containing resins for the removal of ions.
The water first passes through the cationic bed, where cations in the water get
exchanged with Hydrogen ion. After this, the water goes into the anionic bed where
the anions are exchanged with the Hydroxyl ions. The cationic resin is regenerated
with 5M HCl, and the anionic resin with 2.5M NaOH every three months.
vi. Activated Carbon: This gets rid of colour, odour and taste. It also reduces organic
compounds and chlorine from water via the process of adsorption. Activated carbons
filters are usually rated by the size of the particles they are able to remove measured in
microns and generally range from 50 microns.
vii. Ultra filtration: This is the removal of endotoxins by molecular sieving.

42
4.1.4.6 Maintenance of Water Treatment Line
 The water treatment line is backwashed and flushed every morning before fresh
production so as to get rid of any debris that may have settled.
 The sand bed and activated carbon chambers are charged with hot water, while
the ion exchange resins is regenerated with 5M HCl and 2.5M NaOH after a
stipulated period of time. The candle filters are changed after specified liters of
water has passed through it.
 Sand bed and activated carbon are backwashed and flushed daily to remove
impurities that may have settled on the surface. These impurities, if not
removed can act as a medium for the growth of microorganisms.
 UV sterilizers are to be washed with HCl, detergent, and then flushed with
excess water to remove any residual acid or detergent.
Things to note in water treatment:
 Drinking water is not deionized because some of the ions are essential to the
body.
 Water for pharmaceutical production is deionized as the ions in the water can
react with the product.
 Bottle water is ozonized for further purification and for longer shelf life.

4.1.4.7 Some Equipment Used in the Potable Water Production

1. Shrink Wrap Machine: Used to shrink wrap filled bottle water in nylon bags.

FIG 3.11: Shrink Wrap Machine

2. Automatic Filling Machine: This machine fills water in PET bottles, which can be
either 75cl or 50cl bottle water cans.

43
3. Automatic Sachet Machine: Used in sealing sachet water.

FIG 3.12: Automatic Sachet Machine

44
 CHAPTER FIVE

5.1 IMPORTANCE OF BIOCHEMISTRY TO THE PHARMACEUTICAL

INDUSTRIES

Biochemistry is becoming more and more important as the industry moves more
toward personalized medicine, gene altering therapies, and identification of the key
biomarkers to demonstrate successful treatment.

The knowledge of a biochemist in pharmaceutical industry helps to develop a new

drug or understand better the actions of a well-established drug. Without
understanding biochemistry, we would not be able to understand why any drugs works
the way it does, what could potentially interfere with it, or whether certain drugs
(when combined) could prove to be fatal.

5.2 CONCLUSION

The Students’ Industrial Work Experience Scheme (SIWES) is an educational

programme, which has been set up to practically educate students on what they have
been theoretically taught in school, and prepare them for the labour market after
graduation. It helps students to acquire applied technical know-how, skills and
managerial abilities.
The Student Industrial Training Programme at Gauze Pharm. & Lab. Nig. LTD was a
good and commendable one as it has exposed me to practical knowledge of
production in a pharmaceutical industry and also exposed me to good morals,
discipline, the use of different equipment and good work ethics for all round
excellence. I also learnt to be very punctual, and to have a good working relationship
with my superiors and co-workers.

45
 REFERENCE

1. Standard operating procedures of Gauze Pharmaceuticals and Labs Limited

2. British Pharmacopeia (2003) volume I &II
3. British Pharmacopeia (2013) volume III
4. Ifemeje, P. C (2018) SIWES technical report.

46