A TECHNICAL REPORT

ON

STUDENTS’ INDUSTRIAL WORK EXPERIENCE SCHEME (SIWES)

AT

GAUZE PHARMACEUTICAL AND LABORATORIES

AT

ENU-IFITE VILLAGE, IFITE AWKA

DONE BY

DONATUS ROSELYN CHIBUGO

(2019544137)

PRESENTED TO

DEPARTMENT OF PURE AND INDUSTRIAL CHEMISTRY, FACULTY OF PHYSICAL

SCIENCES, NNAMDI AZIKIWE UNIVERSITY, AWKA, ANAMBRA STATE.

IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE AWARD OF

BACHELOR OF SCIENCE ([Link]) DEGREE IN PURE AND INDUSTRIAL CHEMISTRY

MAY,2023

CERTIFICATION
This is to certify that this report is a detailed account of student industrial work experience scheme
(SIWES) undertaken by DONATUS ROSELYN CHIBUGO with registration number 2019544137 at GAUZE
PHARMACEUTICALS & LABORATORY NIGERIA LIMITED located at Enu-ifite village, Awka, Anambra state,
for a period of six months and has been prepared in accordance to regulations guiding the preparation
of reports in the Department of Pure and industrial chemistry, Nnamdi Azikiwe University, Awka.

STUDENT SIGNATURE/DATE

INDUSTRIAL BASED SUPERVISOR SIGNATURE/DATE

C.E.O Gauze Pharm and Lab SIGNATURE/DATE

DEDICATION
I solely dedicate this technical report to God Almighty for His special grace and favour during the course
of my industrial training. Also to my lovely parents for their supports both financially and otherwise
throughout my training.
 ACKNOWLEDGEMENT
I am mostly grateful to God Almighty for life, sound health, mercies, protection and guidance and also for
seeing me through this industrial training. May His name be praised Amen.

In a massive way, I also wish to say a big thank you to the CEO Gauze pharmaceuticals and laboratories
Nig. Ltd. Prof Lady Ebele Faith Anyachebelu for the opportunity of been trained in her Industries and
establishment. To the Manager and other staffs of the company for your time and support towards me, I
say thank you all.

To my company based supervisor Miss Ukamaka Okika, I want to appreciate her efforts, time, guidance,
supports and direction towards me throughout the period of my industrial training program.

Also to My Lovely Parents, I want to say a very big thank you for your support both financially and all
round throughout my program. To my friends and my IT colleagues, I want to appreciate y'all for making
my Training and Experience a wonderful one.
 ABSTRACT
The aim of this technical report is mainly on the knowledge, exposures and experiences gathered during
the course of my Industrial training at Guaze Pharmaceuticals and Laboratory Nigeria Limited Awka,
Anambra State. This report is basically on the Indicative steps and principles involved in the maintenance
of current Good Manufacturing Practices (cGMP), the packaging and sales of pharmaceutical and non –
pharmaceutical products produced at the industry. Also to meet the requirements of the regulatory bodies
like NAFDAC and PCN. It also contains a detailed explanation of the various activities carried out by the
various departments in the company. The scientific concept of this training cuts across my field of study
as an Industrial chemist.
 TABLE OF CONTENT
TITLE PAGE

DEDICATION

ACKNOWLEDGEMENTS

ABSTRACTS

TABLE OF CONTENTS

LIST OF FIGURE

CHAPTER ONE ; INTRODUCTION

1.1 Background of SIWES Program

1.2 Objective of the SIWES Technical Report
1.3 Scope of the Technical SIWES Report
1.4 Significance of the SIWES Program
1.5 History of the Company
1.6 Company’s Organogram

CHAPTER TWO ; VARIOUS DEPARTMENT OF THE COMPANY AND THEIR FUNCTION

2.1 Production Department

2.1.1 Pharmaceutical Line

2.1.2 Oral Line

2.1.3 Oral Powder Line

2.1.4 External Line

2.1.5 Beta - Lactam Line

2.1.6 Tablet Line

2.1.7 Non Pharmaceutical Line

2.1.8 Portable Water Line

2.1.9 Bottle Blowing Line

 2.1.10 Soap Production Line

2.1.11 Bottle Washing Line

2.2 Admistration Department

2.3 Account Department

2.4 Technical Department

2.5 The Quality Management Department

2.5.1 Quality Assurance Department

2.5.2 Quality Control Department

2.5.3 Chemistry Laboratory

2.5.4 Microbiology Laboratory

2.5.5 In Process

CHAPTER THREE; JOB DESCRIPTION: WATER TREATMENT

3.1 Water Treatment in Gauze pharmaceuticals and laboratories

3.1.1 Primary Water Treatment

3.1.2 Secondary Water Treatment

3.1.3 Treatment of Portable Water

3.1.4 Treatment of Production Water

3.1.5 Terms used in Water Treatment

3.2 Production of soap

3.3 Sample Analysis done in Chemistry and Microbiology laboratories.

CHAPTER FOUR CONCLUSION

4.1 Recommendation and References

 CHAPTER ONE

INTRODUCTION

1.1 Background of Siwes program

The students industrial work experience scheme (SIWES) was introduced into Tertiary Institutions by
Industrial Training Fund (ITF) and funded by the federal government in 1973 to solve the problem of lack
of adequate practical skills preparatory for employment in industries by Nigerian graduates of Tertiary
institutions. The management of SIWES does not rely on ITF alone as the task is enormous with
increasing population of students. Before the establishment of the scheme, there was a growing concern
amongst the industrialist that graduates of the Tertiary institution lacked adequate practical background
studies preparatory for employment in industries. Thus the employers were of the opinion that the
theoretical education going on in higher institutions was not responsive to the needs of the employers of
labour. It was against this background that the rationale for initiating and designing the scheme by the
fund during its formative years 1973/74 was introduced to acquaint students with the skills of handling
employment equipment and machinery. Aribodor 2019Therefore participation in SIWES has become a
necessary pre-condition for the award of Diploma and Degree certificates in the country. There are
several other bodies involved in the management, functionality and operation of the SIWES scheme
which includes; industrial training fund, the supervising agencies like National University Commission
(NUC) and National Board for Technical Education (NBTE), various institutions, the employer, the
students and the federal government. These bodies also play a vital role in the scheme to ascertain its
goal.

1.2 Objective of the SIWES technical report

SIWES is strategized for skill acquisition. SIWES 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. Objectives of SIWES include:

 To bridge the gap between theory and practice by providing a platform to apply
knowledge learnt in school to real work situations.
 To enable easier and smoother transition from school by equipping students’ with better
contact for future work placement.
  To introduce students to real work atmosphere so that they know what they would most
likely meet once they graduate.
 To provide an avenue for students to acquire industrial skills for experience during their
course of study. Aribodor 2019
 To expose students to work methods and techniques that may not be available during
their course of study.
1.3 SCOPE OF THE TECHNICAL REPORT
This report covers the areas of paint production, the processes and procedures involved as
experienced in GAUZE PHARMACEUTICALS AND LABORATORIES NIGERIA LIMITED
for the said duration of six months according to SIWES mandate. This report is my entire
compilation of my experience and knowledge acquired during the stated period of attachment.
As a glad student of Pure and Industrial chemistry, I was able to obtain important
industrial training experience which is beneficial in my field of study and to the proper
sustainability of my environment.

1.4 SIGNIFICANCE OF THE SIWES PROGRAM

• The program also enables students understand the technicalities of their profession as
well as competence and professionalism in their field of study.
• The SIWES is aimed at exposing students to real life working environments, thus
enabling them to put into practice what they learnt in class.
• In addition, SIWES also provides students the opportunity to work in one or more area of
industry and this will enable them to relate their theoretical

1.5 HISTORY OF GAUZE PHARMACEUTICALS

Gauze Pharmaceutical and Laboratories Nig Ltd, located at Enu-ifite village, Awka, Anambra
state, was established in 1992. She earnestly commenced production in the year 2000 with Eight
(8) products after approval from the National Agency for Food and Drug Administration Control
(NAFDAC) and the Pharmacist Council of Nigeria (PCN).
The delay in the commencement of production was due to imbalance and financial constraints.
Still, the company's resolve from inception to manufacturing genuine pharmaceutical products
will restore the vitality of life. The company took time to ensure all that was needed to align with
the Current Good Manufacturing Practices (cGMP) were in place and subjected her products to
various Vivo and in Vitro pharmaceutical testing processes.
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
customer’s satisfaction. This entails why NAFDAC and PCN in 2003 encouraged the company
to register more products and currently have over fifty (50) products registered with NAFDAC.
Gauze Pharmaceutical and Laboratories Nig Ltd maintaining its pace-setter status, has never
compromised the quality of its products, endangering its product recognition in Nigeria and far
beyond. The company's products have barged so many National awards, and currently exports its
products to many African countries.
The company manufactures various pharmaceutical products such as Analgesics, Antipyretics,
Antacids, Antihistamines, Antidiarrhea, Antimalaria, Antibiotics, etc., with seven distinct
production lines (sections), namely;
• The Oral Liquid line
• The External Liquid line
• The Beta-lactam line
• The Dry Powder/ORS line
• The Tablet line
• The Soap line
• The Water line
THE COMPANY’S ORGANOGRAM
 Chapter Two
LITERATURE REVIEW
Various Department and functions in the Company.
Gauze pharmaceuticals and laboratories Nig Ltd comprises of different department that harmoniously
carry out their peculiar duties for effectively and efficiency in the company activities.

Department in the company includes:

1. Production department.

2. Quality management and development.

3. Administrative department.

4. Accounts department.

5. Technical department.

2.1 PRODUCTION DEPARTMENT :

This is a very essential and largest department in Gauze pharmaceuticals and laboratories Nig Ltd, this
department is concerned with the production and packaging of the company's products using machines
and human labour. Each production line is headed by a production pharmacist who is in turn supervised
by a supritendent pharmacist. Under this department we have two main production lines which are :

1. Pharmaceutical production line

2. Non pharmaceutical production line.

2.1.1 Pharmaceutical production line

2.1.2 Oral Liquid Production Line: This line of production is in charge of the production of liquid drugs
that are administered orally. The company produces two types of liquid drugs which are; syrup
(Paracetamol syrup etc) and suspension (Magcid suspension etc).

 Syrups are relatively thick solutions of sugar. They usually contain flavour that helps mask the
medicinal substance’s task. Syrups are taken by both children and adults, but primarily by
children. Some examples of syrup drugs produced at Gauze Pharmaceuticals include;
 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 distributed, the
suspended particles should not settle rapidly and produce sediment, it should be
straightforward to pour yet not watery, and it should have a pleasing odour and colour.
Examples are the Magcid and Zimatrim suspensions.

2.1.3 Oral Powder Line: The Oral Powder line is concerned with the production of Oral Rehydration Salt
(ORS), which is used for oral rehydration therapy. The salt is produced as a dry powder which is then
dissolved in water before being administered orally. Example is Kosylite Oral Rehydration Salt.

2.1.4 External Liquid Production Line: This production line is in-charge of the production of liquid drugs
that are used externally i.e outside the body. They have local action and are applied on the surface of
the skin. Examples include Methylated spirit, Hydrogen peroxide, Calamine lotion etc.

The Oral and External Liquid Lines have the same production flow chart.

The Production Flowchart is shown below:

Weighing (Active and Inactive ingredients)

Compounding (In the compounding room)

Filling (Automatic and manual filling)

Packaging (In the packaging room)

Fig 5: Production Flowchart for Oral and External Liquid Lines

Equipment Used in The Oral and External Liquid Lines

1. Manual Filling Machine: Used for filling drugs into PET bottles.
Fig.6: Manual Filling Machine

2. Manual Capping Machine: Used to tighten the caps on the PET bottles.

Fig.7: Manual Capping Machine

3. Compounding Tanks: Used for mixing all raw materials for drug production.

Fig.8: Compounding Tank

2.1.5 Beta - Lactam Line : This line of production oversees the production of beta - lactam antibiotics.
Beta - Lactam antibiotics agents contains a beta - lactam ring in their molecular structure. Groups of
beta -lactam antibiotics include penicillin derivatives, cephalosporin, monobactams, carbapenems and
carbacephems. Examples of their products are Zimacillin, Zimamox, Zimacloz, which fall under the group
of penicillin derivatives. These antibiotics are produced as dry powders which are reconstituted with
water before it is being administered orally.

2.1.6 Tablet Production Line: This line of production is concerned with the production of tablet drugs
that are administered orally. Drugs produced in this section are either in tablet form (round - shaped
form) or in caplet form (oblong - shaped form). Examples include Ibuprofen caplet, Paracetamol tablet,
Vitamin C tablets etc.

Tablet Production Flowchart

Dispensing (Active and Inactive Ingredients)

Granulation (In-process checks)

Compression (In-process checks)

Blistering/Coating (Optional)

Packaging

Fig.17: Flowchart for Tablet Production

2.1.7 Non - pharmaceutical Production Line:

2.1.8 Portable Water Line: This line deals with the production of portable water which goes with the
brand "Gauze Table Water ", it is also packaged in sachets and also in 50cl and 75cl Pet bottles.

2.1.9 Bottle Blowing Line: This line is responsible for the production of PET (Poly Ethylene

Teraphthalaete) containers which requires moulding and blowing for subsequent stretching of these

into their various desired bottle sizes. Also this section is in charge of blowing perform bottles used to fill

drugs. The polymer used in manufacturing preform is Polyethylene Terephthalate, commonly known as

PET which is the most common thermoplastic polymer resin of the polyester
family and has a chemical formula of (C10H8O4)n. These performances vary in neck finish, weight shape,
colour and size. A PET BLOWER is a machine responsible for blowing the PET or preform into a bottle
(blown bottle). It blows hot pressurised air into the preform from the neck to the base.
Fig.18: The PET Blower Machine

2.1.10 Soap Production Line: This section of the non pharmaceutical production line deals with the
production of solid soaps. The solid soap produced in the company is called Trakas soap.

2.1.11 Bottle Washing Section : This section is responsible for the washing of all bottles used in the
company for filling products. The process of bottle washing involves soaking of bottles in a solution of
HTH (High Test Hypochlorite). The reason behind the soaking of the bottles in a solution of HTH is to get
rid of the micro organisms and impurities in the bottles. The bottles are washed in three different bath
tubs, the first being a solution of HTH with raw water, while the bottles are rinsed in the second and
third bath tub with production water. Two samples of the washed bottles are then taken to the
chemistry laboratory for the HTH carry over test that would be done by the chemist. If the washed
bottles passed the test, they are then good for use.

2.2 ADMINISTRATIVE DEPARTMENT

This department is headed by the administrative manager, and together with other administrative
officers, they run the affairs of the company. They make and implement decision and company's
policies. The functions of the administrative manager includes;

1. Employment or Recruitment of workers.

2. Supervision of workers and business affairs.

3. Organizing the training and retraining of staff.

4. Assigning of duties to other staffs as required.

5. Assisting in preparation of budgets and expenses.

6. Management of staff schedules.

2.3 ACCOUNTS DEPARTMENT

The head of this department is the Chief accountant, the basic function of this department is to control
the company's finance and cash flow. Other functions includes;
 1. Documentation of revenue

2. Budgeting

3. Procurement of raw materials and packaging materials

4. Preparation of income statement

5. Computation of staff salaries, payee, and taxes.

2.3.1 Sales Department: This section is headed by the sales manager; some of the functions include;

Account transaction

Sales

Customer sourcing

Advertisement of the company’s products and services

Customer care service

Carrying out a market survey (to know what the customers need) etc.

2.3.2 Store Department: This department is responsible for receiving and stocking raw materials, packaging

materials, finished products, and other equipment required for manufacturing. The Store Manager

heads this department. They are responsible for issuing raw materials and packaging materials meant

for production. They also handle newly received raw materials by sending them to their quarantine

stores, where they await

analysis from the quality control department. The quality control department collects samples and places

labels indicating that analysis is still being conducted. After the analysis, the raw materials and the

finished products will be transferred to the store room. Here, the raw materials and finished products

are arranged and issued according to FIFO (First In, First Out), FEFO (First to Expire, First Out), or FAFO

(First Approve, First Out). They ensure the number of products produced after a single run, tallies with

the number of raw materials used up.

2.4 TECNICAL DEPARTMENT

They are responsible for handling all technical issues within the company. They ensure that all the

equipment is in perfect condition and take and maintain all the company’s machines. They also provide

a steady power supply and repair electrical faults noticed in any section of the company.

Some of the company products, their active ingredients and their uses.

Product Name Active Ingredients Uses

Calamine Lotion Calamine, Zinc Oxide, Relieves discomfort due to rashes,

Liquid Phenol, Sodium sunburns, stings, insect bites, etc.
Citrate, Bentonite Glycerine.

Jamjerm Antiseptic Chlorhexidine Gluconate, Centimide. Disinfectant

Hydrogen Peroxide Hydrogen Peroxide They are used as first aid to treat
cuts, wounds and abrasions. It can
also be used as a mouthwash.

Methylated Spirit Alcohol, Wood Naphtha. They are used as first aid for
cleaning wounds and skin surfaces
when administering an injection.

Koslyn Adult Cough Diphenhydramine Hydrogen Chloride, For the relief of cough and Bronchial
Sodium Citrate, Menthol. congestion in adults.

Zimperazine Piperazine citrate For treatment of round worms and

thread worms.
Magcid Magnesium trisilicate, To relieve hyperacidity, heart burns,
Magnesium carbonate (light), Sodium flatulence, indigestion and pains due
Bicarbonate, Peppermint oil. to gastric and duodenal ulcers.

Zimacillin Ampicillin Treatment of bacteria such as

respiratory tract infections,
gonorrhoea, and meningitis.

Diamix Light kaolin Treatment of protozoan,

bacterial infections, especially
in diarrhoea.

Zimamox Amoxicillin Treatment of bacteria such as

tonsillitis, bronchitis, etc.

. 2.5 The Quality Management Department

This department ensures that the right thing is done correctly and that the results from the analysis of
the samples conform to the standard. They detect and correct defects, qualify equipment and
machinery, and validate the system and processes of qualification when necessary. They equally analyse
the finished products after production to ascertain their efficacy and quality and approve them for sale
or distribution or reject them. They also ensure that the Current Good Manufacturing Practice is
maintained at a consistent level. The Quality Assurance Manager heads the Quality Management
Department. This department is divided into two:

• Quality Assurance Department

• Quality Control Department

2.5.1 Quality Assurance Department

Quality assurance activities involve the entire team. They include standards for training documentation
and review across the workforce. The result of quality assurance activities is a road map for creating
high-quality products. Quality assurance is process-oriented, and it focuses on preventing quality issues.
Quality assurance involves the actions which make the products. Quality assurance has one sub-section
under it:

• Documentation: This is a subsection of the quality assurance unit. Documenting in a

pharmaceutical firm is putting down in black and white all the processes undertaken in
 the production of a drug, starting from the dispensary of the raw material for the

product from the store section to the analysis of the finished product by the quality

control unit.

There are four types of documentation:

• Policy Documentation Records: This describes what is to be done and who is

accountable for it. In other words, it keeps records of duties or responsibilities allocated

to individuals or departments in the factory and, in turn, relates the result to the

management.

• Standard Operating Procedure (SOP) Records: Standard Operating Procedure serves as

a gateway to achieving Current Good Manufacturing Practice (cGMP), principles laid

down by regulatory bodies regarding the efficacy of drugs. SOP is a part of cGMP which

gives step-by-step instructions on how operations are to be carried out in the various

sections of the factory to avoid errors upon repetition.

• Batch Manufacturing Records (BMR): These records are generated from an approved

master formula. They define the recipe for a product and describe the processes

involved. A BMR contains the following information;

➢ Dispensary records.

➢ Manufacturing process.

➢ Time the production started and ended.

➢ Quantity of finished product in litres to be transferred to the filling supervisor.

➢ Packaging material reconciliation.

➢ Certificate analysis for the finished product to include; ❖ Chemical analysis with

the signature of the analyst.

 ❖ Microbial analysis with the signature of the analyst.

➢ Batch release authorisation.

➢ Signature and name of the production pharmacist

➢ Signature and name of the superintendent pharmacist.

➢ Signature and names of the quality control and assurance managers.

• History Records: This provides a history of each product batch, including distribution to

the sales representative and wholesalers. It may also be non-product specific and

include all other circumstances about the quality of the final product.

. 2.5.2 Quality Control Department

Quality control is generally the responsibility of certain personnel within the organisation whose duties
include following SOPs (Standard Operating

Procedures) for product testing. Quality control is product oriented and is focused on identifying quality
issues in manufactured products that could affect customer satisfaction. Quality control involves
verification of products post-manufacture and before distribution or confirming safety and efficacy. They
focus on parts used to create the final product, such as raw materials from a supplier. There are three
sub departments in Quality Control Department, they are:

• Chemistry Laboratory

• Microbiology Laboratory

• In-Process

2.5.3 Chemistry Laboratory

This section of the quality control department deals with the chemical analysis of water and raw
materials used to produce drugs, in-process drug samples, and finished products. These analyses ensure
that the drugs contain all the ingredients in proportion.

The Chemistry lab is well equipped with validated apparatus, and they are involved in the;

❖ Calibration of equipment in the company, e.g., pH/conductivity meter, weighing balance, etc.

❖ Carrying out the in-process tests and chemical analyses on the finished products to ensure and

maintain quality.
 ❖ Carrying out various water tests used at different sections of the company.

❖ Carrying out analysis of raw materials before issuing them for production.

❖ Separation of active ingredients using high-pressure liquid chromatography.

❖ Observation and analysis of drugs kept in the retention room.

❖ Documentation of all analyses carried out.

Standard Operating Procedure for Chemistry Laboratory

1. The chemistry laboratory should be cautiously approached to avoid disrupting the delicate and

precise equipment.

2. All glass wares used for analysis should be scrupulously washed with water and detergent, and

rinsed with distilled or de-ionized water.

3. All chemicals that produce fumes on opening during reaction with other chemicals should be

placed in the fume chamber to avoid contaminating the laboratory with dangerous fumes.

4. Never use gas flames for heating inflammable solvents. Use a heating mantle, hot plate, and

steam bath.

5. Preparation of reagents for analysis is done with distilled water. After each preparation, the

reagent is transferred and accurately labelled. Labels are protected from water and fumes using

masking tape or coating with a thin film or paraffin wax.

6. Result data must be entered into the laboratory notebooks and report sheets.

Some Equipment in the Chemistry Laboratory and Their Uses

Apparatus Description
Fume Cupboard This is used to inoculate reagents that produce fumes, such as the HCL
and H2SO4, so the extractor fan traps them.

High-Pressure Liquid This uses chromatography principles to extract an analyte from a solution
Chromatography (usually an active ingredient from a mixture containing more than one
Machine active ingredient).

Desiccator This is glassware containing a silica gel dryer that absorbs the moisture
of any compound placed in it. It is used to store standard samples.

Digital pH Conductivity meter It is used to check the pH of a solution by inserting its electrode into the
solution.

Karl Fischer titrator This is used to determine trace amounts of water in a sample.

Pycnometer This is a device made of glass with a stopper used to determine the
density of a liquid.

Dissolution Counter This is used to check the dissolution rate of tablets in a given solution and
thereby be able to determine the dissolution rate in the stomach.

Electronic Weighing It is used to measure the amount of matter present in a

Balance sample. It gives its reading to three decimal places.

Moisture Analyzer This is used in analyzing the percentage moisture content of drugs.

UV Spectrophotometer This machine works on the principle of Beer Lambert’s Law. It measures
the intensity of visible light at a particular wavelength after it has passed
through a sample.
 Fig 2: Some equipment in the Chemistry Laboratory.

2.5.4 Microbiology Laboratory

This section of the department is mainly concerned with the microbial analysis of raw materials, in-
process checks of drug samples, finished products, water products, etc. This section also ensures the
sterility of the production environment, such as the compounding room air, compounding room wall,
filling room air, filling room wall, and analysis of the already washed PET (Polyethylene Terephthalate)
bottles. At the end of all the analysis, microorganisms are isolated and identified in a situation where
they are found present.

Standard Operating Procedure for Microbiology Laboratory

1. Always wash your hands before, between, and after analysis.

2. Swab the workbench with 70% alcohol before performing any analysis to create an aseptic

environment.

3. Always label and record your results and samples appropriately.

4. Keep adequate records of the isolated micro-organisms.

5. Maintain other aseptic conditions such as:

❖ Sterilizing culture media and water samples using an autoclave before analysis.

❖ Sterilizing glass wares using a hot box oven before they are used for analysis.
 ❖ Flame the inoculation loop before every use.

❖ All forms of inoculations should be done under an ultraviolet inoculation chamber.

Some Equipment in The Microbiology Laboratory and Their Uses

Apparatus Description

Autoclave An electric heat stabiliser is used to sterilise media and water samples.

Microscope A magnifying instrument used for high-quality microscopical reporting

of any analysis.

Colony Counter This determines the number of discrete colonies growing in an already
cultured sample.

Incubator This is used to enhance the growth of microorganisms at a controlled

temperature.

Triple Beam Balance It is used in weighing agar for preparing media.

Laboratory Oven This electric heat steriliser sterilises materials, such as glass rods, Petri
dishes, pipettes, etc., unaffected by relatively high temperatures.

Culture Media Used in Microbiology Laboratory

A culture or growth media is a solid or liquid preparation as broth or an agar used to grow, transport and
store microorganisms. The purpose of using cultural techniques in microbiology laboratories is to
demonstrate the presence of organisms which may be causing diseases and, when indicated, to test the
susceptibility of pathogens to antimicrobial agents.

Different Types of Culture Media

For a culture medium to successfully grow the pathogen sought, it must provide all the essential
nutrients, ions and moisture, maintain the correct pH and osmotic pressure, and neutralise any toxic
materials produced. It is also necessary to incubate the inoculated medium in the right atmosphere, at
the optimum temperature and for an adequate period. The types of media used are:
 • General-purpose media: This type of media sustains the growth of many microorganisms.

Examples are Nutrient agar, tryptic soy broth and tryptic soy agar.

• Enriched media: They are fortified media added to the supportive media to encourage the

growth of fastidious microbes. The term is usually applied to fluid-selective media containing

substances that inhibit unwanted organisms' growth. An example is the Blood agar.

• Selective media: These are solid media which contain substances such as antibiotics, which

inhibit the growth of one organism to allow the development of another to be more clearly

demonstrated. This medium is also used when culturing a specimen from a site having a normal

microbial flora to prevent unwanted contaminants from overgrowing a pathogen.

• Indicator/differential media: These are media to which dyes or other substances are added to

differentiate microorganisms. Many differential media distinguish between bacteria by

incorporating an indicator that changes colour when acid is produced following the

fermentation of a specific carbohydrate. An example is the MacConkey agar.

Culture media can be classified based on their consistency:

• Solid Culture Media: This media type is classified by incorporating a gelling agent such as agar or

gelatine.

Agar (polysaccharide extract obtained from "seaweed") is commonly used to solidify

culture media because of its high gelling strength, 32- 39°C and melting temperature of
90-95°C.

Examples are:

1. Nutrient Agar: A general-purpose medium for routinely cultivating and culturing

non-fastidious organisms.
 2. Mannitol Salt Agar: It is a differential medium used to isolate pathogenic

staphylococcus.

3. MacConkey Agar: For isolation and differentiation of lactose fermenting and

non-fermenting lactose enteric bacteria.

4. Sabourand Dextrose Agar (SDA): For yeast cultivation, moulds and aciduric

microorganisms. It typically contains dextrose and peptone.

5. Eosin Methylene Blue (EMB): A differential medium for isolating gram-negative

enteric bacilli from clinical and nonclinical samples.

6. Peptone Water: A general-purpose liquid culture medium as the base of

carbohydrate fermentation media.

N.B: All these media are cool at room temperature except Sabour and Dextrose Agar for
fungi at 45-50°C.

• Semi-fluid Culture Media: This culture medium is prepared by adding a small amount of agar to

a fluid medium.

• Fluid Culture Media: They are mainly used as enrichment where organisms are likely few. An

example is the blood culture.

2.5.5 In-Process
This is where the analysis of produced drugs is carried out. Some of the analyses carried out are done at
intervals during production. Analyses carried out in the inprocess test room include hardness test,
weight variation test, dissolution test, leak test, disintegration test, thickness test, and moisture content
test.

• Hardness Test: This test is carried out to check a tablet's breaking point and crushing point

under specific storage, transportation, and handling conditions before usage. It is carried out

using the hardness tester. The range for tablet hardness is usually 2-6hg/cm.
 • Weight Variation Test: This test ensures that each tablet uniformly contains the appropriate

drug content. 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

CHAPTER THREE
JOB DESCRIPTION
 WATER TREATMENT
Water is the mostly used substances; it is also the most essential raw or starting material in drug
production, processing andergo various kinds of treatment to obtain the quality required.

The Water used in Gauze pharmaceuticals are categorized into four;

1. Raw Water

2. Demineralized or Production Water

3. Portable Water

4. Distilled Water

Raw water :

This is the water gotten directly from the borehole. It hasn't undergone treatment and therefore it's
minerals, ions, particles, bacteria and impurities are still present. This water is unsafe for human
consumption and is only used for domestic activities like cleaning and washing.

Demineralized or Production water :

This is a type of specielly treated and purified water that has most of all its minerals or ions removed,
such as calcium, magnesium chloride etc. It is also known as Deionized water and is used only for drug
production. It has a pH range of 5.0-7.0

Portable water :

This is the water that is safe for drinking. The water is free from bacteria and impurities and not all the
ions are being removed it because the human body needs most of the ions present in water. It has a pH
range of 6.5-8.5

Distilled water :

This is the mostly pure form of water and it is gotten after condensing water vapor. It is free from both
microbial and chemical contaminants and is used mostly in the chemistry and microbiology laboratories
for carrying out water analysis.

3.1 WATER TREATMENT IN GAUZE PHARMACEUTICALS AND LABORATORIES

In Gauze pharmaceuticals and laboratories Nig Ltd, there are two phases of water treatment used, namely;

1. Primary water treatment line

2. Secondary water treatment line

3.1.1 Primary Water Treatment Line :

The primary treatment line comprises of two giant activated carbon columns, each with an aeration
chamber which blows air into the water as it flows in from the borehole, as a result of this, the heavy
metals present in the water as ions reacts with the air to form deposits which is subsequently filtered off
with the aid of the sand bed column. The activated carbon also performs the functions of absorption, this
helps to boost up the pH of the water before it is channeled to the secondary treatment line for further
purification. This treatment is mostly important for the portable water given that the WHO requirement
for the pH portable water is 6.5-8.5

3.1.2 Secondary Treatment Line

The secondary treatment line comprises the micron filters, sand bed column, activated carbon columns, reverse
osmosis, demineralization plant (for production water), carbon filters, UV sterilizers and ozone generator. The de-
mineralization plant is not used in the treatment of potable water because the body needs the ions in the water to
maintain the electrolytes in the body.

3.1.3 Treatment of Portable Water

The treatment process for portable water goes through the primary process, where filtration, sterilization and
removal of color,taste and odour is actively involved.

Water from the borehole flows through the primary line to the overhead storage [Link] the water is channeled
to the reservoir tank with the use of pipes that is arranged in the form of showering cap to aid aeration. The water
from the reservoir tank moves through a smaller sand bed and two powered activated carbon columns for filtration
to the reverse osmosis and from there, it passes through the 5 micron, 1 micron and 0.5 micron filters before passing
through the UV sterilizer.

3.1.4 TREATMENT OF PRODUCTION WATER

Production water undergoes secondary treatment, it is a continuation from the treatment of portable water. Here ions
or minerals are removed from portable water so as to make it suitable for production.
Ions found in water is seen as impurities when used for production, therefore it is required that the ions are removed
before its used for production, especially in drug production, since it alters the chemical constituents of the
production.

The D-M plant is used for the removal of ions from the water. It uses the ion exchange mechanism in removing ions.

The D-M plant is made up of two beds containing resins of cation and an anion. The cation bed is charged with HCl
(Hydrochloric Acid) while the anion bed is charged with NaOH (Sodium Hydroxide).It is more preferable to use
HCl in the cation bed.

As the water flows through the columns in the D-M plant, the electropositive ions in the water displaces equal
amount of H+ in the cation bed as the electronegative ions also displaces the OH - in the anion bed and becomes
trapped to the resin. The limitation of the D-M plant is that it only acts on ionic bonds. Every microbiological or
covalently bonded contaminant will not be affected.

To solve this problem, the water from the D-M plant moves to the reverse osmosis where water moves from a region
of higher concentration of solutes to a region of lower concentration of solutes through a semi-permeable membrane
that is constructed to allow just the size of water molecules to pass through. The water, by means of pressure, flows
to the micron filters which have pore sizes 5μ, 1μ and 0.5μ at the end. These micron filters removes left over
particles from the water.

At the end the water passes through the UV sterilizer that gets rid of the microorganisms that may still be present in
the water. The water sample at this point is taken to the quality control (QC) department for analysis and once
certified, is ready for production.

Difference between Portable and Production Water for Drug

The major difference between the two types of water is the presence.

In portable water, ions are needed in the body to conduct electrolyte, therefore during treatment ions are not
removed.

In production water ions are removed through the process called de-ionization using the D-M plant. Ions are
removed to avoid further reaction with the constituents during production.

Importance of Water treatment in Pharmaceutical

Water treatment helps in removing contaminants and hazardous substances from the water, making it clean
and safe to drink and be used for other purposes and also prevent water-caused incidents, such as water-
borne diseases and fatalities.
 On the other hand, water treatment is also helpful in ensuring that water gets reintroduced back to nature’s
cycle. One of the end-uses of this process is to safely return water to environmental sources like rivers,
lakes, and oceans. Of course, water treatment facilities must ensure that water is free from harmful
substances before doing so to avoid contamination and other environmentally disastrous issues such Was
water pollution.
Water treatment is also done to help improve quality of water used at various stages, especially portable
and production water.

3.1.5 TERMS USED IN WATER TREATMENT

Filters: Filter systems are a relatively simple and effective way to control a variety of contaminants. These
include mechanical filters (sand bed) and activated carbon filters.
Activated Carbon Filters: Activated carbon filters absorb impurities as they pass through a carbon cartridge.
Generally, they are used to eliminate undesirable odors and tastes, organic compounds and to remove
residual chlorine via the process of adsorption. Most inorganic chemicals, metals, microorganisms and
nitrates are not removed by the filters. The chamber is activated using ZnCl2, CO2 or heat to about 900°c.
Ozonation: Ozone is created when a silent discharge of high voltage alternating current passed through air,
and is admitted into water through an injector. Ozone helps to kill microorganisms, precipitate heavy
metals, improves the taste of the water and removes color and odor present in the water.
Backwashing: This is method is a method used to remove foreign bodies from the water treatment plant. It
involves the reversal of the normal flow of water by means of pressure to flush out germs and debris.
Ultraviolet Radiation (UV): Low-pressure mercury arc lamps produce ultraviolet light, which has
germicidal properties. The radiation kills or deactivates pathogens. Bacteria are killed with relatively low
amounts of radiation, viruses are more resistant, and cysts and worms are unaffected. The lamp's efficiency
decreases with age and must be replaced quarterly. Color, turbidity and organic impurities in the water also
interfere with transmission of ultraviolet energy and may reduce efficiency to unsafe levels. Also, radiation
leaves no residual product that continues to disinfect beyond the treatment period.

Important things to note:

Sand bed filter and activated carbon columns are back washed and flushed daily to remove impurities that
have settled on the surface. These impurities must be removed as they 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 once every three weeks.
Drinking water is not deionized because some ions are essential to the body.
Water for pharmaceutical operations are deionized as the ions can react with the drug product.
Bottle water is ozonized for further purification and to ensure a longer shelf life

3.2 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 combining 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).
 Properties of Soap

Both soda and potash soaps are readily soluble in alcohol or hot water. In cold water, they dissolve more
slowly and have slight decomposition due to hydrolysis. The solution becomes turbid.

Raw Materials Used in The Production of Soap

Palm Kernel Oil

Palm oil

Hydrogen peroxide

Caustic Soda

Fatty acid

Palm stearin

Sulphuric acid

Perfume

Equipment/Machines Used in Soap Production

Bleaching Tank

Plodder

Saponification Tank

Amalgamator

Cutting Machine

Chiller

Reserve Tank

Reservoir Tank
Boiling Pot
The processes involved in the production of soap are summarised 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.19: Flowchart Showing Soap Production Processes and the machines.

PROCEDURES OF SOAP PRODUCTION

Soap can be simply seen as a result of fatty acid. The salt is simply the reaction of an acid and base. At
Gauze pharm & lab soap factory, we produce Tracas multipurpose

RAW MATERIALS USED IN SOUP PRODUCTION

Here are the common raw materials for soap production;

Fats and Oils - Fats and oils are the primary raw materials for soap making. They can be of animal
origin, such as tallow or lard, or vegetable origin, such as coconut oil, palm oil, olive oil, or sunflower oil.
The chemical formula for fats and
oils are: Fats: C55H98 O6 Oils: C57H104 O6

Alkali: - The alkali used in soap making is usually sodium hydroxide (NaOH) for solid soap or potassium
hydroxide (KOH) for liquid soap. The chemical formula for sodium hydroxide is NaOH, while that of
potassium hydroxide is KOH.

Water: - Water is an important ingredient in soap making and is used to dissolve the alkali.
Additives: - Additives can be added to soap to improve its properties, such as fragrance, color, or
texture. Some common additives include essential oils, herbs, and colorants.

Glycerin: - Glycerin is a byproduct of soap making and can be added back into the soap to improve its
moisturizing properties. Its chemical formula is C3H8O3.

3.4 CHEMISTRY OF SOAP PRODUCTION

Soap production involves a chemical reaction between fats or oils and an alkali, usually sodium
hydroxide (NaOH) for solid soap or potassium hydroxide (KOH) for liquid soap. This reaction is called
saponification, and it results in the formation of soap molecules and glycerol.

The saponification reaction can be represented by the following equation:

Fat/Oil + NaOH/KOH → Soap + Glycerol

In this reaction, the ester bonds in the fats or oils are broken down by the alkali, and the resulting fatty
acids combine with the alkali to form soap molecules. The glycerol is a byproduct of this reaction.

The soap molecules have a hydrophilic (water-loving) head and a hydrophobic

(water-hating) tail. When the soap is used, the hydrophobic tails attach to dirt and oils, while the
hydrophilic heads attach to water. This allows the dirt and oils to be removed from the surface being
cleaned and washed away.

Once the saponification reaction is complete, the soap is usually poured into molds and allowed
to cool and harden. The soap is then cut into bars or other shapes and allowed to cure for several weeks.
During this time, any remaining water and alkali evaporate, and the soap becomes harder and more
stable.

Additives such as fragrance, color, and texture enhancers can be added to the soap before
pouring it into molds. Glycerin, which is a natural byproduct of soap making, can also be added back into
the soap to improve its moisturizing properties.

The chemical reaction involved in soap making is called saponification. It is a hydrolysis reaction
between fats or oils and an alkali, which results in the formation of soap molecules and glycerol.

The saponification reaction can be represented by the following equations:

For fats:

Fat + 3 NaOH → Glycerol + 3 Soap molecules for oils:

Oil + 3 NaOH → Glycerol + 3 Soap molecules

In these reactions, the alkali (sodium hydroxide or potassium hydroxide) breaks down the ester
bonds in the fats or oils, and the resulting fatty acids combine with the alkali to form soap molecules.
The glycerol is a byproduct of this reaction.

The soap molecules have a hydrophilic head (polar, attracted to water) and a hydrophobic tail
(non-polar, repelled by water). When soap is used, the hydrophobic tails attach to dirt and oils, while the
hydrophilic heads attach to water. This allows the dirt and oils to be removed from the surface being
cleaned and washed away.

After the saponification reaction, the soap is usually poured into molds and allowed to cool and
harden. The soap is then cut into bars or other shapes and allowed to cure for several weeks. During this
time, any remaining water and alkali evaporate, and the soap becomes harder and more stable.
Additives such as fragrance, color, and texture enhancers can be added to the soap before pouring it
into molds.

QUALITY CONTROL IN SOAP PRODUCTION

Quality control is crucial in the soap production process to ensure that the end product meets the
desired standards and specifications. Here are some measures that can be implemented to maintain
quality control in soap production:
Raw Material Inspection: The quality of raw materials, such as oils, fats, and additives, should
be inspected before use. This involves testing for impurities, moisture content, and other
physical and chemical properties to ensure that the raw materials meet the required quality
standards.

Process Control: The production process should be closely monitored to ensure that it is
consistent and meets the required quality standards. This involves checking the temperature,
mixing speed, and other parameters to ensure that they are within the desired range.

Batch Testing: Each batch of soap should be tested to ensure that it meets

the required quality standards. This includes testing for pH, moisture content, hardness, and
other physical and chemical properties.

Quality Assurance: Quality assurance personnel should be involved in the production

process
to ensure that all quality control measures are being followed. They should also conduct regular
audits to identify any potential quality issues and implement corrective actions.

Packaging and Labeling: The packaging and labeling of the soap should be inspected to ensure
that they meet the required standards. This includes checking for proper labeling of the
product name, batch number, date of manufacture, and safety information.
 Microbial Testing: Microbial testing should be performed regularly to ensure that the soap is
free from harmful microorganisms. This involves testing for bacteria, fungi, and other
microorganisms that may affect the quality of the soap.

USES OF SOAP

Soap is a versatile cleaning agent that has been used for thousands of years. Its uses include:

Personal hygiene: Soap is primarily used for personal hygiene, such as cleaning the hands, face, body,
and hair. It helps to remove dirt, sweat, and excess oil from the skin and hair, leaving them clean and
refreshed.

Laundry: Soap is commonly used for laundry to remove stains, dirt, and odors from clothes and fabrics.
It helps to break down and remove oils and other contaminants that may be present in the fabric.

Dishwashing: Soap is often used for washing dishes to remove food particles and grease from plates,
bowls, and utensils. It helps to break down and emulsify the oils and fats present in the food, making
them easier to remove.

Cleaning: Soap can be used for cleaning a variety of surfaces, including floors, countertops, and
appliances. It helps to remove dirt, grease, and other contaminants, leaving the surface clean and shiny.

Pest Control: Soap can be used as a natural pesticide to control pests such as aphids, mealybugs, and
spider mites. It works by suffocating the pests and disrupting their cellular membranes, ultimately
leading to their death.

Industrial Applications: Soap is also used in various industrial applications, such as metalworking,
mining, and oil drilling. It can be used as a lubricant, emulsifier, or surfactant, among other functions.

However, soap is a versatile and essential cleaning agent that can be used for a wide range of
applications. Its uses continue to expand as new applications are discovered and developed.

3.3 Sample Analysis Done in Chemistry and Microbiology laboratories.

We also have another section which is the chemistry and microbiology laboratories, they deal in the
running of different analysis on raw materials of drugs samples before they are ready for production and
use.

Types of Analysis
There are two basic types of analysis in chemistry. These analyses are utilised in the chemistry
laboratory with the aid of the British Pharmacopoeia, the reference book used in the lab. They are;

Quantitative Analysis: This involves calculating or determining the amount or quantity of elements

or compounds present in a given sample solution of a substance. Two methods are employed in
 quantitative analysis: Volumetric Analysis and Gravimetric Analysis. Volumetric Analysis is based

on the volume measurement of solution through titration, while Gravimetric Analysis is based

on the direct mass measurement of substances.

Qualitative Analysis: This deals with the identification of elements or compounds present in a

sample. It deals with the chemical constituents of raw material or dug used by the company.

This analysis considers parameters such as colour, pH, melting point, boiling point, etc.

Calibration of Equipment
Calibration can be described as the correction of a measuring device by adjusting it to conform to a
depending known and unvarying measure. The chemist calibrates equipment in the company's various
sections every day. The equipment being calibrated is the electronic weighing balance, and the pH meter
in the chemistry laboratory is calibrated every morning by the chemist before daily usage.

Test for Water

The chemist must analyse water used in the various sections of the company before the commencement
of production every day. In the chemistry lab, the following tests are carried out on a water sample;

Organoleptic test: This test is carried out using the five-sense organ, or it is a sensory evaluation of the taste,

smell, odour, and appearance of the water samples.

pH test: This test is used to check for the degree of acidity or alkalinity of a solution. The pH of water is

between the range of 6.5-8.5, which conforms to the Gauze and SON standard. The instrument used in

this test is the pH meter.

Fig 3: Handheld pH Meter

Total Dissolved Solids (TDS) test: This is the amount of organic and inorganic materials, such as metals,

minerals, salts, and ions, dissolved in a particular volume of water. TDS is essentially a measure of

anything dissolved in water that is not a water molecule. Total dissolved solids in water include calcium,

chlorine, magnesium, potassium, aluminium, zinc,

etc. TDS is measured as a volume of water with the unit milligrams per litre (mg/L), otherwise known as
parts per million(ppm).

TDS is obtained by dividing the Electrical Conductivity of a water sample by 0.05.

TDS = 𝐸.𝐶
0.05

Electrical Conductivity test: This test determines a sample's electrical conductivity. It is double of TDS.

Fig 4: Electrical Conductivity Meter

Test for chloride ions (Cl‾): This test is carried out on production water using Nitric-acid (HNO 3) and Silver-

Nitrate (AgNO3). If there is a presence of Chlorine, it will form a cloudy precipitate while the absence of

chlorine would be colourless.

Preparation Of Solution

Preparation Of Indicator Solution

Aim: To prepare phenolphthalein indicator solution.
Apparatus: 100cm3 measuring cylinder, electronic weighing balance, spatula, beaker.
Reagents: 0.1g phenolphthalein solid, 80ml of 96% ethanol, distilled water.

Procedure: 0.1g of white powdery phenolphthalein solid was weighed in a beaker with the electronic
weighing balance. It was transferred to a 100ml volumetric flask, and 80ml of the ethanol solution was
used, measured using a measuring cylinder, and moved to the 100ml volumetric flask. Distilled water
was added to the volumetric flask until it reached 100cm3. The prepared solution was then transferred
to its reagent bottle.

Conclusion: This is the method stipulated by the British pharmacopoeia for preparing phenolphthalein
indicator solution.

Preparation Of Standard Solution

Aim: To prepare 0.1M HCL in a 500cm3 volumetric flask.

Apparatus: Beaker, 500cm3 volumetric flask, measuring cylinder.

Reagent: Distilled water, a stock solution of Hydrochloric acid.

Theory: From the label on the stock bottle, the following data was obtained;

Specific gravity = 1.177, % purity = 36-37%, molar mass = 36.5g/mol

Using the relation,

V = 𝑀𝑜𝑙𝑎𝑟 𝑚𝑎𝑠𝑠∗𝑀𝑜𝑙𝑎𝑟𝑖𝑡𝑦∗𝑉𝑜𝑙𝑢𝑚𝑒 𝑜𝑓 𝑑𝑖𝑙𝑢𝑡𝑒 𝑠𝑜𝑙𝑢𝑡𝑖𝑜𝑛 𝑟𝑒𝑞𝑢𝑖𝑟𝑒𝑑

10∗𝑠𝑝𝑒𝑐𝑖𝑓𝑖𝑐 𝑔𝑟𝑎𝑣𝑖𝑡𝑦∗% 𝑝𝑢𝑟𝑖𝑡𝑦

% purity = (36+37)/2 = 36.5%

V = 36 .5𝑔/𝑚𝑜𝑙∗0.1𝑀∗500𝑐𝑚3 = 4.25cm3
Procedure: 200cm of distilled water was poured into a volumetric flask, 4.25cm 3 of the stock solution
3

was added to the volumetric flask and the volume of the flask was made up to the 500cm 3 mark with
distilled water, after which it was stirred to ensure through mixing.
Conclusion: This process is used to prepare liquid reagents in the laboratory. N.B: Add acid to water

and not water to acid.

Chemical Analysis of Raw Materials/Finished Products
Chemical analysis of raw materials/finished products is carried out to determine the quality and
percentage purity of the raw materials/finished products in line with the range stipulated by the British
pharmacopoeia and the certificate of analysis.

The physiochemical parameters determined include:

Solubility: This determines the extent of dissolution of a substance in solvents such as water,

ethanol, ether and chloroform, etc.

Physical Characteristics: This is concerned with the physical characteristics of the substance, which

includes; colour, taste, smell, texture, etc.

Identification Test: This is carried out to determine the specific gravity, apparent density, pH,

melting point, boiling point, etc.

Assay: This is a quantitative test used to determine the amount or presence of an active ingredient

in a raw material. This could be determined using titrimetric or spectrophotometric methods.

Chemical Analysis on Liquid Finished Product

This test is carried out on all the liquid drugs produced where the physical appearance and filling volume
are observed. The pH and the specific gravity or apparent density are also calculated and compared with
the range stated in the reference.

Aim: Analysis of Gauze’s Methylated Spirit

Apparatus: Pycnometer, Electronic weighing balance, Digital pH conductivity meter.

Reagents: Distilled water, Methylated Spirit solution (sample)

Procedure: To determine the specific gravity, a Pycnometer was weighed in the electronic weighing
balance, and the weight was recorded. The water was discarded, and the pycnometer was rinsed with
the sample before filling it up with the sample. It was also weighed and recorded. The weight of the
water and sample was then calculated by multiplying the weight of the sample by the constant

0.99718g/ml and dividing by the weight of the water.

Theory:
Physical appearance: A clear, colourless liquid

Specific gravity at 20°C

Weight of Pycnometer = 21.866g

Weight of Pycnometer + Water = 51.423g

Weight of Pycnometer + Sample = 52.133g

Weight of Water = 29.557g

Weight of Sample = 30.269g

Sample gravity = (𝑤𝑒𝑖𝑔ℎ𝑡 𝑜𝑓 𝑠𝑎𝑚𝑝𝑙𝑒 ∗ 0.99718𝑔/𝑚𝑙)/(𝑤𝑒𝑖𝑔ℎ𝑡 𝑜𝑓 𝑤𝑎𝑡𝑒𝑟)

= (30.269 ∗ 0.99718𝑔/𝑚𝑜𝑙)/(29.557𝑔) pH = 2.10

Filling volume = 100ml

Remark: The sample passed the test because the specification range of the specific gravity is from 1.00
to 1.10g/ml

Sample Analysis Done in Microbiology laboratories

Microbiology laboratories done in pharmaceuticals industry is also essential because it ensures safety
and efficacy of pharmaceutical products. It embraces the process like the validation of disinfectant,
evaluation of the efficacy of disinfectant in suspension, on surfaces and through field trials. There are
different microorganisms studied and examined in this field too as regards pharmaceutical industry.
There are also different types of test performed on pharmaceutical drug samples in the laboratory which
are; Antimicrobial Efficacy Testing (AET), Microbial limits testing, Bioburden determination, Water
analysis etc.

The Six main types of microorganisms studied in the microbiology laboratories are :

1. Bacteria

2. Archaea

3. Fungi
4. Protozoa

5. Algae

6. Virus

Microbiologist use these five basic procedures to examine and characterize microbes :

1. Inoculation

2. Incubation

3. Isolation

4. Inspection (Observation)

5. Identification

In the Microbiology laboratories, there are also some kind of medias that are used to enhance the
analysis taking in the laboratory such as; Basic Media, Enriched Media, Selective, Indicator Media,
Transport Media and Storage Media. There are various types of equipment also used in the laboratory
for the analysis taking by the Lab microbiologist Which are :

1. Microscopes

2. Slides

3. Test tubes

4. Petridish

5. Growth mediums

6. Inoculation loops

7. Pipettes and tips

8. Incubator

9. Auto claves

10. Laminar air flow (both solid and liquid)

 CHAPTER 4

CONCLUSION

The Six months’ industrial attachment with GAUZE PHARMACEUTICALS

AND LABORATORIES NIGLTD has been one of the most interesting, productive

and instructive experience in my study days. Through this training, I was able to

gain new insight and more comprehensive understanding about real industrial

working condition and practice. It has also improved my functional skills, and

broadened my knowledge in the area of Pharmaceuticals and Non -

Pharmaceuticals production processes. It is worth of note however that these

valuable experience and knowledge that I have gained were not only acquired

through the direct involvement in task but also through other aspect of the training

such as; work observation, interaction with colleague, superior and other factory

workers. I can say for sure that Industrial Training Program has achieved its

primary objective of bridging the gap between classroom theory and life

application of concepts. I stand a good chance of being employable in any paint

manufacturing firm.

Recommendations

In view of the relevance of the SWIES program, it is important that it is sustained

by the government through the Industrial Training Fund (ITF) as it exposes the

student to work tools, facilities, and equipment that may not be available in their

respective institutions in relation to their course of study.

To this end, I recommend that the following under-listed points should be

implemented:

First, I recommend that this programme should be suistained at all cost

considering its relevance to students and the society at large.

Students’ and supervisors’ allowances should be paid in order to ensure a

smooth and happy work experience by both parties.

Industrial Training Fund (ITF) officials and the institution-based supervisors

should ensure proper supervision of the student concerned to ensure they are

active in their place of attachment.

The ITF program co-coordinators in the various states and the Federal

Capital Territory should ensure that that the students concerned are placed in

the relevant department in these organizations with respect to the students’

discipline.

The companies should put in place all the necessary facilities needed to

enhance the knowledge of the student in industrial attachment otherwise

should not be approved for students’ attachment.

The company/firm should provide and teach students how to use safety

tools to reduce work place accident.

References

Standard Operating Procedures of Gauze pharmaceuticals and laboratories Nig Ltd

British Pharmacopea (2003) Volume I & II

British Pharmacopea (2013) Volume III

Ezeani, C.F (2021) SIWES Technical Report

Ogoegbunam, U.N (2022) SIWES Technical Report