1

TECHNICAL REPORT

ON

THE STUDENT INDUSTRIAL WORK EXPERIENCE SCHEME (SIWES)

UNDERTAKEN AT

DE-SHALOM PHARMACEUTICAL LABORATORY

KM4, ILKO-IJESA ROAD, ILESA, OSUN STATE.

PRESENTED BY

ADEBAYO OLUWAJOMILOJU PRECIOUS

2018/1/00002FS

SUBMITTED TO

THE DEPARTMENT OF FOOD SCIENCE AND TECHNOLOGY

SCHOOL OF AGRICULTURE AND AGRICULTURAL TECHNOLOGY

FEDERAL UNIVERSITY OF TECHNOLOGY MINNA, P.M.B 65, MINNA,

NIGER STATE.

IN PARTIAL FULFILLMENT OF THE REQUIREMENT(S) FOR THE

AWARD OF BACHELOR OF TECHNOLOGY IN FOOD SCIENCE AND
TECHNOLOGY.

NOVEMBER, 2023.
 CERTIFICATION

This is to certify that this report was compiled by ADEBAYO OLUWAJOMILOJU

PRECIOUS with matriculation number 2018/1/00002FS in partial fulfillment of the

requirement for the award of Bachelor of Technology (B.Tech) in Food Science and Technology,

School of Agriculture and Agricultural Technology, Federal University of Technology Minna in

affiliation to Federal Polytechnic Offa, Kwara State.

_____________________ ______________________

SIWES Supervisor Signature and Date

_____________________ _______________________

SIWES Coordinator Signature and Date

_______________________ _______________________

Head of Department Signature and Date

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 DEDICATION

This report is dedicated to the ALMIGHTY GOD and special dedication also goes to my ever-

supportive parents, ENGR AND MRS ADEBAYO.

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 ACKNOWLEDGEMENT

I appreciate the ALMIGHTY GOD who is my sufficiency, the one who was and

the one who is to come for granting me the Knowledge and understanding needed during

the course of my industrial training, may His name forever be praised.

My appreciation goes to my Supervisor, MRS LAWRENCE INI-OBONG for

her guidance and support.

My appreciation also goes to my wonderful Parents, ENGR AND MRS

ADEBAYO for their unrelenting effort and constant support.

My gratitude also goes to my institution for providing me with the opportunity to

participate in the SIWES program.

Also, I am grateful to the staff and management of DE SHALOM

PHARMACEUTICAL LABORATORY LIMITED for their warm welcome,

cooperation, and willingness to share their expertise that have made my experience

fruitful and enriching.

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 TABLE OF CONTENT

TITLE PAGE……………………………………………………………………………...i

CERTIFICATION ..............................................................................................................ii

DEDICATION .................................................................................................................. iii

ACKNOWLEDGEMENT ................................................................................................ iv

TABLE OF CONTENT…………………………………………………………………..v

CHAPTER ONE

1.0 HISTORY OF SIWES .................................................................................................1

1.1 OBJECTIVE OF SIWES .............................................................................................1

1.2 INTRODUCTION TO THE PHARMACEUTICAL INDUSTRY..............................2

1.3 BRIEF HISTORY ABOUT INDUSTRIAL TRAINING FUND (ITF)………………3

1.4 ROLE OF INDUSTRIAL TRAINING FUND (ITF)…………………………………3

CHAPTERTWO

2.0 HISTORY OF THE ESTABLISHMENT....................................................................4

2.1 OBJECTIVES OF THE ESTABLISHMENT..............................................................4

2.2 COMPANY MISSION AND VISION……………….................................................5

2.3 ORGANOGRAM OF THE COMPANY……………………......................................6

2.4 COMPANY PRODUCTS AND THEIR ACTIVE PHRAMACEUTICAL

INGREDIENTS (API)…………………………………....................................................6

2.5 THE COMPANY ORGANIZATION STRUCTURE………......................................8

2.6 GOOD MANUFACTURING PRACTICES BY DE-SHALOM

PHARMACEUTICALS LABORATORY LIMITED (GMP & cGMP)...........................11

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CHAPTER THREE

3.0 FOOD SCIENCE AND TECHNOLOGY AS A COURSE........................................13

3.1 DRUGS PRODUCTION OPERATION ....................................................................14

3.1.1 The Oral Solid Line (Tableting Line).......................................................................14

3.1.2 The Oral Liquid Line ...............................................................................................18

3.1.3 The External Liquid Line .........................................................................................21

3.2 QUALITY ASSURANCE AND QUALITY CONTROL ..........................................21

3.2.1 Analysis of Raw Materials……................................................................................22

3.2.2 Chemical Analysis On Tablets .................................................................................23

3.2.3 Determination And Calculation Of The Specific Gravity Of Oral And External

Liquid Drugs. ...................................................................................................................28

3.3 WATER TREATMENT..............................................................................................29

3.3.1 Sources of Water; .....................................................................................................29

3.3.2 Steps Involved in The Treatment of The Water Used in De-Shalom Pharmaceutical

Lab. Limited......................................................................................................................29

3.3.3 Maintenance Of The Water Treatment Plant............................................................30

CHAPTER FOUR

4.0 CONCLUSION………………………………………………………………………31

4.1 EXPERIENCE GAINED.............................................................................................31

4.2 PROBLEMS ENCOUNTERED………………………………………..……………32

4.3 RECOMMENDATION...............................................................................................32

REFERENCES.................................................................................................................33

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 CHAPTER ONE

1.0 HISTORY OF SIWES

SIWES was established by ITF in the year 1973 to solve the problem of lack of adequate

practical skills preparatory for employment in industries by graduates of tertiary institutions.

The Scheme exposes students to industry-based skill necessary for smooth transition from

the classroom of the world of work. It affords students of tertiary institution the opportunity to

being familiar and exposed to the needed experience in handling machinery and equipment

which are usually not available in the educational institutions.

The Students Industrial Work Experience Scheme (SIWES) was initiated in 1973 by the

Industrial Training Fund (ITF). It is tripartite programme involving the students, the universities

and industries. It is funded by the Federal Government of Nigeria and jointly coordinated by the

ITF and the National Universities Commission (NUC).

1.1 OBJECTIVES OF SIWES

The objectives of SIWES include:

1. To provide an avenue for students in the Nigerian universities to acquire industrial skills

and experienced during their course of study.

2. To prepare students for the work situation they are likely to meet after graduation.

3. To expose the students for the work method and techniques in handling equipment and

machinery that may not be available in their universities.

4. To allow the transition phase from school to the world of working environment and

facilitates students’ contact for later job placements.

5. To provide students with opportunities to apply their theoretical knowledge in real work

situation thereby bridging the gap between theory and practice.

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1.2 INTRODUCTION TO THE PHARMACEUTICAL INDUSTRY

The pharmaceutical industry deals with the production of drugs, while a drug can be

defined as any substance that is used to modify or explore the systematic or pathological state for

the benefits of the recipient (WHO).

The pharmaceutical industry departments are sectioned into;

 The raw materials store, where the raw materials are kept or stored.

 The quarantine room where the damaged or unsafe raw materials are offloaded to.

 The raw materials flow passage where the raw materials to be used for production are

being transported.

 The weighing room where ingredients or raw materials been used are measured in the

right proportion before sending it to the production section.

 The production department which consists of three lines. The oral liquid line, external

liquid line and the oral solid line (tableting line).

 The quality control and assurance department which entails the physio-chemicals

laboratory, microbiology laboratory and instrument laboratory.

 The cloak room where clothes are changed.

 The bottle rinsing department where the bottle used for filling finished products is being

sterilized.

 The packaging materials store where materials used for packaging are stored.

 The finished products store where the finished products are stored for sale.

 The reference sample room where sample of products produced are retained for reference

purposes.

This report entails the entirety of my industrial training at De Shalom Pharmaceutical

Laboratory Ilesha, Osun State. The company deals with production, processing and

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 packaging of both tablet drugs and syrup drugs. This report is based on the practical

experience gained during the period of attachment as seen in laboratory scientist point of

view.

I explained the activities and experiences gained within the several departments and

subunits I worked in the company. I was posted to the Quality Assurance (QA) department

where I performed different analyses like specific gravity, friability test, disintegration time test,

moisture content etc. So also, I was posted to other subunits like the water department,

production department (oral liquid, external liquid and oral solid), the raw materials and

weighing section. I was opportune to learn totally new things, gain practical knowledge as well

as learn various laboratory techniques, procedures, understand the working of specialized

equipment and gain insight in the principle of some of the test procedures.

1.3 BRIEF HISTORY ABOUT INDUSTRIAL TRAINING FUND (ITF)

It is an agency of the federal government of Nigeria, given the responsibility to mediate and be a

channel between the nation’s tertiary institutions and the industries, to enable students, to enable

students to participate in industrial activities prior to their graduation. This participation in

Industrial activities (training) is to ensure and prepare students to fit well into the industrial

system when they secure employment after graduation. In some way bridging the gap between

theories acquired in school and industrial work.

1.4 ROLE OF INDUSTRIAL TRAINING FUND (ITF)

1. Formulate policies and guidelines on SIWES for distribution to all the SIWES

participating bodies, institution and companies.

2. Regularly organize orientation programmes for students prior to their attachment.

3. Supervise students on industrial Attachments.

4. Disburse supervisory and students’ allowances.

5. Provide insurance cover for students on attachment.

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 CHAPTER TWO

2.0 HISTORY OF THE ESTABLISHMENT

De-shalom pharmaceutical laboratory (Nig) limited was incorporated in Nigeria in the year

1998. The company commenced pharmaceutical manufacturing activities in the year 2004 with

the registration of oral liquid line and external liquid line and with the pharmacist council of

Nigeria (P.C.N) and national agency for food and drugs administration control (NAFDAC). The

company is 100% indigenous to Nigerian and fully owned by Nigerian. The approved and

registered factory was located at G141F Oke-Oye Street, Ilesha, Osun state, Nigeria. In the quest

to improve the company CGMP, 9 hectares of land was acquired by the company management at

km 4, Iloko-Ijesa road Ilesha, Osun state, Nigerian. New building was built on the site that

accommodated;

i. Oral liquid line

ii. External liquid line

iii. Oral solid line or Tableting

2.1 OBJECTIVES OF THE ESTABLISHMENT

The objective of the establishment is to contribute positively towards the good health of

humans by producing quality pharmaceutical products and making them available at affordable

prices for the masses all the time.

 The establishment is also concerned about ensuring the necessary good manufacturing

practices which are required from NAFDAC, W. H. O, and other related bodies

 To be among or join W. H. O in the next two years

 To ensure continuous production of new drugs so as to meet the requirement of the

consumers

 To ensure even distribution of their products nationwide

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2.2 COMPANY MISSION AND VISION

COMPANY MISSION:

De-Shalom pharmaceutical laboratory limited is committed to zero defect quality products

and shall endeavor to continually Improve her current Good Manufacturing Practice to conform

to NAFDAC-cGMP,WHO-cGMP and ISO standard. We shall continually put in our best to

achieve total satisfaction of the needs and expectation of our customers.

We shall achieve the above by the following objective;

 Improved products performance.

 Improve effectiveness and efficacy of processes and quality management system.

 Facility/Technology upgrading.

 Development and maintaining partnership.

 Putting in place policies and processes that ensures consumer’s safety.

COMPANY VISION:

The company’s vision is to be a global player in the manufacturing of high-quality

pharmaceutical products.

This glorious vision necessitates the need for good policy and this quality manual.

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 2.3 ORGANOGRAM OF THE COMPANY

DESCRIPTION OF THE ESTABLISHMENT

DE-SHALOM LTD

2.4 COMPANY PRODUCTS AND THEIR ACTIVE PHARMACEUTICAL

INGREDIENT (API)

The company has registered all their pharmaceutical products with NAFDAC January 2004 till

date. These products are;

ORAL PRODUCTS

PRODUCTS ACTIVE PHARMACEUTICAL

INGREDIENTS(API)

Peacetone blood tonic Ferric Ammonium Citrate, Vitamin B12 and

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 folic acid

De-shalom mixture of magnesium trisilicate Magnesium trisilicate, Sodium bicarbonate and

light magnesium carbonate

De-shalom mixture of potassium citrate Potassium citrate

De-shalom vitamin C syrup Ascorbic acid

De-shalom Babyccan syrup Paracetamol powder

Peacecoole- Antiseptic Ethyl alcohol and Peppermint extract

Paracetamol syrup Paracetamol powder

De-shalom cough syrup Ammonium chloride,liquorice root extract,

chlorpheniramine maleate and menthol

Metronidazole suspension Metronidazole benzoate

Cipretrin suspension Trimethoprim and sulphamethoxazole

Demag suspension Magnesium trisilicate, Sodium bicarbonate and

light magnesium carbonate

De-shalom kaolin mixture Light kaolin and zinc

Eldertone in honey Ferric ammonium citrate, vitamin B12, vitamin

A and vitamin D3

Honeyglobin-12 Ferric ammonium citrate, vitamin B12, vitamin

A, vitamin D3 and folic acid

De-shalom multivitamin syrup Vitamin B12, vitamin A and vitamin D3

EXTERNAL PRODUCTS

De-shalom methylated spirit Methanol and ethanol

De-shalom calamine lotion Calamine powder and bentonite

De-shalom gentian violet Gentian violet

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Eusol lotion Boric acid and chlorinated lime

De-shalom hydrogen peroxide solution Hydrogen peroxide

ORAL SOLID OR TABLETING PRODUCTS

Bacagin tablet Paracetamol powder and ibuprofen

De-shalom paracetamol tablet Paracetamol powder

De-shalom calcium tablet Di-calcium phosphate

De-shalom metronidazole tablet Metronidazole

De-shalom cotrimoxazole Cotrim

De-shalom nitrofurantoin tablet Nitrofurantoin powder

De-shalom compound magnesium trisilicate Magnesium trisilicate and calcium carbonate.

De-shalom ciprau tablet Ciprofloxacin powder

De-shalom Rividtab tablet Ofloxacin powder

So also, the company also engages in the manufacturing of flavored drinks, namely;

Comovit-C Orange flavored drink

NAFDAC REG. NUMBER; 01-5864

Comovit-C Black currant drink flavored drink

NAFDAC REG NUMBER; 01-5864

2.5 THE COMPANY ORGANIZATION STRUCTURE

Departments/sections in the organization and their functions;

 Administrative Department: This department is where the policy of the company is

made. They organize and oversee the affair of the company. The session includes the

managing director, general manager, accountant, sales department headed by the sales

manager and others.

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  Maintenance Department: This department ensures that the electrical, computer and

mechanical appliances used in the company are working in order. They are responsible

for the repairing any faulty equipment or machine. They are also responsible for power

supply.

 Operation Department: This department oversees the production operation of the

company. They ensure that the production schedule is duly observed and they are

responsible for any process due to manpower in the production line.

 Quality Control Department: The department ensures that the products of the company

are good quality and meet the specification according to the pharmacopeia. They analyze

raw material to be used for the production of drugs, identify the excipient used, inspect

the production process, and analyze the finished products after production.

The department is comprises of two sections;

a. Physio-Chemical Laboratory: They deals with the physio-chemical analyses of

the raw materials, excipients, water and finished products.

b. Microbiology Laboratory: This is where microbial analysis of raw materials and

finished products as well as microbial count during environmental analyses is

carried out.

Under the Quality Control section, we also have In-process. In-process is a middleman between

the production and chemical laboratory which is strictly concerned with the monitoring of

production from the raw material stage to the packaged stage. After mixing all the active

ingredients together in the vessel, the product is then transferred to the chemical laboratory to

carry out some analysis to check if the products meet all requirements and 9 specifications.

Afterwards, the chemical laboratory analyst will now send the result back to the in-process

section and by doing this, the production section will know whether to start filling or not.

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  Production Department: This is the section of the company where all production of

company’s product takes place. The production section is divided into 3 which are;

a. Tableting section

b. Oral liquid section

c. External section

a. Tableting Section: Where drugs inform of tablets are produced. It is sub – divided into 4

categories

- Granulation area

- Blistering area

- Compression area

- Packaging area

b. Oral Section: Deals with the production of drugs that are in liquid form which are taken

directly through the oral cavity e.g., Honeyglobin blood tonic, mist–mag, cough expectorant.

c. External section: This deals with the production of drugs that are used externally on the body

e.g., methylated spirit, Gentian violet pain, hydrogen peroxide.

The production section has several subunits which include

1. Receiving Bay: This is the where the raw materials, bottles, packets, labels, and other

things needed for production are being received.

2. Quarantine Room: This is where all materials are set apart for analysis by the

quality control department. Materials tested and deemed as fit for production are

passed for production while those that fail the test are rejected and returned.

3. Dispensary or Weighing Room: All materials needed for the production of each

product are accurately weighed in Batch Manufacturing Record (BMR).

4. Coding Unit: This is where batch number, manufactured date, expiry date, and other

relevant are inscribed on the packaging materials.

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 5. Filling Room: Finished product that has been analyzed and confirmed safe for use

and filled into bottles and sachets with tightly sealed caps.

6. Packaging Unit: All finished products are labeled and packed into proper containers

in this section.

 Finished Goods Department: This department that store and keeps a record of finished

products that enters or leaves the finished goods store

2.6 GOOD MANUFACTURING PRACTICES BY DE-SHALOM PHARMACEUTICALS

LABORATORY LIMITED (GMP & cGMP)

For every pharmaceutical line of production, there are certain rules that apply both within and

without production areas. These rules are known as cGMP which means current Good

Manufacturing Practices. These rules are what guide the organization in ensuring that the

manufacturing of pharmaceutical products follows the standard order. Below are some of the

manufacturing practices that are kept by De-shalom Pharmaceuticals Laboratory Ltd to ensure

they meet both the standard of the National Agency for Food, Drugs, and Administration Control

(NAFDAC)as well as the World Health Organization (WHO).

1. Gowning must be properly carried out before entering into the production area. This

means that individuals or personnel are allowed into the production area while putting on

their street outfits (street shoes and clothes). This rule applies to the production area

because it is marked as one of the company’s white areas. Other areas like the

administration block do not require gowning.

2. No production or quality control personnel is allowed to apply makeup or any form of

cosmetics on their face as this is hazardous to the production of IVF products.

3. Jewelry and wristwatches are prohibited inside the production floor.

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 4. Daily documentation of work carried out is expected to be done without transferring the

duty to the next day.

5. Production personnel in the sterile section are to always go through a bathing process

before being allowed into the sterile production area.

6. Keeping beards or any facial hair is highly prohibited both in the quality control

laboratory and in the production area.

7. Use of factory shoes, cap, and gown is mandatory to access the production area

8. Products are first sampled by the quality control for analysis before manufacturing can

proceed.

9. Finished products must be analyzed at different stages of production by the quality

control department to ensure that it follows the standard production procedure. There are

several other manufacturing practices adopted by De-shalom Pharmaceuticals Laboratory

Ltd to ensure the quality production of all their products

EXAMPLES OF DE-SHALOM DRUG

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 CHAPTER THREE

3.0 FOOD SCIENCE AND TECHNOLOGY AS A COURSE

Food science and technology is the study of how food is created and preserved, from the

growing and harvesting of raw materials to the processing and packaging of the final product. It

involves understanding the chemistry, microbiology, and engineering behind food production.

Food scientists and technologists work to ensure that food is safe, nutritious, and appealing. They

also work to develop new food products and improve the quality of existing products. It's a field

that's constantly evolving and growing, and it's an important part of the food industry.

Importance Of Food Science and Technology in Drugs

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 Food science and technology plays a critical role in the development of new drugs and

medications. Many drugs are derived from natural products, such as plants and microorganisms.

Food scientists and technologists study these raw materials and how they can be processed to

produce the desired compounds. They also work to develop new methods for extracting and

purifying these compounds.

The packaging of drugs is a critical part of the process, as it protects the drugs from

contamination and degradation. Food scientists and technologists develop packaging materials

and designs that are specifically tailored to the needs of drugs. This includes factors like the type

of drug, its stability, and the conditions under which it will be stored and transported.

Food science and technology are important in drug production because they provide

valuable insights into the formulation and manufacturing of medications. By applying principles

of food science, researchers can optimize drug stability, solubility, and bioavailability, ensuring

that the medication is effective when taken by patients. Additionally, food science techniques

help in the development of drug delivery systems, such as nanoparticles or liposomes, which can

enhance drug targeting and release. This field also contributes to the development of taste-

masking strategies, making medications more pleasant to take. Overall, food science and

technology play a vital role in improving the quality, efficacy, and patient experience of

pharmaceutical products.

3.1 DRUGS PRODUCTION OPERATION

De Shalom pharmaceutical Laboratory production department is divided into three lines

 The oral solid line (Tableting line)

 The oral liquid line

 External liquid line

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3.1.1 THE ORAL SOLID LINE (Tableting line)

The oral solid line deals with the production of tableting which involves three stages.

a. Granulation: This is the act or process in which primary powder particles are made to

adhere to form larger multiple called granules. It comprises of the following steps.

 Dispensing: This is the first step in tablet manufacturing process. Dispensing is the most

critical step in manufacturing of tablet. The weight of each ingredient in the mixture is

determined according to dose. Dispensing may be done by purely manual hand scooping

from primary containers and weighing each ingredient by hand or on manual scale.

During manual handling, a lot of control of each ingredient, material movement into and

out of the dispensing should be considered during dispensing.

 Sizing: The sizing (size reduction, milling, crushing, grinding pulverization) is an

important step in the process of tablet manufacturing.

 Drying: It is the important to keep the moisture low enough to prevent product

deterioration and ensure free flowing particles.

b. Compression: This is an act of compressing granules into tablets of uniform size and

weight using mechanical device.

c. Blistering: A packaging in which the products is seal between an aluminum foil backing

and a clear plastic e.g. PVC

A tablet comprises a mixture of the active ingredients and excipients, usually in

powdered form pressed or compacted from a powder into a solid dose the excipients can include

diluents, binder or granulation agents, glidants (flow aids), and lubricants to ensure 19 efficient

tableting, disintegration to promote tablet break-up in the digestive tract, sweeteners or flavors to

enhance taste and pigments to make the tablet visually.

Drugs produce in the production line are;

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a) Paracetamol Tablet: Active ingredient is acetaminophen BP (paracetamol powder).

Paracetamol belongs to a group of medicine known as analgesics or painkillers. It is used

to relieve mild to moderate pain. It is also used to lower a raised temperature (fever) such

as after childhood immunization.

b) Compound magnesium trisilicate Tablet (gelluci): These tablets are used to treat

dyspepsia (heartburn or indigestion) and reflux. They can also help to heal duodena

ulcers.

c) Calcium Tablets: This is used to prevent or treat low blood calcium levels in people who

do not get enough calcium from their dents. It may be used to treat conditions caused by

low calcium levels such as bone loss (osteoporosis), weak bone (osteomalacia/rickets),

decreased activity of the parathyroid gland (hyperparathyroidism), and a certain muscles

disease (latent tatany). It may also be used in certain patients to make sure that they are

getting enough calcium (e.g., women who are pregnant, nursing or postmenopausal,

people taking certain medications such as phenytoin, phenobarbital, or prednisone).

Calcium plays a very important role in the body. It is important for the normal

functioning of the nerve cells, muscles and bones, thereby weakening bones. Having the

right amount of calcium is important for building and keeping strong bones.

d) Metronidazole Tablet: metronidazole tablet is used in bacterial infection of virginal

fungating tumors, rosacea, skin ulcers, and treatment and prevention of certain types of

infections. The information in this medication guide for metronidazole varies according

to the condition being treated and the particular preparation used.

e) Nitrofurantoin Tablet: It is used to treat or prevent urinary tract infections.

ADVANTAGES OF ORAL SOLID DRUGS;

 They are simple and convenient to use.

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  They provide an accurately measure dosage of the active ingredients in a convenient

package portable package.

 Colored coatings, embossed marking and printing can be used to aid tablet recognition.

DISADVANTAGES OF ORAL SOLID DRUG

 Some drugs may be unsuitable for administration by the oral route. For example, protein

drug such as insulin may be denatured by stomach acids.

 Some drugs may be deactivated by the liver when they are carried there from the

gastrointestinal tract by the hepatic portal vein.

 A proportion of populations have difficulties swallowing tablets either because they don’t

like taking them because their medical condition makes it difficult for them (dysphasia

vomiting).

3.1.1.1 PRODUCTION OF DE-SHALOM CALCIUM TABLETS

Raw materials Used

 Dicalcium powder

 Starch bulk

 Starch paste

 Methyl paraben

 Propyl paraben

 Carboxyl Methylcellulose (C.M.C)

PROCEDURE

 Dicalcium powder and starch bulk were dispensed into 120kg of the mass mixer and

mixed for 15 minutes

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 Methyl paraben, propyl paraben, carboxyl methylcellulose, and starch paste were then

dissolved into 2 litres of cold water followed by the addition of 3 litres of hot H2 O to

form a paste.

 The prepared paste was poured into the mixed product in the mass mixer and mixed for

10 minutes

 2 litres of hot H2 O were poured into the mixer and leave for vigorous mixing. After

thorough mixing of the ingredients, wet milling followed.

 It was then dried for 25 minutes, and turning and re-drying for another 20 minutes

occurred.

 The sample was then taken to Quality Control Department for approval of the water

content test.

 The weight of the total granules was checked.

 The granules were milled with 3.5mm mesh and later transferred the granules to the

compression room.

 During compression, the weight and hardness of the tablets were checked at an interval

of 10 minutes.

USES OF CALCIUM TABLETS

1. Calcium supplements are standard for treating and preventing Osteoporosis (Weak and

easily broken bones).

2. Calcium can help to prevent or control high blood pressure; it also aids in weight loss.

3. Calcium is used for many other conditions, it’s an ingredient in many antacids.

4. The mineral calcium is well-known for its key role in bone health calcium also helps

maintaining heart rhythm, muscle function and more.

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Fluidizing bed dryer machine used in tableting section

3.1.2 THE ORAL LIQUID LINE

Any pharmaceutical product, which are syrup or liquid are formulated or composition of

the active ingredient and excipient. Action of a particular product depends on the active

ingredient of the formulation.

Excipients are thickening or suspended agent (carboxyl methyl cellulose (CMC) or artisol),

preservatives or antimicrobial agents such as methyl paraben and propyl paraben, sweetening

agent such as raspberry, colorant such as amaranth, reducing agent such as sodium

metabisulphate, flavors such as fruit flavors and stabilizers such as benzoic acid and phosphoric

acid are used in the oral liquid line.

Drugs produce in this line include;

1. Peacetone blood tonic: Active ingredient is ferric ammonium citrate, it is used in the

treatment of iron deficiency (anemia), and it also serves as an iron supplement.

2. Peacecoole: Active ingredients are ibuprofen BP and sodium benzoate, it is used to help

digestion, pain relief, to combat fatigue, as a stimulant, it freshens breath and can be used

to stop toothache.
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3. De-shalom Mag: Active ingredients are light magnesium carbonate and sodium

bicarbonate and magnesium trisilicate. It is used for the treatment of ulcer patients,

indigestion, heartburn, flatulence, and gastric hyperacidity, it is also good for adsorbent.

4. Paracetamol syrup: Active ingredient is acetaminophen BP also paracetamol powder, it

is used as an antipyretic drug for children.

5. Vitamin C syrup: Active ingredient is ascorbic acid BP, it is used to treat scurvy,

prophylaxis, and also for the treatment of bone, teeth, and wounds.

6. De-shalom cof expectorant: Active ingredients are ammonium chloride,

chloropheramine and, liquorice root. It is used to treat cough, cold, and catarrh.

7. De-shalom cipretin pediatric suspension: Active ingredients are trimethoprim and

sulphamethoxazole. It is used for the treatment of sensitive bacteria infection of the

respiratory tracts, urinary tract and other bacteria infections.

ADVANTAGES OF ORAL LIQUID LINE DRUG

 It is appropriate for any patient whatever the age is.

 The most natural and easiest way of administration.

 It includes a big variety of dosage forms.

 It includes a big variety of dosage form.

 Economic and safe to patient.

 No nursing is required which means the patient can take it without any help.

DISADVANTAGES OF ORAL LIQUID LINE DRUG

 Delayed onset of action because absorption takes time.

 Not suitable in emergency and for unconscious patient.

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  Not convenient for patient with gastrointestinal disorder such as diarrhea, constipation,

ulceration and hyperacidity in stomach.

 Not appropriate for patient suffering from chronic vomiting.

 Not appropriate if patients is suffering from malabsorption syndrome in which absorption

through the small intestine is not ensured.

Oral production mixing machine

3.1.3 THE EXTERNAL LIQUID LINE

This external liquid line deals with the production of drugs that are used for the external

purposes.

Drugs produce in this line include;

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 1. Methylated spirit: This drug is used for dressing of wounds, also used as an organic

solvent.

2. Hydrogen peroxide: This drug is used as first aid to help prevent the risk of infection on

minor cuts, scarps, and burns.

3. Gentian violet: This also belong to this family of medicine called antifungal, it is used

to treat fungus infection on the skin.

4. Eusol lotion: This is used for wound irrigation and wound debridement, for disinfection

of surfaces such as furniture and mops.

3.2 QUALITY ASSURANCE AND QUALITY CONTROL

The Quality Assurance department embraces the concept comprising the totality of the

process to provide confidence that the final product made is of desired quality for the intended

use. This is also a section of the company whose major activity is to provide a final product of

the desired standard that meets the given needs. The activity of the QA department includes

sampling; testing against required specifications and releasing procedures that ensure the final

products are of specification quality. The Quality control section is concerned with the analysis

of raw materials and finished products to ensure the safety of the drugs. They have the

responsibility to approve or reject any product of the company that have gone through testing.

There are two sections under this department, both of which I was opportune to be part of.

Roles and Objectives of Quality Control

1. To evaluate the methods and processes of production and suggest further improvements

in their functioning.

2. To establish the desired quality standards which are acceptable to the customers.

3. To analysed in detail the causes responsible for such deviation.

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 4. To undertake such steps which are helpful in achieving the desired quality of the product.

3.2.1 ANALYSIS OF RAW MATERIALS

Below is the importance of raw materials used in the production of products of the company.

Drug Formulations and Compositions

EXCIPIENTS FUNCTION

Talcum powder Lubricant

Magnesium stearate Lubricant

Carboxyl methyl cellulose Thickener

Xanthan gum Thickener

Povidone Binding agent

Methyl and Propyl paraben Preservatives

Sucrose Sweetener

Aspartame Sweetener

Glycerine Lubricant

Propylene glycol Lubricant

Allura red Colourant

Orange flavor Flavour

Raspberry flavor Flavour

Dicalcium phosphate Bulking agent

Corn starch Bulking agent

Sunset yellow Colourant

Banana flavor Flavour

Amaranth colour Colourant

Caramel flavor Flavor

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Dextrose Electrolyte

Sodium chloride Electrolyte

Sodium saccharine Sweetener

3.2.2 CHEMICAL ANALYSIS ON TABLETS

This analysis includes moisture content determination, friability test, disintegration time

test and tablet hardness test.

a) Moisture content determination of tablets

Aim: To determine the moisture content in any tablets granules in other to inhibits the growth of

micro-organism within a short period of time.

Apparatus: Petri dish, oven, analytical weighing balance and stop watch.

Procedure:

 Petri dish was labeled using paper tape and weighed (Wp)

 Granules were weighed as well inside foil paper • Granules + petri dish was weighed

(W1)

 The petri dish was inserted into the oven already on, set to 105 ℃ for 1 hour • The petri

dish was removed from the oven and the granules were re-weighed (W2)

 Final weight was subtracted from the initial weight divided by the initial weight

 Calculation was done as stated below

Moisture content= 10 – (Final weight (W2) – Petri dish weight (Wp) X 100%

10

Calculations: Assume that,

Weight of petri dish (Wp) = 43.09g

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Weight of petri dish + granules (W1) = 53.09g

Weight of dish + granules + heat (W2)= 53.05g

% Moisture content = 10 - (53.05 - 43.09)g X 100

10

Conclusion: Since the specification for the moisture content is < 0.8%, therefore the granules

passed the test and so can be compressed to tablets.

b) Disintegration time test of tablets

Aim: To determine the time required for tablets to dissolve in the human system. Apparatus:

Weighing balance, Standard Calibrated Beaker, thermometer, tablet disintegration time test

apparatus.

Procedure:

 After sterilization of the beakers then they are filled with 600ml of distilled water and

placed under the basket of the disintegration machine.

 Six tablets were weighed with weighing machine and kept inside foil paper to prevent

being affected by the moisture.

 The tablets disintegration test apparatus was then disassembled and each of the

assembling basket was filled with tablets, covered with disc.

 Warm H2 O boiled at room temperature (370 c) was poured into 1000ml beaker up to a

required level of 700ml.

 The beaker with warm water was then hung to the apparatus and gently lowered into the

beaker without getting in contact with the H2 O.

 The apparatus was on, stop watch was set and basket started dangling in H2 O

 The time frame for the dissolution of the tablets is 5mins based on batch manufacturing

records.

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Conclusion: Since the tablets dissolve less than 5minutes then the tablets passed the test and can

pass out to market.

Disintegration time machine

iii. Tablet friability Test

Aim: To determine how friable a tablet (i.e., the ability to remain rigid and not to break or cap or

crushed when exposed to various tossing and handling right from the manufacturing state to the

consumer.

Apparatus: Friability test apparatus, sensitive weighing balance, cotton wool, ethanol

Procedure:

 20 tablets were weighed and readings was taken as (W1)

 The two plates hang at either side of the apparatus were removed

• The plates were cleaned inside and outside including its cover using cotton wool already

soaked with ethanol

• 20 tablets were shared into the plates in 10 tablets per one

• The plates were hung on the either side of the apparatus and screwed tightly

26
 • The equipment was set at 25 revolutions per minutes for 4minutes which implies 100

revolutions.

• After revolution, the tablets were taken out of the plates, re-weighed and recorded as(W2)

Calculation: Assume weight of 20 tablets = 5.032g

Weight of the tablets after revolution= 5.029g

Friability calculations formula = W1 – W2/W1 X 100.

Conclusion: since the specification for the friability test is <0.8%, therefore the tablet

passes the test and is due for market.

Friability machine

Other equipment used for analysis and their uses;

 pH meter: A pH meter is used to measure the pH (acidity or alkalinity) of the liquid.

Digital pH meter

 Water base sonicator: It is used in the laboratory for agitation of undissolved solution.

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 Water base sonicator

 Oven: used for heating wet samples in the laboratory.

Oven

 Weighing balance: used for accurate measurement of substance.

Weighing balance

 Fume cupboard: Reaction or reagents that produce toxic fumes are done in the fume

cupboard. Air is drawn from the cabinet and expelled out of the laboratory.

Fume cupboard

 Hardness Tester: This is used to determine the hardness of Tablet.

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 Hardness Tester

3.2.3 DETERMINATION AND CALCULATION OF THE SPECIFIC GRAVITY OF

ORAL AND EXTERNAL LIQUID DRUGS.

Aim: To maintain and control the quality of products produced in the industry to ensure

similarities in the same product being produced over the years.

Apparatus: Pyrometer (specific gravity bottle), analytical weighing balance.

Procedure: Weigh the specific gravity bottle(W1), pour any of the products you want to test, and

weigh(W2).

Calculation: Assume value for W1 = 20.4 and the assume value for W2 = 45.79

Specific gravity = Relative density = density of sample

density of water

To get the density of sample = W2 – W1

volume of pyrometer(50ml)

Density of sample = 45.79 – 20.4

50ml

Specific gravity = density of sample

density of water (0.996g/cm^3)

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3.3 WATER TREATMENT

Water treatment is essential part of the daily living, is to be taken in its purest form. It is

therefore important that the water samples used in pharmaceutical companies be analyzed to

ensure that it is safe as possible.

3.3.1 SOURCES OF WATER;

The major source of water in De-shalom pharmaceutical laboratory ltd is ‘borehole’ which

contain of two types, the borehole A and the borehole B.

3.3.2 STEPS INVOLVE IN THE TREATMENT OF THE WATER USE IN DE-SHALOM

PHARMACEUTICAL LAB. LTD.

 Filtration: water coming from the two boreholes are allowed to pass through 5microns

filter.

 Treatment and disinfection: the water is collected into a 3000liters storage tank where

80mls of chlorine water and 100g of soda ash was added.

 Bed filtration: The water is allowed to pass through two composite filters (sand filter and

activated carbon bed filter). The sand filter is composed of sand of graded sizes i.e. from

the finest sand to the coarsest and from bottom on the top.

Water will be allowed to pass through series of micron filter ranging from 5micron-

0.5micron so that the smallest particles will be filtered out. Water was then allowed to pass

through deionizer which contains ion-exchange resin which removes unwanted ions such as

potassium and calcium.

Then the water was allowed to pass through the UV lamps to kill micro-organism and

germs. Samples of treated water is collected and taken to the quality control laboratory for

chemical and microbial analysis.

3.3.3 MAINTENANCE OF THE WATER TREATMENT PLANT

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 The surface tank is washed every month to remove the dirt like calcium carbonate and

chlorine that has been deposited.

 The holding tank will be washed every month with liquid soap and rinsed with a lot of

ordinary water.

 Replace the filter cartridge every two weeks.

 Back washing the composite filters to remove dirt every 3 month.

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 CHAPTER FOUR

4.0 CONCLUSION

Concisely, the overall importance of this program (SIWES) cannot be overstated. The period

of training enables student to gradually get composed into the working environment of their

chosen career, a very important step in creating skilled professionals.

4.1 EXPERIENCE GAINED

The Student Industrial Work Experience Scheme (SIWES) program has provided me

with a valuable opportunity to gain practical experience in the pharmaceutical industry as a Food

Science and Technology student. Over the course of my internship, I have been exposed to

various aspects of the industry, including quality control, research and development, and

production processes.

During my time at the pharmaceutical company, I participated in laboratory experiments,

conducted tests on raw materials and finished products, and learned how to analyze data using

sophisticated instruments and techniques. These experiences have enhanced my practical skills in

the field.

Moreover, working in the pharmaceutical industry has exposed me to the importance of

strict adherence to regulatory standards and quality control procedures. I learned about the

rigorous processes involved in ensuring the safety and efficacy of pharmaceutical products. This

experience has instilled in me a strong commitment to upholding quality standards and

prioritizing the well-being of consumers.

Overall, my SIWES experience in the DE-shalom pharmaceutical laboratory limited has

been immensely beneficial to my professional development as a Food Science and Technology

student. I have gained practical skills, improved my scientific knowledge, and developed a

broader understanding of the pharmaceutical industry. I am confident that the skills and

32
experiences I have acquired during this internship will greatly contribute to my future career in

the field of Food Science and Technology.

4.2 PROBLEMS ENCOUNTERED

I faced series of challenges during the program. The challenges face includes the inability to

withstand the odour of some raw materials used in the industry e.g., chlorine, ammonium

chloride, peppermint oil, ethanol etc.

Also, transportation from residence to work because the company is located out sketch of the

town, therefore it’s a difficulty thing seeing bike or cab going to the location.

4.3 RECOMMENDATIONS

I recommend that students should be given their placement letter as soon as possible so that

there will not waste of time of attachment place hunting.

I recommend that the government should try their possible best to encourage the companies

that are helping us so that they can help people coming behind.

I finally recommend that the supervisor should try to visit the student more than one time in

order to know the seriousness of such student.

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field of medicine. Last accessed 13/09/2017

De – Shalom limited 2017, about us. Available form: https://www.vconect.com/de-shalom -

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