1. The document summarizes a student's visit to the Zirabo plant of Incepta Pharmaceuticals, describing the journey, location of the plant, production areas visited, quality control lab, and key takeaways. 2. The production area was observed, including tablet granulation, blending, compression, coating, and packaging. Solid dosage forms like tablets are prepared through processes like dispensing, milling, blending, granulation, compression, coating and packaging. 3. The quality control lab has sections for raw materials, packaging materials, and finished products and is equipped with sophisticated instruments to ensure quality standards are met according to GMP and ICH guidelines.

1. 1
Department of Pharmacy
A report
on
Visiting Zirabo plant of Incepta Pharmaceuticals.
Course title: Industry tour
Course code: PHAR-3222
Date of submission: 21/07/2019
Submitted by Submitted to
Name: Md. Jahidul islam
Roll : 151025
3rd year, 2nd semester
Session: 2015-16
Dept. Of Pharmacy
Jashore University of Science and
Technology
Mohammad jashim Uddin
Assistant professor
&
Kishore Kumar Sarkar
Assistant professor
Department of Pharmacy
Jashore University of Science and
Technology

2. 2
Contents
1. Journey ……………………………………………………… 02
2. Location ………………………..…………………………….02
3. Company visit ………………………………………………. 02
4. Dress code ………………………………………..………… 02
5. Production area ……………………………………..……… 03
6. Steps of formulation ………………………………...……… 04
6.1. Dispensing …………………………………….……...… 04
6.2. Milling ………………………………………….………. 04
6.3. Blending ……………………………………….……….. 04
6.4. Granulation …………………………………………….. 05
6.5. Compression …………………………………………… 05
6.6. Coating ………………………………………….…….... 06
6.7. Packaging ……………………………………….……… 06
7. Quality control lab ………………………………….….…… 07
8. Quality control laboratory equipment’s …….………….……. 08
9. Warehouse ……………………………….…………………. 13
10. Experience and Perception …………………….……………. 14
11. Reference ………………………………….…..………….….. 15

3. 3
A brief review on sessional tour at Incepta Pharmaceuticals
Journey
Our journey started at 11:59 pm of 7th July, Sunday, from Jashore University of Science and
Technology by bus before the day of company visit. We were a team of 39 students of the 6th
batch of pharmacy department of Jashore University of Science and Technology. Our team was
led by two of our respected teacher “Mohammad jashim Uddin and Biswajit Biswas” of our
pharmacy department. We were using the ‘Dhaka to Aricha’ route through the ‘‘Dhaka road”
of Faridpur. There was a jam in ‘Aricha Ferrighut’ that prolonging our journey time. However
we reached Dhaka at the morning of the day. We stayed half an hour in Jahangirnagar
University. Then we reached in Incepta pharmaceutical at 10:50 am.
Location
At present Incepta has one fully operational plant at Zirabo, Savar, Dhaka (Zirabo plant) and
another at Dhamrai, Dhaka. The second site is currently under development and several
projects of finished formulation unit are being set up. The Zirabo manufacturing plant is located
about 35 Km north of Dhaka City and covers an area of land about 15,000 m2
. The total built
up production area is about 300,000 square feet. At present all the products are coming from
this plant at Zirabo.
Company Visit
Our tour to company visit started at 11:30 am. We all reached to the incepta pharmaceuticals
at Zirabo of Savar within 10:50am of the morning. First we were gathered to a well-furnished
conference room of the Incepta pharmaceuticals and cordially welcomed by the authority.
At first a wonderful presentation on whole activity of Incepta was given. After breakfast we
began to visit the company by dividing two groups. Each group was led by an honorable person
of the company. We all groups visited the production floor, QC lab and warehouse.
Dress code
The standard dress code for pharmacist would be a clean white dress apron with either black
or tan slacks and clean closed shoes, also wear hair covers and dust masks. Every person will
wear these dress after wearing shoe cover by sitting on “step over bench” and stands inside.
Dust mask Hair cover Apron

4. 4
Production Floor
Pharmaceutical manufacturing or Drug manufacturing is the process of industrial-scale
synthesis of pharmaceutical drugs by pharmaceutical companies. The process of drug
manufacturing can be broken down into a series of unit operations, such as milling, granulation,
coating, tablet pressing, and others. Controlled area in Sterile Pharmaceutical Manufacturing
used for sterile pharmaceutical products, the controlled areas ensure low levels of
environmental pollutants, such as airborne microbes, dust, aerosol particles and chemical
vapors. Generally Production Floor are made of Epoxy.
We visited unit 6 which is used as a production floor in Incepta Pharmaceuticals. In unit six
our team was led by the plant manager Md. Maruf Hossain. This floor contains high speed
tablet compressor, coating room, tablet granulation room. Highly sophisticated HVAC systems
are used to condition, monitor and supply clean air to the working zone according to the
manufacturing zone concept, capture and control any dust, vapor, gas or fume generated, as
well as treat re-circulated and/or exhausted air. Temperature and moisture level are maintained
at the desired level through this system. Here the following procedures are completed.
Tablet Granulation Room: It is facilitated by,
After granulation the granules are blended with lubricant and disintigrant, and then they are
compressed into tablets of different shapes. For some tablets, such as Pantonix, coating
methods are used. Incepta is the brand leader of Pantonix which is a pronounced proton pump
inhibitor. We also observed the highly automated blistering packaging of tablets which is done
by the following machine. The machine can automatically detect the fault of blistering.
Corridor

5. 5
Solid dosage form (tablet) preparation
Dispensing
Dispensing (weighing) the right materials to the right batches prior to the manufacturing
process is a key activity in life sciences and other process industries. The process is critical
when working with potent active pharmaceutical ingredients (APIs) in drug manufacturing.
Milling
During the drug manufacturing process, milling is often required in order to reduce the average
particle size in a drug powder. There are a number of reasons for this, including increasing
homogeneity and dosage uniformity, increasing bioavailability, and increasing the solubility of
the drug compound. In some cases, repeated powder blending followed by milling is conducted
to improve the manufacturability of the blends.
Powder blending
In the pharmaceutical industry, a wide range of excipients may be blended together with the
active pharmaceutical ingredient to create the final blend used to manufacture the solid dosage
form. The range of materials that may be blended (excipients, API), presents a number of
variables which must be addressed to achieve target product quality attributes. These variables
may include the particle size distribution (including aggregates or lumps of material), particle
shape (spheres, rods, cubes, plates, and irregular), presence of moisture (or other volatile
compounds), particle surface properties (roughness, cohesion), and powder flow properties.
Dispensing
Milling
Blending
Granulation
Compression
Coating
Packaging

6. 6
Granulation
In general, there are two types of granulation: wet granulation and dry granulation.
Granulation can be thought of as the opposite of milling; it is the process by which small
particles are bound together to form larger particles, called granules. Granulation is used for
several reasons. Granulation prevents the "demixing" of components in the mixture, by creating
a granule which contains all of the components in their required proportions, improves flow
characteristics of powders (because small particles do not flow well), and improves compaction
properties for tablet formation.
Compression
Tablets are being formed by compressing the granules by using the compression machine.
Tablet formed in compression machine by pressing the granules in die with lower and upper
punch. Tablet formation takes place by the combined pressing action of two punches (lower
and upper) and a die.
Double cone blender
Granule

7. 7
Coating
Tablet coating is the key step involved in the manufacturing of tablets having controlled
release, delayed release profiles. The tablet coating have number of advantages like masking
odor, taste, color of the drug, providing physical and chemical protection to drug, Protecting
drug from the gastric environment.
Packaging
Pharmaceutical packaging (or drug packaging) is the packages and the packaging processes for
pharmaceutical preparations. It involves all of the operations from production through drug
distribution channels to the end consumer.

8. 8
Strip packaging is an alternative form of pack for a unit dosage. It is a method of enclosing the
article concerned between the two webs of material so that each is contained between spate
compartments.
Blister pack is a term for several types of pre-formed plastic packaging used for small consumer
goods, foods, and for pharmaceuticals. The primary component of a blister pack is a cavity or
pocket made from a formable web, usually a thermoformed plastic.
Quality control (QC) Lab
QC lab of Incepta pharmaceuticals has three sections for,
• Active pharmaceutical ingredients and raw materials.
• Packaging materials.
• Finished products.
Quality Control Department is equipped with highly sophisticated instruments like UPLC, Gas
Chromatography, Atomic absorption spectrophotometer, FTIR, etc. This QC lab follows STP
(Standard Test Procedure). It maintains ICH (International Conference on Harmonization of
Technique) based on GMP (Good Manufacturing Practices).
Quality control is a system of maintaining standards in manufactured products by testing a
sample of the output against the specification. Quality control is an essential operation of the
pharmaceutical industry. Drugs must be marketed as safe and therapeutically active
formulations whose performance is consistent and predictable. New and better medicinal
agents are being produced at an accelerated rate. Every person involved in making a product is
responsible for making it a quality product. Quality departments, such as Quality Control (QC)
or Quality Assurance (QA) cannot inspect quality into the product. The Quality Departments
exist as an audit function within the manufacturing and packaging areas. Quality control (QC)
Strip Blister
QC lab

9. 9
plays an important role in the development of products and services in pharmaceutical and
biotech, as part of GMPs.
Quality control laboratory equipment’s:
 Analyzers, Chemical
 Hardness tester
 Microscopes
 Sieve shaker
 LC-MS/MS
 Corrosion Testing Devices
 Crack Detection, Automatic
 Creep Testing Devices
 Eddy Current Testers
 Flaw Detectors
 Case Depth / Microstructure
 Ultrasonic tester
 Eddy Current Testers
 Extensometers
Dissolution Test:
Drug dissolution testing is routinely used to provide critical in vitro drug release information
for both quality control purposes, i.e., to assess batch-to-batch consistency of solid oral dosage
forms such as tablets, and drug development, i.e., to predict in vivo drug release profiles.
Dissolution tester includes at least 6 testing stations, 6 stirrers, a heating device to heat the
dissolution media to a constant temperature and a speed control usually adjustable within a
range of 20 to 200rpm.
 Film Thickness Meters
 Flammability / Smoke Testers
 Grinders / Polishers
 Dissolution Test
 HPLC
 UPLC
 Fume hood
 Atomic Absorption Spectrophometry
 Gas Chromatography
 FTIR
 Fatigue Testers
 Auto Titrator
 Desiccator
Dissolution Tester

10. 10
UPLC:
The Incepta pharmaceuticals are using today more efficient tools to develop, deliver and
monitor the drugs. In this contest the development of rapid chromatographic method is crucial
for the analytical laboratories and it would be possible by outstanding performance of ultra-
high performance liquid chromatography (UPLC), which holds back the principle of HPLC
technique. UPLC shows a dramatic enhancement in speed, resolution as well as the sensitivity
of analysis by using particle size less than 2 pm and the system is operational at higher pressure,
while the mobile phase could be able to run at greater linear velocities as compared to HPLC.
This technique is considered as a new focal point in field of liquid chromatographic studies.
HPLC: High-performance liquid chromatography (HPLC) is a chromatographic technique
used to split a mixture of compounds in the fields of analytical chemistry, biochemistry and
industrial. The main purposes for using HPLC are for identifying, quantifying and purifying
the individual components of the mixture. HPLC play an important and critical role in the field
of pharmaceutical industries and analysis, since it is used to test the products and to detect the
raw ingredient used to make them i.e., qualitative and quantitative analysis. Moreover, the
importance of HPLC uses in these fields falls under the stringent regulations established by the
U.S. Food and Drug Administration (FDA). This obligates the Incepta Pharmaceuticals to
detect the quality of their products by using the HPLC before allowing them to sell it in the
global market. The most important benefits gain from the uses of HPLC technique in the
industrial and analytical field that it is help in structure elucidation and quantitative
determination of impurities and degradation products in bulk drug materials and
pharmaceutical formulations. These benefits which gain from the using of HPLC not only
limited for the synthetic drugs and formulas but also include herbal medicine too.
Fume Hood:
Incepta pharmaceuticals uses sophisticated fume hood in consideration of personnel safety in
laboratory. Laboratory fume hoods serve to control exposure to toxic, offensive or flammable
vapors, gases and aerosols. Fume hoods are the primary method of exposure control in the
laboratory. The laboratory fume hood is a type of local exhaust ventilation system (engineering
control). A typical fume hood is a cabinet with a moveable front sash (window) made out of
safety glass. A properly used and properly functioning fume hood exhausts hazardous gases,
dusts, mists, and vapors from a confined location and helps protect workers from inhalation
exposure.
HPLC

11. 11
Atomic Absorption Spectrophometry:
The Company uses this technique for both qualitative and quantitative analysis. Copper,
manganese, mercury and cadmium hallow cathode lamps were used for qualification purposes.
Design qualification such as wavelength accuracy and reproducibility, resolution and baseline
stability and installation qualification met the criteria of pharmacopeia requirements.
Multivitamins and other drugs are used to analyze by this process. For example Naproxen and
ibuprofen (aryl propionic acid derivatives) both are classified as non-steroidal anti-
inflammatory agents. Except HPLC, no sensitive methods were reported for both the drugs.
HPLC methods suffer from two drawbacks- first; requirement of costly chemicals and second;
more time consuming. Because atomic absorption spectroscopy (AAS) methods are simple,
sensitive, rapid, reproducible and use low cost chemicals. The objective of present research
work was to develop highly sensitive and economical analytical methods for the quantitative
estimation of naproxen and ibuprofen in pharmaceutical formulations by AAS. The methods
were based on the reaction of naproxen and ibuprofen with copper and cobalt chloride to form
colored metal complexes. These complexes were extracted with organic solvents and digested
with acids. Naproxen and ibuprofen were indirectly estimated by AAS via the determination
of the copper and cobalt content in the formed complexes. The proposed methods may be used
for routine analysis of pharmaceutical formulations containing aryl propionic acid derivatives
and similar pharmaceutical drugs.
Gas Chromatography (GC):
Incepta uses GC for the following purposes,
1. Gas Chromatography is used to determine the identity of natural products which contains
complex mixture of the similar compounds.
2. Gas chromatography is used in separation of volatile mixture.
3. Amount of chemicals in the drugs can be identified by gas chromatography.
4. GC is used in Analysis of various solvents used in manufacturing of pharmaceutical
products.
5. GC is also used in analysis of various organic functional groups.
6. Qualitative and quantitative estimation of solid, liquid and gaseous organic compounds.
FTIR: FTIR offers quantitative and qualitative analysis for organic and inorganic samples.
Fourier Transform Infrared Spectroscopy (FTIR) identifies chemical bonds in a molecule by
producing an infrared absorption spectrum. The spectra produce a profile of the sample, a
distinctive molecular fingerprint that can be used to screen and scan samples for many different
components. FTIR is an effective analytical instrument for detecting functional groups and
characterizing covalent bonding information.
Atomic Absorption Spectroscopy

12. 12
ATR: Attenuated Total Reflection (ATR) spectroscopic imaging has been employed to great
effect to study the compaction and dissolution of pharmaceutical formulations. It has many
advantageous capabilities suited for the study of pharmaceutical formulations compared to
other imaging approaches, due to the high levels of chemical and spatial specificity that can be
achieved along with relatively fast acquisition times. It is now becoming a very important tool
in the development and testing of oral dosage formulations.
LC-MS/MS:
Liquid chromatography tandem mass chromatography (LC–MS/MS) is an important
hyphenated technique for quantitative analysis of drugs in biological fluids. Because of high
sensitivity and selectivity, LC–MS/MS has been used for pharmacokinetic studies, metabolites
identification in the plasma and urine. This manuscript gives comprehensive analytical review,
focusing on chromatographic separation approaches as well as different acquisition modes for
quantitative analysis of drugs and stimulants. This equipment consists of three parts.
 Ionizer.
 Quadro-pole.
 Analyzer.
It is a very rare and valuable machine in Bangladesh and only a few company possess it and
Incepta Pharma ceuticals is among of them.
Attenuated Total Reflection
LC-MS/MS

13. 13
Auto Titrator:
In lab of the Incepta Pharma, autotitrators are used to save time and for the accuracy of titration.
Karl Fischer Titration:
Karl Fischer titration is a classic titration method in analytical chemistry that uses coulometric
or volumetric titration to determine trace amounts of water in a sample. It was invented in 1935
by the German chemist Karl Fischer.
QC Test for Packaging Materials:
Packaging materials are classified into three categories according to their nature. They are
primary, secondary, and tertiary. About thirteen officers are involved in testing the packaging
materials. Following tests are done for the inspection of packaging materials,
• Appearance test.
• Dimensional test.
• Physical test.
• Microbial test.
• Chemical test.
After receiving the packaging materials, the Incepta authority sampling it by a yellow color
quarantine seal. If approved the test, the lot are used as packaging materials for packing finished
products.
Auto Titrator
Karl Fischer Titration

14. 14
Warehouse
A warehouse is a building for storing goods. Warehouses are used by manufacturers, importers,
exporters, wholesalers, transport businesses, customs, etc. They are usually large plain
buildings in industrial parks on the outskirts of cities, towns or villages. A warehouse may be
referred to as a “godown”.
The warehouse of Incepta is an enclosed building and protects the stored goods from
environmental influences. They are secured against fire by the design of the buildings and
technical facilities. The fire brigade facility has access to enable appropriate firefighting. The
locking system of the stored goods ensures that the access to the building is controlled.
The warehouse is equipped with four different storage conditions;
 Cold temperature – 2 to 8 degree Celsius
 8 to 15 degree Celsius
 Controlled temperature – 15 to 25 degree Celsius and
 Ambient condition.
There is specific quarantine and sampling areas with dedicated separate storage location for
cephalosporin, and steroids. Temperature sensing is equipped with remote sensor technology.
Quarantine is a status when goods must not be shipped from the warehouse. During quarantine
analyses and controls to ensure goods quality are carried out. Goods can be put to storing
location directly without waiting in quarantine warehouse. Webster defines quarantine as "a
period of enforced isolation”. The purpose of quarantine is to contain the contamination such
that others (e.g., animals, food, or product) are not put at risk.
There are controlled rooms with HVAC for specific materials and the conditions are monitored
to confirm compliance with the requirements. Also there is retention sample room. The
materials are stored in the warehouse by pallet racking. The status of materials and products is
controlled by colored status sticker.
Warehouse
Quarantine Sampled Approved

15. 15
The transaction of materials is done according to "first in first out" (FIFO) and “first expire
first out” system. Accounting and storage is maintained through SAP, highly sophisticated
software. Warehouse management systems work to do things like track products and
manufacturing resources, while providing handheld scanners, computer software, label
printers, packing slip printers, and other tangible products to companies to get to the point
where they can track shipments and products very easily.
Five Types of Warehouses –
1. Private Warehouses:
2. Public Warehouses
3. Bonded Storage
4. Co-operative Warehouses
5. Distribution Centers
Experience and Perception
Our tour to Incepta ended almost at the afternoon. It is a great experience in my life. Incepta is
one of the esteemed pharmaceutical companies in Bangladesh. They strictly follow the GMP
rules of WHO. Incepta is fully dependent on automated software, SAP, which is bought from
Germany for five years. All the instruments that Incepta uses are highly sophisticated and
bought from renowned companies of worldwide. Shimaduh of Japan, solac are among of them.
Their HVAC system and warehouse facilities are highly admirable. Incepta has a bunch of hard
working, intelligent, experienced and highly qualified employees. I really want to thank Incepta
for giving us such opportunity and wish a good future of the company in the pharma market.

16. 16
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