Acknowledgement

Firstly we would like to express our utmost gratitude to the Almighty Allah for helping us to
accomplice this industrial training successfully.
We are thankful to the Department of Mechanical Engineering, BUET for providing us this
unique opportunity of industrial training.
We are also very thankful to all the employees of Incepta Pharmaceuticals Ltd who were very
helpful and co-operative during our whole training schedule. Our special thanks go to Ms.
Zokhroof Yeasmin Khan (Training Coordinator), Mr. Shah Sharfin (Associate Senior Officer,
QC), Mr. Mizanur Rahman Chowdhury (Manager, Engineering), Mr. Mohammad Mamunur
Rashid (Senior Executive Officer, Engineering) for helping us with valuable information and
cooperation during the whole training program.

1. Introduction
Purpose:
The fundamental objective of Industrial Training is to prepare students for future employment
in their chosen engineering discipline. Industrial Training enhances the academic material
studied at University by allowing students to practice what they have learned and to develop
key professional attributes. Industrial training provides an opportunity for us to:

Experience the discipline of working in a professional engineering organization.

Develop understanding of the functioning and organization of a business.

Interact with other professional and non-professional groups.

Apply engineering methods such as design and problem solving.

Develop technical, interpersonal and communication skills, both oral and written.

Industrial training gives students an opportunity to evaluate future employers as well as

enabling informed decisions about the discipline and career paths to follow.

Training Duration:
Start Date

End Date

Duration

05 April, 2015

18 April, 2015

2 Weeks

Industry at a glance
Incepta Pharmaceuticals Ltd. is a leading pharmaceutical company in Bangladesh established
in the year 1999. The company has a very big manufacturing facility located at Savar, 35
kilometer away from the center of the capital city Dhaka.
Incepta Pharmaceuticals Ltd. is now the 2nd largest company of the country and recognized
as the fastest growing of the top five manufacturing company in the country. Established in
the year 1999, the company has come a long way.
The company has a clear vision to become a leading research based dosage form
manufacturing company with global presence within a short period of time. With this view in
mind the company started to expand its business in overseas markets. Currently Incepta
exports to 40 different countries around the world. With hundreds of brands registered in
different countries, and many more in the pipeline, Incepta is gradually expanding its global
footprint across all the continents.
Main products:
The company produces various types of dosage forms which include tablets, capsules, oral
liquids, ampoules, dry powder vials, powder for suspension, nasal sprays, eye drops, creams,
ointments, lotions, gels, prefilled syringes, liquid filled hard gelatin capsules, lyophilized
injections, human vaccine etc.
Production Capacity:
It manufactures more than 650 products from 30 therapeutic classes. The products of Incepta
is sold in 44 countries along with the local market.
Total Area: The Zirabo manufacturing plant covers an area of land about 15,000 m2. The
total built up production area is about 300,000 square feet.
Yearly Turnover:
The sales turnover of Incepta in 2014 was more than 7.4 Billion Taka (US$ 92.71 million)
with about 9.21% market share having a growth rate of about 15.64%.

No. of Production Facilities:

There are total 3 production facilities in Zirabo factory. These are:

Incepta Pharmaceutical Ltd.

Incepta Vaccines Ltd.

Bio-Derived Product Facility (BDPF)

Power requirement:

Pharmaceutical unit: 3.2- 3.4 MW

Bio-Derived Product Facility (BDPF): 0.8-1.2 MW

Vaccine plant: 1.2- 1.4 MW

No of Engineers: 53 engineers.

Raw materials used and their source:

Pharmaceutical raw materials are essential to producing pharmaceutical drugs and include
active pharmaceutical ingredients (API). Different type of chemicals such as ethanol, Liquid
Glucose, Lactic Acid, Manitol, Citric Acid, Glycerine are used as raw materials. All the raw
materials are purchased from foreign countries. Incepta has no facilities for the production of
API or ingredient for the production of medicines.

Contribution to Bangladeshs economy:

Incepta plays an important role in the economy of Bangladesh. It sells products not only in
local market but also in international market. It has become the second largest pharmaceutical
company in Bangladesh. It has been creating a wide job opportunities for a lots of people.
Besides, Incepta not only supplies the local market but also it exports its products in about 44
countries. In this way they bring a lots of foreign currency in Bangladesh and enhance the
reputation of the pharmaceutical industries of Bangladesh.

Organogram
Managing Director

Director

Administration
section

Manager
(Admin)

Production section

Engineering
section

Director Operator
Manager
(Engineer)
Plant Manager

Deputy Manager
Production
Manager

Deputy/Senior
Engineer

Senior Officer

Officer

Assistant Officer

Deputy
Production
Manager
Senior Officer

Officer
Junior Officer
Assistant
Officer

5 Officer
Junior

Assistant
Engineer

Sub Assistant
Engineer

Production Line
The following product forms are manufactured on site:
A. Sterile Products:

Liquid dosage forms (LVP & SVP, Terminally sterilized and aseptically filled
ampoule)

Eye Drops

Solid dosage forms (Solid fill, Dry vials and Freeze-Dried Products)

B. Non Sterile Products:

Liquid dosage forms (Oral Liquid, Nasal Solution, Nasal Spray)

Semisolid dosage forms (Creams, Ointments, Gels)

Solid dosage forms (Tablets, Capsules, Powders, Granules)

C. Biological Products:

Aseptically prepared injectables: Erythropoetin, Enoxaparin, Insulin, Insulin Glargine

(rDNA), Filgrastim

D. Cephalosporins:

Solid dosage forms (Tablets, Capsules, Powder)

Sterile Powders (Aseptically filled vials)

The production area is serviced with HVAC system comprising of multiple AHU that
virtually divides the production area in different zones to implement effectively the latest
concept of GMP. All production activities including primary packaging are operated in the
controlled area where as operations like secondary packaging are conducted in the optical
clean area. To avoid cross contamination, the pressure of production area is kept lower than
that of the passage and to avoid micro-organism the pressure of production area is kept higher
than that of the passage.

Flow chart of medicine production:

Tablet:

Capsule:
Raw material
collection

Packing

Raw material sieving

Blending or
Mixing

Stripping by strip
packing machine

Encapsulation

Syrup:

Sucrose solution
preparation

Dissolving API in

Sealing

Filling

Clarity checking

Buffering agent

Coloring
agent

Final volume and

mixing

Flavoring
agent

Specific solvent

Labeling

Packing

Packing Section:
After completing production every product needs to be packed. It is done in the packing
section.
Flow Chart:

Product

Clarity Checking

Labeling

F.G. Store

Packing

Final product analysis

and inspection

Quality Control & Quality Assurance

The (Quality Management System) QMS of Incepta Pharmaceuticals Limited is established
in a frame to describe its operations in different documents and practices which is based on
the principles of PICS and WHO guidelines. The Quality Manual describes the Quality
Policy of Incepta Pharmaceuticals Limited.
The responsibilities for the technical aspects of Quality Assurance are defined in the Quality
Manual. It encompasses all activities necessary to generate, maintain and verify the quality of
drugs.
The Quality Assurance of Zirabo Plant consists of Quality Control, Quality Compliance and
Quality Surveillance. The main tasks and duties of Quality Control have been described in
the Quality Manual and relevant SOPs. The Head of Quality Assurance or his delegates are
responsible for releasing drug substances, excipients, dosage forms and packaging materials.
Quality Compliance is responsible for IPC, GMP co-ordination and training. Performances of
routine GMP checks are done as per need. Monitors to respect GMP regulation in the
manufacturing by instant checks of Batch Record completion, visual checks of cleaning of
working place, line clearance, performance checks of balance & other equipment.
Quality Surveillance is responsible for the implementation of the Quality Management
System in different areas in collaboration with different departments. Quality Surveillance
play active role in conducting external and internal audits with their follow-ups.
Research & Development is responsible for formulation development and method
development, implementing technical transfer to Production and Quality Control, and also
covers process validation, cleaning validation, method validation and follow up stability.
The Quality Manual describes how testing instructions are established and used. The testing
instructions include the specifications and testing methods. The testing instructions are
binding for release testing and for follow-up stability testing.
A routine inspection is being done in the name of "Self Inspection" mainly concerned with
safety, sanitation and infra-structural facilities leading to GMP including documentation.
9

Supply of raw materials are mainly obtained from approved suppliers. We select and evaluate
the supplier as per procedures. This procedure is also applicable in case of supply of Primary
and Secondary Packaging Materials.

10

Technical Features
Main Utilities:

Power or Electricity

Pharmaceutical Water

Steam

HVAC system

Compressed air

Effluent Treatment Plant

Utilities

Power or
Electricity

Potable Water

WTP

Compre
ssed Air

Boiler

Purified Water
(PW)

Water for
Injection (WFI)

WTP = Water Treatment Plant

ETP = Effluent Treatment Plant
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HVAC
System

Chilled water

ETP

Power Generation
The total power of Incepta is generated from two units. One is situated at Pharmaceuticals
facility and the other is situated at BDPF.
Incepta Pharmaceuticals Facility
The total power generation capacity of Incepta Pharmaceuticals Ltd. Is about 8 MW. The
power is generated from gas and diesel generators. There are 4 gas generators and 6 diesel
generators.
4 Gas Generators

One generator of 2 MW capacity

Three generators of 1 MW capacity each

6 Diesel generators

One of 800 KW capacity,

One of 256 KW capacity and
Four of 500 KW capacity each.

Besides, a part of the required power is supplied from Rural Electrification Board (REB) as
per requirement.
The average power requirement ofInceptaPharmaceuticals Ltd. is about 3.2 MW.

Bio-Derived Product Facility (BDPF);

This facility has its own power generation system. It consists of

One gas generator of 2MW capacity

Two diesel generators of 800 KW and 830 KW capacity

So the total generation capacity of BDPF is about 3.6 MW. This facility receives about 200
KW power from REB.
The other facility i.e. Incepta Vaccines Ltd. has no power generation system. This facility
receives its power from both the above mentioned power generation units.

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Fig. 1: Caterpillar G3516E Gas Generator

GENERATOR SETS SPECIFICATION (2 MW)

UNITS: US METRIC
Maximum Continuous Rating: 2027 kW
Fuel Type: Natural Gas
Maximum Electrical Efficiency
Maximum Standby Rating
Frequency:

44.7%

2027

50/60Hz

Rpm: 1500rpm
ENGINE SPECIFICATION
Engine Model: G3516H
Bore: 6.7 in
Stroke: 8.5 in
Displacement: 4765.0 in3
Aspiration:

TA
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GENERATOR SET DIMENSION

Length: 291.0 in
Width: 84.0 in
Height: 95.0 in
Dry weight genset:

40384.0 lb

G3516H STANDARD EQUIPMENT

AIR INLET
Package Mounted Air Cleaner with service indicator
COOLING
Engine driven water pumps for jacket water and after-cooler
EXHAUST
Center section cooled turbocharger with Cat flanged outlet

14

Waste Heat Recovery System (Cogeneration)

At Incepta waste heat recovery system is in operation. A boiler is operated by means of the
exhaust of the 2 MW and 1 MW generators. On the other hand a chiller is run by means of
hot jacket water.

Fig. 2: Waste Heat Recovery System (Trigeneration)

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HVAC System
The acronym HVAC stands for Heating, Ventilation and Air-Conditioning.
It is the technology of indoor and vehicular environmental comfort. Its goal is to provide
thermal comfort and acceptable indoor air quality.
HVAC system design is a sub-discipline of mechanical engineering, based on the principles
of thermodynamics, fluid mechanics, and heat transfer.
HVAC is important in the design of medium to large industrial and office buildings such as
skyscrapers and in marine environments such as aquariums, where safe and healthy building
conditions are regulated with respect to temperature and humidity, using fresh air from
outdoors.
Purposes of HVAC System In Pharmaceutical Industries
- Maintaining temperature and humidity in a definite range.
- Maintaining pressure.
- Filtration.
- Avoiding contamination.
- Effective airlock system.

Components of HVAC System

Air conditioner
AHUs
Dehumidifier / Heater
Filters (Pre & HEPA)
Dust Extractors
Ducting (For supply & return of conditioned air)
Supply Fans
Dampers
Humidity / Temperature / Pressure sensors
Bag Filters
Heating / Cooling Coils

16

Air Handling Unit (AHU)

An air handler or air handling unit (AHU) is a device used to regulate and circulate air as part
of a heating, ventilating, and air-conditioning (HVAC) system. An air handler is usually a
large metal box containing a blower, heating or cooling elements, filter racks or chambers,
sound attenuators, and dampers. Air handlers usually connect to a ductwork ventilation
system that distributes the conditioned air through the building and returns it to the AHU.

Components of Air Handling Unit

Fig. 3: Components of AHU

1 Supply duct
2 Fan compartment
3 Vibration isolator ('flex joint')
4 Heating and/or cooling coil
5 Filter compartment
6 Mixed (recirculated + outside) air duct

17

Fig. 4: Schematic diagram of an AHU

Filters
Air filtration provides clean dust-free air to the building occupants. It may be via simple
filtering media, HEPA, electrostatic, or a combination of techniques. Gas-phase and
ultraviolet air treatments may be employed as well.
Filtration is typically placed first in the AHU in order to keep all the downstream components
clean. Depending upon the grade of filtration required, typically filters will be arranged in
two (or more) successive banks with a coarse-grade panel filter provided in front of a finegrade bag filter, or other final filtration medium.
The life of a filter may be assessed by monitoring the pressure drop through the filter medium
at design air volume flow rate. This may be done by means of a visual display using a
pressure gauge, or by a pressure switch linked to an alarm point on the building control
system. Failure to replace a filter may eventually lead to its collapse and thus contamination
of the air handler and downstream ductwork.

18

Fig. 5: Different types of filters used in pharmaceutical industries

Heating and Cooling Elements

Air handlers may need to provide heating, cooling, or both to change the supply air
temperature, and humidity level depending on the location and the application.
Such conditioning is provided by heat exchanger coil(s) within the AHU air stream, such
coils may be direct or indirect in relation to the medium providing the heating or cooling
effect.
Coils are typically manufactured from copper for the tubes, with copper or aluminum fins to
aid heat transfer.
If dehumidification is required, then the cooling coil is employed to over-cool, so
condensation occurs. A heater coil placed after the cooling coil re-heats the air to the desired
supply temperature. This has the effect of reducing the relative humidity level of the supply
air.
Heat recovery device
A heat recovery device i.e. heat exchanger of many types, may be fitted to the air handler
between supply and extract airstreams for energy savings and increasing capacity. Commonly
used heat recovery devices include Recuperator or Plate Heat exchanger, thermal wheel etc.
Thermal wheel or Rotary heat exchanger: A slowly rotating matrix of finely corrugated
metal, operating in both opposing airstreams.

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Fig. 6: A thermal wheel

When the AHU is in heating mode, heat is absorbed as air passes through the matrix in the
exhaust airstream, during one half rotation, and released during the second half rotation into
the supply airstream.
When the AHU is in cooling mode, heat is released as air passes through the matrix in the
exhaust airstream, during one half rotation, and absorbed during the second half rotation into
the supply airstream. Heat recovery efficiency up to 85%.

20

Clean Room
A cleanroom or clean room is an environment, typically used in manufacturing or scientific
research, with a low level of environmental pollutants such as dust, airborne microbes,
aerosol particles, and chemical vapors. More accurately, a cleanroom has a controlled level of
contamination that is specified by the number of particles per cubic meter at a specified
particle size.
In the pharmaceutical industry, clean rooms play a crucial role in the manufacturing of
pharmaceutical products which are required to be free from microbial and particulate
contamination and protected from moisture. Such pharmaceutical products are manufactured
and manipulated in cleanrooms, which are fitted with HEPA(High-Efficiency particulate
Arrestance) and, if required, ULPA (Ultra-Low Particulate Air) filters as well as dehumidifier
systems.

Fig. 7: A clean room corridor

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Cleanroom zoning
There are four types of clean zones in manufacturing sterilized pharmaceutical products. The
grade is defined by the type of product and a part of process which needs to be protected from
contamination.
A local zone. For operations that affords high risk for product quality, e.g. filling, closing,
ampoule and bottle opening zones. Usually in such zones is used laminar air flow which
provides similar velocity 0.36-0.54 m/s.
B zone, which is circled A-zone, is used for an aseptic preparation and fulfill
C and D is a clean zones for less responsible stages of manufacturing sterilized products.

Washing of containers

D
X

Preparation of solution for terminal sterilization

Preparation of solutions for aseptic filling

Depyrogenisation of containers

Filling for terminal sterilization

Filling for aseptic process

etc.
Fig. 8: Level of protection for Cleanrooms

22

Pressure Cascade
Controlling room pressure is only one aspect of cleanroom facility design when creating
segregated zones of different class. Specifying room overpressure in cleanroom design is a
common contamination control concept. To achieve this the HVAC needs to be designed to
control the room pressure by some means. Most commonly this is achieved using pressure
controlled actuated dampers in the return ducting. These dampers have to be designed to
modulate within a certain airflow range and with a specific accuracy and speed of reaction.

Fig. 9: Pressure Cascade (sterile production)

(Protection from Micro-organisms and Particles)

23

Fig. 10: Pressure Cascade (Solid Production)

(Protection from Cross-Contamination)

24

Boiler:
There are total 7 boilers present in different plants of Incepta. Only 2 of the boilers are run by
the exhaust of generators. The rest of the boilers are run by natural gas or diesel. The use of
fuel depends on the availability of natural gas. 2 boilers have capacity of 5 tons each, 3
boilers have capacity of 2.5 tons and the exhaust run boilers have capacity of 2 tons.
Potable water is used as feedwater of boiler thereby preventing corrosion of boiler. The steam
produced is known as industrial steam. It has several applications e.g. laundry, production of
pure steam, in HVAC system etc.

Fig. 11: Boiler

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Boiler Mountings:
These are different fittings and devices necessary for the operation and safety of a boiler.
Boiler mountings are generally mounted over the boiler shell. The following mountings are
usually installed on a boiler

Water level indicator

Pressure gauges

Pressure relief valves

Steam stop valve

Feed check valve

Blow down valve

Low water alarms

Fusible plug

Man and mud holes covers, etc.

Boiler Accessories:
These are auxiliary plants and devices required for the proper and efficient operation of
boilers. Commonly used accessories are

Air pre-heater,

Economizer,

Super heater,

Feed pump,

Injector, etc.

Application of boiler in Incepta

Production of pure steam

Heating purpose

Autoclave and sterilization

26

Chiller
In Incepta Pharmaceuticals Ltd both absorption chiller and compression chillers are present.
The absorption chillers use LiBr-H2O system. The temperature of chilled water is kept
between 7-8 C.
There are 8 chillers in Incepta. 5 of them are absorption chiller and 3 of them are compression
chiller. 1 of the absorption chillers is run by the hot jacket water from gas generator, and
another chiller is run from the exhaust of a boiler. The other absorption chillers use either
natural gas or diesel as fuel.

Fig. 12: Chiller

27

Cooling Tower:
Cooling towers are used to reject heat from generators, condenser water of chillers etc. The
cooling towers in Incepta are evaporative type.

Fig. 13: Cooling tower

28

Air Compressor
A sterile environment is essential in the pharmaceutical industry. So when it comes to
compressed air, only oil-free will do.
Any contaminates in compressed air, such as oil, can cause process disruptions, production
shutdowns, and expensive product recalls and company reputation.

Fig. 14: Srew Compressor

Use of Compressed Air

Process air air used in direct contact with products for cleaning, aeration and
product moving

Control valves & cylinders to control equipment used in the manufacturing process

Material handling Fluid pumping systems are operated by compressed air in

volatile environments without the risk of explosion

Nitrogen generation air is filtered via a membrane to produce nitrogen

Air curtains air is used as a curtain to create a safe and clean area

Product drying air is mixed with products to accelerate the drying process.

29

Water Treatment Plant

Water is the most widely used substance, raw material or starting material in the production,
processing and formulation of pharmaceutical products.Control of the quality of water
throughout the production, storage and distribution processes, including microbiological and
chemical quality, is a major concern.
Types of Water in Pharmaceuticals Industries:

Drinking or potable water

Purified Water (PW)
Water for Injection (WFI)

Potable Water
Typical processes employed include:
Desalinization;
Filtration;
Softening;
Disinfection or sanitization (by sodium hypochlorite (chlorine) injection);
Iron (ferrous) removal;
Precipitation;
Reduction of concentration of specific inorganic and/or organic materials.

30

Fig. 15: A Water Treatment Plant

Purified Water (PW)

Fig. 16: Schematic diagram of Purified Water (PW) production

31

Water for Injection (WFI):

Fig. 17: Schematic diagram of WFI production

32

Effluent Treatment Plant

Generally three types of waste are generated from pharmaceutical industries:

Process waste water,

Utility waste water and

Domestic waste water.

The combine waste from different areas of the pharmaceutical industries were subjected to
consecutive three stages of treatment

Physical treatment,

Chemical treatment, and

Biological treatment.

Fig. 18: Effluent Treatment Plant at Incepta

33

Physical Treatment
Physical treatments are used primarily to remove the unwanted solid substances from the
waste stream. Raw waste stream is passed through the bar racks for screening followed by
grit chamber and sedimentation tank. The waste sludge, collected from the sedimentation
tank, is then sent to the solid waste treatment plant for combustion and then the effluent is
passed to the chemical treatment plant.

Chemical Treatment
The effluents, collected from the physical treatment plant, are neutralized with lime in the
neutralization tank and then alum is added to the flash mixing tank. After that the effluents
are taken to the flocculation tank. After flocculation the heavy solids are removed from the
sedimentation tank and sent to the solid waste treatment plant and the decant solution were
further treated in the equalization tank.

Fig. 19: Chemical treatment of waste water

Biological Treatment
Biological treatments again can be subdivided into two types:

Anaerobic and

Aerobic biological treatment.

34

From the equalization tank, the effluents are subjected to two steps biological treatment. In
the first step, anaerobic digestion was carried out by acidogenesis and volatile organic acids
are formed. Then they are converted to acetic acid and methane through acetogenesis and
methanogenesis respectively.
After anaerobic treatmentthe effluents are again treated by two stages aerobic digestion after
settling in the hopper bottom settling tank.

Fig. 20: Flow diagram of the biological treatment of waste water.

35

Conclusion:
This industrial training was a great learning curve for all of us. Through this industrial
training we have learnt a lot about pharmaceutical industry. We learnt about pharmaceutical
water, clean room technology, pressure cascade, effluent treatment plant and many other
things which were unknown to us before. Moreover, we have got practical knowledge about
HVAC system and its different components. We got a very practical knowledge about
generator, boiler, chiller, cooling tower etc. We have learnt how an industry operates and
earned basic knowledge about Operational and Technical Management of Engineering,
Production, Quality Assurance, Warehouse Department etc.
Finally, we can conclude that this training program was a great experience for us. It helped us
to take a closer look at an industry and taught us professionalism. The knowledge and
experience gathered from this training program is invaluable to us.

36