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Introduction:
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. 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. Since its inception, Incepta has been launching new and
innovative products in order to fulfill unmet demand of the medical community.

Since 1999, the name “Incepta” has been synonymous with trust and reliability inherent
with the word quality. Quality is ingrained with the work of the colleagues here and all
their values. They are dedicated to the delivery of quality healthcare throughout the
nation. Their business practices and processes are designed to achieve quality results that
meet the expectations of patients, customers, business partners, and regulators. Incepta
has a relentless passion for quality in everything they do.

Every one in Incepta strives for continuous improvement in their performance measuring
results carefully and ensuring that respect for people are never compromised

Corporate Head Office Plant

Incepta Pharmaceuticals Limited Incepta Pharmaceuticals Ltd.

Ahmed Mansion (1st floor) Dewan Idris Road, Bara Rangamatia
24, Chamelibagh, Shantinagar Zirabo, Savar,
Dhaka-1217 Dhaka
Bangladesh Bangladesh
Phone: +880-2-8316402 Phone: +880-2-7708502-5
Fax: +880-2-9350684 Fax: +880-2-7708507
Email: incepta@inceptapharma.com
info@inceptapharma.com
Web: www.incepta pharma.com
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Values of Incepta

Quality

Teamwork

Performance

Community
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Clients

About Incepta Pharmaceuticals Limited:

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. 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. Since its inception, Incepta has been launching new and
innovative products in order to fulfill unmet demand of the medical community. The
focus has been to bring more new technologically advanced molecules to this country.

The company specializes in value added high technology dosage forms like sustained
release tablets, quick mouth dissolving tablets, effervescent tablets, barrier coated
delayed release tablets, prefilled syringe products, Insulin and Insulin analogue and
biological products, among others . It has established a modern research and development
laboratory for the development of new, advanced dosage forms for various drugs and
devices like poorly soluble drugs, dry powder inhalers, coated pellets, modified release
products, taste masked preparation etc.

Incepta has a very competent sales team, which promotes the specialties throughout the
country. The company virtually covers every single corner of the rural as well as urban
area of Bangladesh. It has its own large distribution network having 18 depots all over the
country. 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
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registered in different countries, and many more in the pipeline, Incepta is gradually
expanding its global footprint across all the continents.

Company's state-of-the-Art R&D lab employs sophisticated and advanced technology to

bring newer products through research hitherto unknown in this country. Such activities
will not only benefit the company but also the total pharmaceutical sector of the country.
In the post 2005 era, the company also intends to embark into the production of Active
Pharmaceutical Ingredient (API). Plans are underway to get into reverse engineering and
analogue research in order to produce new API.

Incepta Vaccines Limited, a sister concern of Incepta Pharmaceuticals, has already

established a State-of-the-Art Human Vaccine production facility. Incepta Vaccines is
planning to launched human vaccines in the Bangladesh market in September 2011.
Incepta emerges as the first Bangladeshi company to acquire the technology to produce
Human Vaccine. The larger production capacity will allow the company to supply its
vaccines globally.

On 15th January 2011, Incepta implemented globally acclaimed ERP software system -
SAP. Incepta is the first Bangladeshi company to implement SAP to manage resources
throughout the company operation. This world class resource management system will
allow the company to become more efficient and effective in its day to day operation.

The company is continuously expanding its activities beyond the geographical boundary
of Bangladesh. The company is open to collaborate with interested and relevant parties in
various countries Incepta will continue to strive to provide high quality medicine at
affordable prices to the people here in Bangladesh and other parts of the globe.

Vision and Mission:

Vision
We want to become a research based global pharmaceutical company in addition to being
a highly efficient generic manufacturer. To discover and develop innovative, value-added
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products that improve the quality of life of people around the world. And contribute
towards the growth of our Nation.
Mission
Provide people globally with high quality health care products at affordable prices in
order to improve access to medicine and to provide employees an enabling environment
that facilitates realization of their full potential.

History of Incepta:

Incepta began its operation with a handful of highly skilled and dedicated professionals
guided by an able leadership. Proper strategic planning, technical excellence, swift and
timely decisions helped us achieve our objectives leading to much faster growth. Incepta
was able to anticipate the need of the market and provide the right product at the right
time. High focus on R&D investment from the very beginning made possible the
introduction of quality products ahead of its competitors in most cases.
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. Currently the Zirabo
plant consists of several buildings with state of the art technology. Dedicated
cephalosporin manufacturing building, a specialized manufacturing building for the
production of lyophilized products, insulin and amino acids and newly built liquid and
semisolid manufacturing building and large warehouse is also in operation.
Incepta now has one of the largest and competent sales force and large distribution
network of its own, operated from 19 different locations throughout the country. A most
dynamic skilled and dedicated marketing team comprising of pharmacists and doctors are
at the core of the marketing operation. These highly skilled professionals play a crucial
role in providing the necessary strategic guideline for the promotion of its product.

Chronology of Events:

The chronologies of events that take place in Incepta Pharmaceuticals Limited are given
below;
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 December 16th 1998, the construction of the factory began.

 August 1999, office operations began.

 December 1999, first batch of product Neodin S 150 (Ranitidine 150 mg tablet)
was produced.

 January 2000, sales began formally.

 February 2000, training of the first batch of medical representatives began.

 April 2000, with the launching of Osartil (Losartan Potassium) the first
prescription product of Incepta was launched in the market. The company started
off in a new direction.

 Several other first ever product, Celenta (Celecoxib), Rofenta (Rofecoxib) and
Omidon (Domperidone) followed in the footsteps of Osartil.

 A total of 23 new generics with 35 presentations were launched this year. 4 of

these generics were first ever in Bangladesh.

 By the end of 2000 Incepta was the number 31st company of the country.

 There was massive restructuring throughout the company. Sales, Distribution,

Marketing Strategy Department, and Factory; all were reorganized.

 A total of 18 new generics with 37 presentations were launched this year. 11 of

these generics were first ever in Bangladesh.

 By the end of the year Incepta was ranked the 12th company of the country. The
company had a phenomenal growth of 448% over the previous year (IMS).

 A total of 32 new generics with 49 presentations were launched. 14 of these

generics were first ever in Bangladesh.
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 Massive expansion project of the factory was envisioned. New office for the sales
and distribution operation was also taking shape.

 The company registered an excellent growth of 55.85% over the previous year.
By the end of the year Incepta was ranked the 10th company of the country
(IMS).

 Incepta kept on introducing innovative and newer molecules to the local market.
A total of 32 new generics with 48 presentations were launched. 18 of these
generics were first ever in Bangladesh.

 The new office (Dhanmondi) for the sales and distribution operation was
inaugurated.

 The company registered an excellent growth of 28.5% over the previous year
(IMS).

 By the end of the year Incepta was ranked the 8th company of the country (IMS).

 A total of 17 new generics with 32 presentations have been launched. 6 of these

generics were first ever in Bangladesh.

 The company maintained an excellent growth of 48.2% over the previous year
(IMS).

 The ranking went up again and the company was ranked the 5th largest company
of the country with the highest growth rate among the top five (IMS).

 We thrived under challenge and excelled in venturing into unexplored grounds

and continued to satisfy our customers. Incepta was audited and accepted as a
supplier for UNICEF & UNDP. We started to supply life saving drugs to
UNICEF from March, 2005.
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 A total of 27 new generics with 76 presentations were launched. 12 of these

generics were introduced first time ever in Bangladesh.

 The company maintained an excellent growth of 34.8% over the previous year
(IMS).

 The company was ranked 3rd largest with the highest growth among the top five
(IMS).

 By 2006 Incepta had positioned itself as an innovative research oriented and

knowledge based pharmaceutical company specializing in analysis, design and
development of new products.

 Incepta successfully started overseas marketing operation from May 2006.

 A total of 25 new generics with 82 presentations were launched. 9 of these

generics were first ever in Bangladesh.

 The company maintained an excellent growth of 31.26% over the previous year
(IMS).

 The company maintained the ranking of 3rd largest (IMS).

 Incepta pioneered the introduction of biotech products (Human Insulin) and

lyophilized products (Pantoprazole injection) in the Bangladesh pharmaceutical
market. This was the first time a local pharmaceutical company produced such
highly sophisticated technology product in the country.

 A total of 32 new generics with 82 presentations were launched. 4 of these

generics were first ever in Bangladesh.

 Marketing, Sales, Distribution and Administration departments shifted to the fully

owned new office premises in Tejgaon, Dhaka. The international standard head
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office of Incepta started operation in the new office premises on 1st October,
2007.

 A marketing and sales team was setup in Myanmar headed by a country manager
from the Marketing Strategy Team to promote the 35 products registered with the
Myanmar FDA.

 The company maintained a growth of 12.93% over the previous year (IMS).

 The company held the 3rd largest ranking (IMS) among the companies.

 Continued investment in our core strength that is our manufacturing plant led to
recognition from European authorities and on January 11, 2008 Incepta attained
European "Certificate of GMP Compliance".

 40 new products with 86 presentations were introduced of which 10 were first

ever in Bangladesh.

 The plant received GMP certification (General formulations and Cephalosporins)

from Kenyan Ministry of Health on January 21, 2008.

 Incepta was also awarded GMP (Cephalosporins) from Ethiopian Ministry of

Health on July 22, 2008.

 Incepta registered 51 products in Mongolia on September 26, 2008 (As first

Bangladeshi Company).

 Incepta registered 3 products in Georgia on October 13, 2008 (As first

Bangladeshi Company).

 In 2008 significant number of products got registration in different countries. 19

products from Democratic Republic of Congo, 20 products from Sri Lanka, 22
products from Togo, 8 products from Hong Kong, 20 products from Mauritania, 6
products from Vietnam, 1 product in Cambodia.
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 The company maintained a growth of 12.10% over the previous year (IMS).

 The company became the 2nd largest (IMS) among the companies operating in
Bangladesh.

 Incepta started venturing in the field of human vaccines and hormonal products.
Construction of the Vaccine & Hormones facilities started on 1st January 2009
and 8th November 2009 respectively.

 Incepta became the first Bangladeshi Company to get GMP Compliance

Certificate from Turkey (Tablets, Capsules and Lyophilized products) on January
08, 2009.

 Incepta achieved GMP certification from the Ministry of Health, Yemen on May
25, 2009 (Sterile and Non-sterile products).

 Incepta launched 51 new products in 2009. 4 of these were first ever in

Bangladesh pharmaceutical market.

 The company maintained an excellent growth of 27.71% over the previous year
(IMS).

 The company maintained the 2nd largest (IMS) position in 2009.

 Incepta was accepted and became enlisted with the Copenhagen office of
UNICEF, UNDP and UNESCO as global supplier of medicine.

 Incepta was awarded GMP certificate from Uganda, National Drug Authority on
5th August 2010 (Sterile Products, Non-sterile products and Cephalosporins).

 Incepta launched 56 product presentations. 10 of which were first ever in

Bangladesh market.
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 Incepta maintained the 2nd largest (IMS) position in Bangladesh pharmaceutical

market in 2010. The company showed the strongest growth among the top 10
companies with a growth rate of 34.97% (IMS).

 Incepta introduced Human Vaccines to the market and become the first
Bangladeshi vaccine manufacturing company.

 Export has emerged as a focus area for Incepta. With over 300 products registered
in different countries export is now set to play more important role in the growth
of the company. Currently the company exports to 37 countries of the world with
many more in the pipeline.

 Since starting supply of medicine to UNICEF in Bangladesh, Incepta has

remained the largest supplier till today.

 In 2011 the company has launched 55 products, 9 of which are first ever in
Bangladesh market.
 In 2012 the company has launched 52 products, 7 of which are first ever in Bangladesh
market.
 In 2013 the company has launched 40 products, 7 of which are first ever in Bangladesh
market.
 Up to June, 2014 the company has launched 9 products, 1 of which is first ever in
Bangladesh market.

Growth in Incepta Comparison with Local Pharma Market:

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Beginning in 2000, Incepta has been launching new and innovative products at a faster pace than
its competitors.

Up to June 2014 it has already launched 390 generics with a total of 696 presentations. The
company produces a wide variety of dosage forms covering nearly all the major therapeutic
classes.

During the last 14 years of operation Incepta launched as many as 139 new generics for the first
time ever in Bangladesh. High focus on quality and timely introduction of much needed essential
medications previously unavailable in the country has enabled Incepta to become the second
largest pharmaceutical company of the country.

Table: Growth In Comparison With Local Pharma Market

Year No. of Products First Ever Product IMS Rank*

2014 696 1 2nd
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2013 686 7 2nd

2012 631 7 2nd
2011 632 9 2nd
2010 594 10 2nd
2009 585 4 2nd
2008 532 10 2nd
2007 451 17 3rd
2006 368 9 3rd
2005 288 12 3rd
2004 198 6 5th
2003 154 18 8th
2002 119 14 10th
2001 78 11 12th
2000 35 4 31st

* Intercontinental Marketing Services (IMS)

Departments in Incepta Pharmaceuticals Limited:

 Marketing Strategy Department

 Medical Service Department
 Human Resource Department.
 Administrative Department
 Engineering
 Sales Department
 Distribution Department
 Regulatory Affairs Department
 Finance & Accounts Department
 Management Information Department
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 Production Department
 Quality Assurance Department
 Product Development Department
 International Marketing Department

However our training covers the following departments-

 Warehouse
 Production
 Quality Assurance
 Engineering

These departments are described in the upcoming section of this report.

Warehouse
Warehouse:

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. 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.

Our warehouse is equipped with four different storage conditions; a) 2 oC – 8oC, b) 8oC –
15oC, c) 15oC -25oC, and d) 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.
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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.

The transaction of materials is done according to "first in first out" system. Accounting
and storage is maintained through SAP.

The area of warehouse includes-

1. Dispensing booth
2. Storage area for
--Raw materials
--Finished products
--Packaging materials
3. Quarantine area for

--Raw materials

--Finished products

 Storage Area for Raw materials:

 Raw material store: Goods kept when released by QC
 Cool room: 2-8 °C
 Dispensing room: for dispensing of ingredient.
 Quarantine area: After receiving of raw material they are stored first in the
quarantine area. If Q.C sampling and checking is approved then shifted to the
store.
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 Storage Area for Finished Product:

 Quarantine area: At first finished products are stored in this area for about 14
days, checked by Q.A.D, if problem arises the product should be rejected and
reprocessed if possible.
 Product ready for marketing: After “pass” from the Q.A.D finished products
are shifted for marketing.

 Storage Area for Packaging Materials:

In this area packing materials are stored in normal condition and in control environment.
The store has well defined are for different packing materials. First the goods are kept in
Quarantine area for packing materials. Some materials like alumunium foil are kept in
AC store.

The major activities of Warehouse:

a. Ensure the reception of right materials.

b. Issue required materials for production within the limit.
c. Reception of Finished Goods from production & timely distribution.
d. Monitoring of temperature & relative humidity.
e. Overall cleanliness of both materials & areas.
f. Materials management (Segregation, QC formalities, Disposition, etc.)
 P a g e | 17

Figure: Warehouse Department of Incepta Pharmaceuticals Ltd.

1. The duties of Ware House is sequentially- (Raw Materials

Receive)

Checking of vehicle with Receiving chalan/Invoice (Exact product, volume/amount)

Unloading vehicles, sorting and palletization

Cleaning of incoming materials

Checking for damage/loss/excess

Information entry in “Systemic Application product in data Processing” (SAP)

Preparation of “Goods Receive Information” (GRI) & Quarantined Label

Affixing of “Quarantined Label” & transfer of materials to the quarantine area of

warehouse.

Sending out of GRI to QC department

Result: Released Result: Reject

Affixing of release label, transfer of Affixing of reject label & transfer of
 P a g e | 18

material to released area & sotware entry material to reject store

Informing PPIC about rejection of

materials.

2. The duties of Ware House is sequentially- Raw Materials issue to

production

Receiving of “Batch Manufacturing Record” (BMR) from Production

Checking of materials “Process Order”

Information entry in the required field of BMR

Arranging of required released materials as per FIFO/FEFO system

Information entry in Bin Card

Issuing materials to the materials dispensing both

Dispensing of Raw Materials & issue to production

Returning the access materials to Warehouse & information entry in “Inventory

software”

Storing of returned excess materials in the respictive location/area of warehouse.

3. The duties of Ware House is sequentially- Finished goods dispatch

Receiving of “Requisition of Finished Goods” from Central Sales Centre.

Checking of availability of Finished Goods

Sending request to Quality Assurance for release (if required)

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Arranging covered van for loading Finished goods

Preparation of Delivery Challan, Issue voucher & gate pass

Information entry in finished Goods register as well as inventory Software.

Exit of Finished Goods Vehicle from Warehouse

Different Units of Warehouse:

 Quarantine area:

After receiving of raw materials they are stored first in the quarantine area. Then Q.C.
sampling and checking is approved and then shifted to the main storage area. Purpose of
Quarantine area-

 To receive the raw materials

 To store the material before it passed the QA test
 To manage the materials properly and systemically.
 Sampling area:

Sampling means the process of taking a small portion from a lot for test and analysis to
show the quality of the whole lot. The purpose of sampling and subsequent testing is to
provide an effective check on the quality of the product or substances being processed.

 Main storage area:

Here raw materials are stored. There is another isolated storage area for sophisticated
materials maintaining temperature and humidity inside the main storage area. The storage
department performs some important functions such as
 P a g e | 20

 Specific raw materials are stored in specific mentioned area with

proper documentation. Cool area: 15-24°C & Humidity: 45-55%.
 According to monthly program, this department has the
responsibilities to get final Q.C. approval for raw materials.
 According to plan and recovery maintenance, the raw materials are
supplied to the production area for required batch size.
 Dispensing area:

Here raw materials are weighing under a laminar air flow cabinet and supplied to the
production areas by weighing according to the proper document and release it from the
RM store. The area from where raw materials and packing materials are dispensed
according to the requisition sheet for the production. Raw materials, packing materials
and finished products kept in different places should be labeled properly. Only the
approved (green tagged) materials are brought to the dispensing area. Materials that come
first are dispensed first according to the FIFO (first in first out) rule.

 Released area:

Here raw materials are stored, those only passed the tests performed by QC and QC
provides released tag. Purpose of released area-

 To store the approved materials

 To store the approved materials in different conditions as
specified by the manufacture.
 Not released area:

Here raw materials are stored, those tests not yet performed by QC and QC provides not
released tag.

 Rejected area:

Rejected materials are stored here those failed the tests performed by QC and QC
provides rejected tag and the local raw materials are returned to the suppliers. Imported
raw materials are destroyed.
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 Special area:

It includes Cold room (Temp. 2-8, e.g. Cephradine, Cephalosporine); Cool room (Temp.
8-15); Controlled room (Temp. 15-25); Ambient room (surrounding room temp.).

 Preservation of products:

Due to some physicochemical changes medicines are sensitive products. So, to protect
the most sensitive ones, manufacturers use different techniques and adjutants. In addition,
each product goes with its own preservation instructions. In the warehouse, it is essential
to preserve the pharmaceutical products from the factors of degradation to guarantee their
stability up to their expiration date.

Production Departments

Solid Dosage forms

Tablets

Tablets are the solid preparations each containing a single dose of one or more active
ingredients and obtained by compressing uniform volume of particles.

According to British Pharmacopoeia, “Tablets are solid dosage forms circular in shape
with either flat or convex faces and prepared by the compression or compaction of
suitably prepared medicament by means the tablet machine”.
 P a g e | 22

Tablets are intended for oral administration. Some are swallowed whole, some after being
chewed; some are dissolved or dispersed in water before being administered and some
are retained in the mouth where the active ingredient is liberated.

Being the most common, convenient and inexpensive dosage form, tablet formulation
and design is the most important consideration in solid dosage form production in the
pharmaceuticals, which may be described as the process whereby the formulator ensures
that the correct amount of drug in the right form is delivered at or over the proper time at
the proper rate and in the desired location, while having its chemical integrity protected
to that point.

Steps involved in the Manufacturing of Tablets:

Granulation (wet or dry)

¯ Blending
Blending
¯ ¯
Compression Direct Compression

Conventional Uncoated Tablets

¯
Coating of Uncoated Tablets
¯
 P a g e | 23

Coated Tablets

Granulation

Granulation is the process in which the primary powder particles are made to adhere to
form larger, multiparticle entities called granules. In other words, granulation may be
considered as a size enlargement process during which small particles are formed into
larger, are physically strong agglomerates in which the original particles can still be
identified.
The pharmaceutical granulations are used primarily to prepare material for tableting.
Some granulations are dispensed as packets or capsules.

The pharmaceutical granules typically have a size range between 0.2 to 4.0mm,depending
on their subsequent use.

Processes of Granulation:
Granulation Processes Which Are Performed In the Incepta Pharmaceuticals Limited Are
Following;
a) Wet granulation
b) Dry granulation
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Figure:Granulation unit of Incepta Pharmaceuticals Ltd.

Wet granulation:
In Incepta Pharmaceuticals Limited the wet granulation technique is used generally,
which is briefly described below with the help of a flow chart;

Weighing of active ingredient as well as excipients

¯
Dry mixing
¯
Wet mixing (in case of wet granulation) by addition of demineralized (DM) water or
Maize starch paste in Rapid Mixer Granulator (RMG) for a certain time period specified
in the Batch Production Record (BPR)
¯
Initial Phase drying in Fluid Bed Dryer (FBD)
¯
 P a g e | 25

Milling in the Multimill

¯
Partial drying in FBD
¯
Milling in the Multimill
¯
Terminal/Final drying in the FBD
¯
Sieving in the Vibratory Sifter according to the required particle/granule size
¯
Measurement of Loss on Drying (LOD)
¯
Granules of desired size ready for blending.

Following the above process, 2 types of granules are produced in the four-granulation
units of the industry, which include;

 Granules with active ingredient/s

 Placebo granules without any active ingredient/s for
moisture sensitive active/s or drug/s
Dry Granulation:
Besides the wet granulation process, dry granulation process is also followed for certain
cephalosporin products in the cephalosporin building. The granulation process is carried
out following the steps given below;
Weighing of active ingredient as well as excipients
¯
Dry mixing
¯
Compression of the powder mixture into a slug on a heavy-duty rotatory tablet machine
or passing of powder through two rollers to produce a sheet of material by the process of
roller compaction
 P a g e | 26

¯
Milling in the Multimill
¯
Granules with desired size ready for blending.

Machines used in the Granulation unit for the purpose of Granulation:

In each granulation unit, the following machines are present for granulation;
Name of the Machine Function Capacity

Rapid Mixer Granulator (RMG) Mixing 300-350 Kg (large) &

100-150 Kg (small)
Paste Kettle Preparation of slurry 600 Liter
Fluid Bed Dryer (FBD) Drying 200 Kg
Multimill Milling -
Vibratory Shifter Sieving -

Condition for manufacturing of Granules:

 Relative Humidity: Not more than 55%.

 Temperature: Below 250C.

Common Problems that arise during Granulation & their Remedies:

Problems Remedies

Over dried granules Addition of more demineralized (DM)

water or solution of binder
Less dried granules Increase in drying time or addition of less
demineralized (DM) water or solution of
 P a g e | 27

binder

Blending

Blending is the process of mixing lubricants, glidants and colorants with the granules
prior to compression (in case of granules containing the active ingredient/s) or mixing of
active ingredient/s along with lubricants, glidants and colorants with the placebo
granules (in case of granules without the moisture sensitive active ingredient/s) prior to
compression. So, the process in often-called lubrication or remixing.

Blending Procedure:
For granules containing active ingredient/s the following procedure is used in the
blending units of Incepta Pharmaceutical Limited;

Granules containing active ingredient/s

in the Drum or Double Cone Blender
¯
Transfer of glidants into the blender
by passing through a sieve of mesh size 20
& Colorants through 200 mesh screen
¯
Blending of the ingredients in the Drum (30 rpm) or
Double Cone Blender (16 or 22 rpm) for 2-3 minutes as specified in
the Batch Production Record (BPR) for a certain product
¯
Transfer of lubricants into the blender
by passing through a sieve of mesh size 20
 P a g e | 28

¯
Blending with the other ingredients
in the same manner as stated above for 1 minute
¯
Granules are ready for compression

Again, for placebo granules without any active ingredient/s the following procedure is
used in the blending units of Incepta Pharmaceutical Limited;

Placebo granules in
the Drum or Double Cone Blender
¯
Transfer of Active ingredient/s &
Glidants into the blender
by passing through a sieve of mesh size 20
& Colorants through 200 mesh screen
¯
Blending of the ingredients in the Drum (30 rpm) or
Double Cone Blender (16 or 22 rpm) for 2-3 minutes as specified in
the Batch Production Record (BPR) for a certain product
¯
Transfer of lubricants into the blender
by passing through a sieve of mesh size 20
¯
Blending with the other ingredients
in the same manner for 1 minute
¯
Granules are ready for compression

Machines used in the Blending units for the purpose of Blending:

The following machines are used in the blending units for blending;
 P a g e | 29

Name of the Machine Function Capacity Speed

(rpm)

Double Cone Blender Blending 300-350 Kg (large) 16 rpm

(DCB) 150-200 Kg (small) 22rpm
Drum Blender Blending 65 Kg (large) -
35Kg (small)
FITZ mill Milling - 4000

Condition required during Blending:

 Relative Humidity: Not more than 55%.
 Temperature: Below 250C.

Compression

Compression can be defined as the technique of applying force or pressure to the granules
or powders (in case of direct compression) to produce tablets of desired shape and size
with the help of tablet press machine.

Two types of compressions are seen in the tablet press units of the factory; they are-
 Compression of previously made granules
 Direct Compression

Process of General Compression:

Granules (previously made)

¯
Transfer of granules in the hooper of tablet press machine
 P a g e | 30

by hand or auto powder/granules loader

¯
Rising of upper punch & dropping of lower punch
¯
Filling of die cavity through feed frame
¯
Removal of extra granules by scrape off plate
¯
Coming down of upper punch for
compression to produce tablet
¯
Raising of both upper & lower punches
to certain extent
¯
Ejection of tablet with the help of take out plate
¯
Conventional Uncoated Tablets
of desired shape and size

Process of Direct Compression:

Direct compression is the preferred method when the active ingredient shows inherently
good compression behavior. The direct compression process assumes that all materials
can be purchased or manufactured to specifications that allow for simple blending &
tableting. The process is described below through a flow chart;
Milling & Screening of active ingredient/s
& the excipients
¯
Mixing of the active ingredient/s
 P a g e | 31

along with excipients including lubricants & disintegrants

¯
Transfer of mixer in the hooper of tablet press machine
by hand or auto powder loader
¯
Rising of upper punch & dropping of lower punch
¯
Filling of die cavity through feed frame
¯
Removal of extra granules by scrape off plate
¯
Coming down of upper punch for
compression to produce tablet
¯
Raising of both upper & lower punches
to certain extent
¯
Ejection of tablet with the help of take out plate
¯
Conventional Uncoated Tablets
of desired shape and size
Machines used in the Tablet Press unit for the purpose of Compression:
In each tablet press unit, the following machines are present;

Name of the Machine Function

Automatic Powder Loader Loading of powder or granules to

the hooper of the tablet press
Tablet press machine (B-tooling/ Compression
D-tooling)
Dust Collector Removal of dust
Electronic balance Weighing of tablets in regular
 P a g e | 32

intervals to maintain equal weight

Condition required during Compression:

 Relative Humidity: Not more than 45%.
 Temperature: Below 250C.
Common Problems that arise during Compression:
Common Problems that generally arise during compression are-

 Capping
 Chipping
 Sticking
 Weight variation
 Mottling
 Hardness problem

Coating

Tablet coating is the application of a coating composition to a moving bed of tablets with
the intention of conferring benefits and properties to the dosage form over the uncoated
variety. The distribution of the coating is accomplished by the movement of the tablets
either perpendicular (coating pan) or vertical (air suspension) to the application of the
coating composition.

There are three primary components involved in tablet coating. They are;
 Tablet properties
 Coating process
- Coating equipment
- Parameters of coating process
- Facility & ancillary equipment
 P a g e | 33

- Automation in coating process

 Coating composition

Reasons of Coating:
Coating is an additional step in the tablet manufacturing process, which increases the cost
of the product, therefore so the decision to coat a tablet is usually based on one or more
of the following objectives;
 To mask the test, odor or color of the drug
 To provide physical and chemical protection for the drug
 To control the release of the drug from the tablet
 To protect the drug from the gastric environment of the stomach with
an acid-resistant enteric coating
 To facilitate product identification specially for distinguishing of
different strength of a drug

Types of Coatings:

Generally there are 3 types of coatings that can be done over tablets, but in
the coating units of Incepta Pharmaceutical Limited, 2 types of coating are performed;
 Film Coating
 Organic solvent-based
 Aqueous solvent-based
 Enteric Coating
 Sugar coating is not performed in the coating units of the factory.
 P a g e | 34

Figure:Solace Auto-coater of Incepta Pharmaceuticals Ltd.

Coating Composition:
For both cases of film coating & enteric coating, the following ingredients are used for
coating;
 Polymers
 Plasticizers
 Solvent system
 Colorants

Commonly used Polymers in Film Coating & Enteric Coating:

P Film Coating Enteric Coating

O
Cellulosic (e.g. HPMC) Cellulosic (e.g. CAP)
L
Glycols (e.g. PEG) Phthalate (e.g. HPMCP)
Y Acrylic acid derv. (e.g.Eudragit E100) Acrylic acid derv. (e.g.EudragitL100)
 P a g e | 35

Vinyls (e.g. PVP) Succinates (e.g. HPMCAS)

M
E
R
Process of Film Coating:
For film coating the following procedure is used in the coating units of Incepta
Pharmaceutical Limited;
Mixing of polymer/s with the solvent system
by the aid of a mechanical stirrer
¯
Transfer of colorant/s containing solution (previously
prepared with the help of a homozinizer) into the coating
solution manufacturing vessel
& mixing with the polymeric solution
¯
Loading of uncoated tablets in the circulating coating pan
for dedusting for 2-3 minutes with a speed of 15rpm
¯
Spaying of coating solution onto the tablets for a certain period
as specified in the Batch Production Record (BPR)
& subsequent drying
by adjusting inlet and outlet air temperature
¯
Drying of coating over the tablets for 15minutes
with same pan speed of 15rpm
¯
Film coated tablets

Process of Enteric Coating:

 P a g e | 36

For enteric coating the following procedure is used in the coating units of Incepta
Pharmaceutical Limited:
Mixing of polymer/s with the solvent system
by the aid of a mechanical stirrer
¯
Transfer of colorant/s containing solution (previously
prepared with the help of a homozinizer) into the coating
solution manufacturing vessel
& mixing with the polymeric solution
¯
Loading of uncoated tablets in the circulating coating pan
for dedusting for 2-3 minutes with a speed of15rpm
¯
Spaying of coating solution onto the tablets for the purpose of sub coating
for some time as specified in the Batch Production Record (BPR)
& subsequent drying
by adjusting inlet and outlet air temperature
¯
Spaying of another coating solution onto the tablets for the purpose
of enteric coating for some time as specified in the
Batch Production Record (BPR)
& Subsequent drying
by adjusting inlet and outlet air temperature
¯
Drying of coating over the tablets for 15minutes
with same pan speed of 15rpm
¯
Enteric-coated tablets
 P a g e | 37

Machines used in the Coating unit for the purpose of both Film &
Enteric Coating:
In each coating unit, the following machines are present;

Name of the Machine Function

Perforated Coating Pan System Loading of Tablets

Spray Gun Spraying of coating solution
Coating Solution Manufacturing Manufacturing of Coating Solution
Vessel
Homozinizer Manufacturing of Homogenous
Solution of Colorants

Condition required during Coating:

 Relative Humidity: Not more than 50%.

 Temperature: Below 250C.
Common Problems that arise during Coating:
Common Problems that arise during coating are-
 Film cracking
 Chipping
 Orange peel
 Picking

Coated Granules

Granulation may be considered as a size enlargement process during which small

particles are formed into larger, are physically strong agglomerates in which the original
particles can still be identified.
 P a g e | 38

Some granulations are dispensed as coated in packets or sachet usually intended for
single dose as the pharmaceutical granulations are used primarily to prepare material for
tableting.
Process of Manufacturing Coated Granules:

Flavored Placebo granules

¯
Transfer of granules in the Drum or Double Cone Blender
¯
Transfer of Active ingredient/s & Glidants into the blender
by passing through a sieve of mesh size 20
& Colorants through 200 mesh screen
¯
Blending of the ingredients in the Drum (30 rpm) or
Double Cone Blender (16 or 22 rpm) for 2-3 minutes as specified in
the Batch Production Record (BPR) for a certain product
¯
Transfer of lubricants into the blender
by passing through a sieve of mesh size 20
¯
Blending with the other ingredients
in the same manner for 1 minute
¯
Uncoated Granules
¯
Coating
¯
Coated Granules
 P a g e | 39

Capsule

Capsule is the solid unit dosage form of medication with a separate body & cap (Both are
gelatin shells). There are two types of capsules-Capsule with hard gelatin shell & Capsule
with soft gelatin shell. Hard capsules are filled with powders & pellets, whereas soft
capsules are filled with liquid or semisolid product.
According to British Pharmacopoeia,” Capsules are the solid dosage form in which the
drug is enclosed either in a hard or soft, soluble container or shell of a suitable form of
gelatin”.
In this pharmaceutical industry filling (encapsulation), sealing and polishing (if required)
of capsules of hard gelatin shell are done during manufacturing, as the industry does not
manufacture any capsule shell.
The active is filled in the empty the hard gelatin capsule shell in the form of-

 Powder
 Pellets
There are 5 different sizes of empty hard gelatin capsule shells used in Incepta
Pharmaceuticals Ltd. for general production, which include-

 Capsule shell size 00

 Capsule shell size 0
 Capsule shell size 1
 Capsule shell size 2
 Capsule shell size 3

The Encapsulation is done by either

 Automatic Capsule Filling Machine

Or
 Manual Capsule Filling Machine by Hand
 P a g e | 40

Encapsulation Process by Automatic Capsule Filling Machine:

For encapsulation of pellets the following procedure is done with the help of Automatic
Capsule Filling Machine in the capsule filling units of Incepta Pharmaceutical Limited;

Blend Pellets with NPS

¯
Encapsulation
For encapsulation of powder the following procedure is done with the help of Automatic
Capsule Filling Machine in the capsule filling units of the industry:

Blending
¯
Slugging
¯
Granulation
¯
Sieving
¯
Encapsulation

Encapsulation Process by Manual Capsule Filling Machine by Hand:

For encapsulation of powder the following procedure is done with the help of Manual
Capsule Filling Machine by hand in the capsule filling units of the industry:
Loading of capsule in the loading plate
¯
Removal of caps of the shells
¯
Filling of powder
 P a g e | 41

¯
Rejoining of caps of the shells
¯
Encapsulation
¯
Sorting of Capsules
¯
Polishing of Capsules

Polishing of Capsules after Encapsulation:

Not all but most capsules need polishing specially those are filled with powder. Polishing
is done first by Capsule Polishing machine which removes dust, adherent powder and
gives a shiny appearance.

Figure:Capsule polishing and inspection of Incepta Pharmaceuticals Ltd.

 P a g e | 42

Machines used in the Capsule Manufacturing unit:

In each Capsule Manufacturing unit, the following machines are present;

Name of the Machine Function

Automatic Capsule Filling Filling of empty Capsule shell

Machine
Capsule Sorting Machine
Dust Collector
Capsule Polishing Machine
Removal of defected capsules
Removal of dust
Polishing of Capsules after powder
filling

Condition required during Manufacturing of Capsule:

 Relative Humidity: Not more than 50%.
 Temperature: Below 250C.

Dry Syrup

A dry pharmaceutical syrup may be defined as a finely divided insoluble particle ranging
from 0.5-5 μ, which is to be distributed in a suitable vehicle Dry syrups are the solid
dosage form that can be reconstituted by the addition of water to administer by the oral
route. Mostly antibiotics are available in dry syrup form. Besides, some moisture
sensitive and pediatric drugs are also available in the form of dry syrup .Dry syrup at
Incepta Pharmaceutical Limited is manufactured in a method namely,
 Direct Mixing,

Flow chart for Direct Mixing for the manufacturing of Dry Syrup:
 P a g e | 43

Crushing the sucrose in FITZ mill at 3000 rpm

¯
Transfer of half portion of sucrose from step-1 into
a double cone blender by passing through a 20 mesh screen
¯
Transfer of all other excipients in the blender
to blend for 30 minute
¯
Transfer the mix from the double cone blender by
Passing through a 20 mash screen

Machines used in the Dry Syrup Manufacturing unit:

In the Dry Syrup Manufacturing, the following machines are used;

Name of the Machine Function

Double cone Blender Blending/Mixing

FITZ Mill Crushing/ Milling
Dust Collector Removal of dust
Bottle Filling Machine Filling of Dry Syrup
Bottle Sealing Machine Sealing of Dry Syrup Bottle

Condition for manufacturing Dry Syrup:

 Relative Humidity: Not more than 45%.
 Temperature: Below 250

Liquids and Semisoloids Dosage Forms

 P a g e | 44

Although tablets and capsules are more widely used than liquid preparations for oral
administration, the oral use of liquid pharmaceuticals has generally been justified on the
basis of administration to those individuals who have difficulty swallowing solid dosage
forms. Drugs that have difficulty in swallowing solid dosage form are administered in
solution. A drug administered in solution is immediately available for absorption and in
most case is more rapidly and efficiently absorbed than the same amount of drug
administered in tablet or capsules.

Liquids and semisolids preparations include-

 Oral Syrup  Emulsion

 Suspension &
Areas of liquid section:

Antacid area Other Liquid Area

Syrups Suspension
 P a g e | 45

Manufacturing Flow Chart of Syrup:

Preparation of syrup (hot water+sucrose)

Clear red solution was made

Addition of preservatives.

Cooling at 400 C

Addition of wetting agent

Transfer the sucrose solution into the vat by transfer pump

Addition of active ingredient

Addition of co-solvent, buffering agent

Addition of color/flavor
 P a g e | 46

Volume adjustment

Filling

Sealing

Labeling

Packing

Machineries used for Compounding (For Syrup and For Antacid):

The machineries and utensils that are used for compounding are listed below:

1. Compounding vessels (capacity: 3000L, 2500L, 1000L and

500L)

2. Silverson stirrer

3. Filter press pump

4. Colloid mill

5. Transfer pump and

6. Storage vessels

Bottle washing and drying:

The bottle are washed both internally and externally with DM water. The washed bottles
are dried at 140oC for 2 hours. For antacid preparation, bottles are first passed through Cl-
water

Name of machine Capacity Manufacturer

 P a g e | 47

Bottle washing 100-120 bottle/min India

machine
6 channels,100 India
Bottle filling & Cap
bottles\min
sealing machine

Figure:Bottle Washing Machine of Incepta Pharmaceuticals Ltd.

Machines used in the Oral Liquid Manufacturing unit:

In the Oral Liquid Manufacturing, the following machines are used;

Name of the Machine Function Capacity

Steam Jacketed Vessel Mixing 1000 Liter

Charge Vessel Manufacturing 2000 Liter
Storage Vessel Storage 2000 Liter
Cartridge Filter Filtration -
Bottle Filling & Sealing Filling & Sealing of Oral 2500 bottles /hour
 P a g e | 48

Machine Liquid Bottles

Problems Associated With Oral Liquid Dosage Form:

 Microbial contamination

 Sedimentation

 Phase separation

 Cake formation

 Color may be changed

Observation:

 Cleanliness & environment are strictly maintained.

 Temperatures are quarterly maintained.

 Water purity quarterly maintained

 Purified water is used.

 Microbial contamination is maintained.

 Separate bottle washing and drying room.

 All machines are operated according to standard operating

procedure (SOP).

 Machines are calibrated timely.

 P a g e | 49

Cream & Ointment

The topical preparations include the manufacturing of ointments and creams. Semi-sterile
condition is maintained as eye and ear preparations are available. As the bases used in
topical semisolid preparations are susceptible to microbial attack entry is strictly
maintained as of the sterile zone, which must be highly appreciated. General flow charts
of cream and ointment preparations are shown below.

General process of manufacturing Creams:

 P a g e | 50

Water Oil

Phase Phase

Water phase to Oil

phase in a Steam
Jacketed Vessel

Blending by
Mechanical Stirrer

Filling

Sealing

General process of
manufacturing Ointments:

Blending by
Oil Oil phase-I OilOil
to
Addition
Mechanical of Stirrer
Active
phase-II inPhase-II
Phase-IIngredient/s a
Filling
Steam Jacketed
Vessel

Sealing
 P a g e | 51

Machines used in the Manufacturing of Creams & Ointments:

In the Manufacturing of Creams & Ointments, the following machines are used;

Name of the Machine Function Capacity

Steam Jacketed Vessel Mixing 250 Liter

Oil Jacketed Vessel Mixing 250 Liter
Mechanical Stirrer Stirring 200 rpm
Storage Vessel Storage 250 Liter
Tube Filling & Sealing Filling & Sealing of 2000 es/hou
Machine cream/ointment Tube r

Condition for manufacturing of Creams & Ointments:

Relative Humidity: Not more than 45%.

Temperature: Below 250

Common Problems that arise during Creams & Ointments

Manufacturing, Filling & Sealing:

Common Problems that arise during Creams & Ointments Manufacturing, Filling &
Sealing are-

 Heterogeneous mixing
 Phase separation
 Change in fill volume
 Change in color of the creams & ointment
 Hardening of base
 Agglomeration
 Improper filling
 Improper sealing
 P a g e | 52

Antidandruff Shampoo

Wide ranges of pharmaceutical topical preparations that are available commercially

include antidandruff shampoo to prevent dandruff on the scalp, which is mainly due to
bacterial and fungal attacks.

General process of manufacturing Antidandruff Shampoo

Addition of
excipients into
demineralized (DM)
water

Addition of Active

Milling

Filling

Sealing

Machines used in the Manufacturing of Antidandruff Shampoo:

In Manufacturing of Antidandruff Shampoo, the following machines are used;

 P a g e | 53

Name of the Machine Function Capacity

Steam Jacketed Vessel Mixing 250Liter

Mechanical Stirrer Stirring 1000 rpm
Storage Vessel Storage 250 Liter
Bottle Filling & Sealing Filling & Sealing of bottle 600 Bottle/hour
Machine

Condition for manufacturing of Antidandruff Shampoo:

Relative Humidity: Not more than 45%.

Temperature: Below 250

Common Problems that arise during Antidandruff Shampoo

Manufacturing, Filling & Sealing:

Common Problems that arise during Creams & Ointments Manufacturing, Filling &
Sealing are-
 Heterogeneous mixing
 Change in color of shampoo
 Change of viscosity
 Improper filling
 Improper sealing

Sterile Preparations

Sterile products are dosage forms of therapeutic agents that are free of viable
microorganisms. Principally these include parenteral, ophthalmic and irrigating
preparations. Of these, parenteral products are unique among dosage forms of drugs
because they are injected through the skin or mucous membrane to the internal body
compartments.
 P a g e | 54

Commonly the small volume parenteral or injectable products are filled in-

 Ampoules
 Vials

Injectable Products in Ampoule:

Injectable Products are dispensed in ampoules following the procedure given below-

Ampoule Deboxing
¯
Ampoule washing
¯
Sterilization (in case of aseptically filled ampoules)
¯
Ampoule Filling (under laminar air flow)
¯
Ampoule Sealing
¯
Terminal Sterilization
¯
Ampoule Inspection
¯
Sealed Ampoules

Ampoule Filling & Sealing (under laminar air flow):

Ampoule on the filling belt
¯
N2 flush ® Filling ® N2 flush ® Sealing by flame ® Ejection
 P a g e | 55

Figure:Ampoule Washing Machine of Incepta Pharmaceuticals Ltd.

Ampoule Inspection:

 The white zone detects visually the black particles,

 The black zone detects the white particles.
 The volume is measured visually by taking 4 ampoules at a time in hand

Particle count:

Particle count at rest Particle count at operation Microbial growth

Class
(/m³) (/m³) (cfu)

0.5µ 5µ 0.5µ 5µ

A 3500 0 3500 0 <1

B 3500 0 350000 2000 <5

 P a g e | 56

C 350000 2000 3500000 200000 <50

D 3500000 20000 Not defined Not defined

Different Sterilization Techniques & their uses:

Sterilization Temperature Exposure Time Pressure Uses

Technique ( 0C) (hrs) (Bar)

180 3 1.1 Vials

Dry Heat Sterilization 220 2.5 1.1
260 1 1.1
(DHS)
Ampoules,
Steam Sterilization 121 0.5 1.1 Gloves, Filters,
/Autoclave Gourmets

Zonal Classification of Clean Rooms & Respective Air pressure:

Zone Class of Environmental Air pressure

Cleanliness (Pascal)

Under Laminar Airflow A NLT 40

Filling zone A 40
Sealing zone B 40
Filtration room B 30
Change Rooms C 15-30
Ampoule cooling room C 20
 P a g e | 57

Ampoule storing room D 10

Machines used in the Manufacturing of Injections (Ampoules):

Name of the Machine Function Capacity

Ampoule washing Washing 12000ampoule (0.2ml)/hr

machine
Ampoule Filling & Filling & Sealing 7000ampoule (0.2ml)/hr
Sealing Machine,
Storage Vessel Storage 50 Liter

Cartridge Filter (0.2μm) Filtration -

Vial sterilization process:

Washing by hot WFI

Sterilized by sterilization chamber at 3300 C temperatures for 7-8 min.

Cooling to 400 C

Turn table

Filling

Rubber stopper

Sealing

Room condition/Critical parameter:

 P a g e | 58

Temperature: Below 250 C.

Relative humidity: Below 60% (Manufacturing area).
Below 50% (Packaging area).
Pressure: Positive pressure in rooms and negative pressure in corridor and pressure
difference 12-15 Pa.

1Figure: Vial Washing Machine of Incepta Pharmaceuticals Ltd.

Maintenance of Sterile Areas:

Area Cleaning solutions Concentration Time

(%)
IPA 70
Covers of Laminar air Before & after
Savlon 17.5
flow Production
Filling & Sealing machine IPA 70 Before & after
Production
Walls IPA 70 Once a week

Ceiling IPA 70 OnceCartoning

Capping a week
Powder Dosing (a) 9/18 Machine
Washer micro Machine
Hypochlorite 1 Once a week
DepyrogenationTunnel
solution
 P a g e | 59

Floors Savlon 17.5 Every day

Dettol 2.5 Every day

Lyophilized Products
Lyophilized Facility:
Lyophilization or freeze drying is a process that is playing an increasingly important role
in the Pharmaceutical industry today. The process is an optimal drying method under
vacuum to extend the lifetime of moisture and temperature sensitive medicine. It gives
products excellent solubility characteristics that allows for rapid reconstitution. In
Bangladesh, Incepta is the first manufacturer of lyophilized products. The whole facility
is set up in clean room environment in order to maintain high quality standard and aseptic
processing. Sophisticated equipments are used to meet the specialized requirements
needed for the process.
Lyophilization process:
Precooling at -45ºC for 2 hours

Primary Drying up to -25ºC (ramp duration)

Wait for 250 minutes at -25ºC (soak duration)

 P a g e | 60

Apply vacuum at 0.2 milibar

Allow temperature to rise up to 10ºC

Secondary Drying at 30ºC for 30 minutes

Wait for another 250 minutes at 30ºC

Deicing by 85-90ºC pure steam

Nitrogen gas is used to remove moisture

Collect product at 25-30ºC

Figure: Lyophilized Filling Machine (Front) of Incepta Pharmaceuticals Ltd.

Lyophilized products manufactured by Incepta include:

 Pantoprazole – Pantonix 40 injection

 P a g e | 61

 Omeprazole – Omenix 40 injection

 Esomeprazole – Esonix 40 injection
 Vecuronium Bromide – Nor Q injection
 Azithromycin – Tridosil IV infusion
 Vitamin B Complex and Vitamin - C – Aritone IV

Figure: Lyophilized products of Incepta Pharmaceuticals Ltd.

Ophthalmic Preparation
With continuous effort to provide better products, Incepta established a state-of-the-art
ophthalmic facility. It is well-equipped with technologically advanced equipments and it
strictly maintains quality standards.

All eye drops are manufactured in a specially controlled aseptic environment, where it
has the highest precision in every area.
 P a g e | 62

Figure: Ophthalmic products of Incepta Pharmaceuticals Ltd.

Pre-filled Syringe Filling Facility:

Self-filling a syringe can be a difficult process, which is not only slow but can also result
in incorrect dosages and spillage. The availability of prefilled syringes allows both
convenience and accuracy to self-administered drugs.

Incepta has built up an international standard, pre-filled syringe filling facility under
aseptic condition. The state-of-the-art machineries have all the latest technologies which
can fill up to 0.1 ml of product. It is a closed system with isolator technology which
protects the medication from contamination.

Some of the products manufactured in this facility are:

 Sodium Hyluronate – Hyronate

 Filgrastim (rDNA) – Filastin
 Erythropoietin (rDNA) – Epoetin
 Enoxaparin Sodium – Parinox
 Hydroxypropyl Methyl Cellulose – Lubric Gel

 PEG Interferon α-2A - Optipeg-A

 P a g e | 63

Figure: Pre-filled Syringe Filling products of Incepta Pharmaceuticals Ltd.

Nasal Preparation

Nasal preparations are intended for application of drug to the systemic circulation via
naso-pharingeal route and so they posses a separate group of pharmaceutical
preparations.
These pharmaceutical preparations are prepared with care because of their administration
in microbial infections.
At Incepta Pharmaceutical Limited, the nasal preparations are manufactured & dispensed
in two forms;
 Nasal Drop
 Nasal Spray

Supported by special controlled production facilities, Incepta has a strong line-up of nasal
sprays and drops. The production is done under condition which minimizes microbial and
particulate contamination.

We have wide spectrum presentation of nasal sprays and drops for effective and safe
treatment of allergic rhinitis and related complications.

Some of the products manufactured in this facility include:

 P a g e | 64

 Oxymetazoline – Rynex Nasal Drops & Spray

 Mometasone Furoate – Momeson Nasal Spray
 Fluticasone Propionate – Lutisone Nasal Spray
 Budesonide – Budicord Nasal Spray
 Triamcinolone Acetonide – Cenolon Nasal Spray
 Olopatadine – Lopadine Nasal Spray

A Figure: Nasal Sprays & Drops of Incepta Pharmaceuticals Ltd.

Cephalosporin Products

According to cGMP regulations separate facility for Cephalosporin is required to prevent

cross contamination with other penicillin products or non-beta-lactum products.
Unintended exposure with Cephalosporin products may cause health concern to patients
sensitive to Cephalosporins.

 Fully separated, well established and isolated manufacturing area only for
Cephalosporin.
 P a g e | 65

 Highly sophisticated HVAC system and AHU are used to condition, monitor and
supply clean air to the working zone.
 Production floors and wall are covered with epoxy resin.

Incepta is the first national company in Bangladesh to build a dedicated state-of-the-art

Cephalosporin facility. Incepta currently produces tablets, capsules, powder for
suspensions and injectables in this facility.

Some of the high quality cephalosporin brands that are produced by this pioneer facility
include:

 Cefadroxil – Adora
 Cefepime – Ultrapime
 Cefixime – Emixef
 Cefpodoxime – Ximeprox
 Cefradine – Procef
 Cefetamet – Tenafet
 Ceftazidime – Sidobac
 Ceftriaxone – Exephin
 Cefuroxime – Kilbac
 Cefotaxime – Cefotim
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Figure: Cephalosporin products of Incepta Pharmaceuticals Ltd.

MACHINERIES USED IN CEPHALOSPORIN AREA:

Serial Name of Machine Brand Name Origin Capacity

No.
01 Vial Washing, Filling, Capping & Macofar Italy 9000/hr
Packaging Machine
02 Tablet Compression Machine N.R Industries Thailand 13 station

03 Film Coating Machine N.R Industries Thailand 20 kg

04 Blister Machine Hoonga Thailand 6000/hr
05 Encapsulation Machine Sejong SF Korea 40000/hr
06 Powder Loader Korea
07 Powder for suspension Filling Jih Cheng Taiwan 3000/hr
Machine
08 Bottle Washing Machine Taiwan
09 Sealing & Labeling Machine Italy
10 Dryer India
11 Blender Cosmec Italy 350 & 700
Kg
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12 Multi Mill India

13 Autoclave Celestar Spain

Packaging

Pharmaceutical packaging has to be carried out for the purpose of the safety of the
pharmaceutical preparations in order to keep them free from contamination, hinder
microbial growth, and ensure product safety through the intended shelf life for the
pharmaceuticals. Packaging is a critical tool in the pharmaceutical industry for product
delivery and regulatory compliance; many pharmaceutical companies will do all their
packaging within a contamination free environment or Cleanroom. Some common
pharmaceutical packaging techniques include foil and heat sealing; polyester and olefin
package printing; polyethylene and polypropylene printing; and flat bed die cutting.

The main purpose of using packaging material is to keep the pharmaceutical preparations
safe from any types of contamination.

Pharmaceutical products are mainly packed into two steps:

Primary Packaging:

The packaging material with which the product always remains directly in contact is
called primary packaging. For example, blister packaging, bottle filling, foiling of
capsule etc.
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Secondary Packaging:

After the primary packaging the products are packed with one or more packing material
is called secondary packing. For example, packing in outer carton or Shipper undergoes
to secondary packaging. Secondary packaging can be also classified into another two
types.These are:

a. Online Packaging
b. Offline Packaging

a. Online Packaging:

The packaging in which the primary packaging and secondary packaging are done
simultaneously is called online packaging.

b. Offline Packaging:

The packaging in which the primary packaging is done first and the secondary packaging
is done later, is called Offline Packaging.

The packaging materials are selected when they fulfill the following characteristics:

 They must protect the preparation from environmental conditions.

 They must not be reactive with the product
 They must not impart to the product tastes or odor
 They must be non-toxic
 They must be FDA approved
 They must applicable temper-resistance requirements
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Figure: Honga Blister machine of Incepta Pharmaceuticals Ltd.

In Incepta Pharmaceutical Limited following packaging materials are used

In primary packaging:
 Poly vinyl chloride (PVC)
 Poly vinyli di-chloride (PVDC)
 Aluminum foil
 Aluminum tubes
 Glass vials and ampoules
 Glass bottles
 Plastic bottles
 Plastic container

In secondary packaging:

1. Paper packet :
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2. Three types-

a. Swedish (gives yellow color when tearing)

b. Cromolex (gives white color when tearing)

c. Duplex (gives gray color when tearing)

3. Shipment carton

Following packs are available here:

 Strip pack
 Blister pack

Following materials are also included in packaging:

 Label
 Insert
 Tape
 Plastic cap
 Dropper
 plastic

Quality Assurance Department

Quality assurance (QA) is a wide-ranging concept covering all matters that individually
or collectively influence the quality of a product. With regard to pharmaceuticals, quality
assurance can be divided into major areas: development, quality control, production,
distribution, and inspections. Quality assurance is the heart and soul of quality control.

QA= Product Design + GMP + QC+ Quality goal activities

Quality is built-in. Only a quality raw material, under correct operation procedure and
quality production facilities, handled by qualified personnel, under controlled
 P a g e | 71

environment can result a quality drug products. Deviation in any stage of manufacturing
can affect the overall quality of a drug product as a result Quality

Assurance is a wide-ranging concept, which covers all matters that individually and or
collectively influence the quality of a product. As whatever not written is not done,
documentation is a very important.

Quality Assurance (QA) department of Incepta Pharmaceuticals Limited is associated

with-
a) Quality Control
b) Quality Compliance
c) Quality Surveillance

The Quality Assurance department maintains product quality through cGMP & various
organized activities. This department is correlated with raw materials & packaging
materials sampling up to market compliance.
Functions
of Quality Assurance:

The main functions

of Quality Assurance include-
 In-process Check/Control (IPC)
 Documentation
 Finished Goods Release
 Retention sample management
 GMP Training/ Coordination
 Market (Drug Product) complaint Handling
 Arranging quality audit visits to suppliers & self-inspection.
 To ensure implementation of GMP in routine operations.
 Establishing manufacturing methods & SOPs covering entire procedure.
 Identifying problems & positive actions for error cause removal.
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 To ensure product quality & adequate training program.

 Ensuring product stability.
 Co-ordination for packaging development and process improvement.
 Review of market compliants for actions.
In-process Check/Control (IPC):

In-process Check/Control (IPC) for:

Solid Liquid Semisolid

Blend uniformity Identity Description

Loss on drying (LOD) Odor Assay
Appearance Viscosity Particle size
Average weight Fill variation weight Foreign matter
Dosages uniformity PH
Hardness Screen
Thickness Average fill intent
Friability Specific gravity
Weight variation
Disintegration
Dissolution

Ampoule/vials Blisters after packing

Filling Filling
Sealing Sealing
Weight variation Leak test
Filled Volume Presence of dust

Documentation:
Documentation of QA department includes the followings-
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 Record of annual Batch Production Record (BPR)

 Record of LOG books
 Temperature & Humidity control record
 Goods destruction records
 BPR Archival
 Product Change Over Certificate
 Out of Specification Certificate
 Process Validation Record

A Batch Production Record (BPR) contains

Maximum Material Received (MMR) Fill Label Pack (FLP) Order

Number Batch Printing Order sheet
Analytical Report Sheet (ARS) In-Process Checks
Bulk or Raw material Scan Sheet Report of Inspection (ROI)
Quality Assurance Profile Label/Carton Sample
Wt./Vol.Chart Sterility Report
Product Change Over Certificate Pyrogen Report
Lot Accountability Toxicity Report
Label Accountability Finished Good Releases order
Others, if any

Retention Sample Management:

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 Sampling of raw materials (Both actives & excipients) & packaging

materials.
 Destruction of rejected or expired Products according to SOP.

GMP Training/ Coordination:

 Arrangement of Training for both
-Officer &
-Worker.
Market complains Handling:
 Collection of rejected goods & maintenance for at least 5years
 Problematic product handling

Quality Control Department

Quality Control Department is very important for a pharmaceutical industry to maintain

GMP. The concept of Total Quality Management refers to the process of striving to
produce a perfect product by a series of measures requiring an organized effort by the
entire company to prevent or eliminate errors at every stage in production.

The Quality control Department confirms the quality of a product not only during
production but also to its final stability in the market, its potency, physical and chemical
parameters of raw materials (both active & excipients). The Quality control department
Maintain record books or file of work done in the factory and others records.

The Quality control Department has the following functions:

 General chemical analysis of-

--Raw materials
--Packaging materials
--Finished products
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 Analytical method development

 Stability test
 Microbiological test

At Incepta Pharmaceutical Limited, Quality Control Department is subdivide into three

sections, namely-

 Raw materials & Packaging section

 Commercial section
 Method Development section

Figure:QC Laboratory of Incepta Pharmaceuticals Ltd.

Raw materials & Packaging Section:

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Raw materials & Packaging section of QC deals with all the analytical procedures
required to meet the specifications of raw materials & packaging. The tests performed by
the section for both raw materials & packaging are as follows:

Raw materials
Solid raw materials: Liquid raw materials

Identification Maximum tests for solid

LOD Refractive index
Residue on ignition PH
Bulk density Weight per ml
Heavy metal testing Viscosity
Impurities
Melting point
Screen test
Assay
Packaging material

Label Cartoon Catch cover

Text Color & Text Same test as done for

Color Proper gumming or gluing cartons.
Size Proper locking Contains no MRP.

Bottles Vials Foils

Body diameter Alkalinity Color

Neck finish & Height Thickness Thickness
External/ Internal diameter Diameter Width
Opacity Leak test
Percentage of Aluminium
& Resin
Rubber closure Ampoules Cap
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PH Alkalinity Printing
Stickiness Thickness Color
Toxicity Height Diameter
Density Breaking point Height
Alkalinity Volume

Commercial Section:
Commercial section of QC deals with all the analytical procedures required to meet the
specifications of finished Products. The tests performed by the section for Finished
Products are as follows:

Finished product

Solid preparation Liquid preparation Dry syrup

Description Description Description

Disintegration time Weight per ml Assay
Dissolution time Assay Reconstitution rate
Weight variation PH Dispersion
Assay Microbiological limit test
Stability Testing

Method Development Section:

Method Development Section of QC performs the following functions-

 Standardization of Standard Operating Procedure (SOP)

 In house analytical method development
 Development of Standard Testing Procedure (STP)
 Equipment verification/ calibration,
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 Process Validation

 Stability test:

Stability test is done for a finished product to predict whether the product be stable for
sufficient time to ease marketing of the product according to ICH guideline (International
Conference on Harmonization) Stability test is done for any new drug, change in the
formulation, change in primary packaging material, for change in the source of raw
material and for registration purpose

 Conditions of stability test:

Real time stability test: In real time stability test, the product is kept up to one year
more than predicted expiry date i.e. shelf life. The storage condition is-

Temperature: RT ± 20C
Relative humidity: 60 ± 5%

Accelerated stability test (AST): In accelerated stability products are kept for short life
(3 or 6 months) in accelerated condition. Upon the stability over this condition, shelf life
is predicted.
Temperature: 40 ± 20C
Relative humidity: 75 ± 5%
 Prediction of shelf life:

 If a product is stable over 1 year real time stability test, then 2 years of shelf life
can be predicted for the product.
 If a product is stable over 3 months accelerated stability test, then 2 years of shelf
life can be predicted for the product.
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 If suppository is stable over 1 year real time stability test, then 1.5 years of shelf
life can be predicted for the products. Accelerated stability test can’t be done for
suppository, as it tends to melt on body temperature.

Stability testing parameters:

 Description  Disintegration
 Assay  Dissolution
 Viscosity  Friability
 pH  Hardness

Figure:HPLC Machine of Incepta Pharmaceuticals Ltd.

Instruments available in the QC Department & IPC:

 PH meter,  Disintegration tester,

 Dissolution tester  Friability Testing Apparatus,
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 Tablet Hardness Tester  UV spectrophotometer

 Melting point apparatus,  FTIR spectrophotometer
 Potentiometric titrimeter  GC machine,
 AtomicAbsorption  Heating Mantle
Spectrophotometer (AAS)  Dehumidifier
 Leak test apparatus  Vacuum Filter
 Halogern-moisture analyzer,  CC
 Electronic balance
 HPLC machine  Polarimeter,
 Magnetic stirrer  Karl-Fischer Titrator,
 Ultrasonic bath  Shaker

Microbiology Department

Microbiology is the study of microorganism. It is concerned with their form, structure,

reproduction, physiology, metabolism and classification. It includes the study of their
distribution in nature, their relationship to each other ands to other living organisms, their
effects on human beings and on other animals and plants.

The Microbiology department at Incepta Pharmaceutical Limited works in association

with the QC department. The areas its analysis and different analytical methods are given
below:

Tests Required for Tests

Microbial limit test
Pyrogen test (LAL test)
Raw materials
Sterility test (in case of sterile RM)
Sensitivity (potency) test for antibiotics
Packaging materials Microbial limit test

Microbial limit test

Pyrogen test (LAL test) (for WFI)
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Conductivity
Water PH
Environment
(Raw, DM, WFI) Microbial limit test by settle plate

Filters Microbial test

Sterility test
Personnel Microbial limit test

Figure:Microbial activities of Incepta Pharmaceuticals Ltd.

Common Microbiological tests:

Microbiological tests Required media Temperature Incubation period

(0C) (Days)
Microbial limit test TSB 37 7
TGM 22 14
Limulus
Pyrogen test (LAL test) Amebocyte Lysate 37 14
(LAL) reagent
Sterility test TSB 37 7
TGM 22 14
Sensitivity test TSB 37 3
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Figure:Kinetic LAL test of Incepta Pharmaceuticals Ltd.

Instruments available in the Microbiology Laboratory:

 Refrigerator  PH Meter
 Hot Air Oven  Conductivity Meter
 Dry Heat Sterilizer  Shaking Bath
 Moist Heat
Sterilizer/autoclave
 Antibiotic Zone reader
 Laminar Air flow unit
 Particle counter
 Incubator (Warmed)
 Incubator (Cooled)
 Microscope
 Micropipettes
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ENGINEERING DEPARTMENT

The Engineering Department guarantees proper production environment. The manufacturing area
of a Pharmaceutical plant demands different grades of cleanliness. Apart from particles, moisture
and temperature should also be within specification. Pharmaceutical plant also uses different
grades of water, steam lines, vacuum system and so on. All these utilities are maintained by the
Engineering Department.

Facilities:

 Electricity:

The electricity supplies from 2 gas Generators of capacity 805 KW & 523 KW. the plant has a
electricity supply from Rural Electrification Board (REB) The plant has its own back up
secondary power system with 2 stand by Diesel generators, which provide 350KW & 252KW.

 Central Air-conditioning system:

The plant is fully air conditioned by central Fan Cooling Unit (FCU) system using 2 chillers of
capacity 350 tons and 250 tons, where ‘air compression’ ® ‘condensation’® ‘expansion’®
‘evaporation’®then again compression cycle is maintained

 Air Handling Unit

There are 17 air-handling units including laminar airflow system. The individual air conditioning
unit is provided for separate section of the plants as per requirement, for example, separate air
handling units for sterile area, cooling area, washing area, production area, administration area ,
Cephalosporin Building etc.
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 Air filtration System:

This system is mainly used for sterile air for sterile area (Injection and Ointment) and
Cephalosporin Building.

 Compressed air:

Compressed air is provided by central system with Two-compressor with speed of 6.98m3/min.

 Boiler (Steam generator):

The boiler or steam generator is of Shellmax company. It has a capacity of 2.00 tons and supply
capacity of 3000 LBS/hr. Although the maximum used now about 2200 LBS/hr.

 Water Supply:

The plant has its own water supply from deep tube-well with a capacity of 17000 Liter/hr and
treated by RO Plant with a capacity of 2000Liter/hr to get purified water and DIP plant with a
capacity of 1500Liter/hr for getting de-mineralized (DM) water. This water goes to the distil
water plant section and after that it goes to multicolumn plant for getting WFI. Finally its goes to
the different section. There are two distil water storage tank of 1500 liter capacity which
maintain water at 800C continuously to avoid the growth of the microorganism and the water is
always remain in circulation which called loop system.

Types of water:

 Well water  DM water

 Hot water  Water For Injection (WFI)
 Purified water
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GSchematic Diagram of Purified Water Plant:

Portable Automatic Break

water Multimedia
filter Reverse Osmosis

Coreless filter (10µ) Automatic Softener Automated Carbon Filter (absorbs Cl and organic molecules

Soften Water tank Heat exchanger Cartridge filter

Circulation pump Booster pump

Storage tank
(600L)
Continuous Electro deionizer

Purified Water

Loop circulation pump

Heat exchanger

User Point (25

 P a g e | 86

Figur
e: STILMAS Water for Injection Plant

HVAC System:

HVAC (heating, ventilation, and air conditioning) refers to technology of indoor or automotive
environmental comfort. HVAC system design is a major subdiscipline 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 temperature and humidity, as well as "fresh air" from outdoors.
 P a g e | 87

Figure: Schematic Diagram of Air Handling Unit (AHU)

Effluent Treatment Plant:

The purpose of an Effluent Treatment Plant (ETP) is to reduce Biological Oxygen Demand
(BOD) & Chemical Oxygen Demand (COD) of pharmaceutical unused chemicals, powders and
waste materials which may cause severe harmful effect on environment as well as human health.

Effluent management in Incepta Pharmaceutical Limited is carried out through biological and
chemical treatment process.

Process Flow Chart of Effluent Treatment Plant (ETP)

Collection Tank
↓
Storage Tank
↓
Mixing & Cooling
↓
Neutralization
↓
Chemical Coagulation
↓
Biological Oxidation Tank
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↓
Sedimentation & Separation of Sludge
↓
Sludge Thickener
↓
Filtration
↓
Discharge to Drain

Collection Tank: Commencing part, waste from different section enter here.

Storage Tank: Several blower pipes in this chamber. Mixing properties are different with temp.
as well.

Mixing & Cooling: Cooling tower is on paddle mixer used for mixing.

Neutralization: PH is controlled here.

Chemical Coagulation: Fe₂ (SO₄)₃, Al₂(SO₄)₃ etc use for coagulation.

Biological Oxidation Tank: Artificially Eco-system established. Blowing air helps to live
micro-organism.

Sedimentation & Separation of Sludge: The blanket of precipitations is skimmed off to

another tank and remaining solution is removed to pressure filter.

Sludge Thickener: After exceeding the required level of recycling, sludge passed through
thickening chamber.

Filtration: Filtration layer consists of sand rock which filters wet sludge to extract water rest in
it.

Discharge to Drain: Release to environment with the check of final load of effluent in it. 
 P a g e | 89

Conclusion

We feel very much proud on the completion of our in-plant training in The Incepta
Pharmaceuticals Ltd. as it is the leading pharmaceutical industry in Bangladesh. Its contribution
for the development of national economy is well known. We have gained cast knowledge during
this training period that will be definitely helping us in future.

Our academic curriculum would be insufficient if we were not here. But why we feel proud, the
cause is, first of all this is the fast growing pharmaceutical industry in Bangladesh that maintains
“quality” first. Most important is that the company is assuring quality of all its products and its
company is doing its best to make medical development of human resources of our country.

We would like to say that we have achieved our best knowledge here by having the opportunity
to have our training here. So we are very much thankful to the Authority of Incepta
Pharmaceuticals Ltd.

We have learned many others thing from here, one of them was discipline. The Incepta
Pharmaceuticals Ltd. strictly follows the discipline, which is the key to their success and also
important in any organizational level. The officers here try heart and soul to lead the company
forward.

The two weeks in plant training has been completed successfully by the help of all the people
The Incepta Pharmaceuticals Ltd. Our achievement during this training will eventually help us in
our professional life.

On behalf of our department and on our own behalf, we would like to express our hearties thanks
to Incepta Pharmaceuticals Ltd. We hope that such cooperation between the authority of Incepta
Pharmaceuticals Ltd. and the department of Pharmacy, Southeast University Bangladesh will be
strengthened day by day and will remain everlasting.

Finally, all best wishes to Incepta Pharmaceuticals Ltd.

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Reference

 www.inceptapharma.com
 The Theory and practice of Industrial Pharmacy- Leon Lachman
 http://en.wikipedia.org/wiki/Incepta_Pharmaceuticals
 Assurance of Quality Pharmaceuticals- Dr.M. Shah Nawaz Khan