DURGAPUR UNIT

WARIA ROAD RATURIA DURGAPUR – 713215

SESSSION 2023-2024
A PROJECT ON
“PRODUCTION QUALITY CONTROL”

NAME- BIDHAKAR RAY

STREAM- BACHELOR OF PHARMACY

COLLEGE- DR. B. C. ROY COLLEGE OF PHARMACY

& ALLIED HEALTH SCIENCES

SUBMITTED TO- EAST INDIA PHARMACEUTICAL

WORKS LTD
 ACKNOWLEDGEMENT
I consider it a great privilege & honour to have had the
opportunity to undergo the industrial training work in East
India Pharmaceutical Works Ltd. Durgapur; for their guidance
and support to get acquainted with the factory during my
training period.
Hence, I would like to offer my heartiest thanks to the
works manager

MR. UTPAL DUTTA CHOWDHURY.

I convey my heartiest thanks to the respected member of the

Mr. Sayan Banerjee, Mr.
company
Buddhadeb Dutta , Mr. Soumen Nandi and
Mr. Patit Paban Pal, Mr. Jayabrata
Debnath& Mr. Amitava Bandhu for their
most valuable suggestions, constant encouragement,
and affectionate guidance during the period of this
training.
I would like to thanks all trainees and staffs, who
help me very much and without whom support and
guidance it was impossible for me to complete the
project successfully.
 PREFACE
Pharmacy is a profession which is concerned with the art and
science of preparing suitable and convenient material for
distribution and use in the treatment and prevention of disease, so it is
a fully technical profession where practical knowledge is much
more important along with theoretical knowledge.
According to curriculum of a four year integrated degree
course of BACHELOR OF PHARMACY each student has to
undergo practical training for a period of one month in any of the
pharmaceutical industry in India.
I was directed to undergo at “ East India
Pharmaceutical Works Ltd. ” and this report contains a brief
description of the
above pharmaceutical industry which was observed during the
training program.
HISTORY INDEX
MISSION &VISION
PLANT AND CAPACITY
PRODUCTS
INTRODUCTION
PRODUCTION UNIT
 QUINIDOCHLOR UNIT
 COLLOIDAL IRON UNIT
 BOILER UNIT

COMPACT EFFLUENT TREATMENT

PLANT (CETP) & EFFLUENT
TREATMENT PLANT (ETP)
TEST PERFORMED IN MICROBIOLOGY
LABORATORY
QUALITY CONTROL AND ANALYTICAL
LABORATORY
SAFETY
CONCLUSION
 HISTORY
On April 27, 1936, East India Pharmaceutical Works Limited (EIPWL)- one of the oldest
pharmaceutical companies of India was born as a brainchild of an Indian entrepreneur and
visionary late Asoke Kumar Sen. The object was simple to develop, through private
entrepreneurship, an organizationto synthesize modern drugs from basic chemicals and cater
to the needs of millions. At the very inception, late Hirendra Nath Duttagupta joined inSri Sen,
a personality with great leadership qualities. EIPWL became a public limited company in 1941.
In addition to being the market leader in quinidochlor, it has a presence in key therapeutic
segments such as Antibiotics, Digestive enzymes, Sedatives, ophthalmic and haematinics,
Nasal Decongestants and Herbal Products.

FOUNDING Fathers :
Late Asoke Kumar Sen :
Ignited by the fire of building a nation that can proudly exhibit its scientific advancement
and industrial self-reliance, Asoke Kumar Sen founded East India Pharmaceutical Works in
1936 – a company that he took to dignifying heights with his relentless passion and
uncompromising persistence on perfection.

A First Class Post-Graduate in Organic Chemistry from the University of Kolkata, he

steered the course of the company, first as its Managing Director till 1976 and then as
the Chairman till 1981. To all those who had the privilege of knowing him closely, Asoke
Kumar Sen was an institution.

Late Hirendra Nath Duttagupta

Matching shoulders with Asoke Kumar Sen was Hirendra Nath Duttagupta, whose
intricate business sense and able leadership guided EIPW to its eminent stature in the
country’s drug industry.

His journey has been an inspiration. Being an active freedom fighter during the Indian
struggle, he was imprisoned while pursuing Physics at Presidency College, Calcutta. As
a result, his quest to proceed with science was forcefully denied. But with strong
perseverance, he went on to complete his graduation in Arts.

He initially joined the erstwhile Managing Agents of EIPW and then gradually became
an ex-officio Director. He rose to become its Managing Director in 1956, a post he
continued to hold till the day he breathed his last in 1987. He was also the past
National President of Organisation of Pharmaceutical Producers of India.
PAST MANAGING DIRECTORS :

Late Dipankar Duttagupta ;

An accomplished alumnus of St. Xavier’s College, Calcutta and New York State University,
Dipankar Duttagupta started his career as a Consultant at AT&T. He joined EIPW in 1975
and served the company for over 37 years, last as Managing Director until his untimely
death in 2012. His skillfull handling of Industrial Relations is an example of ideal relationship
between the employer and employees, which was a major stimulus for growth of EIPW. His
interest in science for new molecular targets of drug development and appreciation for
novel discoveries was inspirational.

He also served as Chairman of Indian Chemical Council (Eastern Region), Chairman of

the Medical Committee of OPPI, President of Bengal National Chamber of Commerce and
Industries and as Chairman of National Safety Council, West Bengal Chapter.

Late Amit Kumar Sen :

One of the few distinguished fellows of the Institute of Chartered Accountants of India to
receive the Golden Membership and a fellow member of the Institute of Company
Secretaries of India and associate member of the Institute of Chartered Secretaries, UK;
Amit Kumar Sen used his precise understanding of finance, accounts and administration
to steer EIPW’s growth for over half a century, till his sad demise in March 2019.

He became the company’s Managing Director in 1987 and with his admirable proficiency
in business relationship development; he not only took EIPW to international shores but
also went on to head the table at major Chambers, Clubs and Organisations.
 MISSION & VISION
MISSION:
To provide thoroughly researched, superior quality and cost-effective
‘medicines for millions’.

 To achieve customer satisfaction as the fundamental to our

business
 To provide products and healthcare services of the highest quality
 To practice dignity and equity in relationships and provide
opportunities for our people to realize their full potential
 To ensure profitable growth
 To foster mutually beneficial relations with all our business partners
 To manage our operations with high concern for safety
and environment
 To be a responsible corporate citizen

VISION:
To increase our global presence. To continuously develop advanced
formulations through precise R&D. To make medication more and more
affordable to people. To explore new-age, futuristic opportunities in the
healthcare industry.
 Plant and Capacity
Presently, we have two state-of-the-art manufacturing facilities, both
located in West Bengal.

One is a 19.06 acre advanced infrastructure at the extreme south fringe

of Kolkata city at Sarsuna. The other is a 20 acre recent facility located at
the sprawling town of Durgapur, just about 170 km from Kolkata.
The Sarsuna unit is strategically spread over multiple manufacturing
blocks and is equipped with the most contemporary and high-end
equipment and machinery; supported by a team of specialists, engineers,
chemists and highly trained workmen. It hosts our entire research and
development infrastructure and hence is the center for all our innovation
activities. The Durgapur unit hosts the main synthetic drugs plant. It is
equipped with the most modern reactors to carry out different unit
processes and operations on a large scale.

Conforming to the highest standards of quality, safety and

manufacturing ethics, our facility has also been credited with GMP (Good
Manufacturing & Quality Control Practice) and we have also received the
WHO-GMP certification. Besides the two units, we have employed various
third party manufacturing facilities across the country that adhere to our
manufacturing standards.
THERAPIES
PRODUCTS
:
 ANALGESIC- ANTIPYRETIC
 ANATACID- ANTIFLATULENT
 ANTIBIOTIC
 ANTIFUGAL
 ANTIPROTOZOAL
 COUGH SYRUP
 HAEMATINIC
 INJECTABLE

HERBAL :
 BODY OIL
 METABOLIC
 IMMUNITY BOOSTER
 HEPATOPROTECTIVE
 UROLOGICAL
 INTRODUCTON
East India Pharmaceutical Works Ltd., can roughly be
divided into 5segments as follows:
 Quinidochlor Plant
 Colloidal iron Plant
 Boiler house
 Compact Effluent Treatment Plant (CETP) and
 effluent Treated Plant (ETP)
 Quality control, Microbiology and Analytical

Hereby, under production we have two Active

PharmaceuticalIngredients (APIS) namely Quinidochlor and
colloidal iron.

Water used in these processes are tested for

microbes inmicrobiology laboratory.

The raw materials and the final product are analyzed in the
qualitycontrol lab.

The waste water from the Plant is processed in ETP and Discharged.

The solid waste are disposed into solid waste storage unit
and the finished API then send to the Sarsuna factory for the
manufacture ofEnteroquinol and Tonoferon.
 PROCEDURE :
I. Charging of raw materials:

150 kg of 4-chloro -2- nitro phenol and 150 kg of 4-chloro -2- amino
phenol along with 272 kg of glycerine is charged into the glass lined
reactor and dozing of 420 kg of sulphuric acid is done in small lots. 140
litre of water is used to complete the reaction, some amount of this
water is used to ensure the free flow of glycerine. This reaction isknown
as Skraup synthesis.

Skraup Synthesis:
Skraup synthesis is a chemical reaction used to synthesize
guinolines.It is named after the Czech chemist Zdenko Hans
Skraup (1850- 1910). In the general skraup synthesis, aniline
is heated with sulphuric acid, glycerol and an oxidizing agent
like nitrobenzene to Quinolines.
Steps Involved In General Skraup Synthesis:
 Dehydration- glycerine reacts with sulphuric acid
to produceacrolein.
 Michael addition- acrolein produced in the
above stepundergoes addition reaction
with aniline.
 Electrophilic attack.
 Oxidation with nitrobenzene.
Reaction Completion:
In general, reactions takes 7-8 hours for completion. Disappearance of oily drops looking
glass Of GLR indicates the reaction completion. At the time of completion, the
temperature of the reaction is around 128°C to 135° C,
the production rate is average for 25 kg per day.
Distilled nitro/ glass condenser :
During reaction, nitro is recycled back to the reactor by the help of
Glass condenser and some part of distilled nitro is collected outside
the reactor by absorption Where water is used as condensing media.
What is also used as coolin media in glass condense, That distilled
nitro which is collected is used again in reactor in the next batch
process.

The two main advantages of nitro distillation -

i. Provide distilled nitro
ii. The excess pressure is released.
The vessel in which Skraup's reaction takes place has 2 mm thick
glass lining and it is maintained at temperature 124 -137°C and
contain a glass lined anchor for stirring. The capacity of this vessel is
1000 ltr.

II. DISCHARGING :
The final product quinoline at the end of Skraup's reaction is being
discharged through the bottom value of GLR into a discharge Vat of
capacity 2000 litres where is already added. This is kept overnight.
The water remove heat from the final product. The storage tank is
made of polypropylene fibre reinforcement plastic.
made of polypropylene fibre reinforcement plastic.
 III. Purification and extraction:
The product is pumped into purification Vat and diluted by adding
water. 410 Kg of commercial caustic lay is them added. The whole
material is mixed uniformly and kept overnight, pH is checked next day
and then passed through a plate and frame type filter. Waste sludge is.
separated and transferred to ETP and filtrate is transferred to iodination
Vat. 38-42% CausticLay is generally added to render the material free
from impurities. pH is then adjusted to 1.5-1.7. Volume of this
extraction tank is 6000 litres

IV. Iodination plant:

i) Preparation of ICL :
200 kg of Iodine and 60 kg of chlorine are added. Rotameter is used
to control the flow of this chlorine gas in a round bottom flask and
this flask is kept in water bath to reduce the heat evolved during the
exothermic reaction. When the reaction completes, 200 L of HCL is
added in small lots and the rest of the volume is made up with water,
thus 200 Kg of ICL is produced. Reaction time for production of ICL is
2-25 hrs.

ii) Dilution of ICL :

ICL is diluted to 10 times with water in a Vat with the capacity of
2000 liters.

iii) Iodination:
The diluted ICL solutions is added to the purified 5-chloro-8-hydroxy
quinoline solution is small lots in the iodination vessel which is
provided with an impeller types stirrer mechanism. This ICL and
quinolinemixture is brick red in colour at the end point and the
addition is carefully monitored. The reaction is tested by taking a
small amount of the reacting liquid in a test tube and filtering it,
using an ordinary filter paper and funnel. The reaction is 100%
complete if no suspended solid appears on the paper point is the
filtrate is reddish in colour, then it shows excess amount of ICL has
been added.

V. Filtration :
Filtration is done to produce acid free QIC. The acidic filtrate is send
to ETP. The plate and frame filter press is used which has 54 plates,
53 Chambers, 100 Ton cylinders hydraulic power pack system,
control panel filter cloth made up of Nylon having a capacity of 45 kg
per plate. The deionized water is used as the wash liquid and
washing is done 2 times diagonally to remove the acid. The first wash
lasts 1 hr 30 mins while the second wash take about 10 minutes
point the entry of water and acid in the plates are regulated by a
valve mechanism. Diagonally Opposite valves are opened up at a
time while the other two remain closed and the feed follow through
a closed path through the center, 70% of the unbound water is
removed by compressed air.

VI. Drying:
The washed cake from the filter press is dropped into the belt
conveyor below the filter press. This leads the cake to the lump
breaker i.e., roller mill. This cake is broken down into smaller lumps
which are dropped on a screw conveyor rotating at 5-6 rpm and then

to the disintegrator for further size reduction to form particles. These

particles are being sucked up into the bag filter where they are air
dried using compressed air. The temperature is maintained at 80°C.
There is an ID fan also situated inside the drying duct, which creates
vacuum and helps expel the particles out. The permissible limit for
moisture content is less than 0.5% w/w. The QIC in powdered form
reaches a second conveyor added by a Rotary valve.

VII. Packaging:
After completion of drying, the Powder is packed anddispatched toSarsuna
factory in Kolkata.
 MAJOR EQUIPMENTS USED :
Equipments Quantities
MS glass lined reactor (1000L) 02
Purification vat 01
MS filter press 02
Iodination vat 01
ICL dilution vat 01
Spin flash dryer with hot air 01
generator
Screw type air compressor 02
Weighing machine 02

MAJOR INGREDIENTS USED :

SL.No. Ingredients Amount used
1 4-chloro-2-amino 150kg
phenol
2 4-chloro-2-nitro phenol 150kg
3 Sulphuric acid 420kg
4 Glycerine 272kg
5 Iodin mono chloride 172-176kg
i Iodine 200kg
ii Chlorine 60kg
iii Hydrochloric acid 200kg
iv Water q.s
6 Caustic lay 410kg
7 Water 140kg

TOTAL BATCH SIZE-479KG

 Flow Diagram

4-Chloro-2-amino Phenol Water 4-Chloro-2-nitro phenol Iodine Water

Sulphuric acid Skraup’s Condensation Glycerin
Reaction temperature 124-137°C ICl
Reaction time 5-7hrs (Average) Chlorine Preparation
Hydrochloric acid
GR Discharge
Caustic Lay 2000 L Water ICl Dilute
Discharge vat Vat (1:10)

Extraction & Purification Iodine mono chloride

pH 1.5-1.7 Kept Overnight

Filtration Iodination & Washing

pH 1.7-2.0
Solid Cake

5-Chloro-7-iodo-8 Q.I.C Wash Water

-hydroxy quinolene
Solid waste
Storage area Filtration E.T.P
Solid Cake 70⁰/₀ moisture

Drying
Air inlet temperature 159-

168⁰C Air outlet temperature

78-89⁰C

<0.5⁰/₀ moisture
Product collection & packing

Dispatch to Sarsuna Factory

Colloids are homogeneous non-crystalline substance consisting of
large molecules or ultra-microscopic particles of one substance
dispersed through a 2TM substance. Colloids include gels, sols &
emulsions; the particles do not settle & cannot be separated out by
ordinary filtering or centrifuging like those in a suspension. Colloidal
iron is basically a triple iron sucrose complex syrup. It is used mainly
as haematinic solution. It is sold under the brand name in the market
is Tonoferon.

Raw materials:
 Ferric chloride (FeCl3)
 Sodium Carbonate (Na₂CO3)
 Citric Acid
 Sugar
 Sodium Benzoate
 Caustic flake
 Water

Procedure:
I. Solution:
(i) Ferric Chloride:
To produce Ferric Chloride solution, 350 kg of anhydrous ferric
chloride is dissolved in 900 liters of water.

(ii) Sodium Carbonate:

To produce sodium carbonate solution 345 kg of sodium carbonate is
dissolved in 900 liters of water.

II. Reaction:
75 It of ferric chloride solution is taken in a vat, having a capacity of 1000lt.
Approximately 37-38 It of water or up to a certain level is added to it & the
 mixture is then stirred. To it, sodium carbonate solution is added slowly, till
ferric hydroxide sludge is. formed. The dozing of sodiumcarbonate is then
stopped, but the stirrers run for additional 3-Sminutes. After which they are
stopped and the material is sent for pH testing (limit5.3-5.7). After checking
the pH, water is added to make the sludge liquefied. The material is pumped
into the washing vats. There are a totalof 12 vats used for this purpose, having
a capacity of 2200-2400 litres.
Total 12times reaction is done 12 vessels and the total material is sent for
washing in 12 number washing vats. The amount of material is divided into
6pairs of washing vats.

FeCl3 + Na2CO3 + H20----> Fe (OH)3 + NaCl + CO2 (gas)

III. Washing:
After the material is transferred into the vat, it is then filled with water.
Total converted and diluted material of 200 lts to 250 lts is taken.
Aeration isdone in each vat for 30 minutes. Then approximately 60-70
minutes is given for settling. After which, the 1st valve is slowly open to
check the
settling status. If no suspended materials found, then the valve Is
completely open for draining out the wash water. Then after 10-15
minutes, the 2nd valve is opened then after 10-15 minutes(approx),
closing of 2nd valve, the 3rd valve is now opened. The same process is
repeated for 2nd & 3rd wash.

IV. Filtration:
After completion of 3 wash, the bottom discharge valve of washing valve of
washing vat & the material is collected in the cage mat trolly with a Capacity
of 650 Its,for filtration.

V. Peptization:
The material from the 12 cage mat trolleys transferred manually to the
peptization vat having a capacity of 2000lt. 55 kg of anhydrous citric acid is
added, it is then stir for 35 minutes, after which thestirrers are
stopped.Approximately 16* kg of caustic soda flake solution, is added to adjust
the pH of the solution to 6.7-7.3,preferably 7.The stirrers are then stop
approximately 390kg of pharmagrade (P.G.) sugar is added. Stirring isdone for
30 minutes and again the stirrers are stopped. 10.5 kg of sodium benzoate
is added as preservative. 30 minute stirring is continued for an
additional 30 minute & the total material is then transferred to the
evaporator for boiling.

VI. Boiling:
After transferring the total material into the evaporator having capacity of
2500 It, the lid of the evaporator is closed. Steam line is opened &
approximately after 330-390 minutes of boiling the desired specific
gravity i.e 1.28-1.32 is reached. After checking & getting the desired
specific gravity & pH, the steam is stopped and the material is transferred
through a pump in the storage tank& kept overnight for settling&
cooling(ph-6.5-7.5).

VII. Centrifugation:
Once again specific gravity & pH of the material is checked ore passing
the material through centrifuge, rotating at a speed of 1400 rpm. The
centrifuged material is directly kept in high density polyethylene (HDPE)
drums for dispatching to Kolkata factory after getting the test reports
from QC department.
 MAJOR EQUIPMENTS USED :

Equipments Quantities
Ferric chloride solution vat 01
Sodium carbonate solution 01
Preparation vat 02
Ferric hydroxide precipitation 02
reactor
Washing vat 12
Trolley type filter bed 12
Peptization vat 01
SS. Evaporator with jacket 01
Centrifuge machine 01
Weighing machine 01

MAJOR INGREDIENTS USED :

SL.No Ingredients Amount used

1 Ferric Chloride 350kg
2 Sodium carbonate 345kg*
3 Caustic flakes 16kg
4 Sodium benzoate 10.5kg
5 Pharmagrade sugar 390kg
6 Citric acid 55kg
7 Water q.s.
TOTAL BATCH SIZE:1050LT.
In East India Pharmaceutical Works Ltd., there are two boilers are
present as energy supplier. One is of 2.0 ton & the other is of 1.5 ton,
which are generating the steam in a large amount. This steam is used
in Colloidal Iron & Quinidochlor plant both, for the purpose of drying
& evaporation.

Steam boiler
 ETP is an essential process to purify waste water coming from different
manufacturing industries for its reuse and safely disposingit to the
environment to protect it from the harmful effects of the effluent.

Different steps involved in the ETP process:

Step 1
Waste water from QIC and colloidal iron comes in 2 channels. Causticlay is
added to QIC in CETP tank and released in the channel. Then, these waste
water are transferred to neutralizing pit which is dividedinto two parts. The
aim of neutralizing the waste water is to adjust the pH of the water.
Hydrated lime is used in this case for the adjustment of pH.

Step 2
The clariflocculator is a
combination of flocculation and
clarification in a single tank. It
consists of a stirrer which causes
the formation of a vortex. The solid sludge sediments below and the liquid
flows upward in the clarifier zone. The deposited Sludge is routed to the
solid waste at ainterval of 3 to 4 months & it dispatches to WBWML and
dischargedand the liquid is transferred to the aerated lagoon chamber
Step 3
An aerated lagoon is a simple waste water treatment system consisting of a pond
with artificial aeration to promote the biological oxidation of waste
waters. Aerobic microbes are added to it. The sludge is channeled to the sludge
drying bed consisting of 4 chambers.
Step 4
The water from aerated lagoon is transferred to the tertiary plant. This
plant consists of 3 equipments arranged in a manner for
furthertreatment of the water.
The first equipment consists of Chlorine dosing unit which chlorinate
water for further filtration. The second equipment is the sand bed unit
which acts as solid liquid separation process. The thirdequipment is
the charcoal bed unit which assists further filtration ofwater.

BIOTECTOR B3500e:
Here, the Chemical Oxygen Demand (COD) of the water is measured. One-
third of COD gives the Biological Oxygen. Demand (BOD).
 EFFLUENT TREATMENT PLANT
Q.I.C C.E.T.P

Neutralizer 1
Neutralizer 2

C.I. Clariflocculator

Drying bed
1 2 3 4

Tertiary plant Aerated Lagoon

Charcoal Bed Sand Bed

Cl

For Testing Biotechtor 3500e

V-Notch Outlet

Drained Out
Drained Out
From Production department, QIC powder and processed water aretested for
detecting the specific microorganisms namely:

1. Escherichia coli:
It is a Gram Negative bacteria, commonly found in lower intestine ofwarm
blooded organisms. Fecal oral transmission is the major routethrough which
pathogenic strains of bacterium can cause diseases.
Optimum growth of E.coli occurs at 37°C but some laboratory straincan
multiply at temperature upto. 49°C. Virulent strain of E.coli causes
gastroenteritis, urinary tract infection, neonatal meningitis, Crohn's disease.
Common symptoms are diarrhoea, vomiting
,abdominal cramps.

2. Salmonella abony:
Salmonella species are non spore forming predominantly motile
enterobacteria. Salmonella genus of bacteria causes major illness inthe world
such as diarrhoea, Cholera, etc. Identities generally foundin both warm and
cold blooded animals.
3. Pseudomonas aeruginosa:
It is a common Gram Negative bacteria that can cause disease in plants and
animals including humans. Mainly found in soil, water andskin Flora
throughout the world. It typically infects the Airway urinary tract, burns and
wounds and also causes other blood infection.

4. Staphylococcus aureus:
It is a Gram Positive Bacteria, frequently found in the upper
respiratory tract and on the skin, and causes skin infection,
respiratory infection and food poisoning. They are also known as"golden
staph" and "oro staphira".

5. Shigella boydii:
It is a Gram Negative bacteria. It is non motile, non pore forming, rodshaped
bacteria which can cause dysentery in humans through fecal- oral
contamination.
 6. Candida albicans:
It is opportunistic pathogenic yeast that is a common member of thehuman gut
flora.it does not proliferate outside the human body. It isdetected in the mouth
and GIT tract in 40-60% of healthy adults.
The main tests that are performed are as follows:

1. TOTAL PLATE COUNT (measured in CFU/ml)

a. Portable water (process water) > limit: 500 CFU/ml b. Purifiedwater >
limit: 100 CFU/ml

2. PATHOGENIC ORGANISM
The above tests are beingperformed with the help of following
instruments:
 Incubator
 Autoclave
 Microwave
 Refrigerator
 Balance
 Laminar air flow
(All these instruments are sterilized before beginning the test).

Identification of pathogenic microorganisms in test sample.

E.Coli, Salmonella abony, Pseudomonas aeruginosa, Staphylococcus aureus,

Shigella boydii, and Candida albicans are four major speciesthat are identified and
isolated from various Samples used for pharmaceutical research and Production
and the lab of microbiology

East India Pharmaceutical Works Ltd. The identification involves 7days

of work, where various reagents and culture media are used.
The following mediums used are:
 Nutrient Agar.
 Cetrimide Agar
 Pseudomonas Agar
 Triple sugar iron(TSI) agar
 Vogel Johnson agar Xylose lysine deoxycholate(XLD) agar
  Macconkey Agar
 Soyabean casein digest agar(SCDA)
 Soyabean casein digest media (SCDM)
 Rappa port vasciliadis soyabean meal broth
 Mannitol Salt agar
 Enterobacteria Enrichment broth
 Peptone water
Reagents used:
 Kovac's indol reagent
 Glycerine
 Ethyl alcohol
 N,N,N,N- tetramethylp-phenylene-di-amine-di hydrochloride.
Procedure:
DAY 1
 100m of samples to be tested is taken in a conical flask by taking
care that it does not get contaminated. The samples isthen
filtered via membrane filter( pore diameter-0.45 micrometre)
The membrane filter is then cut into 2 equal halves.one half of thefilter
paper is immersed in a conical flask containing
filter paper is immersed in a conical flask containing
  Enterobacteria Enrichment broth that supports the
growth ofE.coli and S.aboni). Another half is immersed
in soyabean casein digest medium broth
 Both the conical flask are incubated at 37°C for 24 hrs.
DAY
2
 The broths are observed after 24hrs.
 1mlof sample from previously incubated EE broth is
taken and added to a test tube containing 10ml of
Macconkey broth and incubated at 44°C for 24hrs.
 1m of sample from the EE broth is added to another test
tube containing RVSM and incubated at 37°C for 24 hrs.
Using a pre strerilized inoculating loop,the solution from
the SCDM is transferred to 3 consecutive plates namely
cetrimide agar, VogelJohnson agar and mannitol salt agar
and streaked. These plates are then incubated at 37°C for
24hrs.

DAY
3
 From the previously incubated macconkey broth, 0.5ml
of Solution is taken and added to another test tube
containing Macconkey broth and an inverted Durham's
tube.Now, the mentioned system is incubated. After
incubation, if the mediacolour changes & a bubble is
observed in the inverted Durham's tube, then we can
say that E.coli may be present.
 One loopful from RVSM is taken and streaked on XLD
media and incubated.Red colonies with or
withoutblack centres areobserved.
 One loopful from Cetrimide agar plate is taken and
streaked onPseudomonas agar plate and incubated for
72 hrs. Greenish colonies are observed around the
streak Previously VJ plate shows black spots in red plate
surrounded by yellow zones.If this is observed ,then
S.qureusis present.
  If the previously incubated Mannitol Salt agar
plate showsyellow spots surrounded by yellow
zones, we can say thatS.qaureus is present.
DAY 4
 . Iml of sample from the previously incubated
macconkey brothcontaining the inverted Durham's
tube is taken and added to a test tube containing
10ml of peptone water. This is then incubated at
37°C for 24 hrs. After incubation, 2-3 drops of
Kovac's indole Reagent is added to the test tube .A
red ring is formed within 1 min of addition. Presence
of E.coli is confirmed.
 One loopful from the previously incubated XLD
media is taken and stabbed followed by streaking on
the TSI agar medium. This is then incubated. The
media turns blackish at the stabbedand streaked
places after incubation, and medium rupture or
crack are observed on the media surface. This
confirms the presence of S. abony.
 Firstly, a blotting paper is taken and 3 consecutive
zones are drawn on it. Then, a loopful from the
previously incubated Pseudomonas agar media is
smeared on these 3 zones and 2-3drops of
Wurster's reagent is added on the smear. If the
colourchanges from pink to purple, then the
presence of P. aeruginosa is confirmed.

Test for efficiency of sterilization process:

Here are mainly the efficiency of the autoclave is
tested via twomain indicators.
 OK strips
 EZ testing
 Quality control is a system of maintaining standards in
manufacturedproducts by testing a sample of the output
against the specification. It is a procedure or set of
procedures intended to ensure that a manufactured
product or performed service adheres to a defined setof
quality criteria or meets the requirements of the client or
customer. QC is similar to, but not identical with, quality
assurance (QA).
Quality Assurance is the maintenance of a desired level of
quality in aservice or product, especially by means of
attention to every stage ofthe process of delivery or
production. In East India Pharmaceutical Works Itd.
primarily two products and their raw materials are
checked in Quality control and quality assurance testing.
Instruments:
The following are the instruments used in quantity control
testing:
 Gas chromatography
 Weight balance.
 Auto titrator
 Single cell UV spectrometer
 Multicell UV spectrometer
 pH meter
 Conductivity meter
 Pycnometer
 Polarimeter
 Raw materials:

Quinidochlor I.P Colloidal Iron

4-Chloro-2-nitro phenol Ferric chloride B. I. S
4-Chloro-2-amino phenol Soda Ash light I. P
Glycerin Citric acid I. P
Sulphuric acid (commercial Refined sugar I. P
grade)
Caustic lay (commercial grade) Sodium benzoate I. P
Iodine (crude) & Hydrochloric Caustic soda flake I. P
acid (commercial grade)

REPORT FOR QUINIDOCHOLOR I.P.

Product name: Enteroquinole

Stability - 5 years.
REPORT ON QUINIDOCHOLOR I.P

 Moisture content
 pH of 596(w/v) solution
 Limit test of the following A. Acidity and alkalinity
 Free iodine
 Halide (Cl)
 Bulk density
 Identification
 Photometer (230nm-360nm)
 Oxygen flask
 Sulphated Ash content
 Gas chromatography
 Autotitrator
 GAS CHROMATOGRAPHY :

Aim: To identify and analyze impurities present in the sample.

Impurities:
 5-chloro-8-hydroxyquinolene
 5,7-dicholoro-8-hydroxyquinolene
 5,7-diodo-8-hydroxyquionolene
Procedure:
 The powder is first dissolved in pyridine.
 The solution is then passed through the
columns of gaschromatography.
 The ionized detector shoes the peaks of the
impurities in themonitor.
SULPHATED ASH CONTENT:
Procedure:
 1gm of quinidochlor powder is taken and 1
ml of conc.Sulphuric acid is added to it.
 The mixture is burntin a muffie furnace at 800 C for 40
minutes.
 The residual ash is then collected and weighed to
calculate theash value.
 The tolerance limit of the Sulphated ash content is 0.2%.
AUTO TITRATOR:

AIM: Assay for purity

Procedure:
 0.2g of quinidochlor powder is taken.
 To it 50 ml of DMF is added and then auto titrator
to get thefinal result.
REPORT FOR COLLOIDAL IRON :
Product name: Tonopherone
Stability: 2 years
REPORT ON COLLOIDAL IRON:
 1.Description
 Odor
 Total iron (%6 w/v)
 Conductivity of original solution
 Conductivity (0.1% iron w/v solution)
 Specific gravity (O. D.) 0.01% iron w/v solution is used at 490nm
 Counter ion effect (M /20 MRC12. 6H20 solution)
 pH of original solution
 pH of 1% iron w/v solution
 Weight per ml of sample at 25"C
 Weight per ml (5% w/v iron solution) at 25"°C
 Chloride testing
 Clarity and sedimentation rate of original solution, 10
timesdilution and 40 time dilution.

ASSAY OF COLLOIDAL IRON SAMPLE:

The following test can be performed to assay the colloidal
ironsample.
Determination of total iron concentration in colloidal iron
Procedure:
 Preparation of 10%:
10 ml of sample is taken in a 100 ml volumetric flask and the
volumeis made up to 100 ml mark by addition of water.
 From the above prepared solution, 10 ml is taken in a
conical flask and to it 25 ml 1:1 HCI is added. Ferric
hydroxide precipitateis observed in the solution.
 The flask is then heated over a water bath for 5 minutes.
 The precipitate is seen to dissolve within this time to
produce aclear yellowish liquid.
The solution is then cooled by keeping over cold water.
And thenthe volume is made up to 100 ml with water.
4 ml of this solution is taken in a 25 ml volumetric flask and
wateris added to make the volume up to 25 ml.
1 ml from the above prepared sample is then taken into
another25 ml volumetric flask and to it 2 ml Ammonium
Thioglycolate isadded which is followed by the addition of
10 ml of 3(M) ammonia solution and then 12 ml of water.
Simultaneously a standard iron solution (160 ppm) and
a blanksolution is prepared.
STANDARD SOLUTION: 1ml of standard iron solution is
taken in a25 ml volumetric flask and to it 2 ml ammonium
Thioglycolate is added followed by the addition of 10 ml
3(M) Ammonia solution and then 12 ml of water.
BLANK SOLUTION: 1ml of water id taken in a 25ml
volumetric flask and then add 2 ml of Ammonium
Thioglycolate which is thenfollowed by addition of 10ml
3(M) ammonia solution.
Optical Density of the 3 solutions are checked at 540 nm.
Total iron concentration = concentration of ferric ion +
concentrationof ferrous ion.
Total iron concentration = [(OD sample /OD Standard) X 10] % w/v

Usually around 10-12% of total iron is obtained at the end

of thetest.
CONDUCTIVITY, pH, OPTICAL DENSITY: From the last
solution thatwas prepared in the last step, 1% solution is
made by taking 1ml of the solution in a 100 ml volumetric
flask and adding 99ml of water in it. This 1% solution is
used to check for pH.
1 ml from the above solution is then taken and to it 10m! water
is added to produce a 0.1% solution. This solution is used in
Conductivitytest.
 1ml from this solution is again taken and followed by the addition
of10ml water, to prepare 0.01% solution. This solution is then
proceeded to check Optical Density.

Chloride Test:
Procedure:
 10% sample solution is prepared first and from this 1ml
of thesolution is taken in a crucible.
 To it 9 ml of 10.6% w/v nitric acid is added.
 Precipitation can be observed in the solution. The crucible is
thenheated over a water bath until clear liquid is seen.
 Silver nitrate is then added to the above formed clear
liquid, which is then followed by formation of white
colored precipitateof silver chloride.
 A standard chloride solution 0.1(M) is prepared
simultaneously.To it 9 ml 10.6 % w/v nitric acid is added
followed by performing the rest of the aforementioned
steps.
 The extent of precipitation is compared in both the
sample andthe standard solution. The sample should
always have lesser degree of precipitation than the
standard to pass the test.
 Counterion Effect:
Procedure :
 0.05% (M) magnesium chloride solution is prepared. • 5
test tubesare arranged and to each of them a specific
amount of the above prepared solution is pipetted in
ascending order of their amounts (Eg: 1.1ml, 1.2ml, 1.3 ml,
1.4 ml, 1,5m).
 To each of the test tubes 2 ml of 0:1 % sample solution
(which waspreviously tested for Conductivity) is added,
which is followed by concurrent addition of water making
the total volume in each testtube to about 4m.
 Turbidity is then checked in each of the test tubes
 The counter ion effect is seen in the first point
where thePrecipitate starts forming.
 Safety is utmost requirement for any plant because by
taking proper measuresagainst accident we can increase
the profit of company andcan save manpower from
injury.Safety is totally an Egineering system. According to
Bell Telephone inotto" No job or service is so urgent that
we cannot take time to perform our work safely". "Safetyis
an attitude, a state of mind that must be sustained in work
environment".
 ACCIDENT
Unwanted undesirable events which has potential to hit
injury to aperson or aloss of property
 CAUSE OF ACCIDENT
Unsafe act - 85-90%. Unsafe condition 10-15%.
 UNSAFE ACT: UNSAFE CONDITION:
 Lack of knowledge No provision of safety attachment.
 Inattention Leakage of oil, water, steam etc.
 HurryDust fumes & temperature •Violating
safetyCondition ofladder/scrapped/stair.
 Overconfidence
 Worry & hypertension
 Lack of experience.

HOW TO PREVENT ACCIDENTS?

 Use of proper safety devices.
 Toxic & inflammable materials store process to be isolated.
 Preventive & periodically maintenance of equipment.
 By training of employees through video, audio, lectures etc.
 To motive the people to make active part -
 -for creatingawareness in the plant.
 Use of personal protective equipment
Environmental Safety Management:
The pharmaceutical industry has been described as dynamic
and growing, in terms of sales, number of employees, and
GDP. It is an industry in which companies, government
regulators and researchers focus on the "safety" of the
products and their effects on end users andthe environment.
Industrialization required for the growth of a country, in the
mean time lot of Efluents, Pollutants, wastes are generated.
So the manufacturing business needs to have a focus on
Environment Health and Safety (EHS). It has become
industry norm andstatutory requirement for the
manufacturing industry to adhere to the laws and guidelines
pertaining to EHS laid down by relevant regulatory bodies.
More than anything else, EHS is critical to ensure safety and
comply with Good Manufacturing Practices (GMP). Along
with safer and healthier employees, a strong EHS
management system can work wonders in increasing the
productivity of an organisation as well.
As the use of pharmaceutical products increases,
environmental issuesresulting from the disposal of these
products must be considered.
Addressing these environmental issues involved multiple stakeholders
including: the pharmaceutical industry, health care providers,
environmental regulators and the public. The goals of environmental
management in the pharmaceutical industry are to keep the
concentrations of pharmaceuticals and related chemicals in our air,
land, lakes, rivers, and streams at a minimum.
East India Pharmaceutical Works Limited (EIPWL) is
having the objective to develop, through private
entrepreneurship. an organization to synthesize
modern drugs from basic chemicals andcater to the
needs of the millions.
Depending solely on national resources and talents - East
India Pharmaceutical Works Limited (EIPWL) now has
emerged as a large pharmaceutical company with two
manufacturing units, workforce of1400 employees and an
annual turnover of around Rs. 1300 million.
Quality is the hallmark of EIPWL. At every stage of
production, from raw materials to finished products,
highest standard of quality is ensured with the help of
most modern equipment, trained personneland the state-
of-the art R&D Department. Maintaining this hallmark
EIPWL has now obtained ISO 9001-2008 Certification.
Right from the inception, EIPWL, concentrated in building
up an effective marketing network to attend to the needs
of the medical profession as well as to reach out to the
common man. At present, the Company has 350 well
trained field personnel, 17 sales offices, channel partners
and a large number of approved wholesalers to ensure
the presence of its products everywhere from metro
cities toremote villages.
With forward looking ideas, R&D orientation, quality
consciousness and a strong financial fundamental, East
India Pharmaceutical WorksLimited is determined to open
up new horizons.