1. Prepared as requirement for the
The Degree in Bachelor of Pharmacy of Gautam Buddha Technical
University, Lucknow (U.P.)
AT
TRINITY PHARMACEUTICALS
Ranwar road,
Karnal-132001
Date: 15/06/2011 to 31/07/2011
Submitted By: Submitted To:
Kriti Sharma Mr. Prabhat Kumar Upadhyay
B. Pharm. (4th yr) Asst. Professor
Roll no. 0824250023
G.L.A. INSTITUTE OF PHARMACEUTICAL RESEARCH MATHURA.
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2. CERTIFICATE
To whom so ever it may concern
This is to certify that KRITI SHARMA, a student of B. Pharm. (4th yr) in
G.L.A. Institute of Pharmaceutical Research, Mathura has completed her
Industrial Training at TRINITY PHARMACEUTICALS, KARNAL from
15/06/2011 to 31/07/2011.
(Signature) (Signature)
Dr. Pradeep Mishra Mr. Prabhat Kumar Upadhyay
Director Asst. Professor
GLAIPR, Mathura. GLAIPR, Mathura
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3. At the onset I must bow down in reverence to the almighty that blessed us with
the understanding & prevalence that is needed in this kind of project report.
I acknowledge my sincere thanks & gratitude to Dr. Pradeep Mishra (Director,
G.L.A.I.P.R.) & Mr. Prabhat Upadhyay (Asst. Professor) who provide me an
opportunity to visit Trinity Pharmaceuticals, Karnal for industrial Training.
With great pleasure I express my heartiest thanks to Mr. S. K. Sharma
(Production Manager) for giving me an opportunity to work under their
guidance in their esteem organization & providing me necessary resources for
my project. It makes & feels me proud to be a part of Trinity Pharmaceuticals,
Karnal.
I am also thankful to Mr. Vipin Gupta (Human Resource Manager), who
provides me an invaluable support in collecting the necessary information
regarding my project.
I would like to thank all the staff and members of Trinity Pharmaceuticals,
Karnal. At last I would like to extend my sincere thanks to all the respondents to
whom I visited for giving their support & valuable information, which helps me
in completing my project work.
Kriti Sharma
B. Pharm. (3rd yr)
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4. Roll No.- 0824250023
CONTENT
Introduction
 Industry Profile
 Industry Layout
Marketed Products
Manufacturing Units
 Parenteral Section
Quality Control Section
Summary
Reference
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6. Industrial Profile
Trinity Pharmaceutical is one of Asia’s most respected ISO-9002 & ISO-14001
certified company with manufacturing facilities complying with WHO-GMP
guidelines. It has pharmaceutical business in India. It was established in 1997at
karnal.
It supplies its products mostly in Uttar Pradesh. It is a vertically integrated
pharmaceutical company with the ability to manufacture & market
pharmaceutical products & services.
The company has world class active pharmaceutical ingredients & formulation
manufacturing facilities with 36 member’s staff. The company has a vision of
becoming a knowledge-driver pharmaceutical company with the highest level
of operational excellence in all spheres.
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7. INDUSTRIAL LAYOUT
PARSEL PARSEL
WINDOW WINDOW
CORRIDOR
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9. LIST OF THE MARKETED PRODUCTS
Sr.No. Name of the products Active Constituents Uses
1 AMLOX INJECTION IP Amoxacillin & Antibiotic
Cloxacillin
(with water for inj. IP)
2 CEFONIK INJECTION IP Cifataxime Sodium Used for
(with water for inj. IP) urethritis
3 MPLOX INJECTION IP Ampicillin & Cloxacillin Antibiotic
(with water for inj. IP)
4 NEMOCEF INJECTION USP Ceftriaxone Sodium Antibiotic
(with water for inj. IP)
5 ONIZID INJECTION USP Ceftazidime (with Antibiotic
water for inj. IP)
6 ONIZONE INJECTION USP Cerfoperazone (with Antibiotic
water for inj. IP)
7 ONIZONE-S INJECTION IP Cefoperazone & Antibiotic
Sulbactam (with water
for inj. IP)
8 AMIKATRIN INJECTION Amikacin Used in T.B.
9 GENTABON INJECTION Gentamincin Sulphate Used in
pneumonia
10 JANVIT-12 INJECTION Vit. B12 + Folic Acid + Used in vit. B
(COMBIPACK) Niacinamide with deficiency
Vit-C
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10. 11 FANCI-12 INJECTION Methylcobalamine + Used in vit. B
(COMBIPACK) Folic Acid + deficiency
Niacinamide with Vit.
C
12 TRIBION INJECTION Vit. B12 + B6 + Used in vit. B
Niacinamide + D- deficiency
Panthenol with
Methylcobalamine
13 POLYNEURONE INJECTION Vit. B1 + B6 + B12 + Used in vit. B
Niacinamide + D- deficiency
Panthenol
14 OPTIBION INJECTION Vit. B-Complex Used in vit. B
deficiency
15 ND-25 INJECTION Nandrolone Used in
Deaconate 25mg osteoporosis
16 ND-50 INJECTION Nandrolone Used in
Deaconate 50mg osteoporosis
17 NP-25 INJECTION Nandrolone Phenyl Used in
Propionate 25mg osteoporosis
18 ONITRON INJECTION Ondensterone Antiemetic
19 PANCLOFEN INJECTTION Diclofenac Sodium Analgesic
20 LICODOL INJECTION Tramadol HCl Analgesic
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13. The manufacturing of Parenterals is carried out in aseptic or sterilized
conditions. The following instruments are used for manufacturing of
Parenterals in the company:-
Multicolumn Distillator
Collection Tank
Pure Steam Generator
Vial Washing Machine
Sterilizer
Dry Powder Injection Filling Machine
Vial Sealing Machine
Visual Inspection Magnifier
Sticker Labelling Machine
1. MULTICOLUMN DISTILLATOR:-
It is used for distillation of raw water in order to get distilled
water.
2. COLLECTION TANK:-
It is made up of steel & is used for the collection of distilled
water.
3. PURE STEAM GENERATOR:-
This instrument is used for the generation of pure steam.
4. VIAL WASHING MACHINE:-
It is used for washing of the vials. All contact parts with the
internal surface of Ampoules/Vials and the wash media are
made of Stainless Steel. It can wash 240 vials per minute. It has
different washing zones with independent circuits to avoid
contamination.
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14. Automatic Vertical Rotary Ampoule & Vial Washing Machine
Cleaning and internal siliconization of vials
5. Sterilizer:-
Sterilizer is used for the sterilization of the vials/ampuls for
complete removal of the microbes. The working of sterilizer
involves the following processes:-
A) Drying Zone
Glass containers entering the drying zone from the up-line
washer are treated with clean vertical laminar air, vaporizes
the moisture, pre-heats the containers and protect hot air
back-flow from the hot zone.
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15. B) Hot Zone
Glass containers then enter the hot zone and are subjected
to a thermal cycle of sterilization and depyrogenation.
C) Cooling Zone
Glass containers further enter the cooling zone, where they
are subjected to cold laminar air to bring down the
temperature before entering the aseptic area.
D) Automation
PLC Controlled and equipped with touch screen colour
graphics display for easy operator access to control screens
and statistics, data storage and retrieval. Data management
system is 21 CFR part II compliant.
Sterilizer
6. Dry Powder Injection Filling Machine:-
This machine is used for filling & rubber stoppering of the vials.
The sterile powder was kept in the powder hopper which will
agitate powder by a pair of mechanical agitator for maintaining
consistency & bulk density. The accurate volume of the powder is
then filled in the vials by means of vaccum. It is then followed by
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16. rubber stoppering of vials by keeping rubber stoppers in the
rubber hopper.
Automatic injectable powder vial filling & rubber stoppering
Machine
7. Vial sealing machine:-
It is used for capping or sealing of the filled & stoppered vials.
Parts coming in contact with the vial / aluminium cap or
exposed to the atmosphere are made out of stainless steel as
per GMP.
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17. Automatic Vial PP / Flip-off Cap Sealing Machine
8. Visual inspection magnifier:-
This magnifier is used to detect the presence of particulates in
the prepared injectable against the black & white background.
9. Sticker Labelling Machine:-
This machine is used for sticker labeling of the prepared
injectables in vials/ampuls.
Sticker Labelling Machine
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18. Production plant for Parenterals
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19. STEPS FOR FORMULATING A PARENTERAL COMPOUND
Cleansing of equipments & containers
Rinsing new containers
Cleaning rubber & plastic components
Sterilization of equipments
Compounding the product
Filtration of the solutions
Filling of the compounded drug
Sealing of ampuls, bottles or vials
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21. Containers:-
Parenteral preparations are supplied in glass ampoules, bottles or
vials, plastic bottles or bags, and prefilled syringes, which are
coloured in the case of light-sensitive substances.
Except where otherwise indicated in individual monographs, these
containers are made from material that is sufficiently transparent to
permit the visual inspection of the contents. They should not
adversely affect the quality of the preparation, allow diffusion of any
kind into or across the material of the container, or yield foreign
substances into the preparation.
Closures:-
Closures for parenteral preparation containers should be equipped
with a firm seal to prevent entry of microorganisms and other
contaminants while permitting the withdrawal of a part or the whole
of the contents without removal of the closure. They should not be
made of components that react with the contents, nor should they
allow foreign substances to diffuse into the preparation. Plastic
materials or elastomers of which the closure is composed should be
sufficiently firm and elastic to allow the passage of a needle with the
least possible shedding of particles. Closures for multidose containers
are made sufficiently elastic to allow the puncture to reseal when the
needle is withdrawn and protect the contents from airborne
contamination. A tamper-evident container is fitted with a device
that reveals clearly whether it has ever been opened.
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23. Labelling:-
Every pharmaceutical preparation must comply with the labelling
requirements established under Good Manufacturing Practice.
The label of a parenteral preparation should include:
(1) the name of the product;
(2) the name(s) of the active ingredient(s); INNs should be used
wherever possible;
(3) the amount of the active ingredient(s) in a suitable dose volume
and the volume in the container; for powder for injections: the
amount of the active ingredient(s) in the container;
(4) the batch (lot) number assigned by the manufacturer;
(5) the expiry date and, when required, the date of manufacture;
(6) any special storage conditions or handling precautions that may
be necessary;
(7) directions for use, warnings, and precautions that may be
necessary; and
(8) the name and address of the manufacturer or the person
responsible for placing the product on the market.
For parenteral preparations that are solutions or dispersions, the
concentration of the active ingredient(s) should be given in terms of
mass or biological activity per volume. For concentrated solutions,
labels should state the composition and the dilution to be carried out
before use.
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25. The quality control section of the company involves the processes 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 stages in production. The in-process quality
control for Parenterals is as follows:-
1) Checking the bulk solution, before filling, for drug content,
pH, colour & completeness of solution.
2) Checking the filled volume of liquids or filled weight of
sterile powders for injection in the final containers at
predetermined intervals during filling.
3) Testing for leakage of flame-sealed ampuls.
4) Subjecting the product to physical examination for
appearance, clarity & particulate contamination.
5) Examining the sterility indicator placed in various areas of
the sterilizer for each sterilization operation.
6) Submitting the product for sterility testing to establish the
safety & other parameters of the product.
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26. The following quality control tests are perfomed in the quality control
section of the company:-
1) LEAKAGE TEST:-
Any leakage in the ampuls may cause entry of micro-organisms
in the ampuls or the drug content may leak outside & spoil the
appearance of package. Thus, this test is carried out to check
the leakage of ampuls.
Leakers are detected by producing a negative pressure within
an incompletely sealed ampul in a vaccum chamber, while
ampul is entirely submerged in a deeply colored dye solution
(0.5% methylene blue). Some amount of dye is entered into the
ampul from opening. This is visible after the ampul has been
washed externally to clear it of dye.
2) CLARITY TEST:-
It is practically impossible to prepare a lot of a sterile product so
that every unit of that lot is perfectly free from visible
particulate matter, i.e.,30 to 40 m & larger in size.
The visual inspection of a product is done by individual human
inspection of each externally clean container under a good light,
baffled against a black & white background, with the contents
set in motion with a swirling action. The care must be taken to
prevent entry of air bubble. A moving particle is easier to see
than that of stationary particle. It is necessary to invert the
container to see the heavy particles as the final step in
inspection.
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27. VISUAL INSPECTION OF A PREPARATION
3) LAL TEST:-
The presence of pyrogens in the preparation can be detected by
an in-vitro test method for pyrogens. This method utilizes the
gelling property of the lysate of the amebocytes of Limulus
polyphemus (the horseshoe crab). A firm gel is formed within 60
min in the presence of pyrogenic endotoxins from gram
negative bacteria when incubated at 37 . This test is
commonly known as LAL test.
4) STERILITY TEST:-
The sterility of the preparation can be determined by incubating
the small volume of preparation in an agar plate at 37 for 48
hours. If the growth of micro-organisms occurs in the agar plate
after 48 hours, then that preparation will be discarded.
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29. The powdered injectables filled in vials/ampuls are then packed into
cartoons. These cartoons are stored in a cold place. The light
sensitive pharmaceutical products are stored in the absence of sunlight.
The region where these cartoons are placed should be neat & clean.
The pharmaceutical products should be stored carefully in order to
prevent the breakage of containers and the spoilage of the drug.
These cartoons should well label.
Injectables Stored in Cartoons
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31. Trinity Pharmaceutical was established in 2008 at Karnal. It is one of
Asia’s most respected, ISO-9002 & ISO-14001 certified company with
manufacturing facilities complying with WHO-GMP guidelines.
The company has different units like manufacturing unit, quality
control & assurance unit.All these parenteral preparations are carried out
in the fully aseptic conditions. The walls & floor are epoxy-coated.
The manufacturing unit consists of a change room, compounding
room, aseptic chamber, vial washing machine, sterilizer, filling & rubber
stoppering machine, sealing machine & labeling machines. The vials are
washed in the washing machine. These are sterilized in the sterilizer. The
compounded injectable powder is then filled into these sterilized vials
which are stoppered by rubber stoppering. These vials are then sealed &
moved forward for visual inspection.at last these are labeled & packed
into the cartoons.
The quality control department deals with assessing of quality of
raw materials, integrity of raw materials, packed materials & finished
products.
It has world class active pharmaceutical ingredients &
manufacturing facilities. It supplies its pharmaceutical products mainly in
Uttar Pradesh (India). Some of the pharmaceutical products of this
company are Amlox Injection, Nemocef injection, Onizid Injection,
Polyneurone Injection, Licodol Injection, Onitron Injection, Gentabion
Injection, Tribion Injection, Amikatrin Injection, Fanci-12 Injection,
Onizone-S Injection, mplox Injection, licodol Injection, etc.
Optibion Injection and Amlox injection are the major marketed
products of the company.
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32. Lachman Leon, Lieberman Herbert A & Kanig Joseph L. The Theory &
Practice of Industrial Pharmacy. 4th ed.(1991). Bombay: Varghese
Publishing House, Hind Rajasthan Building, Dadar.
www.google.com
www.pharmaonline.com
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