Varsha it report

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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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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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)

Roll No.- 0824250023

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CONTENT

Introduction Industry Profile Industry Layout

Marketed ProductsManufacturing Units

Parenteral Section Quality Control SectionSummaryReference

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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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INDUSTRIAL LAYOUT

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PARSEL WINDOW

PARSEL WINDOW

CORRIDOR

LIST OF THE MARKETED PRODUCTS

Sr.No. Name of the products Active Constituents Uses

1 AMLOX INJECTION IP Amoxacillin & Cloxacillin

(with water for inj. IP)

Antibiotic

2 CEFONIK INJECTION IP Cifataxime Sodium (with water for inj. IP)

Used for urethritis

3 MPLOX INJECTION IP Ampicillin & Cloxacillin (with water for inj. IP)

Antibiotic

4 NEMOCEF INJECTION USP Ceftriaxone Sodium (with water for inj. IP)

Antibiotic

5 ONIZID INJECTION USP Ceftazidime (with water for inj. IP)

Antibiotic

6 ONIZONE INJECTION USP Cerfoperazone (with water for inj. IP)

Antibiotic

7 ONIZONE-S INJECTION IP Cefoperazone & Sulbactam (with water

for inj. IP)

Antibiotic

8 AMIKATRIN INJECTION

Amikacin Used in T.B.

9 GENTABON INJECTION Gentamincin Sulphate Used in pneumonia

10 JANVIT-12 INJECTION (COMBIPACK)

Vit. B12 + Folic Acid + Niacinamide with

Vit-C

Used in vit. B deficiency

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11 FANCI-12 INJECTION (COMBIPACK)

Methylcobalamine + Folic Acid +

Niacinamide with Vit. C


12 TRIBION INJECTION Vit. B12 + B6 + Niacinamide + D-Panthenol with

Methylcobalamine


13 POLYNEURONE INJECTION Vit. B1 + B6 + B12 + Niacinamide + D-

Panthenol


14 OPTIBION INJECTION Vit. B-Complex Used in vit. B deficiency

15 ND-25 INJECTION Nandrolone Deaconate 25mg

Used in osteoporosis

16 ND-50 INJECTION Nandrolone Deaconate 50mg


17 NP-25 INJECTION Nandrolone Phenyl Propionate 25mg


18 ONITRON INJECTION Ondensterone Antiemetic

19 PANCLOFEN INJECTTION Diclofenac Sodium Analgesic

20 LICODOL INJECTION Tramadol HCl Analgesic

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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 DistillatorCollection TankPure Steam GeneratorVial Washing MachineSterilizerDry Powder Injection Filling Machine Vial Sealing MachineVisual Inspection MagnifierSticker 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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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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B) Hot ZoneGlass containers then enter the hot zone and are subjected to a thermal cycle of sterilization and depyrogenation.

C) Cooling ZoneGlass 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) AutomationPLC 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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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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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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Production plant for Parenterals

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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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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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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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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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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 40μm & 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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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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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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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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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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http://www.pharmaonline.com/

http://www.google.com/

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