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Varsha it report
 

Varsha it report

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    Varsha it report Varsha it report Document Transcript

    • 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. 0824250023G.L.A. INSTITUTE OF PHARMACEUTICAL RESEARCH MATHURA. 1
    • 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 UpadhyayDirector Asst. ProfessorGLAIPR, Mathura. GLAIPR, Mathura 2
    • At the onset I must bow down in reverence to the almighty that blessed us withthe 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 anopportunity 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 theirguidance in their esteem organization & providing me necessary resources formy 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), whoprovides me an invaluable support in collecting the necessary informationregarding 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 towhom I visited for giving their support & valuable information, which helps mein completing my project work. Kriti Sharma B. Pharm. (3rd yr) 3
    • Roll No.- 0824250023 CONTENT Introduction  Industry Profile  Industry LayoutMarketed ProductsManufacturing Units  Parenteral SectionQuality Control SectionSummaryReference 4
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    • Industrial ProfileTrinity Pharmaceutical is one of Asia’s most respected ISO-9002 & ISO-14001certified company with manufacturing facilities complying with WHO-GMPguidelines. It has pharmaceutical business in India. It was established in 1997atkarnal.It supplies its products mostly in Uttar Pradesh. It is a vertically integratedpharmaceutical company with the ability to manufacture & marketpharmaceutical products & services.The company has world class active pharmaceutical ingredients & formulationmanufacturing facilities with 36 member’s staff. The company has a vision ofbecoming a knowledge-driver pharmaceutical company with the highest levelof operational excellence in all spheres. 6
    • INDUSTRIAL LAYOUT PARSEL PARSEL WINDOW WINDOW CORRIDOR 7
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    • LIST OF THE MARKETED PRODUCTSSr.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 9
    • 11 FANCI-12 INJECTION Methylcobalamine + Used in vit. B (COMBIPACK) Folic Acid + deficiency Niacinamide with Vit. C12 TRIBION INJECTION Vit. B12 + B6 + Used in vit. B Niacinamide + D- deficiency Panthenol with Methylcobalamine13 POLYNEURONE INJECTION Vit. B1 + B6 + B12 + Used in vit. B Niacinamide + D- deficiency Panthenol14 OPTIBION INJECTION Vit. B-Complex Used in vit. B deficiency15 ND-25 INJECTION Nandrolone Used in Deaconate 25mg osteoporosis16 ND-50 INJECTION Nandrolone Used in Deaconate 50mg osteoporosis17 NP-25 INJECTION Nandrolone Phenyl Used in Propionate 25mg osteoporosis18 ONITRON INJECTION Ondensterone Antiemetic19 PANCLOFEN INJECTTION Diclofenac Sodium Analgesic20 LICODOL INJECTION Tramadol HCl Analgesic 10
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    • The manufacturing of Parenterals is carried out in aseptic or sterilizedconditions. The following instruments are used for manufacturing ofParenterals 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. 13
    • Automatic Vertical Rotary Ampoule & Vial Washing Machine Cleaning and internal siliconization of vials5. 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. 14
    • 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. Sterilizer6. 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 15
    • rubber stoppering of vials by keeping rubber stoppers in the rubber hopper. Automatic injectable powder vial filling & rubber stoppering Machine7. 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. 16
    • Automatic Vial PP / Flip-off Cap Sealing Machine8. 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 17
    • Production plant for Parenterals 18
    • 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 19
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    • Containers:-Parenteral preparations are supplied in glass ampoules, bottles orvials, plastic bottles or bags, and prefilled syringes, which arecoloured in the case of light-sensitive substances.Except where otherwise indicated in individual monographs, thesecontainers are made from material that is sufficiently transparent topermit the visual inspection of the contents. They should notadversely affect the quality of the preparation, allow diffusion of anykind into or across the material of the container, or yield foreignsubstances into the preparation.Closures:-Closures for parenteral preparation containers should be equippedwith a firm seal to prevent entry of microorganisms and othercontaminants while permitting the withdrawal of a part or the wholeof the contents without removal of the closure. They should not bemade of components that react with the contents, nor should theyallow foreign substances to diffuse into the preparation. Plasticmaterials or elastomers of which the closure is composed should besufficiently firm and elastic to allow the passage of a needle with theleast possible shedding of particles. Closures for multidose containersare made sufficiently elastic to allow the puncture to reseal when theneedle is withdrawn and protect the contents from airbornecontamination. A tamper-evident container is fitted with a devicethat reveals clearly whether it has ever been opened. 21
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    • Labelling:-Every pharmaceutical preparation must comply with the labellingrequirements 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 usedwherever possible;(3) the amount of the active ingredient(s) in a suitable dose volumeand the volume in the container; for powder for injections: theamount 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 maybe necessary;(7) directions for use, warnings, and precautions that may benecessary; and(8) the name and address of the manufacturer or the personresponsible for placing the product on the market.For parenteral preparations that are solutions or dispersions, theconcentration of the active ingredient(s) should be given in terms ofmass or biological activity per volume. For concentrated solutions,labels should state the composition and the dilution to be carried outbefore use. 23
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    • The quality control section of the company involves the processes ofstriving to produce a perfect product by a series of measuresrequiring an organized effort by the entire company to prevent oreliminate errors at every stages in production. The in-process qualitycontrol 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. 25
    • The following quality control tests are perfomed in the quality controlsection 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. 26
    • VISUAL INSPECTION OF A PREPARATION3) 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. 27
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    • The powdered injectables filled in vials/ampuls are then packed intocartoons. These cartoons are stored in a cold place. The lightsensitive 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 toprevent the breakage of containers and the spoilage of the drug.These cartoons should well label. Injectables Stored in Cartoons 29
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    • Trinity Pharmaceutical was established in 2008 at Karnal. It is one ofAsia’s most respected, ISO-9002 & ISO-14001 certified company withmanufacturing facilities complying with WHO-GMP guidelines. The company has different units like manufacturing unit, qualitycontrol & assurance unit.All these parenteral preparations are carried outin the fully aseptic conditions. The walls & floor are epoxy-coated. The manufacturing unit consists of a change room, compoundingroom, aseptic chamber, vial washing machine, sterilizer, filling & rubberstoppering machine, sealing machine & labeling machines. The vials arewashed in the washing machine. These are sterilized in the sterilizer. Thecompounded injectable powder is then filled into these sterilized vialswhich are stoppered by rubber stoppering. These vials are then sealed &moved forward for visual inspection.at last these are labeled & packedinto the cartoons. The quality control department deals with assessing of quality ofraw materials, integrity of raw materials, packed materials & finishedproducts. It has world class active pharmaceutical ingredients &manufacturing facilities. It supplies its pharmaceutical products mainly inUttar Pradesh (India). Some of the pharmaceutical products of thiscompany are Amlox Injection, Nemocef injection, Onizid Injection,Polyneurone Injection, Licodol Injection, Onitron Injection, GentabionInjection, Tribion Injection, Amikatrin Injection, Fanci-12 Injection,Onizone-S Injection, mplox Injection, licodol Injection, etc. Optibion Injection and Amlox injection are the major marketedproducts of the company. 31
    • Lachman Leon, Lieberman Herbert A & Kanig Joseph L. The Theory &Practice of Industrial Pharmacy. 4th ed.(1991). Bombay: VarghesePublishing House, Hind Rajasthan Building, Dadar.www.google.comwww.pharmaonline.com 32
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