MICROBIOLOGICAL ANALYSIS OF PHARMACEUTICAL PRODUCTSA

Project ReportSubmitted In Partial fulfillment of the

Requirement for the award of The Degree ofMASTER OF SCIENCEin Microbiology

Submitted by

Yogesh KrishanDepartment of Botany & Microbiology

Gurukul Kangri Vishwavidyalaya

Haridwar- 249 404 (U.K.)

2013CERTIFICATE

I have the pleasure in forwarding the M.Sc. 4th Semester of Mr. Yogesh krishan who carried out a piece of project work on Microbiological analysis of Water and Pharmaceutical Products at Akums Drugs and Pharmaceuticals Ltd., SIDCUL, Haridwar for partial fulfillment of M.Sc. Degree in Microbiology from this vishwavidyalaya.

Date:

(G.P. Gupta)

(H.O.D.) Department of Botany and Microbiological

ACKNOWLEDGEMENTWords are very poor comforters to express the deep debt of gratitude which one feels in ones corner of the Thank when one is helped to achieve the ultimate goal, in this boundless & endless field of project work.. I would like to express my sincere gratitude and indeptness to Dr. G.P. Gupta. Head of Department of Botany & Microbiology Gurukul Kangri University,Haridwar (Uttarakhand) whose constant guidance and suggestion helped me throughout my M.Sc. Program and also my dissertation work. I am thankful to AKUMS DRUGS & PHARMACEUTICAL Ltd. For permitted me for project work at HARIDWAR Plant-VI as a part of my M.sc.Microbiology (IV Sem)I wish to take this opportunity to thank the following who have assisted with the completion for selecting me as a candidate to complete my project work I offer my cordial thanks to Mr. Kuldeep Tyagi ( H.R.Manager ), Mr. Parvindra Tyagi ( Q.C.Manager) for suggesting me to undergo training in Q.C. Department.I deeply convey my homage with regards to all Q.C. Staff members for their constant encouragement ,and valuable criticism throughout the course of my work and beyond that.DECLARATIONThis is to be certifying that this project entitled Microbial testing of pharmaceutical products has been carried out by me at department of Q.C. (Microbiology) AKUMS DRUGS & PHARMACEUTICALS LTD. SIDCUL , HARIDWAR at Gurukul kangri vishwvidyalaya No parts of it have been copied as a whole from any other journals /books/thesis ,it is futher certified that this dessertation or any part of this has not been submitted/for diploma degree in any other university.

DATE: YOGESH KRISHAN M.Sc IV sem Microbiology

PLACE: Haridwar G.K.V. Haridwar

CONTENTS An Overview Of The Company

Environment Monitoring Water Used For Pharmaceutical Purpose

1. Raw water

2. Purified water

3. Water for injection

Microbial Limit Test Antibiotic assay Bioburdon sterility test

Observations

Summary

ReferancesAN OVERVIEW OF THE COMPANY

Akums Drugs and Pharmaceutical Ltd. Haridwar was established 2004 jointly by Mr.D.C. Jain, Mr. Sanjeev jain and Mr. Sandeep jain , the promoter directors, who had over 30 years of experience in Pharmaceuticals trading and manufacturing. Akums is endeavouring to make a name in the global pharmaceutical industry.

The Present capacity

Standards ,avers Mr. Sanjeev jain . No wonder the motors of the company are Quality gyrates Around Customer Satisfaction and Essence of business is to create Customer and Profit will followAkums has huge capacity to manufacture 40 million tablet The company is into contract manufacturing for more than 35 leading pharmaceutical companies in the country on a third party/lone licensce and P to P basis. At present, Akums Manufactures over 500 formulations in the form of Tablets, Capsules, Dry Syrups, Liquid Orals, soft Gelatin preparations, liquid injections, dry powder injection s, eye and ear drops, etc. Sprawled on an area of about 1,70,000 sq.ft. Akums is an independent state-of-the-art manufacturing unit having modernand sophisticated manufacturing facilities of international standards, which include an ultra modern plant, machinery and equipment. Besides, the company boasts of an in-house testing laboratory along with an R & D center supported by highly qualified, technical and skilled personnel.

ENVIRONMENTAL MONITORING

(E. M.) Environmental monitoring is done to check the bioburden of the aseptic area of the controlled environment. The purpose of this is to understand the various issues that is related to aseptic processing of bulk drug substance or finished products (sterile), dose forms, and in certain cases and to establishments maintenance and control of the microbiological quantity in the controlled environment.

Methods of E. M.:-

1) By Settle plate

2) By Active Air sampler

3) By Swab

4) By Finger Dab

5) By Contact plate

Personal Monitoring:-

This is done by two methods as follows:-

1) By Contact Plate

2) By Finger Dab

1)E. M. By Settle Plate Method:-

Plate Preparation:- Prepare SCDM Medium. Aseptically transfer the preincubated plate into the manufacturing room and mention plate code and exposure time on the plate, expose as per layout. For class 100 expose the plate for 30 min and in other for area for 2 hrs. After completion of exposure time close the plates in the same manner.

Incubate the plate at 30 to 35C for 48 hrs bacterial count and after 48 hrs transfer the plate in BOD incubator at 20 to 25C for 72 hrs. After completion of each incubation period observe the result for bacterial and fungal count respectively.

LIMIT:- Bacterial count

CLASSALERT ACTION LIMIT

1,00,00060 CFU80 CFU100 CFU

10,00030 CFU40 CFU50 CFU

100 B03 CFU04 CFU05 CFU

100 A