A Project report On microbiological practice in pharmacutical industries At morepen laboratories submitted By

a Project reportOnmicrobiological practice in pharmaceutical industriesAtmorepen laboratories

Submitted to :- Submitted by :-Dr. DEEPIKA UPADHAYAY PRIYANKA RANI Mr. HIMANSHU SINGH M.Sc. IV SEM. (MICRO.)Faculty incharge of microbiology Introduction of companyMorepen laboratories limited (Morepen) was incorporated in 1884 and is engaged in manufacturing active pharmaceutical ingredients (APIs) and pharmaceutical formulations.Morepen has established credentials as an API supplier to large MNC player in regulated markets.Therapeutic area of companyThey are: Antibiotics, gastro-intestinal ,CNS, Ortho and pain,Cardiology,Respiratory,Anti- Allergic,Nutraceuticals and Antioxidantsetc.Equipment

AutoclaveIncubatorOvenLaminar air flowPh meterColony counterMedia PreprationMacConkey Agar(MCA)Nutrient Agar (NAM)Manitol Salt Agar(MSA)Soya bean Casein Digest Agar(SCDA)Sabouraud Dextrose Agar(SDA) Storage Media

Protect the stored media from exposure to light and exit temperature use heating plating.Do not store agar at below 0 as freezing

Growth promotion testEach batch of ready prepared medium and each lot/batch of medium prepared of dehydrated shall be checked for growth promotion test. Growth promotion test for Media plates Microbial testing of primary packing materialThe main step involved in microbiological testing are:1.Prepration of test solution2.Microbial enumeration test(a)Total aerobic microbial count(TAMC)(b)Total combined yeast and mould count(TYMC)3.Test for specific pathogen: (a)Bile- tolerent gram- nagative bacteria(test for absence) (b)Test for Escherichia coli (c)Test for salmonella (d)Test for Staphylococcus aureus (e)Test for Pseudomonas aeruginosa (f)Test for Candida albicansMicrobial enumeration test(a) Total aerobic microbial count(TAMC)1.Prepration Soya bean Casein Digest Agar(SCDA) Transfer 1ml Sample Incubate the plates 3-5 days at 35 c Count the no. of colonies and calculate cfu/gm. (b)Total combined yeast and mold count(TYMC) 1.Prepration sabouraud dextrose agar(SDA) Inoculate 1ml sample into the plate Incubate at 22-25c for 5-7 days Count the colonies yeast and mold(a)Test of Escherichia coliTake loop full culture fromscda plate and streak on macConkey agar(MCA) Incubate at 32-35 for 24-48 hours Result: Red colonies with or without black centers. If colonies have to detect to be salmonella do the identification test viz.Microscopic: Gram negative straight rod. (b)Test for salmonella Take 1ml sample from preparation of test solution pour with Rappaport vassiliadis salmonella enrichment agar Incubate at 32-35 for 24 hours

Result: Red colonies with or without black centre. gram staining

Test for Pseudomonas aeruginosaAdd 10ml sample as prepared under preparation of test solution in to the soya bean digest broth make uo the volume of 100ml Incubate at 30-35 temperature for 18-24 hours. microscopic: Straight or slightly curved Gram negative rod.The product complies with the test of no colonies are present .Test for staphylococcus aurousAdd 10 ml of sample as prepared under preparation of test solution into the soya bean casein digest brought make up the vol. of 100 ml .Incubate at 30-35 c temp. for 18-24 hrs.Result :-Growth of yellow zone further do the identification .Microscopic :- Gram positive cocci occurring singly , in pairs and in regular shape

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