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A

PROJECT REPORT
ON
MICROBIOLOGICAL PRACTICE IN
PHARMACEUTICAL INDUSTRIES
AT

MOREPEN LABORATORIES
Submitted to :-

Submitted by :-

Dr. DEEPIKA UPADHAYAY


Mr. HIMANSHU SINGH
(MICRO.)
Faculty incharge of microbiology

PRIYANKA RANI
M.Sc. IV SEM.

Introduction of company

Morepen 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 company

They are: Antibiotics,


gastro-intestinal ,
CNS,
Ortho and pain,
Cardiology,
Respiratory,
Anti- Allergic,
Nutraceuticals and Antioxidantsetc.

Equipment

Autoclave
Incubator
Oven
Laminar air flow
Ph meter
Colony counter

Media Prepration
MacConkey 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 test

Each 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 material
The main step involved in microbiological testing are:
1.Prepration of test solution
2.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 albicans

Microbial 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 coli

Take 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


gram staining

black centre.

Test for Pseudomonas


aeruginosa
Add 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 aurous


Add 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

THANK YOU

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