Page 76 - MNU-PM502- Pharmaeutical Microbiology Theoritical Book

Pharm D- Clinical Pharmacy Program Third Level Pharmaceutical Microbiology& Antimicrobials (PM 502)

Finished product testing

The microbial tests used for finished product testing are

➢ sterility

➢ bacterial endotoxin test (Pyrogen test)

Sterility tests

Sterility tests are conducted by the following methods:

A. Direct inoculation (immersion)

performed by directly inoculating the test article into 2 distinct kinds of media
that help the development and growth of aerobic and anaerobic bacteria,

respectively. Test articles are incubated for 14 days followed by testing for
microbial contaminants

Membrane filtration method

By filtering the sample aseptically through a
membrane filter (pore size usually 0.45 µm ), then cut
into 2 halves, inoculate each on appropriate culture
media

Application of sterility test to some dosage forms

Aqueous Small volume: direct inoculation
solutions large volume: membrane filtration
Soluble solids dissolve in a suitable solvent that is sterile and has
no antimicrobial activity.

product suitable portions (2-5%) should be transferred to fresh
produces media after 14 days, and incubated for a further 7 days
suspension,
flocculation or
deposit in
media
Oils and oily Oils of low viscosity are filtered directly via a dry
solutions membrane filter

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