QC Microbiology

Yersinia yersinia at CYBERNEX.NET
Fri Feb 13 18:46:36 EST 1998


tan poh ewe, ixelles at cyberway.com.sg  writes,

<I wonder if anyone can tell me what a QC Microbiologist does in a 
pharmaceutical company, in some detail
as soon as possible??>

Numerous things, which include (and are not limited to), depending on the 
specific company, etc.:

1. Microbial limits testing of finished products and raw materials.
2. Preservative efficacy testing.
3. Environmental monitoring of production areas.
4. Identification of bacteria, yeast and mold isolated from all of the 
above.
5. LAL endotoxin testing of water and parenteral products.
6. Bacterial counts and coliform screens for water used in production, by 
either membrane filtration or plate-count methods.
7. Sterility testing of parenterals.
8. Methods validation.
9. Stock culture maintenance of control microorganisms.
10. Validation and qualification of media, reagents and test equipment.



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