Monday, September 27, 2010

sterility testing 2

The testing for the presence or absence of microorganisms is essential for the development of a biopharmaceutical or a manufactured sterile product. Charles River Biopharmaceutical Services (BPS) provides sterility testing that is compliant with the requirements of the US Pharmacopoeia (USP), European Pharmacopeia (EP) and US Food and Drug Administration (FDA) GMP 21 CFR 610.12.
Sterility testing is offered by BPS in isolators or clean room environments. The isolators are Grade A units housed in a Grade D room and are preferred for testing biopharmaceutical products. Sterility testing for medical devices utilizes a Grade B clean room that houses a Grade A laminar flow hood in which the tests are conducted. 
  • Direct inoculation
  • Membrane filtration

In conjunction with the sterility test, a bacteriostatsis/fungistasis (B/F) test is performed to determine whether the test article is inhibitory to the growth of microorganisms.
Microbial Testing
The following microbial testing capabilities are provided:  
  • Bioburden/Total Microbial Count: Designed to determine the number of viable microorganisms. 
  • Endotoxin: For in vivo pyrogen and in vitro detection of contaminating endotoxin. 
  • Mycoplasma*: Designed to determine whether mycoplasma are present in the test article (agar cultivable and non-cultivable).
  • Mycoplasmastasis: Designed to show if the test article is inhibitory to the growth of mycoplasma (EU requirements).
  • Spiroplasma: Designed to detect the presence of spiroplasma, an insect cell-specific microorganism, in the test article.

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