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.
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.