Sterility Testing for Biologics to Expand with New Isolator
October 13, 2011 - Isolator sterility testing is now the preferred method for companies developing biologics as it provides a more controlled environment, which reduces the risk of sample contamination and the probability of false positives. In an effort to expand our sterility testing services, a new isolator in Malvern, PA will be coming online in early 2012. This addition will give Charles River two isolator systems–one in the US (Malvern, PA) and one in Europe (Ballina, Ireland)-expanding our experience dealing with both US and European Pharmacopoeia regulations and providing us with a backup isolator to eliminate testing delays.
In addition to sterility testing via isolators, we have individual clean room suites outfitted with an ISO 5 Biological Safety Cabinet (BSC) or Laminar Air Flow (LAF) cabinet for sterility testing at these sites.
Malvern, PA
- Option 1 – Clean Room: Testing is carried out in an ISO 5 (Grade A) BSC in an ISO 6 (Grade B) clean room. Environmental monitoring is performed for the clean room (both viable and non-viable).
- NEW Option 2 – Isolator: Testing is carried out in a fully validated Getinge La Calhene isolator located in an ISO 8 (Grade D) classified laboratory. Environmental monitoring is performed within the isolator work area (viable).
Note: For both options, all procedures comply with GMP guidelines.
Ballina, Ireland
- Option 1 – Clean Room: Testing is carried out in an ISO 5 (Grade A) LAF cabinet in an ISO 6 (Grade B) clean room.
- Option 2 – Isolator: Testing is carried out in a fully validated SKAN-ARIS isolator located in an ISO 8 (Grade D) clean room.
Note: For both options, all procedures comply with GMP guidelines for monitoring of the classified areas (viable and non-viable monitoring).
We offer technical guidance to clients with questions regarding sterility testing. For additional information on what type of testing is appropriate for your needs, contact us at askcharlesriver@crl.com.
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