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Facility Design Considerations for Sterility Testing Isolators (Presentation) by Les Edwards, MSE May 15-16, 2000
 
Examples of sterility testing suites are discussed, highlighting the design of the Lancaster Laboratories contract sterilty test system, including the sterilant manifold and exhaust systems.
 
Isolated Sterility Testing System Lancaster Labs, Lancaster, PA (Presentation) by Les Edwards, MSE 14-Apr-01
 
Media fill and environmental qualification data is reviewed for an isolated filling line approximately two months prior to license application submission.
 
 

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