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Implementing Validation Strategies for Isolator-Based Systems (Presentation) by Leslie M. Edwards, MSE and James R. Rickloff, MS January 27-28, 2003
 
This presentation thoroughly reviewed the overall strategies and basic validation methodologies for isolator system validation utilizing gaseous decontamination methods. Facility design and qualification, equipment qualification, performance qualification, and process simulation testing was reviewed, with practical examples and demonstrations of key methods and techniques.
 
 

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