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Practical Validation Strategies for Isolated Sterility Testing Labs - Part II (Presentation) by James R. Rickloff, MS June 13-14, 2002
 
The second part of the Workshop focused on the Performance Qualification studies that are needed to properly validate the gaseous decontamination method in sterility test isolator systems. Practical examples, a discussion of acceptance criteria, and the demonstration of test methods were included. Key learning objectives included determining a D-value for your BIs, developing and qualifying decontamination cycles, isolator aeration, sterilant ingress methods, and creating a meaningful process simulation (no false negative) study.
 
D-value Determination by R. Chris Smith, BS, Validation Scientist 29-Mar-01
 
This paper covers the factors that can affect a D-value and it discusses the equipment and methods that have been used to satisfactorily estimate it within isolator applications.
 
 

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