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Aseptic Processing Isolators (Presentation) by Richard L. Friedman, MS June 7, 2001
 
The highlights of this presentation by a leading FDA-CDER authority on aseptic processing isolator systems include basic design and validation approaches as well as feedback by FDA inspectors on various isolator applications during pre-approval inspections.
 
Isolator Microbiology Issues of Interest to the Project Engineer (Presentation) by James R. Rickloff, MS 10-Mar-98
 
This presentation reviewed the microbial aspects of sterile isolator applications, which a project engineer should consider when the system design and validation requirements are being considered.
 
Current Trends and Concepts in Validating Sterility Testing Isolators (Presentation) by James R. Rickloff, MS May 25-26, 2000
 
Past practices and current trends in validating sterility testing isolators was reviewed with an emphasis now being placed on productivity. Although, the key validation criteria remain the same, i.e. no false negatives, improvements to the overall system design have permitted the optimization of the decontamination cycle.
 
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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