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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.
 
Industry Survey on Sterility Testing Isolators: Current Status and Trends by Carmen M. Wagner, Ph.D. and Jennifer Raynor, Pharmaceutical Engineering March/April 2001, pp. 134-140
 
This article presents the current results of an ongoing survey assessing the implementation status of sterility test isolator systems worldwide. The results from the survey confirmed that sterility testing in isolators is now the "norm" vs. being a novelty. One key finding of the survey was that these systems have been predominantly placed in unclassified, although controlled access, areas.
 
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.
 
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.
 
Sterility Testing Isolators: Current Status and Trends (Presentation) by Carmen M. Wagner, Ph.D. September 2000
 
This presentation given by Dr. Carmen Wagner reviewed the current results of an ongoing survey assessing the implementation status of sterility test isolator systems worldwide. The results from the survey, coordinated with the assistance of Ms. Jennifer Raynor of Serentec, confirmed that sterility testing in isolators is now the "norm" vs. being a novelty. One key finding of the survey was that these systems have been predominantly placed in unclassified, although controlled access, areas.
 
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.
 
The Effect of VHP® on Testing Devices & Culture Media Used in Sterility Test Isolators (Presentation) by Michelle Stafford October, 2 2001
 
This presentation reviewed the physical and microbiological testing performed by Millipore on Steritest canisters following their exposure to hydrogen peroxide gas. The microbiological test results on new line of agar plates containing a sterilant neutralizer were also shared with the attendess.
 
H2O2 Gas Decontamination Cycle Comparisons Between Rigid and Flexible Wall Isolators (Presentation) by Les Edwards, MSE October 3, 2002
 
This presentation provides an overview on the decontamination cycle and regulatory expectations for the process. Past flexible wall data and its' implications are reviewed and how new trends in validation techniques are implemented to reduce them. The benefits of rigid wall isolator construction are also discussed.
 
Microbiological Monitoring in Isolators (Presentation) by James R. Rickloff, M.S. September 18, 2002
 
This presentation reviews the principles of microbial monitoring in isolators, current US and European regulatory requirements for monitoring, and the means to achieve and maintain a germ free environment. The current means to monitor the air and surfaces in isolators is also touched upon.
 
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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