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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.
 
Biological Indicators for Use in Isolator Decontamination Applications by James R. Rickloff, M.S. , Principal Scientist 8-Mar-01
 
This paper reviews the issues that isolator users need to be aware of prior to specifying and using a biological indicator for their decontamination cycle validation studies.
 
Fundamental Principles of Isolator Decontamination by James R. Rickloff, M.S., Principal Scientist 28-Mar-01
 
The industry consensus on decontamination at the present time is to eliminate detectible levels of microorganisms on non-product contact surfaces within the isolator environment. This can be accomplished by treating a pre-cleaned and properly designed isolator with a sporicidal agent in a quantifiable and reproducible manner with contact points kept to a minimum during the decontamination cycle.
 
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.
 
Equivalency Testing for Multiple Isolator Systems by James R. Rickloff, MS, Principal Scientist 5-Mar-01
 
A second identical isolator can be shown equivalent to another through the use of a single test if all critical decontamination cycle parameters can be duplicated.
 
Isolator Sterilants: Common Issues and Differences (Presentation) by James R. Rickloff, MS Oct. 16-17, 2000
 
This presentation discussed the similarities and differences of the current chemical germicides used for isolator decontamination in the pharmaceutical industry with emphasis placed on validation issues and safety considerations.
 
Key Aspects of Validating Hydrogen Peroxide Gas Cycles in Isolator Systems by James R. Rickloff, M.S., Journal of Validation Technology,pp. 61-71 November 1998
 
The purpose of this paper was to revisit some essential validation aspects of sanitizing isolators with H202 gas in order to assist the industry in demonstrating reproducibility of the process under worst-case conditions.
 
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.
 
Sterilant Ingress Testing by James R. Rickloff, M.S., Principal Scientist 29-Mar-01
 
This paper reviews some typical sterilant ingress methods and discusses one approach on how to include a variety of test supplies into the study.
 

 
 

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