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Validation Topics
 
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D-value Determination

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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Biological Indicators

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.
 
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Chemical Indicators

The gas distribution characteristics inside an isolator during a decontamination cycle are important to establish prior to initiating actual validation studies. Chemical Indicators are useful in obtaining this information.
 
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Current Trends and Concepts in Validating Sterility Testing Isolators

Past practices and current trends in validating sterility testing isolators are 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.
 
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Equivalency Testing for Multiple Isolator Systems

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.
 
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Fundamentals of Hydrogen Peroxide Gas Decontamination PQ Testing

Fundamental methods for sterilization performance qualification testing are reviewed.
 
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Hydrogen Peroxide Gas Sterilization: A Review of Validation Test Methods

The importance of performing temperature distribution studies, the use of chemical and biological indicators in optimizing and verifying proper gas distribution, a technique to easily perform square-wave D-value determinations, and a means to quantitatively monitor aeration efficiency when using a prototype VHP1000 are reviewed.
 
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Key Aspects of Validating Hydrogen Peroxide Gas Cycles in Isolator Systems

This paper revisits some essential validation aspects of sanitizing isolators with hydrogen peroxide gas in order to assist the industry in demonstrating reproducibility of the process under worst-case conditions.
 
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Sterilant Ingress Testing

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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Sterilant Residue Effects Testing

This paper explains the process of determining if hydrogen peroxide (H2O2) gas is retained in, on, or around product containers, rinse solutions, and Environmental Monitoring (EM) supplies at levels that will produce “false negative” sterility test results.
 
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Factors Influencing Hydrogen Peroxide Gas Sterilant Efficacy  

This paper discusses the three (3) major processing parameters that affect the inactivation of microorganisms by H2O2 gas
 
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COMING SOON…

       Cycle Development Principles

       Generator Equivalency Testing

       Temperature Issues for Hydrogen Peroxide Gas Sterilization

 
 
 

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