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Chemical and Biological Aspects of Hydrogen Peroxide Gas

The interactions of hydrogen peroxide concentrations and surface temperatures were studied in an isolator using chemical and microbiological techniques. These tests verified commonly accepted theories of the gaseous properties of flash vaporized hydrogen peroxide that have recently been challenged.
 
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Current Trends in Controlled Environments

An overview of conventional aseptic processing is presented, and it addresses the key issues that corporate decision makers are faced with when implementing isolation technology, such as regulatory requirements and IOQ & PQ Validation.
 
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Fundamental Principles of Isolator Decontamination

The industry consensus on decontamination at the present time is to eliminate detectable levels of microorganisms on non-product contact surfaces within the isolator environment.
 
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Glossary of Terms Related to Isolation Technology

Commonly used (and mis-used) terms related to isolator technology are defined.
 
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Isolator Microbiology Issues of Interest to the Project Engineer

This presentation reviewes the microbial aspects of sterile isolator applications, which a project engineer should consider when the system design and validation requirements are being determined.
 
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Isolator Sterilants: Common Issues and Differences

This presentation discusses 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.
 
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Resistance of Various Microorganisms to Vapor Phase Hydrogen Peroxide in a Prototype Dental Handpiece / General Instrument Sterilizer

Testing results have shown that Bacillus stearothermophilus spores are the most resistant microoganisms to gaseous hydrogen peroxide, and the presence of organic soil does not affect the ability of the gas to sterilize stainless steel surfaces.
 
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Should Your Company Consider Isolators?
It has been generally recognized for years that conventional aseptic processing has its drawbacks when compared to terminal sterilization of a sterile drug product. An FDA mandate to improve aseptic processing has caused the industry to consider isolation technology as a viable means to accompolish this goal.

 
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COMING SOON…

      Environmental Monitoring in Isolators
 
 
 

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