_______________ 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.
_______________ 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.
_______________ 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.
_______________ Glossary
of Terms Related to Isolation Technology
Commonly
used (and mis-used) terms related to isolator technology are defined.
_______________ 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.
_______________ 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.
_______________ 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.
_______________ 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.
Environmental Monitoring in Isolators