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.
_______________ 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.
_______________ 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.
_______________ 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.
_______________ 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.
_______________ Fundamentals
of Hydrogen Peroxide Gas Decontamination PQ Testing
Fundamental
methods for sterilization performance qualification testing are reviewed.
_______________ 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.
_______________ 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.
_______________ 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.
_______________ 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.
_______________ 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
_______________ COMING SOON…
Cycle Development Principles
Generator
Equivalency Testing
Temperature Issues for Hydrogen Peroxide Gas Sterilization
Cycle Development Principles