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Optimizing
EtO Sterilization, Paul J. Sordellini (MDDI, Aug 2001, p. 70). Category:
Sterilization.
EtO Sterilization: Microbiological Aspects of Process
Validation
Deliberate decision making during the structuring of microbial challenges,
product loads, and biological indicators can provide
a validation process for EtO sterilization that ensures accuracy, the absence of microbes, and a smooth
testing procedure.
EtO Sterilization: Principles of Process Design
By following a structured method, process engineers can design and
validate safe and efficacious EtO sterilization cycles.
Speeding EtO-Sterilized Products to Market with
Parametric Release
The difficulty of measuring EtO and water vapor during processing has been a
major obstacle to adoption of parametric release
by EtO sterilizers, but the
latest gas analysis techniques are making in-process monitoring and control
possible.
Biocompatibility Testing Is Needed Despite Material
Supplier Claims
When selecting materials, medical device manufacturers must perform
biocompatibility tests, even if material suppliers claim
their materials are
biocompatible.
Evaluating Sterilizer Performance as Part of Process Equivalency
Determination
Medical device manufacturers that use ethylene oxide (EtO) to sterilize
their products, either in-house or at a contract sterilizer,
often validate the
cycle in one particular vessel and later find it no longer satisfies their
requirements. A validated vessel
becomes outgrown when the number of devices
manufactured per week exceeds its volumetric sterilization capacity.
Investigating and Preventing BI Sterility Failures
Because microbiological destruction is logarithmic and therefore can only
be expressed in terms of the probability of a survivor,
the term sterile device
does not actually refer to a device that is totally free of viable organisms,
but rather to one whose
probability of containing a viable organism is so small
that it is considered acceptable. Hence the use of the sterility assurance
level
(SAL) to describe the degree of sterility of a device.
Parametric Release Comes To ETO
Sterilization
After decades of anguishing over long aeration times and interminable
incubation periods, manufacturers of medical devices
sterilized with ethylene
oxide (EtO) may finally be getting something of a break. Thanks to the efforts
of industry experts in the
United States and abroad, significant attention is
now being paid to the possible use of parametric release for EtO-sterilized
devices.
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