 Lisa Foster Sterigenics Vice President of SteriPro® Services Visit Website |
Lisa Foster began her medical device career at Sterigenics International in 1989 in Quality Assurance. In 1997, Ms. Foster was named Vice President of Quality Assurance for Sterigenics, the global leader in sterilization services becoming V.P. of SteriPro® Services.
Ms. Foster is an Executive Committee Member of the AAMI Sterilization Standards Board and Committee. She serves as Co-Chair and ISO delegate to AAMI/ISO/TC 198/WG2. She has served as co-chair for the AAMI Radiation Process Control Task Group, which developed TIR 29, Guide for Process Control in Radiation Sterilization.
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Sterilization Q&A
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Asked May 22nd, 2009
If you are asking if there is a “quick and dirty” simple way to assure sterility of a clinical batch, unfortunately, the answer is “No.” One must still perform an EO Batch Release to assure the 10-6 SAL. The details of such a batch release are detailed in AAMI TIR 16, Process development and performance qualification for ethylene oxide sterilization-Microbiological aspects. The batch release includes the performance of the half cycle for microbiological validation and with the full cycle, the performance of EO residuals. If you are not claiming “sterility” of the product, you may be able to use a generic overkill EO cycle, however, you should still be concerned with EO residuals and would need to perform those tests to ensure patient safety regarding the residuals.
