 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 March 22nd, 2009
Yes, the current ANSI/AAMI/ISO 11137-2:2006 includes VDmax dose substantiation for both 25 kGy and 15 kGy. However, if you are using VDmax 15 kGy, bioburden is limited to no greater than 1.5 CFU. In addition, there is AAMI TIR 33:2005, Sterilization of health care products – Radiation- Substantiation of a selected sterilization dose – Method VDmax, which expands the VDmax method to several other doses, 15 kGy up to 35 kGy at approximately 2 kGy increments, where bioburden range is defined for each dose. AAMI TIR 33:2005 is available for purchase at www.aami.org.
