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Bioburden Testing

May 15, 2014

Importance of Cleaning and Sterilization Validations, Even When they may Not be Required

Department Scientist-Healthcare Reprocessing I recently attended the 10th Annual FDA and Changing Paradigm for HCT/P Regulation Conference, with my colleague Wendy Wangsgard, Department Scientist, Bioburden. We presented topics of interest that have surfaced the validation realm, in addition to learning...

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April 22, 2014

ISO Meeting in Australia Updates International Standards for Medical Device Testing and Validation

The International Organization for Standardization (ISO) hosted the Sterilization of Health Care Products Committee meeting (ISO Technical Committee 198) to update the worldwide standards used for testing and validating medical devices. Australia was the site of this year’s meeting. I...

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February 5, 2014

What You’ll Learn by Attending the MD&M West Nelson Laboratories Classroom on Radiation Sterilization Validation Overview

Martell Winters will present an overview on radiation sterilization at the 2014 MD&M West Conference. Martell is a Senior Scientist at Nelson Laboratories in Salt Lake City, Utah. His presentation will include: Bioburden Testing: How it is performed and what...

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November 14, 2013

Increase Efficiency by Combining Bioburden and Tests of Sterility

When it comes to radiation sterilization validation, there is a perception that the bioburden and sterility testing need to be conducted under separate submissions, with results from both then used to compile a statement report by the medical device manufacturer. Nelson...

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