Confirming EO Sterility with PCDs

March 1, 2018Biological Indicators BlogBy Nikki Wolf

Mesa’s Process Challenge Devices (PCD) are designed to help medical device manufacturers and contract sterilization providers efficiently and accurately confirm Ethylene Oxide (EO) sterility assurance. Our convenient to use test pack replacement device provides greater EO resistance than almost all medical devices in most EO process cycles.

Mesa’s PCD products are packaged in a controlled environment, consistent with ISO 13485. We have shelf-life testing to support that our pouches do not affect spore population or EO resistance, and 15+ years of BIER vessel results and comparisons prove our PCD pouch consistency.

They are also a unique, patented packaging of B. atrophaeus (B. subtilis var. niger) biological indicators that are very convenient to use and are engineered to consistently demonstrate greater sterilization resistance than packaged medical devices in typical industry EO sterilization cycles.

To help streamline your Process Challenge Device (PCD) selection process, Mesa Labs has created a PCD Selection Guide. Please utilize this document as a reference when choosing which PCD is best for you. We can also develop and assist with qualification of custom PCDs to satisfy your unique needs for any gas sterilization process. Please contact us today for more information.

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About the author

Nikki Wolf

Nikki Wolf joined Mesa in June of 2016 as a Marketing Specialist for all product lines. As a marketing specialist, Nikki is responsible for developing and creating content for all social media channels, managing Mesa Lab’s tradeshow presence and participation, and writing content for Mesa's website, blogs, newsletters, and press releases. Prior to joining the company, Ms. Wolf provided marketing services in several industries, including contract manufacturing, sustainability services, optics, medical, and finance. Nikki received her Bachelor of Arts degree in Leadership and Organizational Studies and her Master of Professional Studies in Public Relations and Marketing from University of Denver.