EO Batch Release Your Way to Full Validation
Sam Lazzara Resume LinkedIn Profile Documents Services Schedule Call +1 510 397 9739 sam@lazzara.net I have had several early-stage device company clients who are interested to get to "First In Man" (FIM) clinical use without breaking the bank. My job is to save the client enough money so they can pay my fee and have money left over for other things (like a great Christmas Party). If device sterilization is a requirement, you do not need to perform a comprehensive (full) sterilization validation study before FIM. You can ensure adequate sterility assurance on a "batch release" basis, and save the time (and money) needed to perform a full validation. For ethylene oxide (EO) sterilization of devices with a "nonpyrogenic" label claim, the following sequence of tests and batch releases can be performed to achieve full validation status per ISO 11135-1. 0. Presterilization Bioburden Enumeration and Extraction Efficiency