Gamma/Ethylene Oxide Sterilization Validation
Today’s testing offers sterilization assurance levels (SAL) for most medical devices of 10-6, meaning a probability of only 1 nonsterile device for every 1 million sterilized.
Microtest provides superior Gamma EO sterilization validation testing for almost any kind of medical device. Tests include
• Bioburden Testing
• Bacteriostasis/Fungistasis
• Sterility
• Ethylene Oxide Residuals
• Spore Strip Population
 Since pioneering the industry’s first procedures for groundbreaking client Boston Scientific, Microtest has written the book on procedures such as endotoxins, sterility, particulates, and bioburden testing. Today, we’re still writing and refining specific procedures — free of charge — for every one of our clients’ unique products. So our technicians know exactly how to proceed in every task, from sample preparation through final reporting via the client’s custom system.
This brings unmatched precision to our testing procedures. Clients report that our records of procedures and revision histories also prove invaluable in FDA or internal audits and recalls.
Where applicable, Microtest testing conforms to recognized quality system regulations (QSRs). In addition, unlike some other laboratories, our broad experience in testing drug products means we bring a pharmaceutical-grade platform of current good manufacturing practices (cGMPs) to our testing of medical devices.
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