Microchem Laboratory

To ensure product safety and support ongoing process validation, accurate bioburden testing is essential. Microchem Laboratory provides complete ISO 11737-1 bioburden evaluations, including extraction efficiency, method suitability, and population characterization. Our microbiologists use validated recovery methods to quantify viable organisms on complex medical devices. With tailored testing strategies for different device types, we help regulatory and compliance teams establish effective sterilization dosing, demonstrate product safety, and meet FDA and notified body expectations.