Sterilization Validation

Sterilization validation is a foundational step for sterile medical device manufacturers seeking FDA compliance. At Microchem Laboratory, we conduct detailed, ISO 17025-accredited sterilization validation studies, including USP <71> sterility testing, ISO 11737 bioburden analysis, and endotoxin analysis. Whether your process involves ethylene oxide, gamma radiation, or e-beam sterilization, our lab confirms the efficacy of your process with scientific precision. We support QA and regulatory teams with clear, audit-ready documentation, fast turnaround, and expert consultation to ensure your sterilization validation aligns with FDA and international compliance requirements.