Sterilization Validation 101: What's Required, How Long It Takes, and How to Plan for It

Ethylene oxide sterilization validation is often treated as a final step, but it's actually a multi phase program with real lead times, starting with bioburden testing and ending with a validated PQ. This guide breaks down the IQ, OQ, and PQ phases, typical timelines, and where validation programs commonly slip, so it doesn't become the bottleneck standing between your device and the market.