WHETHER you are using a contract sterilizer or in-house equipment, a protocol outlining the procedure that will be used to validate the process must be prepared. The critical first step after validation planning is the protocol. There are many methods and approaches to validation that are scientifically sound, but it has become commonplace for the validation effort to be broken into segments: installation qualification, operational qualification, performance qualification, and requalification. In many cases, each segment is run under its own protocol.