Autoclave cycle development is a process that allows autoclave users to determine which combinations of autoclave cycle parameters and loads will meet their process requirements. This process is a design study performed before validation studies occur and provides the necessary data to determine which cycles and loads will be validated.

Autoclave cycle development is best accomplished by following a cycle development protocol. The cycle development protocol is similar to a Performance Qualification Protocol except it does not typically have acceptance criteria associated with it. The Cycle Development Protocol describes the particular procedures, cycle parameters and loads to be tested. The Protocol also describes the data to be collected. The cycle development protocol provides a systematic means of collecting the data necessary to determine which cycle parameters and loads meet the process requirements and should subsequently be validated.

Biometrix works closely with our clients to develop high quality cycle development protocols. Our cycle development protocols include a customized approach and methodology, clearly defined procedures, cycle descriptions and load configurations. We offer fast turnaround of documentation and can often schedule projects with short lead times.

Our validation personnel are always available to answer questions and can provide the kind of guidance that will assure a highly compliant cycle development study.
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