Autoclave Qualification to Achieve Regulatory Compliance
Our Cosmetic Client retained the services of the Brevitas team to provide them with appropriate technical documentation to ensure compliance with regulatory agencies for the qualification of the two autoclaves located in their R&D laboratory.
Business Challenge
A client in the cosmetic industry required two Autoclaves to be qualified for their Clinical and Microbiology Laboratories. The project followed a complete autoclave qualification lifecycle approach from cycle development studies, affirmed sterilization parameters, and the performance of a PQ to ensure sterilization is achieved.
Our Approach
We conducted various meetings to outline the product matrix for each of the autoclaves. Once the product matrix was agreed upon by the Client, we then developed a Qualification Plan. This plan outlined the approach taken to qualify both autoclaves. A User Requirement Specification was developed to ensure all requirements were to be met during qualification. A Cycle Development Study was conducted in which the load configuration and cycle parameters were finalized. Biological Indicators and Chemical Integrators were used along with the calculation of F0, to ensure adequate steam sterilization. Upon completion of the Cycle Development Study a Performance Qualification was executed to provide formal documentation of the successful autoclave qualification.
Results Achieved
From inception to completion, the Brevitas team contributed to the success of the project by:
- Developing all qualification lifecycle documents from URS to qualification summary report
- Developing & executing cycle development studies to identify optimal loads & sterilization cycles
- Developing training documentation, SOPs and work instructions
- Developing and Executing a Performance Qualification
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