Sterilization in Process Validation

• Steve
  19/02/2015 19:41

  I had a question regarding whether sterilization is required on process validation units. Having worked at a big medical device company for 8 years, sterilization was never a requirement as a part of process validation. At my new company (small ~40 employees) the discussion came up whether process validation samples need to be sterilized. My thought was sterilization is covered in design verification. Also researching external standards and just on google in general, I could not find any information on that. Other feedback that I have received internally was that sterilization needs to be addressed in process validation. If it affects the process output that is being validated, then it needs to be conducted. Any feedback would be appreciated.
• Henny Koch
  10/03/2015 09:24

  Hi Steve, Assuming that your medical device must be sterile before application, it is included that sterilization is an integral part of your manufacturing process and as such subject to qualification and validation. The sterilization process is Always risk critical and as such the ISO 14971:2012 is applied. Depending on the methodology used for sterilization you have to follow the relevant EN ISO guidance (e.g. EN ISO 17665 in case of using an autoclave for sterilization. If you require more info just let me know. Good luck, Henny
• Henny Koch
  10/03/2015 10:07

  Steve, also check the ISO 14937:2009(E) for sterilization requirements of health care products (including validation). Regards, Henny
• Colette McIntyre
  12/03/2015 15:01

  Steve, My first thought was that if it is a requirement that the device is capable of being sterilized then the verification and validation of this requirement would be part of the design V&V process. If there are any issues with the design of the device which are incompatible with the proposed sterilization process you would want to be aware of this as early in the design process as possible to allow redesign of the device or reconsideration of the sterilization process.

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