I would suggest maintaining your current schedule for bioburden testing, as this is a good double check that nothing has changed in the manufacturing process. Also, the environmental monitoring of the manufacturing facility should also be maintained (air sampling, water samples, and swipe testing of surfaces).
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Debbie Koeneman
Consultant
Mesa AZ
United States
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Original Message:
Sent: 13-Dec-2019 10:51
From: Anonymous Member
Subject: Sterilization Dose Audits and Bioburden Testing
This message was posted by a user wishing to remain anonymous
I am looking into reducing the frequency of sterilization dose audits for a Class II sterile (gamma) device from quarterly to twice per year. According to ISO 11137 the frequency can be reduced if:
- At least four consecutive sterilization dose audits, whose outcomes have required neither dose augmentation nor sterilization dose re-establishment, have been performed at the previously selected interval of time (3 months for this product);
- Data are available that demonstrate the stability of bioburden within the bioburden specification over the same period of time as item a.:
- bioburden determination performed at least every three months
- characterization of biodurden
3. The manufacture of the product in relation to bioburden is controlled and the effectiveness of this control is demonstrated through the implementation of the elements of a quality management system identified for sterile medical devices in ISO 13485.
Given all of the above, do you still have to do quarterly bioburden testing even if you reduce the frequency of sterilization dose audits from quarterly to twice a year?