Hi, we have a few questions about sterilization validation.
1. Fractional cycle is used to demonstrate that the relative resistance of EPCD>IPCD>Product. The minimum number of BI/PCDs used in fractional cycle is recommended in Annex C.3 Biological indicators of ISO 11135. We are confused what is the minimum amount of product used for sterility test? Are there any requirements?
2. If the most difficult part of product to be sterilized was previously wrongly determined, but from the test result it can be determined that the resistance of EPCD>IPCD>product. The mistake does not influence the slection of worst-case product in product family. Would the mistake affect effectiveness of the sterilization validation?
3. In Figure D.1 Requalification decision tree of ISO 11135, full requalification is needed if there is significant change. It seems there is not definition of significant change. Does the significant change mean changes that creat a new worst-case condition which may be a new worst-case product, worst-case or most-difficult-to-sterilize location, worst-case loading configuration? How to determine if it's a significant change?
Thanks a lot!
1. Fractional cycle is used to demonstrate that the relative resistance of EPCD>IPCD>Product. The minimum number of BI/PCDs used in fractional cycle is recommended in Annex C.3 Biological indicators of ISO 11135. We are confused what is the minimum amount of product used for sterility test? Are there any requirements?
2. If the most difficult part of product to be sterilized was previously wrongly determined, but from the test result it can be determined that the resistance of EPCD>IPCD>product. The mistake does not influence the slection of worst-case product in product family. Would the mistake affect effectiveness of the sterilization validation?
3. In Figure D.1 Requalification decision tree of ISO 11135, full requalification is needed if there is significant change. It seems there is not definition of significant change. Does the significant change mean changes that creat a new worst-case condition which may be a new worst-case product, worst-case or most-difficult-to-sterilize location, worst-case loading configuration? How to determine if it's a significant change?
Thanks a lot!
