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Hello all,
I am asking a related topic to pyrogen testing raised by an auditor during review of our file of sterile administration sets.
We have performed a Pyrogen Test in one product reference but the auditor comments that "it does not address the requirement for on-going batch testing of finished product which is typically required to claim that the devices are pyrogen free."
We asked for clarifications and the auditor replied that "Testing more than 1 set is necessary to ensure a product is non-pyrogenic" and that this is required as a matter of practice; it is not in guidance or regulation.
Any comments on this or similar situation faced would be very helpful!
Thanks
I am asking a related topic to pyrogen testing raised by an auditor during review of our file of sterile administration sets.
We have performed a Pyrogen Test in one product reference but the auditor comments that "it does not address the requirement for on-going batch testing of finished product which is typically required to claim that the devices are pyrogen free."
We asked for clarifications and the auditor replied that "Testing more than 1 set is necessary to ensure a product is non-pyrogenic" and that this is required as a matter of practice; it is not in guidance or regulation.
Any comments on this or similar situation faced would be very helpful!
Thanks