Is Pyrogen testing done on non sterile units?

D

dionysisf

#11
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
 
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Ronen E

Problem Solver
Staff member
Moderator
#12
As a matter of practice, it is common to test a number of consecutive lots once production commences to establish non-pyrogenicity over time. Upon favourable results the testing frequency can be lowered and after a clean history is established (say 6-12 months of fairly ongoing production, maybe 30 lots or so) testing might stop completely.
 
D

dionysisf

#13
Hello Ronen,

Thanks for your useful answer!

Further to this, in our initial perogen testing, the acceptance criteria was "an individual rise in temperature up to 0.5 oC". If this is zero rise in a number of 5 consequent tests, would this result to a clean history or more testing is needed?

Also, FYI we make the Rabbit Pyrogen test (material mediated) according to ISO 10993-11. Is this enough or we shall test for both types of pyrogenicity origin: material-mediated and endotoxin-mediated?

Thanks in advance!
 
D

Docken

#14
You can perform pyrogen testing either before or after sterilization. You should confirm this through your process validation to determine which time period is best for your product. We do this testing pre-sterilization so we don't sterilize a product that may not have passed the pyrogen testing and may need additional processing before sterilizing. You want to address this in your process validation before implementing.
 
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