K
Does anyone has experience with very small batches for validation according to ISO 11137 (VDmax25)?
We are an independent microbiological testing lab and receive occasionally this question from (small) companies. They manufacture expensive devices in very small batches (in the range of 30 - 40).
The value of product loss for validation, which requires at least 20 samples, depending on the type of validation, is something they can not carry.
I am thinking of Bioburden n=5 and the verification experiment also n=5.
Some additional criteria can be applicable like a minimal variation in Bioburden and no failures in the test of sterility.
I want to start making a rationale for this but would like to know any other possible experience and acceptance for this.
Thanks in advance,
Kees
We are an independent microbiological testing lab and receive occasionally this question from (small) companies. They manufacture expensive devices in very small batches (in the range of 30 - 40).
The value of product loss for validation, which requires at least 20 samples, depending on the type of validation, is something they can not carry.
I am thinking of Bioburden n=5 and the verification experiment also n=5.
Some additional criteria can be applicable like a minimal variation in Bioburden and no failures in the test of sterility.
I want to start making a rationale for this but would like to know any other possible experience and acceptance for this.
Thanks in advance,
Kees