S
Hi,
I wonder if anyone can help me please, is there a maximum SAL you can claim when using aseptic processing for sterilisation. We sterilise with liquid chemical, (which gives a really good SAL), then aseptically process for further manufacturing. Is there a max we can claim, or is it whatever we can validate. I had heard that we can only claim 10-3?
Thanks very much for your help
Sarah
I wonder if anyone can help me please, is there a maximum SAL you can claim when using aseptic processing for sterilisation. We sterilise with liquid chemical, (which gives a really good SAL), then aseptically process for further manufacturing. Is there a max we can claim, or is it whatever we can validate. I had heard that we can only claim 10-3?
Thanks very much for your help
Sarah