Filter Testing

GOOD MANUFACTURING PRACTICE (cGMP)
1

Does anyone have any ideas about the frequency of testing the sterile filter on the autoclave.

We also have filters (0.2um) for compressed air and nitrogen. We can test these upon installation. However how do you decide on the frequency of testing given that these are product contact / critical services.

You can test as part of the preventative maintanence programme but how do decide how often this occurs?

Austin

2

I was reading somewhere else on autoclave qualification and remember it as bi annual. Please read ‘autoclave validation’ article on the same forum