I am a little in doubt about the next...
We have an new built plant which is planned to fill parenteral sterile vials. I was in inspection of the same and I have found too much mistakes there.
The first one (and serious...by my opinion) is the number of air changes inside of class B. This room will be used for filling of vials.
Machines are under laminar flow cabinets in ISO 5 class A and that is OK, but in background of the filling process (mentioned class B), I have measured only 20 to 25 AC/Hr
What I will do??? To say '' this is not good'' or try to do recovery test and wait for results??? What will happen if recovery test approach successfully?? Shall I give permission to continue media fill test???
What say the law in this case, how is your expiriences?????
thanks in advance, kindly regards