Hi,
We have ISO Class 8 clean rooms to manufacture parts for medical devices. When we qualified the clean rooms, we did not include the Bioburden (or bacteriological monitoring) for the clean rooms.
Now, we have one customer who is insisting that we should qualify and routinely monitor the clean rooms for Bioburden.
Can I know from you all if you are doing the monitoring. If yes, why and also if No, why No ?
We have ISO Class 8 clean rooms to manufacture parts for medical devices. When we qualified the clean rooms, we did not include the Bioburden (or bacteriological monitoring) for the clean rooms.
Now, we have one customer who is insisting that we should qualify and routinely monitor the clean rooms for Bioburden.
Can I know from you all if you are doing the monitoring. If yes, why and also if No, why No ?