Is Bacteriological Monitoring required in ISO Class 8 Cleanrooms ?

[Ajit Basrur]

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 ?

 

[jgossett]

We recently had a similar experience, but on a non classified room. We were able to avoid routine testing by doing a small study to show the baseline and then routinely document housecleaning procedures and bench cleaning. However, our product has a very high tolerance to bacterial contamination. We are now waiting on the next customer to ask that we do a larger study, but until then, we have escaped. The final answer will probably depend on the nature of the product and its intended use.

Good luck.

 

[Rob Udo]

We always did it quarterly on our products. Apart from house cleaning activities in the cleanroom. It is evidence to validate your cleaning procedures. I'm not sure if it is a must, but is is good practice. Bioburden level is also one of the indicators for the sterility of the finished product.

Rob Udo

 

[Ajit Basrur]

We always did it quarterly on our products. Apart from house cleaning activities in the cleanroom. It is evidence to validate your cleaning procedures. I'm not sure if it is a must, but is is good practice. Bioburden level is also one of the indicators for the sterility of the finished product.

Rob Udo

Thanks Rob.

Ours is a non sterile product and I have been taking up this issue with the customer that for non sterile devices, bioburden test holds no good.

Lets see how it goes.