C
carlosandrosie
Hello everybody.
Even though I've been a member of the forum for a while this is actually my first post...
I'm looking for some insight on how to determine alert and action limits for bioburden in our Class 8 clean room.
2 years ago we started operations and since we have been monitoring bioburden levels (among other things) on a monthly basis. Now we fill it is time to establish alert and action limits.
However, by reviewing lots of standards and doing extensive research I have been unable to find any guideline on how to establish those. I found the 50/100 cfu guideline from FDA but that specifically applies to Drug products (we are a devices manufacturer).
Also found references in USP 797 but again, that applies to drug compounding environment.
Based on my findings it seems that there is no regulatory requirement for device manufacturers other than establishing your own limits, but I want to believe there is more than just setting them somehow arbitrarily based on historic data.
Any help/advise will be greatly appreciated. Thanks in advance to everyone who stops by.
Even though I've been a member of the forum for a while this is actually my first post...
I'm looking for some insight on how to determine alert and action limits for bioburden in our Class 8 clean room.
2 years ago we started operations and since we have been monitoring bioburden levels (among other things) on a monthly basis. Now we fill it is time to establish alert and action limits.
However, by reviewing lots of standards and doing extensive research I have been unable to find any guideline on how to establish those. I found the 50/100 cfu guideline from FDA but that specifically applies to Drug products (we are a devices manufacturer).
Also found references in USP 797 but again, that applies to drug compounding environment.
Based on my findings it seems that there is no regulatory requirement for device manufacturers other than establishing your own limits, but I want to believe there is more than just setting them somehow arbitrarily based on historic data.
Any help/advise will be greatly appreciated. Thanks in advance to everyone who stops by.