Bioburden testing for Class 10000 (Grade C) clean room

[mpfizer]

we have a class 10k grade c clean room, what is the standard applicable for microbiological testing for bacteria and fungi . and where the settle plates should be placed and how many ?? there is a standard for particle count but i am not finding a standard for bacterial and fungal count testing and how alert and action limits should be fixed..Is there a relation between the size of room and number of locations to test?

Thanks

michelle

 

[Ajit Basrur]

Refer an existing thread - How to set Cleanroom Alert and Action Limits as part of Microbiological Evaluation

For the limits on bacterial and fungal colonies, USP <1116> is a good start.