Environmental monitoring in clean rooms

GOOD MANUFACTURING PRACTICE (cGMP)
1

Hi to all,

Is there any specifications for microbial anlysis in clean rooms. Particularily is there any specific information regarding Total Microbial Count, Yeast and Mould count and Pathogens (E-coli, Staphylococcus aureus etc.,) limits.

Thanks in advance

T.NAGESHWAR

2

Dear Mr Nageshwar,

Check out this chapter from USP (29):

USP General Chapters: <1116> MICROBIOLOGICAL EVALUATION OF CLEAN ROOMS AND OTHER CONTROLLED ENVIRONMENTS

It provides all the specifications you need.