environmental monitoring in clean rooms

[nageshwar]

Hi 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

[krickos]

Hi

Generally speaking you can check the "Eudralex Volume 4 Good Manufacturing practicies", Annex 1 gives recommendation for various grades of clean areas.

As for limits it seems to be total limits (CFU per m3, hours,plate or glove), but I have no idea if this part has been updated as for example drug substances where CFU is being replaced by TYMC, TAMC etc or if limits for pathogens are commonplace.