Chromatography Forum

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

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.