Clean room disinfection

Is it Necessary to filter Disinfectant through 0.22µ filter for disinfection of Class 10,000 ( Class C ) Area for Manufacturing area where the terminally sterilized product is processed??? Can any guideline support for such requirement???.

Sujit Mishra

I don’t understand the question? You mean Filter sterilize the final product?

BTW, you don’t filter “disinfect”, but filter "sterilize: thru a 0.22.

Simply read item #38 in the current Annex 1 to EU-GMP :

“Disinfectants and detergents should be monitored for microbial contamination ; dilutions should be kept in previously clean containers and should only be stored for defined periods unless sterilised. Disinfectants and detergents used in grades A and B areas should be sterile prior to use”

Okay. So you mean cleaning liquids.

You can PURCHASE pre-sterile, or WFI prepped cleaning liquids. Therefore no need to push thru a 0.22 filter.