Dear all,
i have a doubt, reg. facility shutdown.
what are the measures to be taken during resume of clean room facility after a period of shutdown (one day, one week, one month)
does viable and non viable monitoring for one day n one time is enough for clearance.
is there any reference documents for this
[quote=vijaypedineni]Dear all,
i have a doubt, reg. facility shutdown.
what are the measures to be taken during resume of clean room facility after a period of shutdown (one day, one week, one month)
does viable and non viable monitoring for one day n one time is enough for clearance.
is there any reference documents for this[/quote]
It is better to do decontamination process with a validated process (the decontamination process may include fumigation, cleaning with disinfectants etc.). If you have the validated process of decontamination then one time testing of your decontamination process is enough for clearance.
Dear Vijaypedineni,
Do you mean clean rooms for aspetic process? And, is it a total shutdown (with no utilities supply)?
If it is, than I don’t think decontamination and monitoring is complete enough. In lot of cases, Media Fill is considered the best way to ensure the sterility of the clean rooms AND your aseptic process. It is better to be 100% sure before you run any commercial products.
Dear
it is depend on period of shut down , if it is for short time like for some hours for preventive maintenance then one time with validated decontamination process will be ok , if it is for long time in terms of days then it is better to prove with the media fill activity
But in both case you have to prove the recovery period by means of validation to define the time required for clean room to achieve the designed conditions, after decontamination by adopted procedures.