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
thanks in advance
vijay
Dear Vijay,
Facility restart after shut down is a critical operation.
In OSD there are less criticalities involved.
In Parenteral facility restart you must look for Viable oragnisms in
-Purified water
-Distrubution and storage loop
-Air/Gas compressors
-Environment inside Critical areas
-Under your LAF’s
Secondly :
Flow of air from Critical areas to outer areas
Integrity of filters : The reason is checking is due to blockage of settling dust on to filters
-Filter cleaning and installation records
-Passivation of water lines both Purified water and WFI as there might be a build up of Biofilms.
Infact FDA critically looks into Airmonitoring, Air flow patterns and Validation programmes in Water.
This is equall to start-up of a company.
First of all a deatialed event issue and Risk programme must be conducted :Why the plant has been shut down, Precautions taken during shut down.
Its not about a single day you shut down the plant or more than a day.Its about the risk.
Regards