I have to maintain a room according to 1 LAKH classification. What all check/testing should i do on regular basis? And can I use exhaust fan in this room.
You have to check the differential pressure between your room and the corridor at each day of production. Depending of the sensibility of your product you also monitor the temperature and humidity of the room in operation at each day. The differential pressure between your filters can be monitor once a week. We consider here that your validation of your ISO 8 room is a success.
You can use an exhaust fan in this room but you must control the inlet ventilation in order to respect the particles charge for ISO 8 and the differential pressure between the room and the corridor or air lock..
I hope you may have done a design qualification of your class 100,000 area and qualified the operations. On a day to day basis you need to have a set of SOPs carefuly written down to systematically review, monitor and control the class 100,000 area. Important things to observe are particulate contamination, air changes / hr, differential pressure, periodical evaluation of microbiological control. Usually after the construction and qualification of the site, the mfg site operation validation master plan includes all of these.
I am pleased to agree with above said both respectives, but at the same time you must check the return air(air vent) pressure and final filter efficiency. Meanwhile you have to check the microbial count periodically by open plate method/air sampler method.
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