How much volume of air in a room is required to b filtered for area qualification?
For Clean room qualification, the air should be filtered through prefilters, conditioned at desired temperature and relative humidity and finally filtered through HEPA filters which are terminally placed. Number of air changes per minute, Velocity of air across HEPA filters and % of fresh air and recycled air to be supplied in Clean room depend upon area class required and occupancy of the persons in that room under dynamic conditions.
Engineers of Clean room system and HVAC designers can provide you details of calculations on this matter.
in term of particle count by particle counter sampling?
Please refer any Regulatory guidelines or Schedule M of GMP (Indian Drug & Cosmetics Act & Rules thereunder) to know limits of particle counts based on Clean room classification.
1000 ltr.air volume required for air sampling
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1000 ltr.air volume required for air sampling
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exactly.good
i want to know its refrence.
ISO14644-1
can send link or screenshot?
i am unable to find