What is the basic caculation/ formula for - number of temperture, % rh & microbial locations for new pharma facility.
Are there any guide lines for the same
[quote=hemanth_c2006]What is the basic caculation/ formula for - number of temperture, % rh & microbial locations for new pharma facility.
Are there any guide lines for the same[/quote]
This is a very broad question. You have to consider some of the following:
What kind of product will be manufacturing/packing/holding etc?
Different areas will have different acceptance criteria.
The amount of locations will depend on mapping studies.
The amount of recorders you will need depends on the capability of the record to the size of the area to be mapped.
Hope that helps.
HI Seal,
This is Udhay, I would like to know the required Temperature, % RH and +ve pressure for injections manufacturing unit. Kindly share if you have clean room validationprotocol
.