I have a question about Area qualification. Is Viable air sampling (Active and Passive) must required for Tablet,capsule or ointment facility having Class D (ISO class 8) area ? May I proceed the area qualification in such class area only through NVPC basis?
Here are the limits “at rest”. There are no standards “in use” for ISO 8, Class D.
Also, it doesn’t matter what your production is, if it is Class D, then you will have to follow those limits, otherwise you cannot call it Class D.