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Pharmaceutical/Life Sciences Particle Counting
- When sampling a room to do a room qualification with the Lasair particle counter, what height should the samples be taken? Close to the floor or at working height?
- When performing a room-qualification for 0.5 micron as well as for 5 μm particles: In order to avoid doing it twice - one should do it at once at 5 um. Correct?
- During revalidation, is it mandatory to particle count for 3 consecutive days in laminar air flow unit and as well as in area qualification?
- If performing particle counting with tubing connected to the isokinetic probe, is there a suggested timeframe to change the tubing due to possible particle hold up?
- Which is the suitable classification for clean rooms in hospitals? Is there any classification that gives the category of ISO for rooms such as "operating theatres", "isolation room", "intensive care room", etc?
- What do we need to do to validate the software for use in a Pharmaceutical GMP environment?
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