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Question

In Grade A areas, do I have to monitor continuously for microbiological particles like I have to for non-viable particulates?

Answer

No, continuous monitoring for microbial contamination is not required; however, EU GMP Annex 1: 2008 mandates frequent monitoring of critical areas. While what constitutes frequent is open to interpretation, the intention of the regulation is that the entire fill process or batch is to be monitored by sampling air in short segments separated by pauses of sufficient length such that the total volume sampled is not so large as to dessicate the capture media. Further, as long as a minimum of 1 m3 is sampled over the course of the batch, the requirements are met.

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