Selecting portable and automated air sampler devices to meet cGMP

Published: 13-Mar-2017 Featured companies: Lighthouse Worldwide Solutions
Analysis

Selecting the right automated air sampler system for active sampling is not always as cut and dry as it might seem. Director of Systems, Lighthouse Worldwide Solutions, Jason Kelly, explains why

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PIC/S Annex 1 was recently updated in January 2017 and, under the Clean Room and Clean Air Device Monitoring section, the recommended limits for microbial monitoring of clean areas during operation have remained intact since 2003. A one cubic meter sample volume is still required using an air sampling instrument for active air sampling (see Table 1).

Table 1: PIC/S Annex 1 Recommended limits for microbial contamination<sup>(a)</sup>. Notes: (a) these are average values and (b) Individual settle plates may be exposed for less than 4 hours

Table 1: PIC/S Annex 1 Recommended limits for microbial contamination(a). Notes: (a) these are average values and (b) Individual settle plates may be exposed for less than 4 hours

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