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Cleanroom classification is an essential part of the qualification activities in pharmaceutical cleanrooms that confirm the effectiveness of the cleanroom’s airborne contamination control system. A review of the classification requirements and principles associated with ISO 14644-1:2015 and the 2008 version of Annex 1 of the EU GGMP is contained in this first article, and a suitable classification test method derived for aseptic manufacturing. A second article will consider the application of the method by means of practical examples.​Key words: Cleanroom classification, ISO 14644-1, EU GGMP Annex 1

Pharmaceutical Cleanroom Classification using ISO 14644-1 and the EU GGMP Annex 1 Part 1: Testing rationale