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

Abstract

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