Pharmaceutical Cleanroom Classification using ISO 14644-1 and the EU GGMP Annex 1 Part 2: Practical Application

Abstract

Classification of cleanrooms and clean zones associated with the manufacture of medicinal products has been assessed in two articles. The first article discussed the classification requirements and principles associated with ISO 14644-1 and Annex 1 of the EU GGMP, and a suitable classification test method for aseptic manufacturing was derived. This second article considers the practical application of the method for the classification of a pharmaceutical cleanroom, and isolator located within it. Key words: Cleanroom classification, ISO 14644-1, EU GGMP Annex 1