An optimal engineering design is crucial for aseptic operation and cleaning. The first draft of the European Union (EU) good manufacturing practice (GMP) Annex 1, “Manufacture of Sterile Medicinal Products” was published for comment on the December 20, 2017 (1) and generated great interest internationally, as it was the first adaptation to the full EU GMP document on the manufacture of sterile medicinal products since November 20, 2008 (2). And, as during the creation of the document, the Pharmaceutical Inspection Cooperation Scheme (PIC/S) and the World Health Organization (WHO) were also involved. The previous applicable document of Annex 1 was completely revised and contained many changes, adaptations, and new contents, which resulted in a large number of comments (6400 in total) to the European Commission. The second published draft of the EU GMP Annex 1 appeared just two and a half years later, on February 20, 2020 (3). For the new draft version, stakeholders such as the International Society for Pharmaceutical Engineering (ISPE), Parenteral Drug Association (PDA), and others were contacted for comments. The comments on the second publication of the draft document concluded in July 2020, and the final version is expected to be published in the beginning of 2021. Barrier systems in Annex 1: RABS and isolators

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• Isolator

• Contamination Control

• Standards

• Pharmaceutical Technology

• 11/2/2020

• Article