Contamination Control Products For Annex I Compliant Facilities

Annex 1 provides guidance for the manufacture of sterile medicinal products produced within or imported into the European Union. It has undergone several revisions since it was first issued in 1971, but none have been as substantial as the complete rewrite published in August 2022. Advances in sterile manufacturing technology (e.g., RABS, isolators, single-use systems, and rapid microbiological testing) and the introduction of Quality Risk Management (QRM) required substantial changes and additions to be made to the Annex. A key requirement is a holistic Contamination Control Strategy (CCS) aimed at minimizing the risk of contamination. Explore the details of a CCS, tips for managing disinfectant residues, general guidelines for removing disinfectant residues, and a wide range of products for cleaning and disinfection.