Recent guidelines have been established by Annex 1 impacting the usage of isolators. With this checklist you can quickly see the key areas referenced, what is required from your isolator and how the Ecolab Bioquell Qube helps you remain compliant.
In August 2022, the European Union made a significant update by releasing a revised edition of Annex 1 to Volume 4 of the EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use. This updated version specifically pertains to the “Manufacture of Sterile Medicinal Products,” outlining essential compliance requirements. This document, an abbreviated version, explains how the Bioquell Qube meets the requirements of Annex 1 based on Ecolab’s