This presentation highlights the current regulatory requirements for isolator systems in accordance with Annex 1 of the EU GMP guidelines. It focuses on the expectations of regulatory authorities regarding the complete lifecycle of an isolator — from design through qualification and validation to routine operation. Key topics include containment concepts, aseptic process management, environmental monitoring, decontamination strategies, requirements for material and personnel flows, and the documentation of regulatory-relevant data.
In addition, the presentation outlines typical audit focal points and common compliance gaps to provide companies with practical guidance for inspections. Participants will gain a comprehensive overview of how modern isolator systems must be designed, operated, and monitored to reliably meet the increasing expectations of regulatory authorities.