This guideline deals with all types of barrier systems for the separation of defined clean environments. The objective includes:

• classification of contaminants

– from the viewpoint of hazard analysis

– applicable to all substances classification of defined clean environments ensuring continued operation of defined clean environments

– monitoring

– limit-value monitoring

– open-loop and closed-loop control systems

• criteria for defined clean environments (isolators, workbenches)
• qualification procedures for barrier systems
• decontamination and cleaning of barrier systems
• transfer systems and disposal at the interfaces of barrier systems

– operating and monitoring barrier systems