Glossary
Barrier Technology
Technology such as RABS or an isolator that places a physical barrier between the operator and the Grade A critical zone.
Details
Barrier technology lowers the contamination risk of aseptic processing by reducing direct human intervention, but gloves, transfers, decontamination, and the background grade all have to be managed together. Inspections cite glove leak testing, bio-decontamination cycles, door openings, and transfer routes that are not adequately reflected in the contamination control strategy. Check the design and qualification, glove integrity, decontamination validation, airflow visualisation, and intervention records.
