Glossary

Barrier Technology

Technology such as RABS or an isolator that places a physical barrier between the operator and the Grade A critical zone.

Source · EudraLex Volume 4, Annex 1 (2022), §§4.3, 4.18–4.22

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.

Related sections

EU GMP Annex 1 §§4.3, 4.18–4.22

Related terms

Restricted Access Barrier System (RABS)9 casesIsolator9 casesCritical Zone1 case

Source

EudraLex Volume 4, Annex 1 (2022), §§4.3, 4.18–4.22

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