restricted-access barrier system for the pharmaceutical industry
for the pharmaceutical industry
Restricted area barrier system:
RABS is a type of barrier system for aseptic processing of pharmaceutical products that reduces or eliminates interventions into the critical zone.
In practice, its level of contamnation control lies somewhere on the spectrum between a conventional clean room aseptic processing and an isolator.
The ISPE has decided that in order to be classified as a RABS, a system must include the following elements:
• Properly designed equipment
• Management oversight
• A quality system in place
• Proper surrounding room design to maintain ISO 5 in critical zone
• Proper gowning practice
• Proper training
• Initial high level disinfection with sporicidal agent
• Proper SOP's for rare interventions
• Appropriate line clearance
• Documentation of event.