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.
However, in the absence of an agreed definition, the industry has been unable to demonstrate with certainty that its would-be RABS do indeed meet the necessary criteria.
ISPE's new paper provides a definition of RABS for the FDA and the pharmaceutical industry, in order to make it possible for companies to demonstrate that they meet the regulatory requirements for RABS.
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 Disinfection Appropriate line clearance Documentation of event "This appears to be the first, and certainly the most current and comprehensive, RABS definition offered by a technical organisation," said Rick Friedman, team leader for guidance and policy at the FDA's Center for Drug Evaluation and Research.
"Now, companies will be able to start sterile facility design discussions with a concrete definition to refer to.
I expect this contribution to be an instrumental step toward reaching consensus on a formal definition," he added.
To read the RABS definition paper, which was released on 16 August, visit www.ispe.org/rabscomment.