ISPE releases RABS definition


Process Control

In cooperation with the U.S. Food and Drug Administration (FDA), ISPE has released a definition paper on restricted access barrier systems (RABS). The paper provides a definition of RABS for the Agency and the pharmaceutical industry. The goal is to reduce confusion about key elements of RABS and their regulatory requirements. ISPE is a global not-for-profit society of pharmaceutical manufacturing professionals.

RABS is a barrier system for aseptic processing of pharmaceutical products that reduces or eliminates interventions into the critical zone, as compared to conventional clean room aseptic processing. There is great confusion in the industry about RABS, its definition, and how it differs from other forms of barrier isolation systems. To be classified as a RABS, a system must include the following elements:

An ISPE committee created a draft definition paper that defines RABS for the industry and describes the 'quality by design' and operational characteristics that must be present to constitute a RABS. The team posted the draft paper for public comment on the ISPE Web site during July and submitted a final version to the FDA. Released in mid-August, the paper defines RABS for the industry and describes the 'quality by design' and operational characteristics that must be present to constitute a RABS.

Founded in 1980, and based in Tampa, FL, ISPE, the International Society for Pharmaceutical Engineering, represents more than 23,000 pharmaceutical-manufacturing professionals in 80 countries. ISPE also has offices in Singapore; Brussels, Belgium; as well as affiliates and chapters in 19 countries.

—Control Engineering
Richard Phelps, senior editor,

To read the RABS definition paper, click here .

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