Just Released: Points To Consider No. 12: Restricted Access Barrier Systems

The report considers the evolution and needs of the modern, global, sterile, pharmaceutical manufacturing industry and addresses the ongoing confusion surrounding regulatory expectations for the use of Restricted Access Barrier Systems (RABS) in the manufacture of sterile pharmaceuticals.

BETHESDA, Md., June 23, 2025 /PRNewswire-PRWeb/ -- PDA has released its latest Technical Document, Points To Consider No. 12: Restricted Access Barrier Systems. The report can be accessed on the PDA bookstore and membership technical report portal.

The report considers the evolution and needs of the modern, global, sterile, pharmaceutical manufacturing industry and addresses the ongoing confusion surrounding regulatory expectations for the use of Restricted Access Barrier Systems (RABS) in the manufacture of sterile pharmaceuticals. It provides clear guidance to aseptic and sterile processing professionals on how to interpret and apply current regulations, including EU GMP Annex 1 and FDA requirements. By clarifying key operational and compliance aspects, the document supports consistent, contamination-free manufacturing within a robust quality framework.

"I am very excited about the release of Points to Consider No. 12: Restricted Access Barrier Systems," said Glenn E. Wright, PDA President, and CEO. "It fulfills a request that we have had from both industry and regulators wanting clearer guidance on many of the design and operational aspects of RABS. My thanks goes out to the members of the volunteer task force of experts for their hard work in creating such an impactful document. Well done!"

The report also communicates PDA's thoughts and considerations pertaining to the design, operation, and use of Restricted Access Barrier Systems (RABS) for aseptic processing, processes subjected to terminal sterilization and low bioburden. It encourages ongoing dialog among professionals in the pharma industry, health authorities, and suppliers of technologies and materials. 

This report does not represent a standard or regulatory guidance and reflects only the views of the Parenteral Drug Association (PDA).

The report is available for purchase at: https://www.pda.org/bookstore/product-detail/8350-points-to-consider-no-12

Media Contact

Walter Morris, www.pda.org, 1 3016565900, [email protected], www.pda.org

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