Points to Consider No. 12: Restricted Access Barrier Systems

This Points to Consider document represents the views of the Parenteral Drug Association (PDA). The document is designed to communicate 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, while encouraging further dialog with industry, health authorities, and suppliers of technologies and materials.  This document considers the evolution and needs of the modern, global, sterile, healthcare product manufacturing industry. This document does not represent a standard or regulatory guidance.