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Quality Digest

FDA Compliance

ISPE Releases Definition of RABS

Published: Tuesday, September 27, 2005 - 22:00

Because of the great confusion about restricted access barrier systems (RABS), the U.S. Food and Drug Administration and the International Society for Pharmaceutical Engineering have released a definition paper to elucidate industry professionals on the topic.The paper includes key elements of RABS, a type of barrier system for aseptic processing of pharmaceutical products that reduces or eliminates interventions. The ISPE paper defines it as including the following elements:
  • Properly managed 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 SOPs for rare interventions

The FDA encouraged ISPE to develop a clearer definition of the elements that characterize RABS technology to assist the agency and industry professionals to understand it.

The International Society for Pharmaceutical Engineering provides pharmaceutical manufacturing professionals with opportunities to develop technical knowledge, exchange practical experience and collaborate with global regulatory agencies. It has affiliates and chapter in 19 countries.

For more information, visit www.ispe.org.


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