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 .

No comments
The Engineers' Choice Awards highlight some of the best new control, instrumentation and automation products as chosen by...
The System Integrator Giants program lists the top 100 system integrators among companies listed in CFE Media's Global System Integrator Database.
The Engineering Leaders Under 40 program identifies and gives recognition to young engineers who...
This eGuide illustrates solutions, applications and benefits of machine vision systems.
Learn how to increase device reliability in harsh environments and decrease unplanned system downtime.
This eGuide contains a series of articles and videos that considers theoretical and practical; immediate needs and a look into the future.
Robotic safety, collaboration, standards; DCS migration tips; IT/OT convergence; 2017 Control Engineering Salary and Career Survey
Integrated mobility; Artificial intelligence; Predictive motion control; Sensors and control system inputs; Asset Management; Cybersecurity
Big Data and IIoT value; Monitoring Big Data; Robotics safety standards and programming; Learning about PID
Featured articles highlight technologies that enable the Industrial Internet of Things, IIoT-related products and strategies to get data more easily to the user.
This article collection contains several articles on how automation and controls are helping human-machine interface (HMI) hardware and software advance.
This digital report will explore several aspects of how IIoT will transform manufacturing in the coming years.

Find and connect with the most suitable service provider for your unique application. Start searching the Global System Integrator Database Now!

Mobility as the means to offshore innovation; Preventing another Deepwater Horizon; ROVs as subsea robots; SCADA and the radio spectrum
Future of oil and gas projects; Reservoir models; The importance of SCADA to oil and gas
Big Data and bigger solutions; Tablet technologies; SCADA developments
Automation Engineer; Wood Group
System Integrator; Cross Integrated Systems Group
Jose S. Vasquez, Jr.
Fire & Life Safety Engineer; Technip USA Inc.
This course focuses on climate analysis, appropriateness of cooling system selection, and combining cooling systems.
This course will help identify and reveal electrical hazards and identify the solutions to implementing and maintaining a safe work environment.
This course explains how maintaining power and communication systems through emergency power-generation systems is critical.
click me