"What, You Call That A RABS?" 7 (Real-Life) Aseptic Filling Blunders To Avoid
Restricted-access barrier systems (RABS) have been a major part of pharmaceutical aseptic filling operations for many years. They were introduced around the year 2000, and by 2007 there were 75 installations in the business globally.1 Today, there may be several hundreds, most of which are in GMP-compliant facilities and serving the needs of the business. RABS were born out of the need to: 1) protect the operators from the products they were filling, 2) improve filling compliance, 3) provide better access to a wider variety of filling process equipment, and 4) bring legacy lines into better compliance. This last point is critical for CMOs because their batch sizes vary widely, necessitating frequent and rapid changeovers, as well as addressing the variations in vial sizes and filling setup parameters.
There are many excellent and scholarly articles written about RABS and RABS vs. isolators; however, this is not a technical article. This article is based upon our travels over the last 10 years, looking at aseptic filling operations and seeing what was described to be “a RABS” by the various owners. These RABS are all dubious devices created by their owners, who are deluding themselves into believing they have a validated aseptic RABS. Some of these are actually amusing, and they illustrate what happens when “hands-on” engineering meets the needs of operations while the compliance department is asleep at the wheel.
Published By: Dr. Tarun Chugh
