There are many benefits to using isolator technology for aseptic processing. Separating the operator from the process/product results in greater product quality and operator safety. Sporicidal agents delivered into the isolator as part of a validated system provide a much higher sterility assurance than in a cleanroom, which is typically disinfected manually.
Data has been taken since 1998 on the use of isolators for aseptic filling. Steady growth can be seen for filling machine isolator use worldwide. Sterility test isolator use continues to be one of the more frequent uses of isolators.
With the need to formulate and fill more potent products aseptically, the use of isolators will continue to grow. The future may include automated or robotic systems to perform sterility testing or handle extremely potent or radioactive products to eliminate operator interaction through gloves.
This cleanroom tip was taken from “The Benefits of Isolator and Aseptic Processing,” which appeared in the July/August 2011 issue of Controlled Environments.
