The potential for use of steam at atmospheric pressure to decontaminate or sterilize parenteral filling lines incorporating barrier isolation technology.

Barrier isolators that enclose aseptic filling equipment are being proposed as a means of: (1) assisting in achieving a 10(-6) sterility assurance level (SAL) in the filling area and (2) minimizing the clean environment required in the manufacturing area. The need for operator and maintenance access to the interior of the barrier isolators presents difficulties in achieving the above goals. Several methods are available for reducing the microbial level inside the isolation barrier. If the objective is the decontamination of all surfaces inside the enclosure, saturated steam at atmospheric pressure can be used. If the objective is to sterilize the inside of the enclosure, saturated steam at atmospheric pressure with added H2O2 can be used. Test data and practical interface considerations relative to various methodologies will be reviewed.