ABSTRACT
Pharmaceutical manufacturers are rapidly adopting integrated barrier isolators to enclose systems for the aseptic filling of products. To better understand the motivation for this trend, a comparison of traditional aseptic filling suites with integrated barrier isolation systems is necessary. There are both quantitative and qualitative differences between these two approaches. The only perceived negative for the application of integrated barrier isolation systems is the instantaneous accessibility of any exposed portion of the filler line. In the case of integrated barrier isolation systems, intervention is accomplished through gloved ports and/or mechanical manipulators operating within the enclosure itself. The materials of construction must not be detrimentally affected by the cleaned-in-place and sterilized-in-place cycles required to render the inside of the barrier isolator clean and sterile. Glass vial transfer is typically the largest volume transfer required to move from outside a barrier isolator into a barrier isolator during a filling operation.
