Aseptic Processing Guidelines and Innovative Engineering Boost Appeal of Barrier Isolators

www.pharmtech.com initial costs of operation, and confusion about validation. Two developments, however, may now change the industry’s collective mindset: an increase in innovative, customized designs that make it possible to use barrier isolators in applications such as tableting and containment of highly potent compounds and, most important, the release of FDA’s long-awaited revised CGMP Draft Guidance “Sterile Drug Products Produced by Aseptic Processing,” in September 2003.