Companies from around the globe joined representatives from FDA to present and discuss the latest in pharmaceutical manufacturing technologies and the future of cGMP for the industry. Aseptic technologies were featured at the 18th Annual Barrier Isolation Forum, moderated by Jack Lysford and Michael Porter. Contamination risk and the application of automation technologies continues to be an area of strong interest, with a continuing advancement in the reduction of risk from successful application of strategies to limit the human element from the production of sterile pharmaceuticals. At the forum, Nathan Beyeler of Merck presented a study of head to head cost comparisons of conventional cleanroom technology versus isolator systems and demonstrated a 75% reduction in operating cost for isolator technology. This was a thoughtful and methodical analysis using real-world data and demonstrated the value, not only in quality, but in operational efficiency to new technology. SAIC (Frederick, MD) detailed the efficiencies of peroxide technologies in isolator systems for viral inactivation, and process considerations for successful validation and operations. Vanrx’s RAPTOR technology was featured in the event, displaying its current project for creation of a hands-off filling system for vials and syringes which removes the need for format changeparts and operator aseptic intervention.

The focus on removal of human intervention was a highlight of the FDA Q&A session, where representatives from the FDA CBER and CDER groups commented on recent experience and the direction of the agencies priorities going forward with aseptic operations. FDA was clear in stating that isolator technology has emerged as the current standard, with the obsolescence of conventional manned cleanroom technology on the horizon. Both CBER and CDER representatives remarked that neither group has rejected a single application involving isolation technology, highlighting the benefits in operation and product protection for new drug processes.

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