More Science to the Art of Blow-Fill-Seal
By Daphne Allen
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Chuck Reed, sales manager, Americas, for Weiler Engineering (Elgin, IL), reports that he has seen international regulatory agencies step up their reliance on “science” to support aseptic processing regulations. “More regulatory oversight is being employed internationally to enhance product safety, and the regulatory agencies are more closely scrutinizing users. As a result, blow-fill-seal has become more universally accepted as an advanced aseptic technology.”
With such acceptance comes more work. The specifics of machine design and operation, for instance, have become more critical, Reed says. “Increased emphasis on environmental monitoring by regulatory agencies is providing challenges, particularly with existing older BFS machines.”
To ensure that science is actually being applied, regulatory agencies expect BFS users to understand the process. “Ongoing microbial challenge studies are being conducted to improve the scientific understanding of the dynamics of the BFS process, giving users more valuable information to address regulatory issues,” says Reed. And, “users must study the stability issues of their product when considering a change of either storage or delivery. Extractables, leachables, and vapor transmission are all components that differ among products and containers and can present challenges to the process.”
Reed says there still appears to be a “disconnect between conventional aseptic processing technologies and blow-fill-seal processes,” but “FDA has begun to recognize and address some of these differences through the Appendix of its Sterile Guidance document.”
For more information, visit www.fda.gov/cber/gdlns/steraseptic.pdf.