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Facility of the Future: Our takeaways from the ISPE Aseptic Conference 2019 - Argonaut Manufacturing
The always-essential 2019 ISPE Aseptic Conference was held in North Bethesda, MD and we were there to assess the trends, check out the leading-edge sessions, and share lessons with industry leaders. Read on to find out what we found interesting or compare with your notes, if you attended. This annual conference brings together industry and regulatory leaders in the aseptic processing field for two days of learning and discussion. The 2019 breakout sessions followed a similar pattern to last year’s event: Barrier, Aseptic, and Containment. Particularly interesting to us was the keynote address by FDA/CDER Director Richard Friedman who commented, “GMP is good GBP, which equals good business practice.” In our view, nearly all talks this year could be unified into a “Facility of the Future” concept that is anchored on patient safety, while gaining added flexibility for personalized medicine. The Facility of the Future This year, there were some engaging presentations and discussions regarding emerging trends that will create sterile manufacturing facilities of the future. The concept is built upon the collective design choices and most advanced aseptic technology available to produce the safest possible product. These technologies include ready to use components, single use solutions, isolators, and robotic applications on filling lines to create more reliable and robust processes. What about legacy facilities? The sessions on “Advanced Technologies for Legacy and Future Facilities” and “Facility Upgrades and Expansion” covered various approaches for transitioning to these newer technologies. Retrofitting can be a time consuming and costly endeavor, however, for …