Marc Pelletier Presenting at ISBioTech

Marc Pelletier Presenting at ISBioTech
Posted: Dec 11 2017
Marc Pelletier will be presenting at ISBioTech’s Fall Meeting in Virginia Beach, VA this week on The Importance of Facility Fitness in Aging Facilities!

The biopharmaceutical industry is currently evaluating future and flexible facility concepts, closed bioprocessing, single-use systems, plug and play drug manufacturing, etc. It may also be time to look back at our traditional stainless steel factories. These aging facilities have been the workhorse of the industry for large-scale manufacturing for decades. Are these facilities ready to face the next few decades in an efficient and cost-effective way? Many cost of goods studies have shown that stainless steel facilities can be the better low cost option in the long term. However, system failures resulting in production interruptions can be extremely costly and may even result in drug supply issues. A proactive approach is required to ensure the drug manufacturing facility is operating in its validated state and that it will manufacture the desired product in an uninterrupted and repeatable and reproducible fashion. Evaluating, monitoring, and maintaining a Fit Facility™ is key to a successful operation.

This presentation looks at the fundamentals of good bioprocessing equipment design that conforms to the ASME BPE standard and offers suggestions for how one may evaluate an existing facility and equipment for its ability to perform in the way it was intended. Design features within new and traditional facilities will be presented in graphic fashion, highlighting basic design flaws that are currently in evidence in many biopharmaceutical facilities. These flaws will result in system and operational failures if they are not rectified in a timely way. The Fit Facility™ is a state that must be achieved, maintained, and validated. This presentation is designed to be interactive, provoking biopharmaceutical manufacturers to re-evaluate their operations and to share their opinions.

His presentation will be Wednesday morning at 8:30 am – for more information, please click here!

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