There’s been a paradigm shift in biopharmaceutical manufacturing site design, spurred by changes in process technologies—especially single-use technologies—as well as new drug developments and more individualistic, personalized therapies. Economic pressure to reduce costs is an additional factor. As a result, large-area single product brick-and-mortar facilities are being replaced by multiple versatile facilities. Modular facilities, which can be deployed more quickly than traditional layouts, initially seemed to offer a solution; once established, however, they proved no more flexible than their traditional counterparts.
They require thorough capacity planning as well, since their inherent inflexibility does not accommodate the need for flexibility of scale, multi-product purposes, or single-use technology processes. Despite this, modular facilities are sometimes incorrectly called “flexible facilities.” So how would one define a flexible facility? Autonomous compact cleanroom systems are truly flexible and suitable for multi-product processing; they can be decontaminated, sanitized, controlled, and reused.
In addition, these systems can be deployed on a fast track, scaled without interrupting existing cleanroom spaces or processes, and moved, if necessary. I’ll discuss the paradigm shift in manufacturing facilities, the need for flexibility, and innovative facility solutions on Monday 7 November at “Facility Flexibility: The Benefits of Modular and Prefabricated Cleanroom Structures,” part of the 2016 Pharma Expo Conference Manufacturing Operations track. I hope to see you there! By: Maik W. Jornitz, President, G-CON Manufacturing Inc. Pharma EXPO Conference Program Details: At Pharma EXPO 2016 (McCormick Place, Chicago, Illionois USA; 6 - 9 November), Maik W. Jornitz's session will be held on Monday, 7 November at 9:00am, as part of the day-long Manufacturing Operations track of the Pharma EXPO Conference Program, curated ISPE. Learn more and register for Pharma EXPO.