earticle

영어

FlexFactory®, a paradigm shift from traditional biologics manufacturing facilities, is based on a modular biologics manufacturing platform and single use operating philosophy. The FlexFactory consists of three critical components; single use manufacturing unit operations, controlled environmental modules and process automation with electronic batch records. Included with the FlexFactory design are the design and specification of all the disposable components. Design,
specification and selection of all product contact components are critical for the successful operation of a FlexFactory. Bag designs, transfer ports and tubing sets, reliable single use instrumentation, and storage containers are considered and designed into the operation of the process equipment used in a typical FlexFactory. Single use equipment eliminates the need for CIP and SIP infrastructure, leading to substantial (70%) reduction in water use. This contributes to a 55% lower carbon footprint with FlexFactory systems. Each FlexFactory process step is isolated in its own controlled environmental module (CEM), effectively shrinking the clean room around each unit operation. Upstream and downstream modules can occupy the same shared space with greatly simplified HVAC requirements. Operators can move freely from operation to operation, without the burden of gowning and degowning. The CEM architecture also enables the FlexFactory train to be 100% modular and to accommodate simultaneous multi product production. The automation portion of the FlexFactory integrated platform allows continuous process oversight in an expeditious and effective manner. The primary result is more efficient
manufacturing, repeatable processes, and faster quality evaluation at the end of a batch. Product batches can be released by exception, eliminating lengthily QA reviews and speeding up overall batch release time by weeks or months.