FlexFactory Design Highlights
The FlexFactory process train is comprised of disposables-based unit operations which minimizes the risk of cross-contamination. Each unit operation is enclosed in a controlled environment module (CEM), which are co-located in common, controlled manufacturing space. The CEM provides a localized clean environment around the equipment and with positive pressure to the room.
The environmental standards for the FlexFactory CEM's are based on traditional clean room standards. Operators stand outside the CEM and access the equipment access through iris ports. The need for multiple airlocks and gowning and re-gowning rooms is eliminated.
Electronic batch records identify errors in real time allowing isolation of problems, increasing the assurance of overall product quality.
FlexFactory operations require only:
Xcellerex has been working closely with the FDA for more than 3 years educating officials about the design and operation of the FlexFactory. We have received positive feedback to date and are confident FlexFactory will be accepted as an approved commercial production platform.
are developed, manufactured & commercialized.
