Bioprocessing Media and Supplements
AF² Production Facility
Pharma-like Manufacturing–Fit, Finish and Segregation
The design of BD’s new AF2™ Production Facility is based on the stringent needs of biopharmaceutical manufacturers, and incorporates the following design features:
Completely segregated manufacturing areas with zoned air handling systems and terminal UPLA filters
State-of-the-art modular clean room systems designed and installed by AES Clean Technology
Continuous nonviable particle measurement system for environmental control and monitoring
Automated CIP (Clean in Place) and SIP (Sanitize in Place) cleaning processes
Water system meets USP and EP requirements and generates USP grade UPW (USP Pure Water) WFI (Water for Injection) and Pure Steam
Unidirectional flow of raw materials, personnel and products including separate areas for gowning, de-gowning and material air locks.
In addition, full viewing corridors throughout manufacturing areas facilitate audits and maintain environmental control.
Unidirectional flow of materials, personnel, and products
State-of-the-Art Pin Milling Technology
The new AF2™ Production Facility employs state-of-the-art Hosokawa Alpine UPZ pin milling technology, ensuring product integrity and consistent performance while minimizing risk of cross-contamination:
Maintains particle size consistency at 95% less than or equal to 212 microns
Capacity – Up to 300 Kgs / hour
Minimal heat generation
Easily cleaned using CIP process
Milling is also available upon request for custom cell culture media formulations.
Hosokawa Alpine UPZ 100 milling pin