Pharma-like Manufacturing–Fit, Finish and Segregation

Unidirectional flow of materials, personnel, and products

The design of BD’s animal-free production facility in Miami 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

Hosokawa Alpine UPZ 100 milling pin

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