New, state-of-the-art, 3-story building to house an isolated vial filling line with two lyophilizers, one initially and the flexibility and space for a second machine when demand requires. An isolated prefilled syringe line (PFS), and a cartridge filling line were also included. Supporting each filling suite are compounding rooms, component preparation rooms, and inspection rooms.

• Team led by industry recognized expert in state-of-the-art aseptic processing facilities and barrier technologies
• USFDA, EUWHO and MHRA compliant
• Best-in-class operational efficiency to facilitate personnel, materials and waste movement.  Controlled and Unclassified spaces clearly defined, environmentally controlled for product specific requirements and gowning procedures outlined for product and personnel protection 
• Implementation of Barrier Technologies, including all filling and lyo loading/unloading processes and formulation/compounding operations
• Developed environmental classifications, including Grade A- C and ISO Class 5, Class 7, Class 8, Class 100, Class 10,000, and Class 100,000
• Supporting infrastructure: warehouses, process utilities, secondary packaging, QA/QC labs, development labs, offices and break rooms
• Developed optimum solutions for an integrated approach to warehousing, weighing, sampling, staging, processing and packaging