- Best-in-class facility with unidirectional personnel and product flows
- Real time QA review on Electronic Batch Records with automated data acquisition
- Fully integrated inventory, EM, and Quality Management systems
- Microbiological, sterility, bioburden, B/F, endotoxin testing
- Validation of analytical test methods
- Aseptic fill and finish
- Terminal sterilization
- Comprehensive analytical testing capabilities
- 100% manual finished product inspection
- Logistics and supply chain support
- Flexible batch sizes, Clinical and Commercial, Class I-III
- Biologics
- Large and Small molecules
- Diluents
- Suspensions
- Single use or stainless steel tanks
- Fully aseptic compounding
- Line dedicated formulation suites
- Fully integrated isolator filling
- Liquid vials, 2mL- 20mL - Capacity now available
- Lyo (planned for 2024)
- Syringes 2mL – 10mL (planned for 2024)
- Bausch and Strobel ADVANCED fill dosing system for high yield filling (~99.9%)
- In-line non-destructive weight checks
- 40-60 units per min nominal speeds
- Ready to use and ready to sterilize vial processes
- Full analytical and Microbiological testing
- HPLC and UPLC
- GC
- Particulate testing
- Compendial testing of all raw materials
- Dedicated Analytical method transfer and validation resources
- ICH Stability testing
