Capabilities

Four filling suites with comprehensive support services.

Manufacturing Capabilities

Groninger FlexPro 50 - ISO Syringe with Franz Ziel Isolator

  • Syringe capabilities: 1mL – 10mL
  • High/Low viscosity compounds
  • Small batch processing capabilities with reduced line loss
  • Two fill nozzles capable of processing 100/160 count tubs of RTU syringes
  • Vacuum stoppering capability
  • Vaporized hydrogen peroxide (VHP) sterilization with optimized decontamination and aeration

Flexicon FPC 50 - ISO Fill/Finish with Franz Ziel Isolator

  • Liquid formulation ranging from 2mL – 50mL
  • Fully disposable equipment train
  • Capable of meeting batch completion targets in a single operating shift
  • VHP sterilization with optimized decontamination and aeration
  • Highest level of dose accuracy in the market through the use of peristaltic pumps

Facility Support Capabilities

Support Capabilities

  • USP Purified Water (Hydro) – 500 L storage tank – Reverse Osmosis-based purification and automated loop sanitation cycle
  • Process WFI – 20,000 L – Generated using a 5-effect distillation process
  • Air Compressor: Provides instrument and clean compressed air for the facility
  • Nitrogen Supply – 1500 Gallon tank
  • GMP Warehouse
  • Air Cooled Chiller – 490 tons
  • Gas Fired Steam Boiler Package
  • Heating Hot Water Boiler – 5,000 Mbh
  • Fire Sprinkler System

Future Capabilities

  • Lyophilization equipment with automatic load/unload system – from development to commercial
  • Liquid filling machines with isolator technology
  • Vial washing/depyrogenation capabilities
  • Terminal Sterilization
  • Semi-automatic/manual visual inspection capabilities for vials and syringes
  • Onsite in-process laboratory supporting analytical and microbiology needs