A NEW STATE-OF-THE-ART PARENTERAL FILLING FACILITY

CLEANROOMS

American Injectables uses quality by design engineering and physical barriers to enhance the critical process segregation for improved safety, cleanliness, and material flow. The result is a cleanroom structure that is easier to control, prevents mixups, and increases throughput.

 

  • 10,000 SQ FT. of ISO 5 / 7 cleanrooms
  • Automated particle monitoring
  • Dedicated gown in / out areas
  • Single pass material flow

PROCESS EQUIPMENT

With all new equipment manufactured in 2017 or later, we have ensured that the latest technologies and efficiencies have been built into every system.

 

  • Syringe filling line (OPTIMA)
  • Vial filling line (BOSCH)
  • Fully automated mixing vessels (20-300L)
  • Autoclave (FEDEGARI)
  • Dry heat oven (FEDEGARI)
  • CIP/SIP (GIRTON)
  • Parts washer (GIRTON)
  • Vial washer (PENNTECH)
  • Automated visual inspection system
  • Labeling machine (OPTIMA)

CLEAN UTILITIES

American Injectables produces all its own critical utilities in house, resulting in a fully self-sufficient operation.

 

  • RO-EDI (BWT)
  • WFI system (BWT)
  • Clean steam generator (BWT)
  • Boiler (Fulton)
  • Process air (Atlas Copco)
  • Process Nitrogen <10 ppm (Parker)

PLANT SCADA

We invested heavily in building automation and custom plant management software. We can control and monitor every piece of equipment and component in our entire plant from the fan speed on a cooling tower to the infeed sensor on our vial line, all from a single interface. This granular level of control means we run a flexible and proactive operation complete with database trending and continuous quality improvement.

 

  • Supervisory control over all facility equipment and systems
  • Complex batch planning and scheduling
  • Database analytics and trending
  • Fully automated maintenance and asset tracking
  • Cost savings efficiencies and peace of mind for our customers

DISASTER RECOVERY

Our engineering team assessed all possible weak points and employed redundancy and resilience wherever possible. Whether related to weather, IT or equipment failure, we invested in all aspects of our system for an unparalleled disaster recovery plan.

 

  • Full facility backup natural gas generator
  • Hyper-converged server and data networks (triple redundancy)
  • Redundant utility hydronic pumping systems
  • Modular/dedicated HVAC systems
  • Spare parts across all systems
  • Emergency maintenance staff (24/7)