Facilities and Equipment

Smiling employee standing in FDA-registered fill-finish site.

FDA-registered fill-finish site

  • 20,000 sq. ft. facility
  • Just-in-time warehousing and production
  • Comprehensive mixing and compounding
  • Single-use and dedicated reusable systems
  • Aseptic filling


Vials being processed at laboratory site.

Laboratory site

  • 2,500 sq. ft. facility
  • Method development and validations
  • Analytical QC release
  • Microbiological QC release
  • ICH stability
Row of shelves at packaging and warehouse site.

Packaging and warehouse site

  • 10,800 sq. ft. expansion
  • Raw material and component warehousing
  • Finished product warehousing
  • Inspection and packaging
American Injectables employee consulting electronic dashboard in full PPE in a clean room.

Clean rooms

We use quality by design (QbD) engineering and physical barriers to enhance 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
  • Dedicated gown in/out areas
American Injectables employee operating equipment in full PPE.

State-of-the-art equipment

With all new equipment manufactured in 2017 or later, the latest technologies and efficiencies are built into every system.

  • Optima syringe filling line
  • Bosch vial filling line
  • Automated mixing vessels
  • Fedegari autoclave
  • Fedegari dry heat oven
  • Girton CIP/SIP
  • Girton parts washer

Schedule a site visit

Visit us in Brooksville, FL to see our facilities in person.
Smiling employees ready to meet you.