Aseptic Fill & Finish




Irvine has again responded to the growing need of our customers by adding our manufacturing facility. The addition of aseptic fill-and-finish completes a seamless outsourcing solution for your pharmaceutical products from early development through manufacturing and stability testing.

Irvine's manufacturing department has received licenses for Pharmaceutical Drug and Device Manufacturing by the California Food and Drug Branch in addition to receiving an ISO 13485 certificate for contract manufacturing and formulation of pharmaceutical, biopharmaceutical, and medical device products.

COMPLETE CMO PACKAGE FROM SMALL MOLECULES TO BIOLOGICS

  • Toxicology, Clinical Trial, and Commercial Manufacturing
  • Aseptic Filling (Liquid or Lyo)
    • 1mL to 100mL Vials
    • R&D Hand Fills
    • Unique Container Hand Fills
  • Formulation Development
  • Analytical Development
  • CMC Analytical Testing
  • Process Validation
  • Terminal Sterilization
  • Inert Gas Purge and Overlay

CUTTING-EDGE FACILITY

  • Three cGMP Manufacturing Suites
  • Passive RABS filling line
  • Dedicated air-handling in each suite         
  • Formulation lab and pilot suite
  • Video viewing of production
  • Flexible and scalable
  • No seasonal uncertainties



REQUEST A PROPOSAL

DOWNLOAD FACT SHEET

PRODUCTION FLOOR PLAN