Aseptic Fill-Finish

Gallus has extensive experience in aseptic filling of vials, dating back more than 25 years.  Our newly upgraded Fill-Finish suite at our facility in Princeton provides reliable aseptic fill/finish services, including formulation, aseptic vial filling, vial inspection and hand-labeling – with expertise in the production of parenteral biologics and pharmaceuticals.  Our filling services are offered either as part of a protein manufacturing project or as a stand-alone offering for clients who have manufactured their products elsewhere.   Our filling services boast a success rate of >98%.

Vial Filling Capabilities

FP Developments Model 1373 Filling & Stoppering machine operates under a Class 100 / ISO 5 soft wall curtained area with Class 10,000 / ISO 7 background with a linear peristaltic pump dispensing mechanism.

  • Filling of liquids into glass or plastic vials
  • Vial sizes range include 2 mL to 100 mL with 13mm or 20mm finish;
  • Fill volumes from 0.1 mL to 100 mL
  • All product-contact parts are single-use disposable
  • Batch sizes of up to 20,000 vials (for certain vial sizes) or 200 L of bulk with
  • Small molecules or large molecules
  • Low line loss and shear process

Vial Overcapping

  • West PW500 Capping Machine operating under Class 100 / ISO 5 Soft Wall Curtained Area with Class 100,000 / ISO 8 background
  • 13 mm or 20 mm finish vials only
  • Overcapping of filled and stoppered vials with aluminum-skirted polypropylene flip-off seal

Visual Inspection

  • 100% visual inspection of filled vials by qualified filling personnel
  • Inspection uses white and black background with fluorescent overhead lighting

Formulation

  • Formulation of liquids up to 200 L volume, greater volumes available upon request
  • Single-use disposable formulation and mixing vessels