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