Flexicon America, Inc.

May 15, 2007
Disposable Filler Provides Fast Set-Up, Simplified Validation

Flexicon America Inc.'s new Disposable Filling Machine offers fast, accurate dispensing of pharmaceutical and biotechnology serums and fluids, easy product changeover, elimination of cross-contamination and simplified aseptic filling and cleaning validation.

The Disposable Filling Machine combines a ready-to-use, fully disposable DAFPA (Disposable Aseptic Fluid Path) assembly with the Flexicon Peristaltic Technology for simplified aseptic filling and cleaning validation. A gamma-irradiated assembly is simply mounted onto a stand and threaded through the Flexicon peristaltic pump head and secured into a disposable filling needle. The closed, disposable DAFPA system dispenses the fully contained product in a gentle transfer through sterile tubing.

Clean-up, validation and product changeover are fast and easy since product does not come in direct contact with the equipment, and there is no possibility for cross-contamination. The used product bag, tubing and filling needle are simply discarded and a new product bag, fresh tubing and a filling needle are set into position on the machine. The Disposable Filling Machine accommodates a wide range of fill volumes and vial sizes simply by selecting an appropriate tube diameter. 

Media bags are available in 2-, 5- and 10-liter volumes. All assemblies are supplied with Flexicon platinum-cured silicone tubing in 0.8, 1.2, 1.6, 4.8 and 6.0 sizes. Customization of assemblies is available to suit specific filling needs.