SINGLE-USE PROCESS SYSTEMS
Single Use / Disposable Silicone Manifolds For Pharmaceutical & Biotech Processing Applications

By combining platinum-cured, Class VI silicone tubing with molded fittings, stoppers and other components, a wide variety of manifold options are possible. Designs range from simple, single fitting connections to complex configurations with varying lengths of tubing and several molded connections.

The process used to join silicone tubing and molded fittings permanently bonds the parts into one unit. Leaks and entrapment concerns, common with the use of barbed fittings, are eliminated.

Single-Use Process Systems are not intended for implantation and are not to be used for continuous steam applications.

Key Features

• Custom manufactured with Y’s, T’s, cross T’s, reducers, mini and standard Tri-Clamps®, bottle stoppers and sealers, and tubing—many configurations are available
• Eliminates entrapment issues and leaks associated with barbed fittings
• Components are permanently molded into one, single-use manifold
• Reduces the risk of cross contamination
• Reduces production downtime by eliminating certain cleaning validation requirements
• Provides a smooth inner surface without seams or crevices for even, uninterrupted flow
• Reduces end-user assembly labor time and expense
• Retains silicone’s wide range of temperature resistance: -100°F to 400°F
• Provides flexibility in facility design—changes are less costly than with hard piping
• Sterilizable by autoclave and gamma radiation
• Imparts no taste or odor to critical streams
• Manufactured and sealed in clear polybags in a controlled environment to ensure cleanliness
• Documented lot traceable with identification on bags
• Documented quality control
• Experienced engineers available for technical assistance
• Tubing and molded silicone connections provide one material contact surface throughout the assembly
• Optional RFID tags easily attach to assemblies for identification purposes—providing reliable electronic data storage and current status of assemblies from inception to disposal

This example of an assembly made from tubing and barbed fittings is comprised of nine separate pieces of tubing of varying sizes and lengths, plus four fittings that require insertion into the tubing at three points each, with double ties wraps installed at each connection for secure attachment. An AdvantaPure Single-Use Process System is a complete unit, packaged in a sealed polybag and ready for use. Leaks, entrapment, and contamination concerns involved with barbed fitting connections are eliminated. Labor, numerous inventories, and time to assemble the manifold is unnecessary. 37 Components 1 Component

Bottle Stoppers and stopper assemblies are manufactured from platinum-cured, Class VI silicone and are available solid, with holes, and with tubing inserts. They can easily become part of your manifold design for batch processing in a variety of sampling and storage containers made from glass, plastics, or metal. Molded silicone Tri-Clamp® fittings with protective backing cups may be incorporated into process systems. True Union silicone stoppers, GL45, and various other container closures, available with or without tubing inserts or holes, are also manufactured from platinum-cured, Class VI silicone.

Silicone tubing is available from stock in nearly 50 sizes. It, too, is platinum cured and meets Class VI standards. Complete biocompatibility validation packages are available.

Experienced engineers with 20 years of knowledge in silicone extrusion and molding are available for technical assistance. Contact your AdvantaPure representative today to see how Single-Use Process Systems can solve your needs: 1-888-755-4370

Click link to download a printable version of our Single-Use Process Systems brochure. Single_Use_Process_Systems.pdf (360KB)