Made in USA
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GammaTag™ - An Option For Process Equipment Tracking Systems
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SINGLE-USE/DISPOSABLE BATCH FILL & SAMPLING ASSEMBLIES
For Pharmaceutical & Biotech Processing Applications
Single-use / disposable assemblies eliminate lengthy production stoppages for sterilization between batch runs, and they simplify safety—use once and discard.
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 Assemblies 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 bonded into one, single-use/disposable manifold
- Reduces the risk of cross contamination when used as part of an integrated contamination control strategy
- Results in a securely closed system for a purer product and reduces opportunities for contamination
- Reduces regulatory risk by eliminating certain cleaning validation requirements
- Provides a smooth inner surface without seams or crevices for even, uninterrupted flow
- Reduces end-user assembly time—arrives ready to install
- Retains silicone’s wide range of temperature resistance: -100°F to 400°F
- Tubing is extremely flexible and easy to handle
- Sterilizable by autoclave and gamma processes
- Optional RFID tags easily attach to assemblies for identification purposes—providing reliable electronic data storage and current status of assemblies from inception to disposal
- Imparts no taste or odor to critical streams
- White-room manufactured
- Sealed in clear polybags during manufacturing process to ensure cleanliness
- Documented lot traceable with identification on bags and boxes
- Documented quality control
- Experienced Pharmaceutical Process Engineers available for technical assistance
- One material contact surface throughout
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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 and secure attachment with tie wraps.
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An AdvantaPure assembly is a single complete unit, packaged in a sealed polybag and ready for use. Leak, entrapment, and contamination concerns involved with barbed fitting connections have been eliminated. Labor and time to assemble the manifold is unnecessary. |
25 Components
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1 Component
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Save even more time and labor by allowing the assembly technicians at AdvantaPure to attach other components such as filters, clamps, bags, stoppers, and RFID tags. Gamma sterilization services of complete assemblies are also available.
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 Bottle stoppers and container sealers, available with or without tubing inserts, are also manufactured from platinum-cured, Class VI silicone. They can easily become part of your assembly design for batch processing in carboys and other vessels.
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 Molded silicone Tri-Clamp® fittings with protective polysulfone or series 304 stainless steel backing cups may be incorporated into filling assemblies.
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Silicone tubing is available from stock in nearly 90 sizes. It, too, is platinum cured and meets Class VI standards. Complete biocompatibility validation packages are available.
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Contact your AdvantaPure representative today to see how Disposable / Single-Use Batch Fill & Sampling Assemblies can solve your needs: 1-888-755-4370 |
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GammaTag is our new 
Click link to download a printable version of our Sterile Batch Filling Assemblies brochure.