Validated Sterile Single Use Manifold Assemblies Now Available From AdvantaPure(R)
High purity tubing manufacturer AdvantaPure now offers single use molded manifold assemblies that are validated as sterile. Assemblies made from silicone or AdvantaFlex TPE are gamma irradiated for a sterility assurance level of 10-6.
Southampton, Pa. (I-Newswire) October 17, 2012 - AdvantaPure announces the ability to deliver its single use/disposable manifold assemblies to customers with a certificate of sterility assurance to the level of 10-6. The tubing assemblies, which consist of molded manifolds and accessories such as filters and connectors, are used for batch filling and sampling in the manufacture and processing of vaccines and other pharmaceuticals. Validated sterility is achieved through gamma irradiation.
“Pharma and biotech manufacturers want to receive a validated sterile part that’s ready to install,” says John Stover, AdvantaPure’s Director of Product Management. “They don’t want to go through the time-consuming process of receiving in a part, sending it out for gamma irradiation, and waiting for its return. They also don’t want to maintain two inventories – irradiated and non-irradiated. Customers need to be able to open a package, attach a part, and go.”
Offering superior material penetration, gamma irradiation is chemical free, residual free and post-process radiation free. The irradiation process destroys microorganisms and bacteria and does not require a quarantine period like some other sterilization methods. Products are ready for shipment and use immediately after sterilization.
AdvantaPure’s single use systems are manufactured from platinum-cured silicone or AdvantaFlex® biopharmaceutical grade TPE in class 7, ISO-certified clean rooms. Combining tubing with proprietary molding techniques, complex and multi-legged manifolds can be produced. Connectors, filters, bags, and other components can be attached to form a complete system. The finished products are bagged, boxed, and shipped to a gamma irradiation services company, then returned to AdvantaPure and inspected before being shipped to the customer.
Third-party testing was performed to determine the proper radiation dosage. Product samples are tested on a regular basis to ensure and maintain a sterility assurance level of 10-6.
For more information on AdvantaPure’s validated sterility for single use manifold assemblies, contact the AdvantaPure team at 145 James Way, Southampton, PA 18966; phone 888-755-4370 or 215-526-2151; fax 888-258-4293 or 215-526-2167; e-mail: email@example.com; or visit http://www.advantapure.com/custom.htm#gamma.
About AdvantaPure and NewAge(R) Industries
The AdvantaPure division of NewAge Industries is ISO 9001:2008 certified and specializes in high purity tubing, hose, single use systems, manifolds, and other molded components for the pharmaceutical, biomedical, food, beverage, and cosmetic industries. All products are manufactured, stored, and shipped using the cleanest methods possible to ensure unsurpassed product purity.
In business since 1954, NewAge Industries manufactures and fabricates thermoplastic and thermoset tubing in both reinforced and unreinforced styles. The company offers one of the broadest product lines of tubing and fittings in the U.S., provides extensive custom extrusion and fabrication capabilities, and services customers worldwide. NewAge Industries maintains a large inventory and prides itself on same-day shipment of 99% of orders for its core product lines. RFID systems, including gamma stable tags and labels, are offered by NewAge’s new Verigenics(R) division. In 2006, NewAge initiated an ESOP (Employee Stock Ownership Plan) for the benefit of both its employees and customers.
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AdvantaFlex(R), NewAge Industries AdvantaPure(R), NewAge(R), and Verigenics(R) are registered trademarks of NewAge(R) Industries, Inc.
145 James Way
Phone : 215-526-2151
Tags:Validated sterility sterile tubing validated sterile tubing assembly validated sterile tubing sterility assurance 10-6 single use tubing assembly
Published On:October 17, 2012
Print Release:Print Release
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