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KEY FEATURES■ Custom manufactured and assembled from a variety of components■ Reduces end-user assembly labor expense and time ■ Reduces cross contamination risks■ Saves energy and resource costs by eliminating cleaning and autoclaving■ Reduces production downtime by eliminating certain cleaning validation requirements■ Provides flexibility and speed in facility design—system redesigns are implemented faster than with hard piping ■ Less costly process development and design compared to systems of hard piping

■ Assembled and packaged in Class 7 (Class 10,000) ISO-certified clean rooms

■ Available with validated sterility assurance of 10-6 via gamma irradiation per ISO 11137 method VDmax 25■ Documented lot traceable with identification on bags ■ Documented quality control■ Experienced engineers available for technical assistance■ Tubing and molded connections provide a single, animal-derived- ingredient-free material contact surface■ Optional RFID tags easily attach to assemblies for identification purposes— provide reliable electronic data storage and current status of assemblies from inception to disposal ■ The silicone and thermoplastic elastomer compounds used to make Single-Use Systems have a Master File with the U.S. Food and Drug Administration

liminate production stoppages for sterilization, reduce the risk of leaks and contamination, and increase efficiency by incorporating Single-Use Systems fromAdvantaPure. Single-Use Systems, or SUS, simplifycleaning validations—use once and discard.

Each system is custom made using platinum-cured,Class VI silicone tubing or reinforced hose orAdvantaFlex® Class VI biopharmaceutical grade tubingto meet sealing and welding application requirements.

Add fittings, stoppers and container closures, filters, sensors,bottles, labels, tracking options and other components.

Single-Use Systems are not intended for implantation or continuous steam applications.

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Silicone Tubing & HoseLow-volatile grade, platinum-cured silicone tubing and braid-reinforcedhose is clean-room manufacturedby AdvantaPure for pharmaceuticaland biotech applications.

Both the tubing (called APST) andhose (APSH) have undergone extensive physical, chemical, andbiological testing and meet USPClass VI, FDA CFR 177.2600, ISO10993, European Pharmacopoeia3.1.9, and 3-A standards.

APST size range: .030” through 1” I.D. (.76mm through 25.40mm I.D.) APSH size range: .063” through 1” I.D. (1.59mm through 25.40mm I.D.)

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AdvantaFlex® BioPharmaceutical Grade TPE TubingAdvantaFlex addresses the need for a flexible,translucent, heat sealable, weldable andmoldable biopharmaceutical tubingwithout silicone oils. AdvantaFlexmaintains its physical propertiesfollowing sterilization processesand remains translucent for visibleproduct flow.

AdvantaFlex is ideal for aseptic tubing welds and helps eliminate aseptic connectors and multiplecontact surfaces. The tubing is madefrom FDA-approved ingredients andmeets various ISO and USP standards,including Class VI, as well as EuropeanPharmacopoeia 3.2.2.1 standards.

Size range: 1/8” to 1” I.D. (3.18mm to 25.40mm I.D.)

Phone: 215-526-2151 Toll Free Phone: 888-755-4370

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ManifoldsSingle-Use molded manifolds provide aseamless transition between tubing and connections for a continuous, leak-proofflow. Molded connections include Y, T, cross,reducer, Tri-Clamp® and mini Tri-Clampstyles. Made from platinum-cured silicone or AdvantaFlex®, they allow for one materialcontact surface throughout the system.Connection sizes vary depending on style.

Size range: 1/8” to 1” I.D. (3.18mm to 25.40mm I.D.)

•Barbed fittingscome in Tri-Clamp, Y, T, elbow andreducer styles. Materials includepolypropylene, polyethylene andPVDF.

Size range: 1/8” to 1” hose I.D. (3.18mm to 25.40mm hose I.D.)

•Overmolded endsare available in mini Tri-Clamp styles inAdvantaFlex TPE for a smooth fluid path.

Size range: 1/8” to 1/2” tubing I.D. (3.18mm to 12.70mm tubing I.D.)

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Tubing SetsIf you’re not sure molded manifolds areright for your application, let us manu-facture your tubing sets. Assembled inClass 7, ISO-certified clean rooms,they’re fabricated from tubing, fittingsand accessories you specify.

Sizes to 1” I.D.

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Contact an AdvantaPure representativeor distributor today to start buildingyour Single-Use System.

FiltersChoose from avariety of styles,sizes, and manufacturersfor your Single-Use System.

Build Your System From . . .

•Quick connectsoffer on-the-spot connections and come inseveral materials. Dependable and secure.

•Aseptic connectorsreduce contamination risksand keep processing systemspure. Several easy-to-usestyles are available.

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SensorsSingle-Use in-line sensors offer real-time monitoring and control of criticalprocesses. They eliminate the need for cleaning, maintenance and recali-bration associated with traditional,reusable technologies. Choose fromsensors for pressure, flow, temperature,conductivity, turbidity and UV absorbance.

Phone: 215-526-2151 Toll Free Phone: 888-755-4370

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Clamps•Pinch clampssqueeze tubing closed anywhere along a line.

One piece construction for sizes up to 3/4” tubing O.D. (19.05mm tubing O.D.)

Vise clamp for tubing 1” and larger

•Tri-Clamp® connection clampscome in durable plastic and 304 stainless steel.

Size range: 1/2” to 4” (12.70mm to 101.60mm), depending on material

Tubing-to-Fitting Attachments•Cable Tiesare quick and easy to apply; no tools areneeded. For added security, it is recommendedthat two ties be used at each attachment.

•Oetiker® Clampsprovide a 360° seal with both a smooth inner and outersurface. Made from stainless steel, Oetiker clamps arelightweight and compact yet robust—only one is neededat each attachment.

Size range: 5/32” to 1-9/16” nominal tubing O.D.

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Contact an AdvantaPure representativeor distributor today to start buildingyour Single-Use System.

Build Your System From . . .

Laboratory and sampling bottles can alsobe incorporated into your system.

For bottle stoppers and containerclosures, see BioClosure®

Systems below.

BioClosure® SystemsAdvantaPure’s BioClosure Systems offer purity, secureseals and versatility in design. Stoppers, caps, TrueUnion and GL45 inserts and other styles, availablewith or without tubing inserts, are manufactured fromplatinum-cured, Class VI silicone or AdvantaFlex biopharmaceutical TPE.

Stopper size range: most sizes from #2 to #12; other styles custom made

Bottles

Phone: 215-526-2151 Toll Free Phone: 888-755-4370

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DocuLink®

DocuLink (patent pending) is a servicedesigned to save time and effort duringdocument retrieval. It identifies aSingle-Use System on the product itself,not only on the bag from which it wasremoved, by encapsulating an affixedlabel into a molded silicone connection.

DocuLink can list the individual part numberand lot number to allow quick lookup of docu-ments such as certificates of compliance and certificates ofanalysis. DocuLink cannot fall off like other labels and handles clean-in-place(CIP), steam-in-place (SIP), autoclave and gamma irradiation processes.

GammaTag® RFID TagsGammaTag is the first read/write RFID tag thatmaintains data integrity after gamma irradia-tion. It provides reliable electronic data storagefor Single-Use Systems and other bioprocesscomponents from inception to disposal.

GammaTag’s key features:

■ Uses read/write RFID technology to identify critical process components■ Record and access the current status of process components on the spot, or use simply for identification (part number, lot number, gamma sterilization date, etc.)■ All critical packaging and labeling documentation resides on the component throughout its useful life ■ Allows gamma radiation sterilization of a complete Single-Use System for the cleanest possible product■ GammaTag’s read/write ability makes it unique – data may be written directly on the tag, unlike read-only bar code labels■ Provides reliable identification without the potential hazards of leachables found in permanent markers■ Will not fall off during cold storage■ RoHS compliant■ Available from NewAge Industries’ Verigenics® division■ Learn more at www.verigenics.com

Purity in Fluid Flow Systems®

Address: NewAge Industries AdvantaPure®

145 James Way Southampton, PA 18966 U.S.A.

Toll Free Phone: 888-755-4370Phone: 215-526-2151Toll Free Fax: 888-258-4293Fax: 215-526-2167Web Site: www.advantapure.comE-mail: sales@advantapure.com

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WARRANTY: NewAge Industries AdvantaPure products are warranted to be free from defects in material and workmanship. Any product found to carry such defects will be replaced without charge. This warranty is limited only to the replacement of NewAgeIndustries AdvantaPure products, item for item, which after examination by NewAge Industries AdvantaPure are deemed defective. NewAge Industries AdvantaPure specifically disclaims any other liability. The data supplied is provided as a helpful guideline and isbelieved to be reliable; however, nothing stated shall constitute a guarantee, recommendation, or warranty for any application.NOTICE: NewAge Industries, Inc. has been a privately owned corporation since 1954. Neither the corporation nor its principals are affiliated, in any way, with any other group or entity either representing themselves as or being referred to by the term New-Age.

DISTRIBUTED BY:

ISO 9001:2015

CERTIFIED

©2017 NewAge® Industries, Inc. Specifications are subject to change without notice.AdvantaPure products are produced by NewAge Industries, Inc.AdvantaFlex®, BioClosure®, DocuLink®, GammaTag®, Purity in Fluid Flow Systems®, NewAge Industries AdvantaPure®, NewAge®, Verigenics®, and the "N" logo are registered trademarks of NewAge® Industries, Inc. Tri-Clamp® reg. TM Alfa Laval, Inc. • Oetiker® reg. TM Oetiker, Inc. 123c

Made in U.S.A.

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Gamma Irradiation ServicesHave your Single-Use System gamma irradiated before it arrives at your locationand save the additional inventorying, transportation costs, and transit time.

Bagged and labeled products are picked up from AdvantaPure’sfacility and conveyed to a local gamma irradiation service provider.Using Cobalt 60 radiation, microorganisms and bacteria aredestroyed while your Single-Use System remains in its originalpackaging. Products are then returned to AdvantaPure for finalinspection and shipment to your location.

Validated sterility assurance of 10-6 per ISO 11137 methodVDmax 25 is available. Contact us for more information.

Bioreactor Tubing KitsAnother Single-Use item fromAdvantaPure is Bioreactor Tubing Kitsfor benchtop bioreactors. The kits arecustom manufactured and assembledfrom a variety of components — tubing, filters, connectors — to provide convenience and greater efficiencies over assembling on site.Choose from platinum-cured silicone tubing or weldable and sealable AdvantaFlex® TPE tubing. Visitwww.advantapure.com/bioreactor-tubing-kits.htm.

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