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PURITY IN FLUID FLOW SYSTEMS ® HIGH PURITY TUBING, HOSE, & FITTINGS SANITARY HOSE ASSEMBLIES MOLDED SILICONE & TPE COMPONENTS SINGLE USE MANIFOLD ASSEMBLIES VERIGENICS RFID SOLUTIONS

PURITY IN FLUID FLOW SYSTEMS - ROMYNOX · surfaces. The tubing is made from FDA-approved ingredients and meets various ISO and USP standards, including Class VI, as well as European

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Page 1: PURITY IN FLUID FLOW SYSTEMS - ROMYNOX · surfaces. The tubing is made from FDA-approved ingredients and meets various ISO and USP standards, including Class VI, as well as European

PURITY IN FLUID FLOW SYSTEMS®

HIGH PURITY TUBING, HOSE, & FITTINGS

SANITARY HOSE ASSEMBLIES

MOLDED SILICONE & TPE COMPONENTS

SINGLE USE MANIFOLD ASSEMBLIES

VERIGENICS™ RFID SOLUTIONS

Page 2: PURITY IN FLUID FLOW SYSTEMS - ROMYNOX · surfaces. The tubing is made from FDA-approved ingredients and meets various ISO and USP standards, including Class VI, as well as European

TUBING & HOSE

Visit our Web site: www.advantapure.com

APSH – Braid Reinforced SiliconeHose: Polyester Braiding; 10 stock sizesfrom .063” I.D. to 1” I.D.

APSH-DB – Double Braid ReinforcedSilicone Hose: Polyester Braiding; 3 stocksizes from 1/2” I.D. to 1” I.D.

APST – Silicone Tubing:43 stock sizes from .030” I.D. to 1” I.D.

APSPG – Silicone Pump Tubing:11 stock sizes from .031” I.D. to 1/2” I.D.

A highly flexible hose constructed of virgingrade fluoropolymer overbraided with atightly-woven fabric and double spiral steelwire. All materials are sanctioned by the FDAfor food contact surfaces. White FEP core isUSP Class VI approved.

Rubber-CoveredFEP Hose

APFOS-WC – White PTFE Core,Convoluted I.D.: 6 stock sizes from1/2” I.D. to 4” I.D.

APEWF – Wire-Reinforced, EPDMRubber Core: 6 stock sizes from 3/4” I.D.to 4” I.D.

APSM – 4-Ply, Mandrel-Wrapped SiliconeHose: Polyester Mesh Fabric; Smooth O.D.;8 stock sizes from 1/2” I.D. to 4” I.D.

APSW – 4-Ply, Wire-Reinforced, Mandrel-Wrapped Silicone Suction Hose: PolyesterMesh Fabric; Smooth or Convoluted O.D.; 8stock sizes from 1/2” I.D. to 4” I.D.

Silicone Tubing & Hose

EPDM Hose

Low volatile grade, platinum cured silicone meets USP Class VI, FDA CFR 177.2600, ISO 10993, European Pharmacopoeia 3.1.9,and 3-A standards. All tubing cores are extruded in a clean room and are animal derived ingredient free.

APFOS-W – White PTFE Core,Smooth I.D.: 6 stock sizes from 1/4” I.D.to 1-1/2” I.D.

Stainless SteelOverbraidedPTFE HoseConstructed of virgin grade white PTFE witha series 300 stainless steel wire braidreinforcement. Also available with a blackconductive PTFE core. Can be configuredwith a silicone or rubber jacket.

Excellent chemical resistance properties makethis hose ideal for many demanding applications.

APFRC-W-FLX – Smooth White FEPCore: 5 stock sizes from 1/2” I.D. to 2” I.D.

This highly engineered formulation of highpurity tubing has been developedfor fluid transfer in thebiopharmaceutical industry.

• Sterile weldable and heat sealable• Provides excellent life in peristaltic pumps• Proven to have a cleaner profile than

competitive products• Eliminates the need to incorporate sections

of silicone tubing into bag filling andsampling applications

• Extensive validation and extractables testportfolios available

• Gamma irradiatable and autoclavable

BiopharmaceuticalGrade Tubing

APAF-BP – Biopharmaceutical Tubing:15 stock sizes from 1/8” I.D. to 1” I.D.

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Page 3: PURITY IN FLUID FLOW SYSTEMS - ROMYNOX · surfaces. The tubing is made from FDA-approved ingredients and meets various ISO and USP standards, including Class VI, as well as European

FITTINGS

For more information call: 1-888-755-4370

Sanitary

Female Bevel Seat

Male I-Line

Mini Tri-ClampTri-ClampElbow

Female JIC Swivel

Tube AdapterTube and Pipe Weld Adapters

Flange Compression

Plastic Barbed

Weld End

Male JIC x FNPTMale JIC x MNPT

Adapters

JIC

Female I-Line

Tri-Clamp®Male Bevel Seat

Cam & Groove

Female C&G(Swivel shown)

Male C&G

Pipe Thread

Female Pipe

Male Pipe

Stainless Steel Flange RetainerFlange (sold separately) available in: 304 & 316 StainlessSteel or Powder Coated Carbon Steel

Thermobarb® FDA PPPolypropylene Barbed Fitting

Contact us about fabricating

your completeHose Assemblies

3

All AdvantaPure® Fittings are made of high quality 316L Stainless Steel. Most are available in sizes from 1/4” I.D. to 4” I.D. Sanitary Fittings, manufactured with a 15 Ra finish or better, meet 3-A standards. Electro-Polishing services are also available.

Page 4: PURITY IN FLUID FLOW SYSTEMS - ROMYNOX · surfaces. The tubing is made from FDA-approved ingredients and meets various ISO and USP standards, including Class VI, as well as European

Eliminate production stoppages for sterilization, reduce the risk of contamination, andincrease efficiency by incorporating single use systems from AdvantaPure®. Single usesystems, or SUS, simplify cleaning validations—use once and discard—and are wellsuited for single-use processes such as batch filling and sampling.

Each system is custom made using platinum-cured, Class VI silicone tubing and hoseor Class VI biopharmaceutical TPE tubing for peristaltic pump applications. Addfittings, stoppers and container closures (see page 6), filters, bags, bottles, labels andtracking options, and other components.

Single use systems are not intended for implantation or continuous steam applications.

SINGLE USE SYSTEMS

Visit our Web site: www.advantapure.com

Tubing and HoseSilicone Tubing and HoseLow-volatile grade, platinum-cured siliconetubing and braid-reinforced silicone hose isclean-room manufactured by AdvantaPure forpharmaceutical and biotech applications.

Both the tubing (called APST) and hose (APSH) haveundergone extensive physical, chemical, and biologicaltesting and meet USP Class VI, FDA CFR 177.2600, ISO10993, European Pharmacopoeia 3.1.9, 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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BioPharmaceutical TPE TubingAdvantaFlex addresses the need for a flexible,translucent, sterilizable, heat sealable, andweldable biopharmaceutical tubing for fluidprocessing. The unique properties of AdvantaFlexhelp it outlast similar tubing tested in peristaltic pumps by 6-10 times.

AdvantaFlex is ideal for aseptic tubing welds, as iteliminates costly aseptic connectors and multiple contactsurfaces. The tubing is made from FDA-approvedingredients and meets various ISO and USP standards, includingClass VI, as well as European Pharmacopoeia 3.2.2.1 standards.

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

Molded Manifold AssembliesSingle use molded manifolds provide a seamless transition between tubing and connections fora continuous, leak-proof flow. Molded connections made using platinum-cured silicone orAdvantaFlex Biopharmaceutical TPE include Y, T, cross, reducer, Tri-Clamp®, and mini Tri-Clamp styles. Connection sizes differ depending on style and material.

Size range: .188” to 1” I.D. (4.76mm to 25.40mm I.D.)

Select from a number of different crevice-free connections

Molded manifolds can be used with avariety of containers, vessels, biobags,etc. for batch filling and samplingneeds in drug and vaccine production.

Available in mini and standard Tri-Clamp fitting styles,molded ends are supplied with male gaskets moldeddirectly to the face of the fitting. Protective backup cupsprovide a stable clamping surface and safeguard thefittings during installation and use.

Page 5: PURITY IN FLUID FLOW SYSTEMS - ROMYNOX · surfaces. The tubing is made from FDA-approved ingredients and meets various ISO and USP standards, including Class VI, as well as European

SINGLE USE SYSTEMS

DocuLink (patent pending) is aservice designed to save time andeffort during document retrieval. Itidentifies a single use system on theproduct itself, not only on the bagfrom which it was removed, by use ofa permanently-affixed label at asilicone connector, which can handle

clean-in-place (CIP), steam-in-place (SIP), autoclave, andgamma irradiation processes.

DocuLink can list the individualpart number and lot number toallow quick lookup ofdocuments such as certificatesof compliance and certificatesof analysis. It can also be linkedto an online data managementsite (optional) for quickdocument retrieval.

Have your single use system gamma irradiatedbefore it arrives at your location and save theadditional inventorying, transportation costs,and transit time. Bagged and labeledproducts are picked up from AdvantaPure®’sfacility and conveyed to a local gammairradiation service provider. Using Cobalt 60radiation, microorganisms and bacteria are destroyed while yoursingle use system remains in its original packaging. Products arethen returned to AdvantaPure for final inspection and shipment toyour location.

Gamma Irradiation Services

For more information call: 1-888-755-4370 5

Contact us about integrating multiple

components into a completeSingle Use System

Overmolded Endsare available in Tri-Clampand mini Tri-Clampstyles in Hytrel® andpolypropylene materials.

Size range: 1/8” to 1-3/16” hose I.D.(3.18mm to 30.16mm hose I.D.)

FiltersChoose from a varietyof styles, sizes, andmanufacturers for yoursingle use system.

BagsAdvantaPure can supplybags from a number ofleading manufacturers. Letus know what you need.

Barbed fittingscome in Y, T, elbow, andreducer styles. Materialsinclude polypropylene,polyethylene, and PVDF.

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

Pinch Clampsof polypropylene or poly-ester squeeze tubingclosed anywhere along aline. One piece construction.

Sizes fit up to 3/4” tubing O.D.(19.05mm tubing O.D.)

Aseptic Connectorsreduce contamination risks and keepprocessing systems pure. Severaleasy-to-use styles are available.

Quick Connectsoffer on-the-spot connectionsand come in several materials.Dependable and secure.

Connections, Filters, Bags, Bottles

BottlesLaboratory and sampling bot-tles can also be incorporatedinto your system. Select fromHPDE and other materials.

Page 6: PURITY IN FLUID FLOW SYSTEMS - ROMYNOX · surfaces. The tubing is made from FDA-approved ingredients and meets various ISO and USP standards, including Class VI, as well as European

Part of our high purity manufacturing suite, the AdvantaPure® Mold Shop features a clean room environment to produce a variety ofmolded components suitable for any number of applications in the pharmaceutical, biomedical, and biotechnology industries. Ourmolded products are custom made to meet your application’s specific requirements, documented lot traceable, and certified to be free ofanimal-derived ingredients. Contact your AdvantaPure representative for more details.

SINGLE USE SYSTEMS

BioClosure™ SystemsHigh Purity Container ClosuresBioClosure container closures are made from Class VI, platinum-curedsilicone elastomer for the utmost in purity and consist of silicone bottlestoppers and sealing systems for carboys and vessels, bottles, laboratoryequipment, and process and storage containers. They are biologically safeand work with receptacles of glass, metal, or plastic. Available with coredholes for tubing, dip tubes, or vents and with tubing installed.

Stoppers, caps, inserts for True Unions and GL45s, and otherstyles, available with or without tubing, are available. Stoppersizes range from 2 to 12. Other items are custom manufactured.

A securely sealed bioprocessing systemis critical. That’s why BioClosure Systemsare clean room manufactured withplatinum-cured silicone following stricttolerance requirements.

Supplied as silicone fittings attached directly to silicone tubing orhose, AdvantaPure’s Molded Silicone Assemblies are well-suited for applications involving aseptic transfer, sterileprocessing, and other critical applications in the pharmaceutical, biomedical, and high purity industries. Theassemblies reduce installation time, improve cleanliness, and retain the many benefits of silicone.

Molded Silicone Assemblies are available from AdvantaPure in mini and standard Tri-Clamp® fitting styles and aresupplied with male gaskets molded directly to the face of the fitting. Straight-through and step-up bore configurationsare produced in sizes up to 1” tube I.D. Protective backup cups, offered in polysulfone or series 304 stainless steelfor extra durability, provide a stable clamping surface and safeguard the fittings during installation and use.

Molded Silicone Assemblies

Standard size bottle stoppers areavailable with tubing already attached tospeed your installation, reduce multipleproduct inventories, and save labor costs.

Use as a disposable item toreduce cross contaminationrisks, cleaning requirements,and validation time and costs.

Visit our Web site: www.advantapure.com6

AdvantaFlex tubing can be an excellent alternative to silicone for many applications, especially for peristalticpump use. It is ideal for aseptic tubing welds and is heat sealable. Molded components made from AdvantaFlexBiopharmaceutical Grade TPE allow for one material contact surface throughout the system, while providing aseamless transition between tubing and connections for a continuous flow.

Biopharmaceutical Grade TPE

Page 7: PURITY IN FLUID FLOW SYSTEMS - ROMYNOX · surfaces. The tubing is made from FDA-approved ingredients and meets various ISO and USP standards, including Class VI, as well as European

What really sets AdvantaPure® apart from other manufacturers is our ability and willingness to offer various services to create acustom part from stock material. This benefits you in two ways—fast delivery and low cost. Contact a helpful AdvantaPure SalesRepresentative to discuss your needs.

SERVICES

For more information call: 1-888-755-4370 7

By combining our broad line of stocktubing, hose, and fittings, theoptimum hose assembly for yourapplication can be fabricated quickly.Let our Fabrication Team handle theassembly labor for you, so youreceive a finished, pressure-tested,ready-to-install product. We can alsoprovide choices for non-entrapmenthose assemblies, where conveyedmaterials contact only the pure inner-core of the assembly—from end toend—providing a seamless transitionand higher flow rates.

Hose AssembliesHose Identification Systems

High Purity Silicone Hosewith Sanitary Stainless

Steel Fittings

AdvantaPure offers various Hose Identification methods thatmay be used together or individually.

• AdvantaLabel® - Silicone hose labeling systemuses permanently-vulcanizedsilicone to encase a label andcolor stripes to the outside ofsilicone tubing and hose forquick, easy-to-readidentification.

• Laser-Etched Collars -Stainless steel collars areetched using precise lasertechnology for sharper andmore legible text and images.

• Color Tracer Braid -Incorporated into flexible, braid-reinforced silicone hose, thecolored braid material offers aquick and easy way todifferentiate between lines.

• Color 4 Ply Silicone Hose -Four-ply, mandrel-wrappedsilicone hose, with or without astainless steel reinforcing wire,is an excellent choice forpressure applications.

• Laser-Etched Tags -Sharper and more legible thantraditional acid-etched parts orhandwritten labels, laser-etchedtags are inexpensive, easy toattach to hoses, and work wellfor existing installations.

Special coverings offer additional protection from high temperatures orpressures, excessive friction, kinking or crushing, etc. Available materialsinclude Stainless Steel Armor, Rubber, Silicone, Polypropylene or Kynar®

braid, and more.

Special Hose Coverings

Contact one of our technicalsales representatives to discussyour application requirements

Stainless SteelArmor

Silicone CoveredStainless Steel Braid

Page 8: PURITY IN FLUID FLOW SYSTEMS - ROMYNOX · surfaces. The tubing is made from FDA-approved ingredients and meets various ISO and USP standards, including Class VI, as well as European

Introducing Verigenics™, a division of NewAge® Industries Inc. Previouslymarketed under the AdvantaPure® high purity products line, Verigenics offerssolutions to enable medical device, pharmaceutical and other regulated companies totrack and authenticate consumables, assets and equipment. Verigenics products useRFID (radio frequency identification) technology to provide enhancements such as

increased safety for providers and patients, brand loyalty, increased productivity, inventory visibility and improved product security. Contact Verigenics directly at – Phone: 888-322-5131; Email: [email protected]; Website: www.verigenics.com

RFID SOLUTIONS

01/26/128

NewAge® Industries AdvantaPure®

145 James Way, Southampton, PA 18966-3817Phone: 888-755-4370 (toll free) • 215-526-2151Fax: 888-258-4293 (toll free) • 215-526-2167Website: www.advantapure.comE-mail: [email protected]

©2012 NewAge® Industries, Inc. Specifications are subject to change without notice. AdvantaPure products are produced by NewAge Industries, Inc.NewAge Industries AdvantaPure®, AdvantaLABEL®, AdvantaFlex®, Hose Track®, GammaTag®, P•E•T Process Equipment Tracking®, Purity in FluidFlow Systems®, NewAge®, and the "N" logo are registered trademarks of NewAge Industries, Inc. • BioClosure™, DocuLink™, and Verigenics™ aretrademarks of NewAge Industries, Inc. • Kynar® is a registered trademark of Atochem North America, Inc. • Tri-Clamp® is a registered trademark ofAlfa Laval Inc. • All other trademarks are the property of their respective owners.

The Hose Track® Hose Lifecycle Analysis System is a unique, revolutionary hose assembly tracking system.Hose Track helps users minimize the risk of contamination and hose failure and the costly repercussionsassociated with batch waste and production stoppages. It offers an excellent way for manufacturing andmaintenance personnel to monitor hose assembly cleaning, usage rates, and replacement. (U.S. Patents7,195,149 and 7,328,837. Other U.S. and foreign patents pending.)

Calendar & Manual Log Methods for replacing critical processcomponents can be unreliable, increasing the risk of productcontamination and wear related failure.

RFID Tags attached to process equipment are scanned by areader/writer to track wear related events and update thecomputer database.

A P•E•T System provides a detailed audit trail to assist in thevalidation process, and consolidates documents by electronicallylinking to notes, cleaning schedules, files, certifications, drawings,installation instructions, warning notices, and other protocols.

RF IDENTIFICATION AND HOSE LIFECYCLE ANALYSIS SYSTEM

GammaTag® – the industry's firstgamma-radiation-resistant read/write RFIDtag is available exclusively from AdvantaPure.Ideal for use on products where gamma sterilization is required.

The same RFID technology developed for hoses can be used for other components in the process chain—valves, filters, vessels, biobags,and more. Track usage and cleaning cycles to ensure timely maintenance and replacement... before parts begin to fail, risk product integrity,and waste time and labor. It’s a logical approach to tracking all critical process components. (U.S. Patents 7,195,149 and 7,259,675. OtherU.S. and foreign patents pending.)