AdvantaPure/New Age Industries Inc.

Molded Connections
Molded Tri-Clamp fittings, BioClosure container sealing systems, and connections such as wyes, tees, crosses, and reducers are now available in AdvantaFlex bio-pharmaceutical-grade thermoplastic elastomer (TPE). When used with TPE tubing, this allows entire single-use molded manifold assemblies to be manufactured from TPE. Molded connections provide a crevice-free, seamless transition for continuous, unrestricted flow. All AdvantaFlex tubing assemblies are custom-made to specifications.

AdvantaFlex biopharmaceutical-grade tubing
AdvantaFlex biopharmaceutical-grade thermoplastic elastomer (TPE), previously available only as tubing, is now used to make molded Tri-Clamp fittings, BioClosure container sealing systems, and connections such as Ys, Ts, crosses, and reducers. This allows molded manifold assemblies to be manufactured from TPE, as an alternative to silicone, and allows an entire assembly to be manufactured from a single resin, which reduces the potential for installation errors. The use of molded connections eliminates the need for barbed fittings (and their potential for leakage and contamination). All styles range in size from 0.125-in. i.d. to 0.750-in. o.d., and other sizes are in development.

Sanitary Hose Fittings
This expanded family of fittings for sanitary hose now includes products made of stainless steel, molded silicone, thermoplastic elastomer (TPE), and polypropylene. The fittings are designed to mate with hose made of silicone, polytetrafluoroethylene (PTFE), polyvinyl chloride (PVC), fluorinated ethylene propylene (FEP), ethylene propylene diene monomer (EPDM), thermoplastic rubber (TPR), and TPE. Each material has distinct benefits. For instance, the Type 316L stainless steel fittings offer a smooth finish (15 Ra or better) to ensure noncontaminating flows, and eight-sided designs for easier tightening in restrictive installations. Sanitary, pipe-thread, and cam-and-groove styles are available. Molded silicone fittings are supplied attached directly to silicone tubing or hose, while TPE fittings are provided directly attached to the company’s AdvantaFlex tubing. Both are well suited for single-use applications involving aseptic transfer, sterile processing, and other critical applications in the pharmaceutical and biomedical industries. These assemblies reduce installation time, improve cleanliness, and eliminate entrapment issues and leaks associated with barb-type fittings.

Hose Identification Systems
Several new solutions now take the guesswork out of hose and manifold identification, which is crucial for safety, traceability, and regulatory compliance, as well as for identifying the capabilities and/or limitations of critical process hoses used in the pharmaceutical, biopharmaceutical, biomedical, chemical, and food and beverage industries. Options range from quick visual identifiers such as color (for the tubing or the braid), to laser-etched components, to radio frequency identification (RFID) tags. The identification system is designed for tubing and reinforced hose manufactured of platinum-cured silicone and for rubber-covered or overbraided hoses of various materials. Laylines offer custom printing along a length of the hose to convey information such as recommended uses, temperature limitations, part numbers, sizes, etc. DocuLink is the firm’s newest identification method, which addresses document retrieval situations associated with audits and validations and is designed for use with silicone process manifolds. The identification methods can be used separately, or in combination for multi-tier identification.

AdvantaFlex biopharmaceutical tubing
AdvantaFlex biopharmaceutical tubing is free of silicone oils and animal-derived ingredients, and contains fewer extractables than other tubing. It outlasts similar tubing tested in peristaltic pumps by six to ten times. It is suitable for aseptic tubing welds and is heat-sealable. AdvantaFlex is available as molded assemblies and closures for glass, metal, or plastic vessels. The material complies with USP Class VI, ISO, and FDA standards, and is made in the U.S.

BioClosure systems
BioClosure systems are multi- or single-use container closures suitable for pharmaceutical, biotech, laboratory, and other clean applications. They are designed for flexible container systems, laboratory bottles, and sampling and storage receptacles made of glass, plastic, or metal. These pure closures are manufactured and packaged in a Class 7, ISO-certified cleanroom from USP Class VI-certified platinum-cured silicone elastomer. Certified to be free of animal-derived ingredients, the closures are biologically safe and can withstand auto-claving and gamma irradiation. They offer a true seal and a secure environment for critical processes. When employed as a single-use component, BioClosure Systems reduce cross-contamination risks, cleaning requirements, and validation time and costs. BioClosure systems have an operating temperature range of –100°F to 400°F (–73.3°C to 204.4°C).

APEWF hose
Made of an ethylene propylene diene M-class rubber (EPDM), the APEWF hose handles a wide variety of fluids in applications that require elevated pressure and vacuum. It is constructed with a smooth, white EPDM rubber core that is reinforced with a wire helix and multiple layers of durable rubber. Its sanitary inner surface allows for unrestricted flow. It withstands temperatures from –40°F to 248°F (–40°C to 120°C), and is available in sizes ranging from 0.75 in. to 4.0 in. i.d. (19 mm to 102 mm). It is suitable for use in pharmaceutical processing and coolant transfer applications, as well as in glycol lines, potable water lines, and washdown stations.

Closures and Stoppers
These closures and stoppers ensure aseptic fluid transfer, sealing, filling and sampling for containers used in pharmaceutical and biopharmaceutical processing. Manufactured from a platinum-cured silicone that is free of animal-derived ingredients, the closures meet USP (United States Pharmacopeial) Class VI and FDA standards — i.e., they are biologically safe and suitable for use in pharmaceutical, biomedical and laboratory environments. The closures are designed for carboys, flexible container systems, solution and media bottles, and other vessels, and work well with stainless steel, glass and plastic. Both closures and stoppers are injection-molded in a clean-room environment and have a smooth finish with gap-free surfaces that produce a true seal. This also reduces cross-contamination and offers a secured environment to minimize product loss. Closures can withstand temperatures from –100°F to 400°F.

AdvantaFlex tubing
AdvantaFlex weldable and heat-sealable tubing is manufactured from biopharmaceutical-grade thermoplastic elastomer (TPE) and is designed for use in high-purity fluid-transfer processes, such as sterile filling, vaccine production, cell media and harvesting, bioreactors, high-purity water transfer, and filtration. It can also be used on equipment in pharmaceutical sampling and delivery systems, peristaltic pump transfer systems, and pharmaceutical production and processing. Featuring low permeability, the tubes can withstand repeated cycles of compression and release. This property enables the tubing to provide consistent, dependable performance compared to similar products. AdvantaFlex can be welded directly to other components to make secure connections without the entrapment issues associated with fittings and clamps. It complies with USP, ISO, EP and FDA cleanliness standards and is free of animal-derived ingredients.

Single Use Process Systems
Single Use Process Systems are comprised of silicone tubing and molded-silicone components, such as Tri-Clamp style fittings, container seals and bottle stoppers. Compared to traditional stainless steel systems, their design results in decreased production downtimes for cleaning activities, which increases productivity and reduces costs of materials and labor. Use of the silicone-based system simplifies cleaning validation procedures and reduces the risk of product cross-contamination. The manufacturer offers GammaTags, which are gamma-irradiatable RFID tags that provide reliable, electronic identification.

Hose Track Identification and Lifecycle Analysis System
The Hose Track Identification and Lifecycle Analysis System modernizes the conventional pen-and-paper log book method of recording usage data for process equipment. Its updated brochure includes an easy-to-read chart that highlights the differences. This patented system features an enhanced level of safety and security to processing functions performed in critical industries, including chemical, pharmaceutical, biotech, food and beverage, and others involving high-purity applications. Developed for hose assemblies, it can also be used for other process components, such as bio-bags, pumps, filters, diaphragm valves, UV lamps, tanks and vessels. Using RFID technology and software, the system identifies individual parts to monitor continual, wear-related events, such as cleaning cycles and the number of batches processed. The system tracks where a critical component has been throughout its useful life and provides a reliable, 21 CFR Part 11 compliant, electronic pedigree for all tagged critical components.

APSPG silicone tubing
A new silicone tubing, designated APSPG, is designed for the unique demands of peristaltic pumps. APSPG is made to withstand repeated compression and release for consistent, dependable performance. It is well-suited for pharmaceutical, biomedical, biotech, chemical, laboratory and R&D applications, and is specially formulated for long life in pumps. It offers smooth surfaces for uniform fluid flow, resistance to bacteria build-up and consistent pump performance. APSPG is made from a low-volatility grade, platinum-cured silicone that meets USP Class VI and FDA 21 CFR 177.2600 standards. The tubing handles temperatures as high as 400_F and is sterilizable/autoclavable. Sizes of 0.031-in. and 0.063-in. I.D. are manufactured in 25-ft lengths. Larger sizes, up to a 0.5-in I.D., are stocked in 50-ft lengths. Custom sizes, lengths and packaging are available.

APSH flexible braid-reinforced, platinum-cured silicone hose
The APSH flexible braid-reinforced, platinum-cured silicone hose is now available with anti-wick seals to prevent liquid absorption within the hose walls. The anti-wick seal is created by molding silicone material to the cut end of a length of hose, which seals in the polyester yarn braid and prevents liquid absorption. It is especially helpful in applications where the hose is used as dip tubing, as it prevents fluids from becoming trapped within the hose walls. The APSH hose has undergone extensive physical, chemical and biological testing. It meets USP Class VI, FDA CFR 177.2600, ISO 10993, European Pharmacopoeia 3.1.9, and 3-A standards, and is certified to be free of animal-derived ingredients. Its core material is NSF 51 listed. The APSH hose is suitable for fluid or air transfer in temperatures ranging from –100°F to 400°F.

Quickly Identify Hoses and Assemblies
Seven solutions for hose identification, including imprinted, laser-etched, electronically tagged and color-coded, are available from this firm. These hoseidentification methods are designed for tubing and hose manufactured from silicone and for rubber-covered or overbraided hoses of various materials. They may be used separately or in combination with each other when applications call for multi-level identification.

Molded Silicone Components Offer Utmost Purity
These molded silicone components consist of stoppers and sealing systems for carboys and vessels, bottles, laboratory equipment, and process and storage containers. Autoclavable, sterilizable and reusable, they are made from Class VI, platinum- cured silicone elastomer for the utmost in purity. The components also feature smooth, gap-free surfaces for a true seal, no taste or odor transfer, and excellent chemical resistance properties. They are biologically safe and work with receptacles of glass, metal or plastic. The components resist cracking and particle migration and provide a secure, sealed environment.

Chemical-Resistant FEP Hose
Newly improved with greater flexibility, APFRC hose provides the chemical resistance properties of FEP fluoropolymer with the durability of a multi-ply rubber cover. The new version is lighter weight than previous styles for easier handling. The FEP core offers a smooth, non-stick surface for unrestricted flow and a wide temperature range for both cold and hot materials. Standard sanitary fittings may be attached for ready-to-install hose assemblies for a variety of applications, including chemical transfer, food and beverage lines, pharmaceutical processing, biomedical use, and others.