Single-Use Tubing Assemblies

For Pharmaceutical & Biopharm Processing Applications

Eliminate production stoppages for sterilization, reduce the risk of contamination, and increase efficiency by incorporating Single-Use Molded Manifold Tubing Assemblies from AdvantaPure. Single Use Assemblies simplify cleaning validations—use once and discard.

Each system is custom made using AdvantaSil® platinum-cured, Class VI silicone tubing or reinforced hose or or AdvantaFlex® Class VI biopharmaceutical grade tubing to meet sealing and welding application requirements. Add fittings, stoppers and container closures, filters, sensors, bottles, labels, tracking options and now GORE® STA-PURE® Pump Tubing as the pump element.

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

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
• Well suited for long production cycles when GORE STA-PURE Pump Tubing is used as the pump element
• 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 ISO Class 7 clean rooms
• Available with validated sterility assurance of 10^-6 per ISO 11137 method VDmax 25
• Documented lot traceable with identification on packaging
• Documented quality control per ISO 9001:2015
• Experienced engineers available for technical assistance
• All AdvantaPure-manufactured tubing and molded components are animal-derived ingredient-free
• Complete validation package available upon request
• Optional RFID tags easily attach to assemblies for identification purposes—provide reliable electronic data storage and current status of assemblies from inception to disposal

BUILD YOUR SYSTEM FROM:

AdvantaSil® Silicone Tubing and Hose

Platinum-cured silicone tubing (called APST), high pressure tubing (APHP), and braid-reinforced hose (APSH) are cleanroom manufactured by AdvantaPure for pharmaceutical and biopharm applications.

All three styles have undergone extensive physical, chemical, and biological testing and meet USP Class VI, FDA CFR 177.2600, ISO 10993, and European Pharmacopoeia 3.1.9 standards. Certified free of animal-derived ingredients.

APST size range: .030″ through 1″ I.D. (.76mm through 25.40mm I.D.)
APHP size range: .125” through 1” I.D. (3.18mm through 25.40mm I.D.)
APSH size range: .063″ through 1″ I.D. (1.59mm through 25.40mm I.D.)

AdvantaFlex® BioPharmaceutical Grade Tubing

AdvantaFlex addresses the need for a flexible, translucent, sterilizable, heat sealable, weldable and moldable biopharmaceutical tubing without silicone oils. AdvantaFlex maintains its physical properties following sterilization processes and remains translucent for visible product flow.

AdvantaFlex is ideal for aseptic tubing welds and helps eliminate aseptic connectors and multiple contact surfaces. The tubing is made from FDA-approved ingredients and meets various ISO and USP standards, including Class VI, as well as European Pharmacopoeia 3.2.2.1 standards. Certified free of animal-derived ingredients.

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

MORE ABOUT ADVANTAFLEX

GORE STA-PURE Pump Tubing

AdvantaPure is pleased to offer GORE STA-PURE Pump Tubing for your Single-Use Process biotech and pharmaceutical applications.

As experts in molded connections, AdvantaPure can now overmold
GORE STA-PURE Pump Tubing into any manifold tubing assembly as its pump element. Overmolding reduces the risk of failure at the connection, decreases the chance of contamination, and helps prevent lost batches of costly pharmaceutical and biopharm product. Alternatively, connections may be made using barbed fittings and clamps.

NOTE: Assemblies that include GORE STA-PURE Pump Tubing cannot be gamma irradiated or be included in AdvantaPure’s validated sterility assurance program.

Size range: 1/16″ to 1″ I.D. (1.6mm to 25.40mm I.D.)

MORE ABOUT GORE STA-PURE PUMP TUBING

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BUILD YOUR SYSTEM FROM:

Molded Manifolds

Single-use Molded Manifolds provide a seamless transition between tubing and connections for a smooth, fluid contact surface with optimal flow. Molded connections include Y, T, cross, reducer, Tri-Clamp® and mini Tri-Clamp styles.

Made from AdvantaSil® silicone or AdvantaFlex® TPE, they allow for one contact material throughout the system. Additionally, GORE STA-PURE Pump Tubing can be integrated into silicone manifold assemblies as the pump element, providing longer production cycles. Connection sizes vary depending on style.

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

MORE ABOUT MOLDED MANIFOLDS

GORE® and STA-PURE® are trademarks of W. L. Gore & Associates.

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BUILD YOUR SYSTEM FROM:

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BUILD YOUR SYSTEM FROM:

Connections

Barbed Fittings come in Y, T, elbow, and reducer styles. Materials include polypropylene, polyethylene, and PVDF.Size range: 1/8″ to 1″ hose I.D. (3.18mm to 25.40mm hose I.D.)

Overmolded Ends are available in mini Tri-Clamp styles in AdvantaFlex TPE for a smooth fluid path. Size range: 1/8″ to 1/2″ tubing I.D. (3.18mm to 12.70mm tubing I.D.)

Aseptic Connectors reduce contamination risks and keep processing systems pure. Several easy-to-use styles are available.

Quick Connects offer on-the-spot connections and come in several materials. Dependable and secure.

Filters

Choose from a variety of styles, sizes, and manufacturers for your single use system.

Sensors

Single-Use in-line sensors offer real- time monitoring and control of critical processes. They eliminate the need for cleaning, maintenance and recalibration associated with traditional, reusable technologies. Choose from sensors for pressure, flow, temperature, conductivity, turbidity and UV absorbance.

Tubing-to-Fitting Attachments

Oetiker® Clamps provide a 360° seal with both a smooth inner and outer surface. Made from stainless steel, Oetiker clamps are lightweight and compact yet robust—only one is needed at each attachment.Size range: 5/32″ to 1-9/16″ nominal tubing O.D.

Clamps

Pinch Clamps squeeze tubing closed anywhere along a line. One piece construction for sizes fit up to 3/4″ tubing O.D. (19.05mm tubing O.D.) Vise clamp for tubing 1″ and larger

Tri-Clamp® Connection Clamps come in durable plastic and 304 stainless steel. Size range: 1/2″ to 4″ (12.70mm to 101.60mm), depending on material

Download a printable version of our Single-Use Tubing Assemblies brochure. Single_Use_Tubing_Assemblies.pdf (1.4MB)

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BUILD YOUR SYSTEM FROM:

• Tubing and Hose
• Molded Manifolds
• Container Closures
• Connections, Clamps,
  Filters, Bottles

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