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

  • single use system
  • 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:

silicone tubing and hoseAdvantaSil® Silicone Tubing and Hose

animal derived ingredients freePlatinum-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 TubingAdvantaFlex® BioPharmaceutical Grade Tubing

animal derived ingredients freeAdvantaFlex 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 TubingGORE 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 silicone manifoldsMolded 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

Leak Free Molded Manifold Connections

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


tubing setTubing Sets

If you’re not sure molded manifolds are right for your application, let us manufacture your tubing sets (line sets). Assembled in ISO Class 7 clean rooms, they’re fabricated from tubing, fittings, clamps or cable ties, and accessories you specify.

Sizes to 1″ I.D.


filling assembliesFilling Assemblies

Sterile molded filling assemblies from AdvantaPure continue the shift to Single-Use processes that save time and reduce the risk of cross contamination while increasing productivity between batches. Manufactured with a focus on quality, the assemblies can be quickly installed and operational in a fraction of time as compared to traditional systems used in pharmaceutical and biotech filling.

The multi-port Tri-Clamp® design reduces potential leak points, minimizes holdup volume and provides seamless flow.

MORE ABOUT MOLDED FILLING ASSEMBLIES


bioreactor tubingBioreactor Tubing Kits

The Single-Use kits are custom manufactured and assembled from a variety of components — tubing, filters, connectors — to meet your needs. Made from platinum-cured silicone or AdvantaFlex® biopharmaceutical grade TPE tubing, AdvantaPure’s Bioreactor Tubing Kits provide convenience and greater efficiency.

MORE ABOUT BIOREACTOR TUBING KITS

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BUILD YOUR SYSTEM FROM:

BioClosure True Union AssemblyBioClosure® Systems – High Purity Container Closures

animal derived ingredients freeAdvantaPure’s BioClosure Systems offer purity, secure seals, and versatility in design. Stoppers, caps, True Union and GL45 inserts, and other styles, available with or without tubing inserts, are manufactured from platinum-cured, Class VI silicone or AdvantaFlex biopharmaceutical TPE. Certified free of animal-derived ingredients.

MORE ABOUT BIOCLOSURE® HIGH PURITY CONTAINER CLOSURES

Bioclosure products   Bioclosure products


BioClosure System AssembliesBioClosure System Assemblies

animal derived indgediantsStandardized configurations for media bottles, flasks and carboys using AdvantaFlex Biopharmaceutical Grade TPE tubing and molded components are available.

MORE ABOUT BIOCLOSURE SYSTEM ASSEMBLIES

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BUILD YOUR SYSTEM FROM:

Connections
ThermoBarb Plastic FittingBarbed 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 EndsOvermolded 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 ConnectorsAseptic Connectors
reduce contamination risks and keep processing systems pure. Several easy-to-use styles are available.


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

Filters
filtersChoose from a variety of styles, sizes, and manufacturers for your single use system.
Sensors
sensor assemblySingle-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 ClampsOetiker® 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 clampsPinch 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-Clover ClampsTri-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


PDF 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:

Made in USA

MOLDED FILLING ASSEMBLIES

filling assemblies

Sterile molded filling assemblies from AdvantaPure continue the shift to Single-Use processes that save time and reduce the risk of cross contamination while increasing productivity between batches. Assemblies can be quickly installed and operational in a fraction of time as compared to traditional systems used in pharmaceutical and biotech filling.

The multi-port Tri-Clamp® design reduces potential leak points, minimizes holdup volume and provides seamless flow.

MORE ABOUT MOLDED FILLING ASSEMBLIES

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OPTIONS

DocuLink Manifold Identification System

DocuLink® – Manifold Identification System

DocuLink is our new silicone manifold identification system providing individual identification and tracking information directly on each manifold in the form of a silicone-encased label. Manifold information can be linked to an on-line data management site to provide easy document retrieval for audits and validations. READ MORE…


gamma irradiation services

Gamma Irradiation Services

Have your single use system gamma irradiated before it arrives at your location and save the additional inventorying, transportation costs, and transit time.

Bagged and labeled products are picked up from AdvantaPure’s facility and conveyed to a local gamma irradiation service provider. Using Cobalt 60 radiation, microorganisms and bacteria are destroyed while your single use system remains in its original packaging. Products are then returned to AdvantaPure for final inspection and shipment to your location.

A number of AdvantaPure’s silicone and AdvantaFlex products, particularly those designed for single use, are available with validated sterility assurance of 10-6 per ISO 11137 method VDmax. Contact us for more information at 1-888-755-4370.

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