Bioprocess Tubing for Single-Use Applications

Product description

Bioprocess tubing for single-use applications provides the flexible fluid path used to transfer pharmaceutical and biotechnology process liquids between bags, bottles, filters, bioreactors, filling equipment and other process systems.

Available tubing constructions include platinum-cured silicone, weldable TPE, dedicated peristaltic pump tubing and reinforced braided silicone. Each material provides different characteristics for fluid transfer, sterile welding, pumping, pressure resistance and process compatibility.

Tubing can be supplied as individual lengths or incorporated into complete single-use assemblies with sterile connectors, fittings, filters, bags, bottles and process instrumentation.

Technical overview

Tubing selection should be based on more than internal diameter alone. Material compatibility, wall thickness, pump requirements, pressure, sterilisation method, connection technology and the required flexibility of the fluid path all influence the appropriate tubing construction.

Platinum-cured silicone provides a flexible and transparent fluid path for general pharmaceutical transfer and pumping. Weldable TPE allows tubing sections to be aseptically welded and heat sealed. Dedicated pump tubing is designed for extended use in peristaltic pumping applications, while braided silicone provides increased pressure capability where conventional unreinforced tubing is insufficient.

Operating principle

Process fluid flows through the internal bore of the flexible tubing between the connected process components.

In gravity- or pressure-driven transfer applications, tubing acts as the flexible connection between containers, equipment and other unit operations.

In peristaltic pumping applications, the tubing is repeatedly compressed between the pump rollers and pump housing. Tubing construction and wall thickness are therefore important for maintaining flow performance and tubing life.

Weldable TPE tubing provides an additional function: compatible tubing sections can be joined using suitable sterile tube-welding equipment or permanently closed using a compatible tube sealer.

Reinforced tubing uses an integrated textile braid to restrict radial expansion under pressure, allowing higher working pressures while retaining the flexibility of silicone.

Material options

Platinum-cured silicone tubing

Clear platinum-cured silicone tubing provides high flexibility and allows visual observation of process liquid, bubbles and other conditions within the fluid path.

It is suitable for:

• General pharmaceutical fluid transfer
• Media and buffer transfer
• Cell-culture processes
• Peristaltic pumping
• Filling applications
• Single-use tubing assemblies

Standard silicone tubing is suitable for ETO treatment, autoclaving and gamma sterilisation. Published material documentation includes USP Class VI, ISO 10993, FDA 21 CFR 177.2600 and animal-derived ingredient-free information.

Weldable TPE tubing

Weldable thermoplastic elastomer tubing is designed for single-use processes requiring sterile tube welding and heat sealing.

Compatible tubing sections can be connected using suitable sterile tube welders without introducing a separate connector into the fluid path. The tubing can also be permanently sealed using compatible thermal sealing equipment.

Typical applications include:

• Single-use fluid-transfer assemblies
• Aseptic connection and disconnection
• Sampling assemblies
• Filling systems
• Cell-culture processes
• Fermentation
• Peristaltic pumping

The clear tubing construction allows visual monitoring of the fluid path. Available material documentation includes USP Class VI, ISO 10993, REACH, RoHS and animal-derived component-free information.

Peristaltic pump tubing

Dedicated pump tubing is manufactured from a thermoplastic elastomer formulated for repeated compression in peristaltic tubing pumps.

Compared with general transfer tubing, this construction is intended to provide extended pump life, chemical resistance, low spallation and flexibility during demanding pumping applications.

The tubing is opaque, which can also provide additional protection for light-sensitive process fluids.

Typical applications include:

• Peristaltic transfer pumps
• Bioreactor feed systems
• Filling applications
• Vaccine manufacturing
• Process-fluid transfer
• Single-use pump assemblies

Reinforced braided silicone tubing

Reinforced braided silicone tubing combines a platinum-cured silicone product-contact surface with an integrated synthetic fabric reinforcement.

The reinforcement increases working and burst-pressure capability compared with conventional unreinforced silicone tubing while maintaining flexibility and visual access to the process fluid.

This construction is particularly suitable for:

• Pressurised pharmaceutical fluid transfer
• Filtration assemblies
• Fluid-distribution manifolds
• Higher-pressure pump applications
• Transfer between single-use and stainless-steel equipment

Available micron ratings

Not applicable. Bioprocess tubing is a fluid-transfer component and does not contain filtration media.

Where filtration is required, a suitable capsule filter can be incorporated into the same single-use fluid path. Filter membrane material and micron rating are then selected separately according to the process.

Design and construction

Standard silicone tubing sizes

Platinum-cured silicone tubing is available across a wide dimensional range from approximately 0.02" ID to 1" ID.

Frequently used bioprocess dimensions include:

• 1/8" ID × 1/4" OD
• 1/4" ID × 3/8" OD
• 1/4" ID × 7/16" OD
• 1/4" ID × 1/2" OD
• 3/8" ID × 1/2" OD
• 3/8" ID × 9/16" OD
• 3/8" ID × 5/8" OD
• 1/2" ID × 3/4" OD
• 5/8" ID × 7/8" OD
• 3/4" ID × 1 1/8" OD
• 1" ID × 1 1/4" OD
• 1" ID × 1 3/8" OD

Different wall thicknesses are available for several internal diameters, allowing tubing geometry to be selected according to pumping, pressure and connection requirements.

Weldable TPE tubing sizes

Weldable TPE tubing is available from approximately 1/8" ID to 1" ID.

Standard dimensions include:

• 1/8" ID × 1/4" OD
• 3/16" ID × 5/16" OD
• 3/16" ID × 3/8" OD
• 1/4" ID × 3/8" OD
• 1/4" ID × 7/16" OD
• 1/4" ID × 1/2" OD
• 5/16" ID × 7/16" OD
• 5/16" ID × 1/2" OD
• 3/8" ID × 1/2" OD
• 3/8" ID × 9/16" OD
• 3/8" ID × 5/8" OD
• 1/2" ID × 3/4" OD
• 5/8" ID × 7/8" OD
• 3/4" ID × 1" OD
• 3/4" ID × 1 1/8" OD
• 1" ID × 1 1/4" OD
• 1" ID × 1 3/8" OD

Pump tubing sizes

Dedicated pump tubing is available in both inch and metric dimensions. Published inch sizes cover approximately 1/32" ID through 1" ID.

Frequently used configurations include:

• 1/8" ID × 1/4" OD
• 1/4" ID × 3/8" OD
• 1/4" ID × 7/16" OD
• 1/4" ID × 1/2" OD
• 3/8" ID × 1/2" OD
• 3/8" ID × 9/16" OD
• 3/8" ID × 5/8" OD
• 3/8" ID × 3/4" OD
• 1/2" ID × 3/4" OD
• 1/2" ID × 7/8" OD
• 5/8" ID × 7/8" OD
• 3/4" ID × 1 1/8" OD

Metric pump-tubing configurations are also available for equipment requiring metric pump-head dimensions.

Reinforced braided silicone sizes

Pressure ratings above apply to the published reinforced tubing construction. The allowable pressure of a complete fluid path may be lower and is determined by the lowest-rated tubing, fitting, connector or other component in the assembly.

Sterilisation compatibility

Suitable tubing constructions can support:

• Gamma sterilisation
• Autoclave sterilisation
• ETO treatment
• Integration into pre-sterilised ready-to-use assemblies

Weldable TPE and suitable pump tubing can also be incorporated into processes using tube welding and sealing equipment.

Sterilisation compatibility must be confirmed for the selected tubing construction and complete single-use assembly.

Quality and documentation

Available pharmaceutical tubing configurations are produced under controlled cleanroom conditions and can be supplied with material and validation documentation appropriate to the selected construction.

Depending on tubing type, available documentation can include:

• USP Class VI conformity
• ISO 10993 information
• FDA 21 CFR material conformity
• BSE / TSE statements
• Animal-derived component-free statements
• REACH conformity
• RoHS conformity
• European Pharmacopoeia information
• Sterilisation compatibility information
• Extractables and leachables information where available

Exact documentation depends on the tubing material and final configuration.

Typical applications

• Single-use fluid transfer
• Buffer and media transfer
• Cell-culture processes
• Bioreactor feed lines
• Peristaltic pumping
• Sampling assemblies
• Filling assemblies
• Sterile filtration systems
• Tangential flow filtration
• PUPSIT assemblies
• Bag and bottle assemblies
• Single-use manifolds
• Aseptic tube welding
• Aseptic tube sealing
• Upstream processing
• Downstream processing
• Pharmaceutical fluid transfer

Key benefits

• Multiple tubing technologies: silicone, weldable TPE, dedicated pump tubing and reinforced silicone cover different single-use processing requirements.
• Wide dimensional range: tubing is available from small-bore laboratory and sampling dimensions through production-scale fluid-transfer sizes.
• Sterile welding capability: suitable TPE tubing can be joined and sealed using compatible tube welding and sealing equipment.
• Peristaltic pump options: dedicated tubing constructions are available for demanding pumping applications.
• Higher-pressure options: braided silicone provides increased working-pressure capability compared with conventional unreinforced silicone tubing.
• Transparent fluid paths: clear silicone and TPE configurations allow visual monitoring of the process liquid.
• Sterilisation compatibility: suitable tubing materials can be gamma sterilised, autoclaved or supplied as part of a ready-to-use assembly.
• Assembly integration: tubing can be combined with bags, bottles, filters, sterile connectors, sensors and other components within a complete custom fluid path.

Configuration and quotation

Tubing selection should begin with the process function and fluid characteristics rather than tubing dimensions alone.

For technical selection and quotation, provide the following information where available:

• Required tubing material
• Tubing ID and OD
• Required length
• Process fluid
• Required flow rate
• Operating temperature
• Maximum operating pressure
• Peristaltic pump requirement
• Pump manufacturer and pump-head type where applicable
• Sterile welding requirement
• Tube sealing requirement
• Gamma sterilisation requirement
• Autoclave requirement
• Required connectors or fittings
• Integration into a complete single-use assembly
• Required material and validation documentation
• Estimated annual quantity

If the exact tubing grade has not yet been selected, process fluid, ID and OD, pressure, temperature and pumping requirements normally provide enough information for an initial technical selection.