DuPont™ Liveo™ Pharma TPE Tubing

Sterilizable, weldable TPE tubing for biopharmaceutical processing

With the launch of new Liveo™ Pharma TPE Tubing, DuPont is now offering a thermoplastic elastomer (TPE) option for fluid transport and single-use bioprocessing applications and is facilitating adoption and compatibility with leading competitive TPE tubing offerings.This new product range complements our silicone-based Liveo™ Pharma Tubing and Overmolded Assemblies product lines and is produced under the same high quality principles as the products our customers already know and trust.

Key features and benefits

  • Improved heat-welding, both to

itself and to competitive offerings

  • High tensile strength and burst

resistance before and after welding

  • Low extractables
  • Good chemical resistance
  • Minimal spallation after 24 hours

of pumping

  • Good clarity; stable clarity after

sterilization

  • Manufactured in ISO Class 7

cleanroom

Comprehensive data package to accelerate qualification and validation under the form of a qualification guide

Applications

  • Fluid, media and solvent transport in biopharmaceutical processes and biotechnology
  • Single-use assemblies
  • Peristaltic pump applications
  • Aseptic connection and disconnection without connectors(e.g., sampling)
  • Applications where compatibility with industry benchmark TPE tubing is needed

 

Typical physical properties of Liveo™ Pharma TPE Tubing

Properties are based on Liveo™ Pharma TPE Tubing with an inner diameter (I.D.) of 3/8" (9.5 mm) and an outer diameter (O.D.) of 5/8" (15.9 mm). Specification writers: These values are not intended for use in preparing specifications. Please contact
DuPont prior to writing specifications on this product.

Purity data for Liveo™ Pharma TPE Tubing

  • USP <85> (Endotoxins)
  • USP <665> (Extractables and Leachables) with autoclave or gamma radiation sterilization methods
  • USP <788> (Particulates)
  • ISO 11737-1 (Bioburdens)

Regulatory data for Liveo™ Pharma TPE Tubing

  • ISO 10993 Biocompatibility tests (5: Cytotoxicity, 6: Muscle Implantation,11: Acute Systemic Toxicity, 23: Intracutaneous Irritation)
  • USP Class VI (Intracutaneous Reactivity, Acute Systemic Injection,Intramuscular Implant)
  • Pyrogenicity (USP <151>)
  • Elemental Impurities

Sterilization methods

DuPont™ Liveo™ Pharma TPE Tubing is sterilizable using the following methods:

  • Steam (1 autoclave cycle of 30 minutesat 121°C)
  • Gamma radiation (up to 50 kGy)

Performance data for DuPont™ Liveo™ Pharma TPE Tubing

Comprehensive studies were conducted on material in common sizes and using different sterilization methods, including steam and gamma radiation.The following is a review of analyses comparing Liveo™ Pharma TPE Tubing to industry benchmark tubing. Further testing data is available; please contact DuPont for more details depending on your application needs.

Benchmark analysis: Summary of typical performance

Test samples steam-sterilized (autoclaved 1 cycle of 30 minutes at 121°C);0 = lowest performance; 5 = highest performance.

Results

Liveo™ Pharma TPE Tubing showed better tensile strength after welding than the benchmark tubing.Testing also revealed better  welding strength and burst pressure resistance by Liveo™ Pharma TPE Tubing versus the benchmark tubing. Excellent welding strength and burst pressure resistance enable Liveo™ Pharma TPE Tubing to improve the safety margin during fluid transfer applications.

Testing protocol

  • Weldability was assessed by sterilization of the samples prior to running specific testing to measure the ability of the welded section to withstand mechanical stress before failure was observed.
  • The specimens were welded using the specific Biowelder® TC preprogrammed setting.
  • Tensile strength of the welded section was determined from the average maximum tensile strength as measured on dumbbells cut out from the tubing using ASTM D412 Die C.
  • Liveo™ Pharma TPE Tubing welded extremely well to itself and to the benchmark tubing using aseptic tubing welders/ standard recipes.
  • Burst pressure resistance properties were determined according to ASTM D380 in a burst chamber apparatus by flowing water through the tubing and increasing the water pressure until ballooning and burst eventually were observed.
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