Express Pharma

DuPont Liveo Pharma TPE Tubing for biopharma processing

DuPont is accelerating its investments for the future of the biopharmaceutical processing industry by expanding its supply capacity of silicone elastomers and tubing and by enlarging its single-use pharma product lines with new thermoplastic elastomer (TPE) tubing

1 542

For several years, the development of new therapeutic agents beyond traditional small molecules has profitably supported the biopharma industry, which has experienced steady and rapid growth. Cell and gene therapies, cancer treatments, the continuing trend of increasing life expectancy, and the unexpected and unprecedented demand for vaccines to control the COVID-19 pandemic blew up the most optimistic forecasts. This unpredictable growth in demand has put notable challenges on the upstream supply chain – especially the single-use-system supply.

While the bioprocessing supply sector works hard to adapt to this expansion, DuPont is accelerating its investments for the future of the biopharmaceutical processing industry by expanding its supply capacity of silicone elastomers and tubing and by enlarging its single-use pharma product lines with new thermoplastic elastomer (TPE) tubing.

DuPont successfully launched its new DuPontLiveo Pharma TPE Tubing product line in Q4 2021. This thermoweldable tubing effectively complements the Liveo Pharma Tubing and Overmolded Assemblies (OMA) line, the well-established DuPont product offering for bioprocessing.

This product launch marks a historic milestone for Liveo, as it adds a range of extruded pharma tubing based on TPE technology – dedicated to fluid transport and single-use bioprocessing applications – produced under similar high-quality and high-performance principles as the recognized Liveo Silicone Pharma Tubing product lines.

Liveo Pharma TPE Tubing is targeted for use in biopharma processes to enable aseptic connection and disconnection of tubing without connectors (e.g., sampling) and can be used in peristaltic pump applications. Strong from its heritage built on purity, quality and performance, the new ISO Class 7 manufactured TPE tubing offers an outstanding purity profile and low extractables. This new generation of high-purity tubing meets the most stringent requirements by enabling improved heat-welding to itself and unquestionable compatibility with any kind of TPE tubing. Not only is LiveoPharma TPE Tubing weldable and compatible with other brands of TPE tubing, but it also improves the weld strength (Fig.1).

Fig. 1 – Improved tensile strength of Liveo™ Pharma TPE Tubing after heat welding to itself and compatibility with other kinds of TPE tubing

Liveo Pharma TPE Tubing also demonstrates high tensile strength, burst resistance before and after welding, excellent resistance to chemicals, minimal spallation after 24 hours of pumping, and suitable stability under different sterilisation routes (Fig. 2).

Fig. 2 – Stability of Liveo™ Pharma TPE Tubing under different autoclave sterilization conditions

These exceptional properties and characteristics are substantiated by a comprehensive set of data results compliant with required, demanding standards: USP <665> to assess the risk profile of the equipment part and potential impact on patient safety; USP <788> for particle counting and identification; USP <85> bacterial endotoxins test; biocompatibility testing according to USP Class VI and ISO 10993;ISO 11737-1 validation of sterilization process; and elemental impurities testing. This data package will help accelerate the qualification process at customer manufacturing facilities. In addition, the performance of Liveo Pharma TPE Tubing and excellence in its category have been confirmed by a comparative benchmark study.

Key benefits

Liveo qualification health data

·         Liveopurity 

      Manufactured in ISO Class 7 cleanroom​

      Low extractables​

·         Improved performance ​

      Welding and welding compatibility with other TPE tubing​

      Burst resistance before and after welding​

      Low level of spallation after 24 hours of pumping​​

·         Good chemical resistance

·         Good and stable clarity after sterilization​

·         Comprehensive data package to accelerate qualification and validation

·         USP <665>:Extractables and leachables with autoclave and gamma sterilization methods​

·         USP Class VI