DuPont™ Liveo™ Pharma TPE Tubing for biopharmaceutical processing

By Stéphane Cornelis
DuPont Healthcare TS&D/R&D Medical Devices Expert

For several years, the development of new therapeutic agents beyond traditional small molecules has profitably supported the biopharmaceutical 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 DuPont™ Liveo™ 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 Liveo™ Pharma TPE Tubing weldable and compatible with other brands of TPE tubing, but it also improves the weld strength (Fig. 1).

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 sterilization routes (Fig. 2).

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.

TPE tubing has been adopted increasingly in single-use bioprocessing applications thanks to their thermoweldability. In the current context of accelerated demand for single-use tubing in the biopharmaceutical industry and the stress on supply chains due to the COVID-19 pandemic, Liveo™ Pharma TPE Tubing represents an additional competitive offering – one with the quality and performance that DuPont Healthcare customers are accustomed to receiving.

“By adding a complementary pharma TPE tubing range to our Liveo™ Silicone Pharma Tubing and OMA lines, DuPont is committed to meeting customers’ requirements in terms of supply flexibility and a broader portfolio of solutions while maintaining our longstanding promises related to product performance, quality and reliability,” said DuPont Healthcare Global Marketing Manager Jennifer Gemo. “We are pleased to add this new line of TPE tubing under the DuPont™ Liveo™ name for our biopharma processing customers.”