MATERIALS | MEDICAL TUBING


while maintaining elastomeric flexibility,” said Ganter.


While low-temperature silicone chemistry is not


new, products optimised for biopharma applications are, she said. Tufel 150 LT remains flexible until -114°C, which helps to store and transport temperature-sensitive biopharmaceuticals without the risk of failure due to cracks or damage. In addition, cell and gene therapies – which use storage temperatures down to liquid nitrogen (-196°C) – are growing, she added.


Above: Biocompatibil- ity and surface properties are among the key criteria when selecting a catheter material at the design stage


polymer replacements,” she said. She said that two Lubrizol TPU grades – Tecoflex


72D and Tecophilic 60D – show similar levels of lubricious performance as PTFE and FEP tubing. And, while surface friction is only one part of device performance, it has great impact on manufacturability and usability.


Silicone performance Beate Ganter, regional marketing manager for healthcare at Momentive Performance Materials, said that silicone elastomers are appropriate materials for low temperature biopharma applications. These have stable properties over a wide


temperature range – and high flexibility at temperatures below -60C, she said. Biopharmaceuticals is a growing market, she


said, with a CAGR of around 11%. There is rapid growth in types of single-use systems (SUS) – with silicone elastomers commonly used in SUS tubing for their biocompatibility, low extractables and leachables, and resistance to sterilisation methods. Bulk drug substances (BDS) such as vaccines may be stored or shipped at temperatures down to -80°C or lower. If the bag or tubing becomes brittle, a vibration or sudden shift in motion could cause the part to crack. Also, when thawing out the assembly and pumping out the high-value fluids, a crack could lead to waste and possible contamination. “Materials optimised for low temperature


flexibility may improve the storage and shipment performance of these assemblies,” she said. The company evaluated its new material – Tufel


150LT, optimised for low temperatures – against a standard grade of its biopharma silicon elastomer tubing. While mechanical and other properties were similar, the standard grade was brittle at -100°C. “Tufel 150 LT simply became stronger at -100°C


18 PIPE & PROFILE EXTRUSION | Summer 2025


Medical recycling Tobias Johnsen of VinylPlus told delegates about a new platform for recycling medical PVC, called Vinyl Healthcare. It brings the activities of PVCMed Alliance – which has been discontinued – together with VinylPlus Med and VinylPlus PharmPack, which recycled medical devices and pharmaceutical blister pack, respectively. One activity is scientific research – including a


project called PVC Loop, looking at the recyclability of flexible PVC. “Scientific literature offers limited insight into the


recyclability of flexible PVC,” he said. Spanish institute Aimplas was commissioned to test how many times flexible PVC medical tubing can be recycled. This included tubing for IV applications and blood and dialysis systems. Tubing was recovered, shredded, micronised and then either extruded into pellets or injection moulded into test bars – for six cycles. Tensile strength and plasticiser content


remained stable, and there was only minor degradation in static thermostability after the fourth cycle. Dynamic thermal stability confirmed material durability. There was slight yellowing seen after six cycles – which was aesthetic, not functional, he said.


Silicone alternative At the US version of the same event, held last year, Shiva Douse, global medical marketing manager at Celanese, told delegates that the company’s Santoprene TPV can be used in place of silicone in peristaltic pump tubing. Elastomers are useful in medical devices because they provide long-term sealing, flexibility, protect critical components of a device and offer soft touch for human contact, she said. “Santoprene TPV behaves like a rubber but


processes like a plastic,” she said. Vulcanised rubber is encapsulated in a thermoplastic matrix in a homogeneous way, giving a locked-in morphology. When applied to medical


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