Публикация: 01. июня 2026

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TPE Medical Tubing – Benefits and Applications


The medical technology and pharmaceutical markets offer a wide range of applications for thermoplastic elastomers (TPE). These applications place the highest demands on materials and their processing. In this article, Matthias Schmidt, Head of Sales Medical at KRAIBURG TPE, explores the possibilities for TPE in the field of medical tubing.

TPE Medical Tubing – Benefits and Applications


The medical technology and pharmaceutical markets offer a wide range of applications for thermoplastic elastomers (TPE). These applications place the highest demands on materials and their processing. In this LinkedIn newsletter, Matthias Schmidt, Head of Sales Medical at KRAIBURG TPE, explores the possibilities for TPE in the field of medical tubing.


The requirements for medical tubing are stringent: In addition to functional properties such as flexibility, kink resistance, and transparency, the focus is increasingly on regulatory compliance, biocompatibility, and material compatibility. At the same time, the market is demanding alternatives to PVC solutions.

Thermoplastic elastomers have already established themselves as a high-performance alternative in the past. The TPE material class combines the soft and flexible properties of traditional elastomers with the efficient processing capabilities of thermoplastic materials, thereby opening up a wide range of possibilities for the manufacture of medical tubing. 

Why are TPEs suitable for medical tubing?


The manufacture of medical tubing is a highly regulated and material-critical sector of medical technology. What matters is not only the tubing’s actual function, but also its biocompatibility, sterilizability, purity, and long-term material stability (low leachable and extractable profile).

TPEs offer a balanced property profile for this purpose. They contain no PVC, silicone, or latex and are therefore free of traditional plasticizers. Health risks that may be associated with potentially harmful substances in these material classes can thus be avoided.


At the same time, modern TPE compounds achieve a level of softness and flexibility similar to that of silicone or PVC. With hardness ranges from 45 to 80 Shore A, different requirements can be precisely met. Good kink resistance is among the key market requirements. Especially for infusion, drug delivery, or supply tubing, an uninterrupted flow of media is essential. TPEs offer high kink resistance here while maintaining good flexibility.

The transparency of the used materials also plays an important role in the medical field, for example, for visual monitoring of fluids. Numerous TPE compounds enable clear and transparent tubing solutions and are also suitable for coating with PVP, for example, in urinary catheters. This allows for improved gliding properties, which increase patient comfort and facilitate insertion and removal.

How are TPEs processed?


Medical TPEs can usually be used in extrusion and injection molding process. This simplifies the processing of complex components and enables cost-effective manufacturing without additional post-processing.

Typical applications for TPE-based medical tubing include:

  • Supply tubing, drug delivery tubing
  • Infusion tubing
  • Drainage tubing
  • Ventilation tubing
  • Tubing for peristaltic pumps
  • Applications in endoscopy and minimally invasive surgery
  • Catheter solutions

Advantages over PVC and silicone


The market trend is increasingly moving toward PVC-free alternatives, specifically TPE solutions. The reasons for this lie primarily in regulatory developments as well as in rising requirements for material purity and biocompatibility.

Styrene-block-copolymer-based thermoplastic elastomers (TPS) are now considered an attractive alternative to polyvinyl chloride (PVC) and thermoplastic polyurethanes (TPU), as they are free of conventional plasticizers. This helps avoid potential migration and extraction risks.

Compared to silicones, thermoplastic elastomers also offer processing advantages. Silicones often require time- and cost-intensive post-processing steps, whereas TPEs can be efficiently processed in extrusion or injection molding processes, resulting in shorter, more economical cycle times.

In various tests, proven TPEs also demonstrate a low content of extractable substances. This is particularly relevant for applications involving direct contact with bodily fluids, such as blood.

Regulatory Requirements

Medical tubing is subject to strict regulatory requirements worldwide. Materials must not only be functionally suitable but also pass extensive testing for safety and biocompatibility.
 

To be used in such demanding applications, medical-grade TPEs must meet at least the following approvals: 

  • EU No 10/2011
  • US FDA CFR 21
  • ISO 10993-05 (Cytotoxicity)
  • VDI Guideline 2017 Medical Grade Plastics


In addition, materials must reliably withstand various sterilization processes. TPEs can be sterilized using standard methods:

  • EtO gas
  • Hot steam
  • Gamma irradiation
  • Beta irradiation (electron beam)

For manufacturers of medical components, process and supply chain security are also becoming increasingly important. That is why quality management systems, documented production processes, and consistent change control management play a central role.

With the THERMOLAST® M series, KRAIBURG TPE offers TPE compounds specifically developed for applications in the medical, pharmaceutical, and diagnostic sectors. The materials are also suitable for applications involving direct contact with bodily fluids. In addition, an established quality and change control management system ensures that high standards for consistency, traceability, and product safety are met.
 

Limitations of TPE


Despite their versatile properties, TPEs are not the optimal solution for every medical application. Depending on the application, high-performance materials such as silicone, fluoropolymers, or special TPU types may offer advantages—for example, in cases of extreme temperature requirements, very long-term implantation periods, or particularly high chemical exposure.

Sterilization resistance must also always be evaluated on a case-by-case basis. Not every TPE behaves identically under gamma or hot steam sterilization. Therefore, application-specific testing and validation are indispensable.

Furthermore, as medical systems become more miniaturized, the demands on dimensional accuracy, surface quality, and long-term performance are continuously increasing. Material selection therefore remains an application-specific decision that must take technical, regulatory, and economic aspects into account in equal measure.

One thing is certain, however: 

In recent years, TPEs have become an important material for modern medical tubing systems. Their combination of flexibility, biocompatibility, processability, and regulatory compliance makes them a sustainable solution for numerous applications in medical and pharmaceutical technology. What experiences have you had with TPEs in this highly sensitive market? Let us know in the comments.

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