A Guide to Medical Device Material Compatibility with Sterilization

Jan Weiss, Development Specialist, R&D, Trinseo

- Tuesday, May 31, 2022

Patient safety is at the forefront of modern health care practices, directing standards for new technologies and their material composition. Medical devices that make direct contact with human tissue or bodily fluids are especially prone to impacting safety. To account for this, various sterilization methods have been adopted across the industry. For medical device manufacturers looking to develop new or improved medical devices, special consideration must be paid to material compatibility with sterilization.

The sterilization process can impact the physical integrity and optical characteristics of materials used for medical devices. Depending on the types of materials and the necessary sterilization method, property retention can vary significantly. Having a comprehensive understanding of how sterilization methods will impact some of the most common medical device materials is essential.

In general, single-use devices are sterilized by the manufacturer once prior to use. Common sterilization methods for these disposable devices include ethylene oxide, gamma radiation, or electron beam radiation. On the other hand, multiple-use devices are sterilized multiple times by the end-user, often via steam autoclave.

When evaluating polymer materials for medical devices, there are several key performance properties and aesthetics that may be impacted by sterilization. These include:

  • Tensile strength – How stiff or pliable is a material? How far can it bend until it breaks?
  • Impact resistance – If a product is dropped, will it break? Will the edges be sharp?
  • Temperature resilience – At what temperature will a device experience deformation?
  • Color retention – How closely does the device’s pre- vs. post-sterilized color match? How long does it take for the original color to recover after sterilization?

At Trinseo, our broad portfolio of materials solutions for medical devices is designed to meet a wide variety of specified performance and aesthetic requirements, including compatibility across the spectrum of sterilization methods. And while some deviations are inevitable, our materials are engineered to achieve the smallest possible deviation.

This includes polycarbonate (PC) resins that reduce post-sterilization color shift in transparent and light-colored opaque products, polymethyl methacrylate (PMMA) resins featuring minimal yellowing and discoloration following sterilization, thermoplastic elastomer (TPE) resins with good property retention directly after sterilization and minimal loss over time, and acrylonitrile butadiene styrene (ABS) resins. For those in need of custom solutions, we can also develop special formulations to meet your unique materials needs.

Determining a material’s compatibility with different methods of sterilization can be involved and complex. At Trinseo, we know our materials. We’ve conducted extensive research on our polymer portfolio’s property retention following sterilization, allowing our team to anticipate how our medical resins will react and properly advise customers on the best solutions for their materials challenges.

If you wish to learn more, we recently collated this data in our Sterilization Guide – a helpful tool you can reference for a snapshot of our medical resin portfolio and its sterilization compatibility.

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