Working together to solve medical device challenges
Molders and brand owners come to us for many different reasons during the developmental journey of a medical device.
• You may have a totally new device and want the best-fit polymer to optimize its performance advantages.
• Your current material may not have the chemical resistance and toughness to meet changing hospital disinfectant protocols and more powerful drugs and carrier solvents.
• Recent regulations may be driving the need for more compliant materials.
Whatever the challenge, working with Eastman lets you access technical expertise and support every step of the way—to help position your device for end-state success.
By collaborating early and often during product development and manufacturing, we can help you work with product engineers, toolmakers, and downstream assembly partners to bring your project to market efficiently and profitably.
Here are a few of the benefits of working together with Eastman:
Why should you choose Eastman medical grade polymers?
By specifying Eastman medical grade polymers, you get help with:
- Quality systems
- Dedicated regulatory support
The effect of electron beam sterilization on Eastman Tritan™
Compared to gamma radiation, e-beam radiation typically costs less due to higher dose rates that reduce the time of exposure at the same target dose. The shorter exposure time also minimizes the oxidation reactions that can occur at the polymer surface, resulting in less effect on resin properties than with gamma radiation.
Overmolding with Tritan
Consider these factors for part design:
- Optimize part and TPE thickness for adhesion and dimensional stability. If the TPE thickness is in excess of the Tritan part thickness, you could see warpage when you remove it from the mold. Use a substrate thickness twice that of the TPE.
- Incorporate mechanical interlocks to improve TPE adhesion and promote part durability. Mechanical interlocks are important for thin TPE layers and very demanding fitness-for-use requirements.
Educating product managers on how plastics affect your brand
The material you choose for your medical devices can have a big impact on your brand’s image. In today’s healthcare environment, not all plastics can withstand exposure to the aggressive disinfectants being used in hospitals. If your device is showing outward signs of suffering from exposure to effects of disinfection, including yellowing, cracking, crazing, or paint peeling, it’s time to reconsider material selection.
Polymer compatibility with oncology drugs
Better bonds between polymers and adhesives
Henkel’s LOCTITE® adhesive continues to be tested at the industry’s most comprehensive ISO 10993 biocompatibility standards. Eastman looked to determine which resins and adhesives, when used with Tritan, could optimize a manufacturer’s assembly process. Results showed that the use of Tritan and LOCTITE together created superior results, including improved
curing to increased flexibility.
Creating strong bonds with LSR technology and Tritan
Clear and opaque grades of Tritan have a lower Tg and require a lower processing temperature than other engineering polymers. Because Silopren LSR 47×9 can cure rapidly at relatively low temperatures, it’s possible to achieve optimal functional performance and efficient processing with Tritan.
This combination is ideal for applications that require properties like handling comfort, waterproofing, durability, and aging stability. Incorporating LSR technology enhances the advantages of Tritan, which include:
- Outstanding chemical resistance
- Excellent impact strength and durability
- Made without bisphenol A (BPA) and halogens
- Superior noise-damping characteristics
Four steps for testing housing material performance
This simple, easily-repeatable test can help predict the reliability of a material after exposure to harsh cleaners and drugs commonly used in hospital settings. The method uses a 1.5% constant strain jig together with wet patches for applying chemical reagents. Here’s how it works:
- Select the appropriate jig.
- Load flex bars onto jig.
- Apply chemicals to the flex bars.
- Perform reverse side impact test.
A preferred supplier that goes the extra mile
Our regulatory group stays current with global regulatory changes and makes this information readily available to the market. We provide you with all the necessary regulatory information for the safe use of our polymers, including details on compliance with Food and Drug Administration standards, chemical and mechanical properties, and more.
We also offer premium technical service for all aspects of the molding process, from conception through bringing your product to market. Eastman Design Services capabilities include: