An innovative solution to medical device housing failure
As healthcare facilities ramp up the use of aggressive disinfectants, traditional plastics are feeling the strain. It’s all too common to see device housings become sticky; wear thin in high-touch areas; or crack, crumble, or shatter after only a few months of service. The issue? Devices that were designed just a few years ago are typically made with materials that lack the right combination of impact strength and chemical compatibility with today’s stringent cleaning protocols.
Eastman Tritan™ copolyester is an excellent choice for medical housings due to its superior toughness and high chemical resistance. Using Tritan in your device can also help prevent costly repairs and replacements, keeping patients safe and customers happy.
Why should you choose Eastman medical grade polymers?
By specifying Eastman medical grade polymers, you get help with:
- Quality systems
- Dedicated regulatory support
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.
Which medical grade polymer is right for you?
We know that material choice is a crucial component of any medical device or device housing. When you’re deciding what medical grade polymer you need for your next project, consider these criteria:
- Does it make the grade?
- Will it match the application?
Tips for tooling design with Tritan
Tooling design review is one important step in the process that will help determine what type of gating system is right for your device. Here are four quick tooling design tips for injection molding with Tritan:
- Proper gating selection
Select a compatible gating style for the selected resin. Most conventional cold gating styles work well with Tritan copolyesters, including sub, pin, fan, edge, sprue, and diaphragm gates.
- Design tooling with good cooling/thermal control
Copolyesters require good thermal control throughout the cavity for optimal processing.
- Design tooling with a plan for venting
Navigating the complexities of compatibility with oncology drugs
The need to mitigate infection risks and enhance patients’ safety and comfort has significantly increased the demand for higher-performing plastics with improved chemical resistance. Many polymers commonly used in drug delivery devices simply do not hold up to modern oncology chemotherapies. After exposure to chemicals in the medical environment, devices made with these polymers can experience environmental stress cracking or premature failure in the presence of applied or residual stress.
Broken devices put patients at risk. What’s more, regulatory agencies may tell manufacturers to stop using certain materials when device performance or life cycle is compromised.
Eastman Tritan™ copolyester—superior attributes for medical devices
Eastman Tritan™ copolyester is raising the bar for durability and cleanability in medical devices and housings. BPA-free Tritan’s attributes include exceptional clarity, toughness, improved heat and chemical resistance, and more. It’s also easy to process due to its unique chemical makeup relative to traditional thermoplastics. This blend of processing and performance properties provides greater advantages compared with other commonly used polymers. Available in clear and opaque formulations, Tritan offers many benefits to enhance innovative device designs:
Clear formulations of Tritan
- Greater toughness, heat resistance, processability, and design freedom
A safer connection for stopcocks
Eastman Tritan™ copolyester is resistant to a wide array of medical fluids, such as oncology drugs, drug carrier solvents, and lipids. Along with its toughness, low residual stress, and color stability post-sterilization, Tritan is an excellent choice for fluid management components.
Regulations in the medical market are constantly changing. When Elcam Medical, a world-class manufacturer of disposable medical devices for the OEM market, wanted to further improve the safety and efficacy of its fluid management devices, they turned to Eastman to find a polymer that complies with new regulations while still optimizing performance.
Secure connections for safer devices
Global design standards for tubing connectors are now helping improve patient safety and device efficacy. ISO 80369 requires small-bore connectors to be made of semirigid and rigid materials, making incorrect interconnections less likely. Enteral devices were the first of all the clinical applications to undergo this change.
To meet this standard, you may have to adjust your design, which means you may need a new mold or new materials. Eastman Tritan™ copolyester is a rigid material with the properties needed to comply with these regulations.
Putting device durability to the test
When choosing a polymer for a medical device, it’s crucial to understand how the material will perform in the real world. Eastman’s 4-step test helps show how plastics hold up when exposed to frequent disinfection, but it’s also important to see how that translates into actual performance in the field.
That’s why we developed the housing drop test. This test can be used alongside the 4-step method to understand how a well-designed device will respond to impact after being disinfected.