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?
Selecting the right medical grade polymers helps ensure your device complies with quality and biocompatibility standards—and that you have reliable support for regulatory approvals. Different polymers offer different combinations of strengths that help ensure performance in specific medical applications. 
 

Tips for tooling design with Tritan


 
What makes for effective molding of Eastman Tritan™ copolyester? Reviewing all aspects of design—from concept to secondary operations—early on in the process is crucial to end-stage success.
 
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

Drug- and lipid-resistant polymers are playing an increasingly important role in enhancing patient safety. Stringent sterilization techniques can cause cracking, crazing, and hazing in commonly used plastics. They can also have a yellowing effect on certain polymers, which can impact color-coding systems in connector applications.

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

Small-bore connectors are important components of many enteral feeding devices. Good design is critical, as tubing misconnections or failure can put patients at risk for serious injury or death.

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.

 

Four steps for testing housing material performance

When exposed to commonly used aggressive disinfectants and drugs, many materials used in medical devices can crack, craze, discolor, and become sticky. Currently, there are no industry standards for evaluating surface compatibility. That’s why Eastman developed a 4-step test method based on ASTM standards to better understand why plastics fail and how different plastics perform in the real world.
 
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:
  1. Select the appropriate jig.
  2. Load flex bars onto jig.
  3. Apply chemicals to the flex bars.
  4. Perform reverse side impact test.

A preferred supplier that goes the extra mile

At Eastman, we go above and beyond the typical duties of a preferred supplier. Unlike many of our competitors, Eastman provides you with regulatory and technical services to help you through the manufacturing process—at no extra cost to you. This guidance, along with access to our high quality, innovative materials, will elevate your brand and ensure that you’re optimizing our polymers for your devices.
 
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:
 

Thank You for Asking

We often receive great questions about molding with Eastman medical grade polymers and are always glad to provide answers and more information. Here is a response to a recent query from our inbox:
 
“How environmentally friendly is Eastman MXF221 copolyester?”

Eastman strives to create solutions that offer more value with less environmental impact.
MXF221 copolyester is one of our many environmentally responsible offerings that meets
industry standards for safety and sustainability. Some of its innovative properties include:
  • It’s made without BPA, halogens, or ortho-phthalate plasticizers.
  • Its toughness and durability can potentially increase product life and reduce waste.
  • The flame-retardant additives used in do not contain antimony, bromine, or chlorine.
  • It’s suitable for transducer housing applications that require contact with the skin.
Read more about how Tritan is improving sustainability and design for devices and diagnostics.

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