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

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.

 

Keys to classifying failures for quality engineers


Medical device failures are a common—and costly—occurrence. They can lead to a product recall, affect the product development cycle, and result in extra expenses for manufacturers. The reasons devices fail can be complex, making it difficult for quality engineers to classify the problem.
 
What can quality engineers do to remedy this problem? Consider these factors:
 
  • Understand why failures occur: Most device failures are caused by a misunderstanding of how a material’s properties, processing, and environment work together. In many cases, failures can result from a combination of wrong material selection, poor chemical resistance, high-stress design, or inconsistencies in manufacturing processes.
  • Collaborate with your supplier: Working with material suppliers on material selection, testing, part and tooling design review, and secondary operations can give quality engineers access to knowledge and resources they may not otherwise have.

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.

Polymer compatibility with oncology drugs

As part of the continued effort to improve cancer treatment, pharmaceutical companies are developing new and improved oncology drugs. However, advanced oncology drugs and carrier solvents challenge the chemical resistance of polymers used in delivery devices. Such conditions can prevent devices from working properly or cause them to fail prematurely. When there is a pattern of compromised device performance or life cycle, regulatory agencies may tell manufacturers to stop using certain materials to protect patient safety.
 

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.

 

UCSF Biomed Shares Medical Device Breakdown

Watch this fascinating conversation with Richard Fechter, a principal developmental engineer at the University of California, San Francisco Medical Center.

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