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.
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:
Eastman Innovation Reaches Times Square
Eastman innovation in the medical market reaches coast to coast this week from this billboard in Times Square to MD&M West in California. Talk about the “wow” factor! To see upcoming MD&M West 2018 recap posts visit our Eastman Medical Polymers Linkedin page.
Join Us at MD&M West 2018!
Eastman will be exhibiting at Medical Design & Manufacturing West 2018 February 6-8, 2018 in booth 2401.
UCSF Biomed Shares Medical Device Breakdown