Making the switch to Tritan™ MXF copolyester



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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?

You want to create medical devices and packaging that ensure patient safety and provide long-lasting reliability. To accomplish that, you have to choose high performance medical grade materials. Manufacturers who specify medical grades of Eastman Tritan™ copolyester not only get access to advanced, high-quality raw materials but also to a strong level of support throughout the regulatory journey to commercialization of a new product.
 
By specifying Eastman medical grade polymers, you get help with:
  • Biocompatibility
  • Sterilization
  • Quality systems
  • Dedicated regulatory support

電子線滅菌のイーストマンTritan™への影響

医療機器を消毒すると、バイオバーデンが安全なレベルまで下がり、ポリマーの物理特性と光学特性に対する影響を最小限に抑えることができます。現在医療業界で最も広く使用されている消毒法には、ガンマ線照射やエチレンオキシド（EtO）、オートクレーブ、過酸化水素低温ガスプラズマなどがありますが、 こうした中でさらに注目されているのが電子線（電子ビーム）滅菌です。電子線滅菌は、昨今その作業効率が改善したことにより、安全で信頼できるエネルギー源とみなされています。
 
ガンマ線照射に比べると、電子線滅菌は概してコストが低いのが特徴ですが、これは線量率がガンマ線照射よりも高く、同じ目標線量率での曝露時間が短くなることによるものです。曝露時間が短いと、ポリマー表面で酸化反応が起こる可能性が非常に低くなるため、ガンマ線照射と比較して樹脂の特性に対する影響が少なく抑えられます。

Overmolding with Tritan

Using overmolded soft-touch materials can provide many functional and decorative benefits to items made from rigid thermoplastics. Eastman Tritan™ copolyester demonstrates exceptional adhesion with commercial grades of TPE. When selecting the TPE you want to use, make sure it is formulated for use with a copolyester substrate.
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.

プラスチックがブランドに及ぼす影響 - プロダクトマネージャーの視点

 

医療機器の材料として使用している樹脂が原因で、ブランドイメージに大きな影響が及ぶことがあります。ヘルスケア分野の現状を見てみると、すべてのプラスチックが病院で使用されている刺激の強い消毒剤への曝露に耐えらるわけではありません。消毒剤にさらされた医療機器に黄変、ひび割れ、塗装はがれなどの兆候が見られたら、樹脂の選定を見直すべきでしょう。

 

がん治療薬とポリマーの適合性

がん治療の向上に対する継続的な取り組みの一環として、製薬企業はより効果の高い新しいがん治療薬を開発しています。 しかし、高度ながん治療薬や 担体溶媒では、薬物送達装置に使用されているポリマーの耐薬品性が発揮されにくい場合があります。こうした状況では、装置が適切に動作しない、あるいは早期に故障する、といったことが起きかねません。装置の性能やライフサイクルに問題が生じ、それが繰り返されると、患者の安全を守るため、特定の材料の使用を中止するよう規制機関に指示される場合があります。
 

Better bonds between polymers and adhesives

We often receive requests from medical device developers and original equipment manufacturers for guidance on the best adhesives to use with Eastman TritanTM copolyester. To help customers achieve the best adhesive solutions, we partnered with Henkel Corporation to test various resins and adhesives for use in medical devices.
 
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

Medical devices and housings are getting a surge of chemical resistance and impact strength thanks to the integration of new liquid silicone rubber (LSR) technology with medical grades of Eastman Tritan™ copolyester. Momentive’s Silopren LSR 47×9 series provides strong in-mold adhesion with Tritan—without the need for primers.
 
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

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.

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