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

电子束灭菌对Eastman Tritan™的影响

医疗器械灭菌有助于将生物负载降低到安全水平,同时对其聚合物的物理和光学特性的影响最小。当今医疗行业使用最广泛的一些灭菌方法包括伽马辐射、环氧乙烷(EtO)、高压灭菌器和低温过氧化氢气体等离子体。另一种越来越流行的方法是电子束(e-beam)辐射。由于运行效率的最新进展,它是一种安全、可靠的能源。
 
与伽马辐射相比,电子束辐射的成本通常更低,因为更高的剂量率可减少在相同目标剂量下的暴露时间。较短的曝光时间也最大限度地减少了聚合物表面可能发生的氧化反应,与伽马辐射相比,对树脂性能的影响较小。

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.

向产品经理宣传塑料如何影响您的品牌

 

您为医疗器械选择的材料会对您的品牌形象产生重大影响。在当今的医疗保健环境中,并非所有塑料都能经受医院使用的腐蚀性消毒剂的影响。如果您的器械显示出受到消毒影响的外部迹象,包括变黄、开裂、银纹或油漆剥落,则是时候重新考虑材料选择了。

 

聚合物与肿瘤药物的相容性

由于为改善癌症治疗而持续努力,各制药公司正在开发经过改进的全新肿瘤药物。 然而,先进的肿瘤药物和 载体溶剂对递送装置中使用的聚合物的耐化学性提出了挑战。这种情况会阻止器械正常工作或导致它们过早发生故障。当出现器械性能或生命周期受损的模式时,监管机构可能会告诉制造商停止使用某些材料,从而保障患者安全。
 

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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