Understanding The Complexities Of Medical Grade Polymers

In rare cases, a medical grade polymer that meets all the device’s performance needs may not be available as a standard “off-theshelf” grade. As non-medical grade polymers are designed to address a very wide variety of applications, they can sometimes offer unique chemistries, functional additives and performance options not available as standard in medical grade polymers. In these instances, direct discussion with the material supplier to discuss options for medical grade customizations may be warranted.

While non-medical grade polymers are of high quality and performance, in most cases, medical grade polymers are best positioned to address both the immediate and long-term requirements for high performing sustainable medical devices.

What Does “Medical Grade Polymer” Mean to Lubrizol?

LLS Health provides a full range of TPU material solutions and specializes in polymer customization to help achieve optimal clinical outcomes for medical device manufacturers. We work in collaboration with our customers to create polymer solutions for use in medical devices.

Lubrizol’s medical grade TPUs offer the following support:

• Assistance with regulatory and product compliance requirements such as providing information necessary to support device filings with the US FDA and other national/regulatory bodies

• Biocompatibility testing performed and results summaries available

• Comprehensive quality systems with manufacturing and quality record retention

• ISO 9001 certified manufacturing facilities with plant audits or audit packets available upon approval

• Extensive commercial product change management and change notification process:
  - Ensures changes are not made to process, procedures or composition without review and approval by all key LLS Health product design groups
  - If a change to commercial product manufacturing location, composition, specification or other significant properties is necessary, notification will be provided prior to implementing the change in commercial products.

• Documentation of the change will be provided, including reason and timing of the change.

• Documentation will be provided as far in advance as possible ahead of the change.

• Every effort will be made to ensure minimal impact to the material end user or processor, including (where possible), options for last-time-buy of products prior to change implementation to allow for technical and regulatory evaluation of any required material changes.

When it comes to selecting materials for development of a medical device, it is clear OEMs have many options and factors to consider. It is not only important to work with a partner that has the expertise to help sift through those complexities, but also work with a polymer supplier that has a robust portfolio of materials, capabilities and quality and regulatory support systems in place to ensure optimal performance of your medical device throughout its lifecycle. Our team understands polymer selection, can answer your questions, and help you identify the right materials for your medical device.

Disclaimer:

Lubrizol Advanced Materials, Inc makes no warranties, express or implied, including, but not limited to, the implied warranties of merchantability and fitness for a particular purpose. No warranties or guarantees are made as to the suitability of the products for the applications disclosed. Full-scale testing and end product performance are the responsibility of the user. Lubrizol Advanced Materials, Inc. shall not be liable for and the customer assumes all risk and liability of any use or handling of any material beyond Lubrizol Advanced Materials, Inc.'s direct control. The SELLER MAKES NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. Nothing contained herein is to be considered as permission, recommendation, nor as an inducement to practice any patented invention without permission of the patent owner.

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