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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