Medical Design Briefs - December 2023 - 20

Class VI Medical Silicones
need to consider, however, is that pigmented
grades need separate testing
per color by the end user and advance
communication with the pigment suppliers
to prevent the use of pigments
that may cause failures in biocompatibility
testing. In addition, a supplier
that makes silicones in different durometers,
such as from 10 to 80 (Shore A),
may have all of the required USP Class
VI testing for a single durometer rather
than for all durometers. If that is the
case, USP Class VI equivalency in these
other durometers may still be sufficient
for the application.
The curing system for USP Class VI
silicones is especially important. Additional
curing through the use of platinum
catalysts produces no by-products.
By contrast, peroxide-cured silicones
contain by-products in the form of organic
acids. For this reason, platinumcured
silicones have inherently higher
purity than their peroxide-cured
counter parts. Platinum curing can also
offer greater control over cure rates and
cross-linking for silicones that are more
consistent in terms of appearance. In
addition, platinum-cured silicones
show less degradation of properties
under sterilization by autoclaving, irradiation,
and ethylene oxide. This combination
of high purity, which translates
to lower toxicity, and superior property
retention under sterilization makes
platinum-cured silicones preferable for
medical applications.
Material Tolerances, Sizes, and
Lead Times
Finally, it's important to consider
the tolerances, sizes, and lead times
of USP Class VI silicones. When sheets
are compression molded, they come in
standard sizes based on available tooling.
Continuous roll technology can
produce 10 times as many sheets per
hour, and with tight tolerances. Importantly,
rolls can also be converted
to custom sheet sizes. For applications
where a medical device manufacturer
needs a ready-to-mold compound
instead, compression molding can be
used for parts production.
Available on Demand!
Webinar
What Really Changed: A Look at the Updated
FDA Guidance Document for ISO 10993-1
In September 2023, the FDA released a new revision to its guidance document on the use of ISO 10993-1, which focuses on the
evaluation and testing of medical devices within a risk management process. This 60-minute Webinar will review the changes to the
FDA's guidance document - including a look at the information provided in the FDA's explanatory webinar given in October 2023 -
as well as how to assess the revision's impact on different situations.
Speakers:
Audrey Turley
Director and Biocompatibility Expert,
Expert Advisory Services,
Nelson Labs
Helin Räägel, Ph.D.
Senior Biocompatibility Expert,
Expert Advisory Services,
Nelson Labs
Vendor Value
USP Class VI silicones can provide the
right balance between cost savings and
patient protection, but medical manufacturers
need to protect themselves
against supplier cost-cutting that can invalidate
compliance. It's also important
to evaluate all of a material's attributes,
such as color and durometer, and to
choose USP Class VI silicones that have
passed third-party testing.
Whether it's for sheets, rolls, or readyto-mold
compounds, it pays to partner
with a supplier whose products are truly
USP Class VI compliant. It's also worth
picking a partner that is willing to answer
questions about chemical compliance
and that will facilitate additional testing
if necessary. By sourcing USP Class VI
silicones from the right vendor, medical
device manufacturers can mitigate risk
and get greater value.
This article was written by Dominic Testo,
Business Development Manager, Specialty
Silicone Products, Bollston Spa, NY. For
more information, contact dtesto@sspinc.
com or visit https://sspinc.com.
Please visit https://www.techbriefs.com/component/content/article/mdb/webcasts/upcoming-webinars/49463
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Medical Design Briefs - December 2023

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