Medical Inc., a medical and pharmaceutical
company, has adopted Eastman (www.eastman.
com) non-phthalate plasticizers for infusion lines
currently available in the marketplace and has
documented the transition process.
For designers who are considering alternative
materials for the development of new devices
or the redevelopment of current devices, it is
important to realize, early in the process, that
replacing DEHP with an acceptable alternative
will require reformulation of the PVC compound being used to manufacture the device.
This will ensure that the performance and appearance will be similar to the current devices.
In addition, requalifications or recertifications
will be necessary in most instances. In the United States, the FDA is allowing this to happen.
New Non-Phthalate Option
Designers who are considering switching
plasticizers want a non-phthalate option for
their products that offers technical performance
consistent with competitive products currently
on the market. Further, they are seeking an alter-
native that comes with extensive test data. When
developing sensitive applications, designers need
easy access to reliable data and test results about
the plasticizer options that could be used in the
materials they are considering. This data offers
peace of mind when changing the plasticizer or
the material of an existing device, or when select-
ing something new for a device in development.
To help meet the long-term needs of device
designers and provide a non-phthalate plasticizer
alternative for use in medical products, Eastman
Chemical Company is offering Eastman 168
SG non-phthalate plasticizer. This material is an
enhanced grade of Eastman 168 non-phthalate
plasticizer and is designed specifically for use in
sensitive applications, including medical tubing.
This option serves as an alternative to DEHP,
trioctyl trimellitate (TOTM), acetyl tributyl citrate (ATBC) and 1,2-cyclohexane dicarboxylic
acid diisononyl ester (DINCH). In comparison,
Eastman 168 SG is more efficient than TOTM,
and both ATBC and Eastman 168 SG show
excellent PVC powder mixing performance.
Additionally, Eastman 168 SG has good sterilization stability, as does Hexamoll DINCH.
To help meet medical device regulations — or
get ahead of impending regulations — customers
who use Eastman 168 SG gain access to propri-
etary ISO 10993, USP Class VI test, IV infusion,
and multigenerational mammalian study data.
For the ISO tests, Eastman 168 SG was
formulated into a PVC film, simulating an OEM’s
formulations for medical devices produced from
flexible PVC and providing comfort that OEMs
will see similar results in their required device
testing. The results of the USP Class VI and ISO
10993-4 tests showed good biocompatibility and
hemocompatibility under the test standards, and
results passed all sections of the Class VI testing.
The ISO 10993-5 test results showed that the test
article is not considered to have a cytotoxic effect.
The preferences of healthcare professionals
and device designers who are becoming more
knowledgeable about the materials used in
medical devices, along with looming regulatory changes, are driving a technology shift to
non-phthalate plasticizers. In turn, the device
designers and OEMs will likely find that switching to a non-phthalate plasticizer can be easy.
With these regulatory forces at work, it is
no surprise that key medical industry players are seeking, trialing, or using alternative,
non-phthalate options for medical tubing. M DT