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NEW Grilamid TR For Healthcare & Medical Applications
QWhat is
Grilamid TR?
Grilamid TR is an amorphous high
performance polyamide from EMS-GRIVORY.
EMS is market leader and o ers more than
100 products under the brand name Grilamid
TR. These products are highly transparent
polyamides which can be processed using
thermoplastic methods.
QWhat material approvals
are necessary?
The grades Grilamid TR 90, Grilamid TR
ICR 12, Grilamid TR 55, Grilamid TR 60 and
Grilamid XE 11292 satisfy all requirements
of the European guidelines for use in contact
with drinking water and foodstu s as well as
the American guideline FDA CFR 21 (Food
and Drug Administration, Code of Federal
Regulations 21). They also correspond to
the testing requirements as per the United
States Pharmacopoeia (USP) Class VI and
are certi ed according to the 3-A Sanitary
Standard.
QHow to select the right
material?
A growing concern with medical devices is a
tendency of many polymeric materials to craze
or crack when exposed to solvents, including
the chemical disinfectants typically used in
healthcare environments. Di erent chemicals
can a ect a polymer in di erent ways. A
polymer can be resistant to one chemical (that
is, su ering no property loss or discoloration),
but easily crack when exposed to another
chemical. This phenomenon can occur when
medical equipment is repeatedly wiped down
by disinfectants. Choosing a polymer that
resists cracking after exposure to cleaners and
disinfectants can eliminate the growing number
of cracked polymer components seen with
medical equipment.
Amorphous polymers such as PC, ABS,
PMMA, PS and SAN but also some semicrystalline
polymers are very sensitive to stress
cracking. Grilamid TR products are NOT
sensitive to stress cracking and thus contribute
to a longer service life for healthcare and
medical applications.
Hard and soft overmoulding has become a
fundamental technique for medical component
designers in recent years. In medical
applications, Liquid Silicone Rubber (LSR) o ers
advantages over other polymeric soft materials
such as TPE and TPU in its chemical resistance,
heat resistance and exibility.
EMS o ers two amorphous polyamides
that are well suited for overmoulding with LSR.
Grilamid TR 60 with its Tg of 190 °C and the
new developed TR XE 11292 with its Tg of 200
°C. Due to its well-balanced Tg both materials
can be overmoulded in a reduced cycle time,
while using higher curing temperatures, without
risking any deformation (warpage).
QIs Grilamid TR suitable for
steam sterilisation?
Reusable medical devices or medical
instruments always carry a degree of risk
for cross-contamination. Among other
regulations, the Medical Device Regulation
(MDR) categorizes medical devices for the
multiple-use in three classes. Devices listed
in category 3 (invasive devices) are only for
single-use. However, plenty of non-invasive
devices mentioned in class 1 and class 2 are
allowed for multiple-uses.
Steam sterilisation, also known as
autoclaving, is a proper method using saturated
steam at a temperature range of 120 -148 °C at
high pressure for a period of time su cient to
provide sterilisation. Transparent polyamides
were not suited for this kind of sterilisation
process until now. With the new TR XE 11292,
EMS-GRIVORY developed the rst transparent
polyamide suitable for steam sterilisation.
The application area for the new TR XE
11292 is wide-ranging. Due to its crystal clear
transparency, high mechanical strength and
toughness and its high chemical resistance
TR XE 11292 can be used for multiple-use
applications requiring high transparency, such
as transparent pump containers, lters, steam
valves, containers, boxes and tool boxes,
ventilation masks, windows and many more.
EMS-GRIVORY stands for reusable instead of
disposable!
QHow can EMS-GRIVORY
support?
EMS-GRIVORY o ers the broadest assortment
of Polyamides and knowing it’s products rsthand
is able to nd for every application the
adequate material. As a strong development
partner EMS-GRIVORY supports its customer
along the whole development process from
feasibility studies to serial production.
SEPTEMBER 2019 | WWW.EUREKAMAGAZINE.CO.UK 11
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