Celcon POM M90 Medical Tubing Fittings - Hi Polymers

APPLICATION SHEET
Celcon® Acetal Copolymer
Grades M90
Precision Medical Tubing Fittings
Typical Related Applications
Requiring Regulatory Agency
Compliance, Material Consistency,
Heat Stability, Tight Tolerance, and
Excellent Dimensional Stability:
■ Valves
■ Faucets
■ Shower heads
■ Consumer food processors
Requirements
Sabin Corporation of Bloomington, Indiana is a
supplier of medical devices, specializing in tight
tolerance components. Sabin produces a variety of
precision medical tubing fittings, some of which have
screw threads for attachment purposes. The fittings
must comply with USP Class VI requirements.
Material Evaluation
The materials that were considered for the medical
fittings include acetal homopolymer and Celcon ®
acetal copolymer. The most important material
property as determined by Sabin was beat stability.
Many of the parts which Sabin produces are small and
have relatively small shot sizes. A small shot size can
sometimes cause material to remain in a heated barrel
of a molding machine for longer than ideal time
periods. Sabin was looking for a material with good
heat stability to resist deterioration and off-gassing.
The tolerance and dimensional stability of the material
were also important for leak-free performance in the
screw thread area during medical procedures. The
fittings required tight tolerances on the threads to allow
proper fit with attaching items and to prevent fluid
leakage. Lack of fines and foreign contamination was
also important to Sabin because they could lead to
Celcon ® M90 provided the heat stability, dimensional stability,
and material consistency which Sabin Corporation required for
these precision medical fittings.
higher reject rates. Chemical resistance was important
because a variety of fluids may potentially pass
through the fittings, including body fluids and medicines.
Sabin wanted to use a material for the fittings,
which would allow the parts to comply with USP
Class VI requirements.
Sabin wanted a material that could be sterilized
because the fittings must undergo an ethylene oxide or
steam sterilization before use. The fittings undergo
only one sterilization procedure because they are used
one time before being discarded.
Results
Sabin chose Celcon acetal copolymer as the material
for its precision medical tubing fittings for the following
reasons:
■ Celcon acetal copolymer has better heat stability than
acetal homopolymer, helping Celcon to better resist
deterioration and off-gassing during processing.
Using Celcon acetal copolymer assures Sabin’s
technical staff of the best heat stability of commercial
acetals, an important asset when molding small shot
size parts which may extend the heat history of
the material.

■ Parts made from Celcon acetal copolymer possess the
dimensional stability and tolerance Sabin required.
Celcon acetal copolymer can hold a tolerance of
±0.002 inch/inch on the first inch of part dimensions
and ±0.001 inch/inch on subsequent dimensions.
Celcon also resists dimensional changes from
exposure to water (see table of relevant properties).
■ Sabin wants a material supplier it can count on to
ensure resin quality. Ticona takes extra steps to meet
Sabin’s requirements for lack of fines and foreign
contamination. These steps include passing the
material through a fines separator and a change
in packaging of resin pellets. This change from
corrugated gaylord packaging to reusable plastic bins
eliminates a potential source of foreign contamination.
■ Celcon M90 has good chemical resistance to aqueous
solutions with a pH of 4 or higher. This satisfies
Sabin’s need to carry a variety of body fluids and
medicines through the fittings.
■ Unpigmented (natural) Celcon M90 complies with the
requirements of a USP Class VI plastic. The fittings
are color coded for various uses. Although pigmented
grades of Celcon M90 were not tested for compliance
with the requirements of a USP Class VI plastic, the
pigmented fittings were found to comply with USP
Class VI requirements.
■ Parts made of Celcon M90 can undergo a steam
or ethylene oxide sterilization process without a
significant effect on its mechanical properties.
If you would like to know more about Celcon M90
and its uses in fittings and/or medical devices, please call
1-800-833-4882 and mention “Application Sheet 95-02”.
Some relevant properties of Celcon ® acetal copolymer for precision medical tubing fittings
Property Celcon ® M90 Significance
Heat stability of molten polymer 0.010% Celcon acetal copolymer is more heat stable
45 minutes in air at 446°F/230°C than acetal homopolymers which lose approxi-
(percent weight loss per minute)
mately 0.05-0.10% of their weight per minute.
The higher weight loss indicates a higher
possibility for degradation of the homopolymer
during melt processing.
Dimensional change from water 0.2% Celcon is dimensionally stable when exposed to
absorption: (12 months immersion
water. The screw threads will resist dimensional
at 73°F/23°C)
change from aqueous solution exposure.
Dimensional tolerance
Celcon acetal can be molded to the needed
(on first inch) ±0.002 in./in. dimensional tolerance for the screw threads.
(on subsequent dimensions)
±0.001 in./in.
USP Class VI Compliance Celcon M90 natural complies with The pigmented fittings meet Sabin’s need for
the requirements of a USP Class VI compliance with USP Class VI requirements.
plastic. Pigmented grades have not
been tested for compliance.
Chemical Resistance Good resistance to mechanical Sabin can use the fittings made of Celcon M90
property loss in contact with
to carry a variety of aqueous fluids without
aqueous solutions with a pH
concern of deterioration or reaction.
of 4 or higher.
Resistance to steam or ethylene Celcon M90 can be sterilized using Fittings made from Celcon M90 can be
oxide sterilization ethylene oxide or steam without sterilized, using steam or ethylene oxide, before
significant loss of mechanical use in medical procedures.
properties.
Ticona
90 Morris Avenue
Summit, New Jersey 07901-3914
(908) 598-4000
© 2000 Ticona
Printed in U.S.A. AP95-02/4M/1200