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Ensinger PEI

DSM Biomedical PurSil® 35 Thermoplastic Silicone Polyether Polyurethane (TSPU)
Categories: Polymer; Thermoplastic; Polyurethane, TP; Silicone Polyurethane, Ether Based

Material Notes: A novel copolymer that is strong yet flexible with proven biocompatibility and biostability Combining the benefits of both silicone elastomers and polyether urethanes, PurSil® TSPU has exceptional stability.

Flexible PurSil® TSPU is comparable in tensile strength to traditional polyether urethanes with added biostability from the silicone component. It is adaptable to various fabrication techniques to accommodate many different device shapes and can be extruded, injection or compression molded, solvent bonded, dipped coated and sprayed. This highly flexible polymer is available in aromatic and aliphatic versions.

Widely Used Because of its outstanding flexibility, oxidative stability and thromboresistance, PurSil® TSPU is used in a wide range of medical devices, including ophthalmic, anastomotic, and continuous glucose monitoring.

Tailor Made PurSil® TSPU can be enhanced with SME® technology to incorporate end groups such as fluorocarbon and/or polyethylene oxide (silicone end groups are standard). This eliminates the need for additional surface processing steps after the device component is fabricated.

Summary of Product Benefits

  • Biostable and biocompatible
  • Adaptable to many different processing techniques
  • Excellent mechanical properties relative to conventional silicone elastomers
  • Thromboresistant
  • Enhanced with SME® technology utilizing various surface modifying end groups
  • Comprehensive FDA Master File

Grade denotes silicone content (%)

Information provided by DSM Biomedical.

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Physical PropertiesMetricEnglishComments
Specific Gravity 1.11 g/cc1.11 g/ccASTM D792
Linear Mold Shrinkage 0.011 cm/cm0.011 in/in4.0 inch Disk; ASTM D955
Linear Mold Shrinkage, Transverse 0.0080 - 0.019 cm/cm0.0080 - 0.019 in/inFlame Bar; ASTM D955
Melt Flow 32 g/10 min
@Load 1.20 kg,
Temperature 224 °C
32 g/10 min
@Load 2.65 lb,
Temperature 435 °F
ASTM D1238
 
Mechanical PropertiesMetricEnglishComments
Hardness, Shore A 8383ASTM D2240
Tensile Strength, Ultimate 25.26 MPa3664 psiASTM D1708
Tensile Stress at Strain  4.67 MPa
@Strain 50 %
677 psi
@Strain 50 %
ASTM D1708
 6.32 MPa
@Strain 100 %
916 psi
@Strain 100 %
ASTM D1708
 13.07 MPa
@Strain 300 %
1896 psi
@Strain 300 %
ASTM D1708
Elongation at Break 492 %492 %ASTM D1708
Flexural Strength 1.86 MPa270 psiat 5% deflection; ASTM D790
Flexural Modulus, 1% Secant 43.3 MPa6280 psiASTM D790
Tear Strength 57.8 kN/m330 pliDie 'C'; ASTM D624
Taber Abrasion, mg/1000 Cycles 8585H-18 Wheel; ASTM D1044
Compression Set 29 %
@Temperature 25.0 °C
29 %
@Temperature 77.0 °F
22 hours; ASTM D395
 
Electrical PropertiesMetricEnglishComments
Dielectric Constant 5.8
@Frequency 60 Hz
5.8
@Frequency 60 Hz
ASTM D150
Dielectric Strength 16.5 kV/mm420 kV/inASTM D149
 
Thermal PropertiesMetricEnglishComments
CTE, linear 193.5 µm/m-°C
@Temperature 20.0 °C
107.5 µin/in-°F
@Temperature 68.0 °F
ASTM E-831
Vicat Softening Point 67.0 °C153 °FASTM D1525
Glass Transition Temp, Tg -12.0 °C10.4 °FASTM D3418
 
Processing PropertiesMetricEnglishComments
Processing Temperature 182 - 204 °C360 - 399 °FOptimum Extrusion Conditions
 
Descriptive Properties
ColorClear to Amber Pellets
Cytotoxicity (1X MEM Elution)Non-cytotoxic
Genotoxicity: Bacterial ReverseNon-mutagenic
Genotoxicity: in vitroNon-genotoxic
In Vitro Hemolysis StudyNon-hemolytic
ISO IntracutaneousNo evidence of significant irritation from
ISO Maximization SensitizationNo evidence of causing delayed dermal
ISO Rabbit PyrogenNon-pyrogenic
Mouse Bone MarrowNo evidence of cellular toxicity
Plasma Recalcification TimeNo significant effect on recalcification time
Subchronic Intravenous ToxicityNo significant evidence of systemic
USP and ISO Systemic ToxicityNo mortality or evidence of significant

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