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USP Class VI adhesives

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SABIC LEXAN™ Healthcare HPS7 PC (Europe)
Categories: Polymer; Thermoplastic; Polycarbonate (PC); Polycarbonate, Gamma Radiation Resistant

Material Notes: LEXAN HPS7 is a low flow polycarbonate (PC) with an MVR (300°C/1.2kg) of 5. This is a biocompatible (ISO10993 or USP Class VI) grade for medical devices and pharmaceutical applications. It is gamma and e-beam sterilizable, contains mold release and adheres to our healthcare management of change policy.

Information provided by SABIC

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Physical PropertiesOriginal ValueComments
Specific Gravity 1.20 g/ccASTM D792
Density 1.19 g/ccISO 1183
Water Absorption 0.14 %24 hours; ASTM D570
 0.26 %23°C/sat; ISO 62
Moisture Absorption 0.100 %23°C / 50% RH; ISO 62
Linear Mold Shrinkage, Flow 0.0050 - 0.0070 cm/cmSABIC method
 0.0050 - 0.0070 cm/cm
@Thickness 3.20 mm
SABIC method
Linear Mold Shrinkage, Transverse 0.0050 - 0.0070 cm/cm
@Thickness 3.20 mm
SABIC method
Melt Flow 5.0 g/10 min
@Load 1.20 kg,
Temperature 300 °C
cm³/10 min; ISO 1133
 5.0 g/10 min
@Load 1.20 kg,
Temperature 300 °C
ASTM D1238
 24 g/10 min
@Load 5.00 kg,
Temperature 300 °C
ASTM D1238
 
Mechanical PropertiesOriginal ValueComments
Tensile Strength at Break 71.0 MPa50 mm/min; ISO 527
 72.0 MPa50 mm/min; ASTM D638
Tensile Strength, Yield 61.0 MPa50 mm/min; ISO 527
 62.0 MPa50 mm/min; ASTM D638
Elongation at Break 125 %50 mm/min; ASTM D638
 126 %50 mm/min; ISO 527
Elongation at Yield 5.9 %50 mm/min; ISO 527
 6.5 %50 mm/min; ASTM D638
Tensile Modulus 2270 MPa50 mm/min; ASTM D638
 2450 MPa1mm/min; ISO 527
Flexural Yield Strength 95.0 MPa2 mm/min; ISO 178
 100 MPa1.3 mm/min, 50 mm span; ASTM D790
Flexural Modulus 2200 MPa2 mm/min; ISO 178
 2340 MPa1.3 mm/min, 50 mm span; ASTM D790
Izod Impact, Notched 935 J/mASTM D256
 785 J/m
@Temperature -30.0 °C
ASTM D256
Izod Impact, Unnotched 2700 J/mASTM D4812
Izod Impact, Notched (ISO) 75.0 kJ/m²80*10*3; ISO 180/1A
 15.0 kJ/m²
@Temperature -30.0 °C
80*10*3; ISO 180/1A
Izod Impact, Unnotched (ISO) NB80*10*3; ISO 180/1U
 NB
@Temperature -30.0 °C
80*10*3; ISO 180/1U
Charpy Impact Unnotched NBEdgew 80*10*3 sp=62mm; ISO 179/1eU
 NB
@Temperature -30.0 °C
Edgew 80*10*3 sp=62mm; ISO 179/1eU
Charpy Impact, Notched 75.0 kJ/m²Edgew 80*10*3 sp=62mm; ISO 179/1eA
 15.0 kJ/m²
@Temperature -30.0 °C
Edgew 80*10*3 sp=62mm; ISO 179/1eA
Dart Drop, Total Energy 82.0 JASTM D3763
 
Thermal PropertiesOriginal ValueComments
CTE, linear, Parallel to Flow 66.0 µm/m-°C
@Temperature -40.0 - 40.0 °C
ASTM E831
 66.0 µm/m-°C
@Temperature -40.0 - 40.0 °C
ISO 11359-2
CTE, linear, Transverse to Flow 75.0 µm/m-°C
@Temperature -40.0 - 40.0 °C
ASTM E831
 75.0 µm/m-°C
@Temperature -40.0 - 40.0 °C
ISO 11359-2
Hot Ball Pressure Test 75.0 °CIEC 60695-10-2
Deflection Temperature at 0.46 MPa (66 psi) 141 °C
@Thickness 3.20 mm
unannealed; ASTM D648
 141 °C
@Thickness 6.40 mm
unannealed; ASTM D648
Deflection Temperature at 1.8 MPa (264 psi) 128 °CFlatw 80*10*4 sp=64mm; ISO 75/Af
 129 °C
@Thickness 3.20 mm
unannealed; ASTM D648
 132 °C
@Thickness 6.40 mm
unannealed; ASTM D648
Vicat Softening Point 145 °CRate B/50; ASTM D1525
 145 °CRate B/50; ISO 306
 146 °CRate B/120; ISO 306
 
Processing PropertiesOriginal ValueComments
Nozzle Temperature 305 - 325 °CInjection Molding
Zone 1 290 - 310 °C
Zone 2 300 - 320 °C
Zone 3 310 - 330 °C
Melt Temperature 310 - 330 °C
Mold Temperature 80.0 - 115 °C
Drying Temperature 120 °CInjection Molding
Dry Time 3.00 - 4.00 hourInjection Molding
 48.0 hourCumulative; Injection Molding
Moisture Content 0.020 %
Back Pressure 0.300 - 0.700 MPa
Shot Size 40 - 60 %
Vent Depth 0.00250 - 0.00760 cm
Screw Speed 40 - 70 rpm
 
Compliance PropertiesOriginal ValueComments
USP Class VI Yes

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PSABI10694 / 244161

USP Class VI Adhesives
USP Class VI Approved Adhesives for Medical Device Applications
Master Bond’s biocompatible adhesives are designed to meet the needs of medical device manufacturers. Compounds withstand various types of sterilization methods.

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