Sultron™ LSG FG R5100 PPSU (Life Science Grde & Food Grade) stock shapes are made from unfilled Radel® PPSU resin that is pre-assessed for biocompatibility. The stock shape is also pre-assessed for biocompatibility for up to 24 hours contact with body and tissue according to USP VI and ISO 10993, as well as wetted contact in bioprocessing. Standard food approvals include the FDA 21 CFR § 177.2500, while this specific FG type has the EU 10/2011 Food Grade as an extra feature.
With superior hydrolysis resistance, Sultron™ LSG FG R5100 PPSU shapes are highly resilient against repeated autoclaving cycles. In addition, components made from this material exhibit resistance to common to acids and bases over a broad temperature range, such as commercial washing solutions.
The additional food grade compliance (based on food-related migration tests) makes this material an excellent candidate for applications in the bioprocessing fields, such as manifolds, valves, connectors, lids and adapters.
PROPERTIES
Pre-assessed on both resin and stock shapes for up to 24 hours contact with body or tissue according to USP VI and ISO 10993, as well as wetted contact in bioprocessing
Pre-assessed for FDA 21 CFR § 177.2500 and EU 10/2011 Food Grade
Unfilled Radel® PPSU base for biocompatibility on resin
Superior ductility and hydrolysis resistance for autoclaving and hot washing
Thermal Properties
Property
Value
Heat Deflection Temperature at 1.8MPa (264 psi) (ºC)
205
Continuous allowable service temperature in air
180
Mechanical Properties
Property
Value
Tensile Strength (MPa)
83
Tensile Modulus of Elasticity (MPa)
2,450
Compressive stress at 1% nominal strain (MPa)
21
Compressive stress at 2% nominal strain (MPa)
41
Compressive stress at 5% nominal strain (MPa)
83
Flexural Strength (MPa)
108
Charpy Impact Notched (kJ/m²)
12.0
Chemical Properties
Property
Value
Hot Water / Steam
Acceptable
Acids, Weak
Acceptable
Acids, Strong (pH 1-3)
Limited
Alkalies, Weak
Acceptable
Alkalies, Strong (pH 11-14)
Acceptable
Hydrocarbons - Aromatic
Limited
Hydrocarbons - Aliphatic
Acceptable
Ketones, Esters
Not acceptable
Chlorinated Solvents
Not acceptable
Alcohols
Limited
Inorganic Salt Solutions
Acceptable
Electrical Properties
Property
Value
Dielectric Strength (kV/mm)
26
Certification Properties
Property
Value
FDA
Compliant
European Food Approval
Compliant
NSF
Not compliant
3A-SSI
Not compliant
Canada AG
USDA
Not compliant
Flammability (UL Rating)
V-0
Medical use
MEDICAL - ISO 10993-5 and USP <87> MEDICAL - ISO 10993-10 (S) MEDICAL - ISO 10993-10 (IR) and USP <88> MEDICAL - ISO 10993-11 and USP <88> MEDICAL - USP <88> (Implant) MEDICAL - USP VI MEDICAL - ISO 10993-4 MEDICAL - USP <661> MEDICAL - BIOPROCESSING - AFO - Animal Free Origin FOOD - FDA FOOD - EU
Miscellaneous Properties
Property
Value
Base Material
PPSU
Brand Family
Colors
Black
Density (g/cm3)
1.29
Water Absorption after 24 hrs immersion in water (%)