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Sultron® LSG FG R5100 PPSU

Polyphenylsulfone
Technical datasheet

Sultron® LSG FG R5100 PPSU (Life Science & 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 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.

Sultron® LSG FG R5100 PPSU black plastic stock shapes
Product Information

Material 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

Available Geometries

Sultron® LSG FG R5100 PPSU stock shapes encompass a range of standard sizes in the following geometries: Rod, Plate

Rod
Plate

Available Colors

Sultron® LSG FG R5100 PPSU stock shapes come in the following colors: Black

Regional Availability

Availability of products, shapes, and colors may differ by region.

Resin Note

Radel® is a registered trademark of Solvay S.A.
Application & Testing Information

Pre-assessment Testing

Sultron® LSG FG R5100 PPSU carries the following compliances:

  • ISO 10993-5 and USP <87> Cytotoxicity
  • ISO 10993-10 Sensitization
  • ISO 10993-10 and USP <88> Intracutaneous Reactivity
  • ISO 10993-11 and USP <88> Acute Systemic Toxicity
  • USP <88> Implantation Test
  • USP Class VI (conclusion of three of the above ISO 10993 and USP <88> tests)
  • ISO 10993-4 Human Blood Compatibility
  • USP <661> Physiochemical Testing
  • Animal Free Origin
  • Food contact - USA FDA 21 CFR § 177.2500
  • Food contact - EU 10/2011

Please note: In some cases, different color variations of a material grade carry different approvals. Please see product documentation for details.

Intended Use

Sultron® LSG FG R5100 PPSU is only intended for applications in which the duration of contact with human body tissue is limited to less than 24 hours, or wetted contact applications in bioprocessing.

Furthermore, LSG materials are not intended for use in the manufacture of medical devices that will be permanently implanted in the body, nor are they intended for use in life-sustaining medical devices.

Documentation

For further regulatory documentation and absence declarations, please visit the regulatory page.