Sultron® LSG R5100 PPSU

Polyphenylsulfone

Sultron® LSG R5100 PPSU (Life Science 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. Some color variations are also pre-assessed for use in wetted contact applications in bioprocessing. 

With superior hydrolysis resistance, Sultron® LSG R5100 PPSU shapes are highly resilient against repeated autoclaving cycles. In addition, components made from this material exhibit resistance to common acids and bases over a broad temperature range, such as commercial washing solutions.

Often favored across the medical and life science fields for their wide array of color options, these PPSU components are excellent candidates for a broad range of applications such as trial implants, sterilization trays, dental and surgical instrument handles, bioprocessing fluid handling caps, couplings, and fittings.

Sultron® LSG PPSU plastic stock shapes
Product Information

Material Properties

  • Pre-assessed on both resin and stock shape for up to 24 hours contact with body or tissue according to USP VI and ISO 10993
  • Some colors pre-assessed for wetted contact in bioprocessing
  • Unfilled Radel® PPSU base for biocompatibility on resin
  • Superior ductility and hydrolysis resistance for autoclaving and hot washing
  • Wide array of color options

Available Geometries

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

Rod
Plate

Available Colors

Sultron® LSG R5100 PPSU stock shapes come in the following colors: Off-white (bone), 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 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

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 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.