Proteus® LSG HDPE
High Density PolyethyleneProteus® LSG HDPE (Life Science Grade) stock shapes are made from HDPE resin and pre-assessed for biocompatibility on both resin and stock shape for up to 24 hours body contact according to USP VI and ISO 10993, as well as wetted contact in bioprocessing.
Proteus® LSG HDPE shapes exhibit low extractables and leaching, low moisture absorption, and great resistance to chemical cleaning agents, allowing parts to retain excellent impact resistance and good tensile strength throughout repeated use. For these reasons, Proteus® LSG HDPE is a great candidate for upstream applications in bioreactors and downstream applications chromatography and filtration.
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Material Properties
- Resin and stock shapes pre-assessed for up to 24 hours contact with body or tissue according to USP VI and ISO 10993, as well as wetted contact in bioprocessing
- Low Extractables & Leaching, and low moisture absorption
- Great chemical resistance
- Excellent impact resistance
- Good tensile strength
Available Geometries
Proteus® LSG HDPE stock shapes encompass a range of standard sizes in the following geometries: Rod, Plate
Available Colors
Proteus® LSG HDPE stock shapes come in the following colors: Natural (white)
Regional Availability
Pre-assessment Testing
Proteus® LSG HDPE carries the following compliances:
- ISO 10993-5 and USP <87> Cytotoxicity
- USP Class VI (conclusion of three of the above ISO 10993 and USP <88> tests)
- ISO 10993-10 and USP <88> Intracutaneous Reactivity
- ISO 10993-11 and USP <88> Acute Systemic Toxicity
- USP <88> Implantation Test
- 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
Proteus® LSG HDPE 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.
