Altron™ LSG PC
PolycarbonateAltron™ LSG PC (Life Science Grade) stock shapes are made from unfilled PC resin. The material is pre-assessed for biocompatibility at the stock shape level for up to 24 hours contact with body and tissue according to USP VI and ISO 10993 and wetted contact applications in bioprocessing.
Altron™ LSG PC offers outstanding impact resistance, toughness and dielectric properties. While the material is not suitable for steam sterilization and dry heat, it offers good resistance to other common methods of sterilization including EtO (Ethylene Oxide), plasma, gamma- and X-ray irradiation. These characteristics make Altron™ LSG PC components a favored solution for applications in the medical and bioprocessing industries such as medical device housings, analyzers and bioreactor equipment.
Material Properties
- Stock shapes pre-assessed for up to 24 hours contact with body or tissue according to USP VI and ISO 10993
- Pre-assessed for wetted contact applications in bioprocessing
- Outstanding toughness and impact resistance
- Sterilizable via EtO, plasma, gamma and X-ray irradiation
- Great dielectric properties
Available Geometries
Altron™ LSG PC stock shapes encompass a range of standard sizes in the following geometries: Rod, Plate
Available Colors
Altron™ LSG PC stock shapes come in the following colors: Transparent
Regional Availability
Pre-assessment Testing
Altron™ LSG PC carries the following compliances:
- Food contact - USA FDA 21 CFR § 177.2500
- Animal Free Origin
- 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
- ISO 10993-5 and USP <87> Cytotoxicity
- ISO 10993-10 Sensitization
- USP <661> Physiochemical Testing
Please note: In some cases, different color variations of a material grade carry different approvals. Please see product documentation for details.
Intended Use
Altron™ LSG PC 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.