These materials have certified compliance to the European Commission framework regulation EC 1935/2004, US FDA Title 21 CFR and NSF Standard 61 and 51 and other certifications are on process.
Quadion, Minnesota Rubber and Plastics (MRP) introduces a new portfolio of materials formulated for Medical and Pharma applications.
Using only the most high purity ingredients, these comply with existing and proposed regulations around elastomeric products. These materials have certified compliance to the European Commission framework regulation EC 1935/2004, US FDA Title 21 CFR and NSF Standard 61 and 51 and other certifications are on process.
This MRP portfolio includes EPDM, FKM so end users can choose the material best suited for their specific application. The portfolio offers medical and pharma equipment and device manufacturers compounds that can be used globally, simplifying the supply chain for equipment exports worldwide, and assuring regulatory compliance.
The MRP portfolio includes the following materials:
- Qmonix 558CH is a high purity, high performance EPDM product which can be used in the most demanding medical/pharma applications. Qmonix 558CH exhibits excellent performance in both hot and cold process applications, and has excellent chemical resistance. It is also resistant to both ozone and UV used in sanitization processes. Standard durometer as formulated is 70 shore A.
- FKM 51 SCG is a highly fluorinated, carbon backbone polymer recommended for the most demanding applications. It resists harsh chemical and ozone attack with a thermal stability to 500°F (262°C). FKM 515CG also offers low compression set and excellent aging characteristics. The material provides excellent service in concentrated alcohols, acids and process chemicals. Standard durometer as formulated is 70 shore A.
- NBR 536EG was developed to withstand environments that require low compression set, abrasion resistance and low temperature performance. It is inherently resistant to oils. Standard durometer as formulated is 70 shore A.
Typical applications for the new material portfolio include seals, catheters, plunger tips, valves, connections, disposables, prosthetics, lab equipment, syringe plugs and diaphragms. All seals used in pumps, valves, heat exchangers and other medical process machine components can use the materials to comply with global regulations.
Minnesota Rubber and Plastics
mnrubber.com
