Mitsubishi Chemical Advanced Materials has a long-term history in development, manufacturing and supply of Engineering Plastics used in Medical and Life Science applications. Cooperating closely with medical devices manufacturers, Mitsubishi Chemical Advanced Materials understands technical, compliance and regulatory aspects associated with the use of polymers in Medical and Life Science applications, including materials for medical implants. Therefore, Mitsubishi Chemical Advanced Materials can provide you with the right technical choice supported by regulatory and compliance expertise.
Compliance: Mitsubishi Chemical Advanced Materials’ “Life Science Grades” are approved for body and tissue contact up to 24 hrs (with the exception of 30 days for Ketron® CLASSIX™ LSG PEEK) and fulfil security and regulatory requirements of notified bodies with. These grades have been developed and tested for biocompatibility according to ISO 10993 and USP requirements. They allow for expedited medical device clearance. In addition, Change Control Processes to comply with notifications and change requests are established for Mitsubishi Chemical Advanced Materials’ “Life Science Grades”. Certification and documentation is provided and established. For implantable UHMW-PE development and manufacturing, Mitsubishi Chemical Advanced Materials is ISO13485 certified; these grades are intended for long-term implantation.
Mitsubishi Chemical Advanced Materials products in action, used in Nonspec prosthetic arms, see more here.
Mitsubishi Chemical Advanced Materials supports Medical Device Manufacturers and Life Science companies with a team of material and industry experts. An array of standard materials out of product families such as Ketron® PEEK, Duratron® PAI, Duratron® PEI and Mitsubishi Chemical Advanced Materials® PPSU, Acetron® POM are available to choose from. Needed security for Medical and Life Science Applications is supported by Mitsubishi Chemical Advanced Materials’ “Life Science Grades” fulfilling compliance and biocompatibility requirements. Contribution in development and design processes is Mitsubishi Chemical Advanced Materials’ key strength.
Mitsubishi Chemical Advanced Materials offers Life Science Grades which have been specifically developed for applications in the medical, pharmaceutical and biotechnology industries. The Mitsubishi Chemical Advanced Materials Life Science Grades portfolio includes plastics which comply with FDA, ISO 10993 and USP guidelines for biocompatibility testing of materials, saving testing costs and time while providing full traceability from raw material to stock shape.
Challenge: Jet systems that utilize a mixture of air, powder and water are used for the removal of soft plaque deposits by dentists. The equipment required has to be of high precision, able to withstand multiple sterilization cycles in steam and hot air temperatures of up to 170-180 °C. Furthermore, it has to be wear resistant to the cleaning mixture.
Solution: Ketron PEEK LSG due to its dimensional stability and steam sterilization resistance and its suitability for body contact time of up to 24 hours - essential in this application.
Benefits: The life time of the Ketron PEEK mixing head exceeds that of the equipment.
Challenge: A material that better adapts to the gingiva form but is also biocompatible was required by surgeons. Traditionally titanium has been used for both the healing cap and as a provisional implant to form the gingiva.
Solution: Ketron PEEK-CLASSIX™ LSG is a high performance material offering excellent mechanical, thermal and chemical properties as well as biocompatibility.
Benefits: Enables completion of the abutment to the desired form, and the material can stay in the body for 30 days / 180 days with written approval.
Challenge: Bioreactors degrade contaminants in water with microorganisms through attached or supended biological systems. Possible leaching of substances from the plastic parts used in the bioreactors would impair the results and efficiency of such systems. Cleaning cycles use strong chemicals as well as several sterilization techniques such as autoclaving or dry heat at 170-180 °C.
Solution: Ketron PEEK LSG has the required mechanical, thermal and chemical properties to perform well in this environment.
Benefits: High and reliable output.
Challenge: Flatness and good dimensional stability are required in this application where the shaker is handling the probes for laboratory systems. The basic concept allows heating and cooling to certain temperatures.
Solution: Acetron LSG offers the dimensional stability required as well as excellent machinability.
Benefits: Low weight, low cost and long lifetime.
Challenge: Guides to function as a kind of cam were needed for a sinusoidal up and down movement of the piston at a speed of 2.7 m/s. The function occurs while the tablet press carrousel is rotating, so complex machining was required to obtain the necessary geometry.
Solution: Ertalyte TX for the parts that form the complete circle. The material has a low coefficient of friction, exceptional wear resistance and outstanding machinability.
Benefits: Grease free solution ideal for a clean production environment.
Want to find out more about our Injection Molding solutions ?
The leading global manufacturer and supplier of medical grade UHMW-PE to the orthopedic implant industry. Click here