On July 26, 2017, Trinseo hosted its first Webinar in Chinese to discuss the importance of medical grade plastic material compliance in end-product safety.
Medical devices are required to be compliant to a series of stringent regulations, and selecting the right plastic material is the first step to achieving product safety. Amy Wang, senior performance plastics development engineer, provided an overview of quality control systems and medical material production and introduce why they were essential for end-product safety. The main topics covered included:
Overview Risk Analysis & Quality Control on Medical Devices
Medical devices refer to any devices intended by the manufacturer to be used, alone or in combination, for human beings for an array of specific medical purposes. Due to the risk involved in using them, the safety of the materials used in making medical devices is of prime importance. Some specific articles in certain chapters under Regulations for the Supervision and Management of Medical Devices were discussed. While emphasis was given to product risk analysis and management, the consultancy and repetitiveness of risk management, manufacturing quality systems (cGMP, ISO 13485, ISO 10993 (USP VI)), biological, physical, and chemical features of materials, and medical device adverse event monitoring (with specific events occurring due to material used in manufacturing) were also covered.
Importance of Material Quality Control for Medical Device Manufacturing
Discussion was made by referring to the data of determination of known or predicted situations for syringes with needle. Reasons ranked the highest were mostly related to the material used in making these medical devices. Risk assessment and control measures for syringes with needle was then referred to prove that choosing a material that was compliant to basic requirements for medical polymer materials would be essential to deal with the root cause. These translate into the requirements to suppliers and further their medical material management system.
Trinseo Global Quality Management System and Material Control
Trinseo has been supporting the medical device industry for decades, since Dow Chemical times. We focused on providing high quality resins and quality management systems to support customer compliance. Most of our plants are ISO 13485 certified. Trinseo medical grade resins have been biocompatibility tested to ISO 10993 and USP standards. To accommodate formal requirements and the need for documentation, Trinseo offers a comprehensive Management of Change process that includes lot traceability, a formulation lock, Notification of Change and an extended record and sample retention. Our manufacturing facilities are strategically located to enable stable supply in a timely manner.
Medical Material Solutions from Trinseo
Trinseo provides various medical material solutions including: CALIBRE™ Polycarbonate (PC) Resins, CALIBRE™ MEGARAD™ PC Resins (radiation stabilized), MAGNUM™ ABS Resins, and EMERGE™ Advanced Resins (alloys) with a range of tints and custom colors available. Several medical grade resins as well as the benefits of mass ABS were showcased.
The webinar was well-received and the discussions were to improve participants’ chances of medical device application compliance by selecting the appropriate materials upfront. Participants also heard about Trinseo materials that have been developed to satisfy customer needs.
The webinar concluded with Amy’s brief summary of her talk followed by a Q&A Session actively participated by attendees as far as those in Malaysia.
If you would like to revisit the useful information covered in the webinar, or you missed the broadcast, the webinar and the PowerPoint slides are now available for download here.