Plastics in Medical Devices

Vinny Sastri, Ph.D., is the President of Winovia, LLC, a consultancy company specializing in quality management systems, notably in the area of medical devices. Dr. Sastri’s areas of expertise include FDA and ISO quality management systems for medical devices and pharmaceuticals, product development processes, design controls, manufacturing and process validation, risk management, six sigma and design for six sigma, CA/PA, and materials. He is a certified Six Sigma black-belt, and has a strong track record in leading, managing, establishing and implementing growth and quality initiatives into client organizations around the world, resulting effective quality management systems and operational excellence.Dr. Sastri was on the faculty of the Association for the Advancement of Medical Instrumentation (AAMI) that provides training (along with the FDA) on the FDA Quality Systems Requirements and Industry Practice, Design Controls, Process Validation and Risk Management to the medical device industry. He now conducts public and in-house training through his company Winovia LLC. Prior to starting Winovia, Dr. Sastri held global leadership positions in technology, quality, manufacturing and marketing in companies including BASF, AlliedSignal and General Electric. He earned a Ph.D. from Rutgers University, completed post-doctoral work at Brooklyn Polytechnic Institute, and was an Adjunct Professor at Virginia Commonwealth University in Richmond, Virginia. Dr. Sastri has over 20 publications and 6 patents, and has presented at many international conferences and webinars in the United States, Europe, and Asia.

• 1. Introduction2. Regulations for Medical Devices and Application to Plastics Suppliers: History and Overview3. Materials Used in Medical Devices4. Material Requirements for Plastics used in Medical Devices5. Polymer Additives Used to Enhance Material Properties for Medical Device6. Commodity Thermoplastics: Polyvinyl Chloride, Polyolefins, and Polystyrene7. Engineering Thermoplastics8. High-Temperature Engineering Thermoplastics: Polysulfones, Polyimides, Polysulfides, Polyketones, Liquid Crystalline Polymers, and Fluoropolymers9. Other Polymers: Styrenics, Silicones, Thermoplastic Elastomers, Biopolymers, and Thermosets10. Supplier Controls11. Process Validation