This module introduces the key processes, standards, and regulatory requirements involved in the manufacture of medical devices. Students will explore the use of cleanrooms, cleaning and sterilisation techniques, and the application of Good Manufacturing Practice (GMP) in compliance with regulatory bodies such as the FDA. The module also covers essential manufacturing methods including surface finishing, coating, and co-extrusion, along with the selection of appropriate packaging, closure systems, and labelling. Emphasis is placed on understanding the technical and regulatory factors that ensure product quality and safety in medical device production.
Advanced Manufacturing Techniques – Practical Focus
Polymer-Based Additive Manufacturing• Operation of FDM and SLA 3D printers using medical-grade polymers• Techniques for achieving functional prototypes with high resolution and accuracy• Post-processing methods for cleaning, curing, and preparing parts for evaluation Metal-Based Additive Manufacturing• Safe operation of metal AM systems such as SLM or DMLS• Key printing parameters and build preparation for high-performance parts• Post-print processing for strength, surface finish, and dimensional accuracy3D Scanning and Reverse Engineering• Use of handheld 3D scanners to capture complex geometries from existing components• Processing scan data into usable CAD models for prototyping or modification• Applications in custom fitting, implant design, and design validation workflows Medical Device Applications of AM Technologies• Rapid prototyping of surgical tools, housings, and anatomical models• Rapid tooling for jigs, fixtures, and moulds in support of manufacturing• Design for Additive Manufacturing (DfAM) tailored to regulatory and clinical constraints Embedded Sensors and Smart Components• Integration of RFID and passive sensor systems into 3D printed parts• Design considerations for sensor placement, protection, and sterility• Applications in traceability, reusable devices, and smart packaging solutions
Cleanroom Technology and Standards
• Cleanroom classifications (e.g., ISO 14644 standards) and their relevance to medical device manufacturing• Design considerations: airflow patterns, filtration systems, and contamination control• Operational protocols: gowning procedures, environmental monitoring, and maintenance• Regulatory requirements and compliance for cleanroom operations
Sterilisation Processes and Validation
• Overview of sterilisation methods: o Ethylene Oxide (EO) sterilisation o Radiation sterilisation (Gamma and Electron Beam)o Steam sterilisation to Dry heat sterilisation• Principles of microbial inactivation and sterility assurance levels • Validation of sterilisation processes: o Overkill method o Bioburden-based method o Combined Biological Indicator (BI)/Bioburden method • Regulatory standards for sterilisation validation (e.g., ISO 11135 for EO sterilisation)
Packaging and Labelling of Medical Devices
• Functions and requirements of medical device packaging• Materials selection and compatibility with sterilisation methods • Design considerations for packaging: barrier properties, durability, and user accessibility• Labelling requirements: regulatory compliance, traceability, and information accuracy• Testing and validation of packaging systems to ensure product integrity
