The module aims to provide the student with a broad understanding of the manufacture of medical devices.
Cleanroom Technology: Classifications, particle size & counting, filtration, design and layout, standards, cleanroom airflow, commissioning and qualification.
Cleaning and Sterilisation: Cleaning requirements, cleaning systems and equipment. Sterilisation types, Ethylene Oxide, Gamma sterilisation, Electron Beam, dry heat. Modes and kinetics of microbial /endotoxin inactivation.
Packaging: Function of packaging, packaging types and properties, sterilisation requirements, Labelling and packaging control. packaging manufacture, materials, methods, closure, testing and regulation.
Regulatory Requirements: European Regulations, European Medical Devices Vigilance system, Global medical Devices Nomenclature system, Overview of 93/42/EEC Medical Device Directive, in-vitro diagnostic directive 98/79/EC, ISO 13485US Perspective: Classification and Medwatch Regulatory Agencies: IMB, FDA, Medical and Healthcare Products Regulatory Agency (UK, Global Harmonisation Task Force(GHTF)
Industry relevant manufacturing processes: Surface finishing, coating technology and processes, co-extrusion
