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 relevany manufacturing processes
Surface finishing, coating technology and processes, co-extrusion
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Formal Examination | 70 |
| Other Assessment(s) | 30 |