Note: Places are limited for this course. Eligible candidates will be considered on a first come first served basis.
€1,450*(includes course notes and exam fee)
* Discounts available for groups of three or more.
Duration: One evening per week for 13 weeks. (Mondays 6pm - 9pm)
The programme familiarises participants with the engineering requirements and standards that apply to cleanrooms employed in the manufacture of medical devices. The programme looks at the specification of appropriate cleaning, packaging and sterilisation operations for medical devices, the assessment of the safety risks associated with manufacturing operations and the requirements for guaranteeing a safe working environment.
The programme also examines the detailed requirements of a Good Manufacturing Practice (GMP) system and the operation of regulatory bodies such as FDA/IMB.
General anatomy, Neuro Anatomy, Cariovascular anatomy, Orthopaedics.
- Medical Devices
Devices used in the treatment of neurovascular, cardiovascular, orthopaedic disorders and product development history.
- Manufacturing Processes
Introduction to manufacturing processes; injection moulding, extrusion, wiredrawing; catheter coating process, embolic coil manufacturing.
- Cleanroom Technology
Cleanroom classification; particle size and counting; filter design and performance, cleanroom layout, materials & standards, cleanroom commissioning and qualification.
- Cleaning and Sterilisation Technology
Requirements for cleaning, soil types, cleaning systems organic/aqueous/ semiaqueous), cleaning equipment. Ethylene oxide. Gamma sterilisation, electron beam. Saturated steam – gravity displacement, porous load, ballasted cycles. Dry heat sterilisation/depyrogenation. Microbial inactivation/endotoxin inactivation.
Functions of packaging, packaging requirements for sterilisation, physical & chemical properties of packaging, labelling and packaging control, distribution hazards, production of packages, forming materials and methods, lidding, sealing.
Introduction to GMP, GMP documentation – SOPs/regulatory documentation/ submissions, Role and requirements of the FDA/IMB/Notified Bodies, introduction to 21 CFR820/Medical Devices Directive, planning for audits. Classification of devices. FDA/IMB submissions – 510k/PMA applications.
Validation protocols – Installation, operational and performance qualification. Process validation, design qualification, validation of sterilisation system, design verification, design validation. URS/FDS/FAT/SAT master validation plans. Change control.
Certificate in Introduction to Biomedical Devices, Special Purpose Award 10 ECTS credits at Level 7 on the National Framework of Qualifications, awarded by Cork Institute of Technology.