Biomedical Device Manufacture

Course details

This programme has been developed for anyone seeking employment in or transferring into the Biomedical Devices Sector as well as anyone wishing to enhance their general knowledge of the industry. The programme is structured around common medical disorders which are treated by biomedical devices manufactured in Ireland. On completion, participants will be familiar with a range of disorders, the anatomy and physiology associated with these disorders, the devices used in their treatment, and the processes involved in the manufacture of these devices.

The programme also 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 Practise (GMP) system and the operation of regulatory bodies such as FDA/IMB.

Course Content

Anatomy

• General anatomy, Neuro Anatomy, Cariovascular anatomy, Orthopaedics

Medical Devices

• Devices used in the treatment of neurovascular, cardiovascular, orthopaedic disorders amd product development history

Manufacturing Processes

• Introduction to manufacturing processes; injection moulding, extrusion, wiredrawing; cathether 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.

Packaging

• 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.

GMP

• 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. Clasiification of devices. FDA/IMB submissions - 510k/PMA applications.

Validation

• 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.

Award

• CIT: Certificate in Biomedical Device Manufacture, Special Purpose Award, 10 ECTs credits at Level 7 on the National Framework of Qualifications.

Admission Requirements:

• This course is open to anyone with a minimum of two years industrial experience.

Course summary

• Places are limited for this course. Eligible candidates will be considered on a first come first served basis.