This programme is designed for personnel who are new to or already work in medical device manufacturing and who wish to gain a comprehensive understanding of processing for medical device manufacturing. The programme covers materials, testing, processing technologies (including injection moulding, extrusion) and validation requirements and is relevant to Operation, Supply Chain or Quality personnel who are involved in the product building (processing & assembly) of medical device products.
This programme is also suitable for anyone who wishes to know more about plastics materials and how they are processed and tested. Validation is also covered on this programme and it is becoming much more important across general manufacturing and not just in the manufacture of medical devices.
No prior knowledge of the subject material is assumed.
Who is the course for
This programme is designed for:
- personnel who are new to or already work in medical device manufacturing and who wish to gain a comprehensive understanding of processing for medical device manufacturing.
- personnel who work in operation, supply chain or quality personnel who are involved in the product building (processing & assembly) of medical device products.
- No prior knowledge is assumed.
Learners will gain:
- A comprehensive understanding of processing for medical device manufacturing
- A good understanding of material, testing, processing technologies and validation requirements and is relevant to Operation, Supply Chain or Quality personnel who are involved in the product building of medical device products.
Day 1: Introduction and Plastic Materials
General overview of Plastics Processing Techniques – Extrusion, Injection Moulding, Thermoforming, Blow Moulding, Rotational Moulding
- Plastic material structures, properties and typical applications – a general overview
- Typical processing conditions and characteristics
- Commonly used medical polymers.
- FDA material requirements.
Day 2: Extrusion
- Extrusion equipment overview
- The Melting process in single screw extruders
- Process Parameter Interactions & Impact of raw material properties on extrusion process.
- Typical extrusion defects and how to solve them
Day3: Injection Moulding Overview
- Overview of injection moulding machines
- The moulding cycle
- Machine parameters (settings) and how they interact with each other
Day 4 : Injection Moulding Troubleshooting
- How to read data from a moulding process. This will include injection press curves, trend graphs etc
- Setting injection speed profiles/ holding pressure profiles
- Overview of part design and mould design for medical devices and common design faults
- Injection moulding defects – Case studies
- Injection moulding simulator – solving moulding defects on our computer simulator
Day 5: Thermoforming and Blow Moulding
- This session will look at the machines, tooling, process cycles, basic troubleshooting of the thermoforming and blow moulding processes as well as typical products made using these techniques.
Day 6: Process Validation
This session will cover the process of validation for regulated industries, with particular focus on validation for the manufacture of medical devices and the requirements of ISO EN 13485 and FDA QSR.
- Regulations that govern the medical device/ healthcare sector – ISO 13485 , FDA requirements – Class I, II and III devices
- GMP – The controlled environment and cleanroom classifications. GDP
- Overview of validation principles – The Validation Flowchart and overview of use of Tools for product and process validation: FMEA, DOE, etc.
- Installation Qualification (IQ), Operational Qualification (OQ), Worst Case Scenario, Operational Windows. Equipment IQ/OQ and Performance Qualification (PQ)
- Process Qualification / Validation
Day 7: Validation Part 2
- Responsibilities within the validation project team.
- Validation Documentation Stages and documents: SOP, MVP, IQ, OQ, PQ; Protocols and Reports.
- Life Cycle approach to validation projects
- Risk Assessment & Validation
Attendees will complete a 45 minute validation assignment during this session
Day 8: Material testing:
Overview of the various test techniques available to test plastic materials and products.
- Various material and product testing techniques – demonstrations including tensile, impact, fall dart, melting point, material flow properties, density and material identification techniques.
- Materials used in principal processes, test techniques and common defects.
Supervised multi choice exam at end of the final day
Steve O’Leary has delivered training in Injection Moulding for First Polymer Training since 2000, initially joining FPT Skillnet as the Training Center Manager. Previous to this he worked as an Extrusion/ Injection Moulding Engineer with Boston Scientific in Galway, Extrusion Technician and Extrusion Supervisor with Sherwood Medical in Tullamore (currently Medtronic Tullamore) and as an Injection Moulding Technician with Tubex in Nenagh, Co. Tipperary. He graduated from Athlone IT having studied Plastics Engineering from 1988 to 1992.
This programme is a QQI component (minor) award, certified at Level 5 on the national framework of qualifications – see www.nfq.ie and is a mandatory component of major awards
- 5M3080 – Plastics Injection Moulding
- 5M3067 – Plastic Extrusion Blow Moulding
- 5M3074 – Plastics Extrusion.