Plastics Materials & Processing for Medical Devices

Course details

Who should attend: This programme is designed for personnel who 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.

COURSE CONTENT – 4 days

• Introduction to Plastic Materials – focus on medical polymers.
• Polymer Processing Techniques – Extrusion, Injection Moulding, Thermoforming and Blow Moulding.
• Material and Product Testing Demonstration.
• Medical Devices and Process Validation

Day 1:

Introduction to Plastic Materials

• Where plastics come from – Overview of different materials structure, properties and typical applications
• Typical processing conditions and characteristics
• Commonly used polymers- specifically medical polymers. FDA material requirements.

Polymer Processing Techniques

• Overview of the various techniques available for conversion of plastic raw material to medical products and devices.

Thermoforming

• Thermoforming Theory – Classroom session
• Practical Demonstration of Thermoforming

Day 2:

Injection Moulding

• Injection Moulding Theory – Classroom session
• Practical demonstrations of Injection Moulding
• Injection Moulding defects and troubleshooting –
• Overview of part design and mould design for medical devices and common design faults
• Defects caused by incorrect machine settings (Practical session)

Day 3:

Extruded Tubing

• Extruded tubing – Classroom session
• Practical demonstration of Extrusion and Blow Moulding

Material and Product Testing – Demonstrations.

• 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.

Day 4:

Medical Devices and Process Validation

• 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
• 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