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Process Validation for Medical Injection Molding - Course Description

Instructor: Sean Tucker

Fee: $1,195

Educational Goals: 

This session will cover aspects of molding ranging from tool specification, process development, and process validation through release to production. Focus will be on the key elements involved with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) as applicable to molding operations. There will also be focus on the use of good analytical and statistical techniques to generate high confidence in the process being used for manufacturing and the long term performance of that process. Benchmarking activities, design of experiments, and measurement system analysis in both the classroom and lab environment will be explored. At the conclusion of this session, participants will have a good understanding of the linkage between process development, process validation and long-term process performance.

Course Outline: 

This workshop is geared toward molding professionals including engineers, technicians, managers, and quality engineers manufacturing plastic components for use in medical applications or an FDA regulated environment. This class will provide two days of classroom and hands-on applications of process development, quality assurance, and process validation techniques and principles.

  • Overview

- Lifecycle

  • Tool Debug and Benchmarking

- Approaches for establishing processes
- Variation
- Process benchmarking

  • Steel vs Plastic

- Tool debug to nominal
- Steel to plastic comparison
- Molding process variation
- Tool debug and acceptance

  • Shot-to-shot variance

- Causes
- Minimizing shot-to-shot variation
- Process parameters

  • Process development DOE

- Parameters impact and importance
- Discovering effects
- Capability and DOE
- Experiments for mold processes
- Screening DOE
- Process development outcomes

  • Validation Protocol

- Molding process validation
- Validation planning
- Control plans
- Protocol contents
- Validation protocol
- Process validation strategy

  • Change Control

- Change considerations for validation
- Change control process
- Change consideration situations