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  1. Home
  2. Community and Workforce Programs
  3. Plastics Training Academy
  4. PTA Course Schedule and Registration

Process Validation for Medical Injection Molding

Course Description

Instructor: Sean Tucker

Fee: $1,350

Offerings

Click the date link to register for that course section.

REGISTER FOR Jun 23-24

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.

  1. Overview
    • Lifecycle
  2. Tool Debug and Benchmarking
    • Approaches for establishing processes
    • Variation
    • Process benchmarking
  3. Steel vs Plastic
    • Tool debug to nominal
    • Steel to plastic comparison
    • Molding process variation
    • Tool debug and acceptance
  4. Shot-to-shot variance
    • Causes
    • Minimizing shot-to-shot variation
    • Process parameters
  5. Process development DOE
    • Parameters impact and importance
    • Discovering effects
    • Capability and DOE
    • Experiments for mold processes
    • Screening DOE
    • Process development outcomes
  6. Validation Protocol
    • Molding process validation
    • Validation planning
    • Control plans
    • Protocol contents
    • Validation protocol
    • Process validation strategy
  7. Change Control
    • Change considerations for validation
    • Change control process
    • Change consideration situations

Plastics Training Academy

  • PTA Course Schedule and Registration
    • Applied iMFLUX Processing
    • DOE for Injection Molding
    • Geometric Dimension and Tolerancing Full Fundamentals (Online)
    • Geometric Dimensioning and Tolerancing Update (Online)
    • Injection Molding Principles
    • Injection Molding Troubleshooting
    • Injection-Molded Part Design Principles
    • Injection-Molded Product Failure Analysis
    • Introduction to Plastics Engineering Technology (Online)
    • Plastic Injection Mold Design Basics
    • Polymer Science and Material Selection Fundamentals
    • Process Validation for Medical Injection Molding
    • Scientific Cooling: Mathematical Water Efficiency Analysis
  • Ways to Register
  • Faculty and Instructors
  • Plastics Training Lab
  • Plastics Training Academy Testimonials

See Also

  • Course List and Schedule
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Penn State Behrend

Penn State Erie, The Behrend College, offers the learning opportunities of a major research university in a welcoming, student-centered campus environment.
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