Seminar Outline

 

  1. Introduction: The Strategy
    1. Purpose
    2. Perspectives on the plastics' industry, Manufacturing
    3. Staying Competitive
    4. Key components of a successful validation/plastics application
    5. Concurrent engineering and its benefits
    6. Organizing the hundreds of variables in processing/parts; four categories
    7. Machine conditions vs. Plastic conditions
    8. Validation Strategy
    9. Case History
  2. Piece Part Design Overview, You cannot violate laws of nature!
    1. Components of Design
    2. The "Golden Rule" for nominal wall
    3. Shrinkage, Amorphous vs. Semi-Crystalline
    4. Cooling and Warp
    5. Draft
    6. Venting
    7. Gating with respect to weldlines
  3. Polymer Overview
    1. Polymer Basics, making and breaking polymer chains
    2. Moisture Sensitivity relative to performance
    3. Critical for success
    4. Costs for replacement
    5. What data sheets tell you
    6. Single point data
  4. IQ (Installation Qualification)
    1. Medical Device Quality Systems Manual Reprints
    2. Check List
    3. Mold/Tooling Requirements
    4. Machine Calibrations
    5. Machine Function (Machine Audit)
    6. Clean room requirements
  5. OQ (Operational Qualification; Establish a Process, Document and Define Ranges/Window; Starting with a Pre-run or Baseline Process)
    1. Step 1: Optimizing First Stage: Plastic Flow Rate
      1. How plastic flows, viscosity
      2. Viscosity curve
      3. Viscosity vs. temperature, lot variations and injection rate
      4. Flow balance
      5. Cruise Control on injection molding machines
      6. Two stage molding
      7. Case history
      8. Non-return valve (check ring) and nozzles
      9. Nozzle tips
    2. Step 2: Optimizing Second Stage: Plastic Pressure
      1. Basic hydraulics
      2. Hydraulic Pressure vs. Melt Pressure
      3. Back Pressure
      4. Intensification Ratio
      5. Pressure Loss
      6. Gate seal vs. unseal
      7. Pressure vs. time graphs
      8. Clamp force
      9. Platen wrap
      10. Pressure Loss Documentation
    3. Step 3: Cooling Rate and Time
      1. Percent of Cycle
      2. Turbulent Flow
      3. Series vs. parallel circuits
      4. Cooling issues
      5. Infrared Thermography
      6. Cycle time optimization studies
    4. Step 4: Plastic Temperature
      1. The hopper
      2. Drying
      3. The feed throat
      4. Barrel vs. melt temperatures
      5. Screw components and design
      6. How plastics melt
      7. Back pressure
      8. Screw problems
      9. How to measure temperature
    5. Step 5: Challenge the Process
      1. When to start saving parts
      2. Force viscosity variations
      3. Different resins?
      4. Capability studies
    6. Step 6: Test the part; expect issues to develop
      1. Test Conditions
      2. Thermocycle
      3. Environment
      4. Metrology
      5. First article inspections (FAI's)
      6. Visual inspections
    7. Do the DOE's Necessary/Correctly
      1. What are the issues, problem(s) clearly defined?
      2. List factors
        1. Possible factors
        2. Recommendations
      3. Factors with respect to four plastic categories
      4. Do we know the response for any of these factors
      5. Select Factors (variables)
      6. Machine "Set Points" vs. "Plastic Conditions"
      7. DOE check list
      8. Screening DOW's to establish process window
    8. Documentation
      1. Set up sheet per machine
      2. Universal Set up sheet, mold specific
      3. Process Monitoring Recommendations
        1. First tier
        2. Second tier
  6. PQ (Process Performance Qualification; Test production performance of the process under "production" conditions)
    1. Run established process for production, time 4 - 24 hours
      1. Lot variations
      2. Different Processors
      3. Shift changes
    2. Run on different machines
    3. Verify output, Dimensions, function, capability, scrap etc.
    4. Document corrective action and confirm
    5. Evaluate entire system, molding, secondary operations, labels, and document results
    6. Implement corrective actions
    7. Document process/equipment changes
    8. Process monitoring variables
    9. Obtain customer approval
  7. Miscellaneous
    1. Universal Setup Sheet
    2. Optimization Guidelines
    3. Recommended resources and web sites
    4. Background
    5. Evaluation