Medical Molding Validation & Process Development

1 Medical Molding Validation & Process DevelopmentSeminar Outline 1)Introduction; The Strategya)Purposeb)Perspectives on the plastics industry, Manufacturingc)Staying Competitived)Components of a successful plastic s applicatione)Concurrent engineering and its benefitsf)Organizing the hundreds of variables in processing/parts; four categoriesg)Machine conditions vs. Plastic conditionsh) Validation Strategyi)Case History2)Piece Part Design Overview, You cannot violate laws of nature!a)Components of Designb)The Golden Rule for nominal wallc)Shrinkage, Amorphous vs. Semi-Crystallined)Cooling and Warpe)Draftf)Ventingg)Gating with respect to weldlines3)Resin Selectiona)Polymer Basics, making and breaking polymer chainsb)Questions that must be answeredc)Properties to watch during the selection processd)What data sheets tell youe)Single point data4)IQ (Installation Qualification, Does the equipment work correctly?

2 A)Procedures and Records ) ) ) )Control )Gage R/R on )Calibration )Software ) Process Failure Mode Effects Analysis (PFMEA s) )Recognize and evaluate potential )Identify actions to reduce or eliminate )Document the )Track changes to the Process made to eliminate potential )Machine Specificationsb)Establish room/building requirementsc)Machine placementd)Auxiliary/Secondary ) )Cooling/heating tool GPMe)Machine ) ) )Timers? )Temperatures ..set points???f)Machine Function (Machine Audit) )Velocity control, Delta )Load )1st to 2nd stage switch over )Velocity )Pack Velocity functiong)Mold/Tooling )Mold drawing )Spare parts )Mold steel measurements )Water flow diagrams with GPM demand )Water flow per channel )Water channels labeled on )Mold filling analysis 5)OQ (Operational Qualification; Establish a Process , Document and Define Ranges/Window); Starting with a Pre-run or Baseline Processa)Step 1: Optimizing First Stage; Plastic Flow )How plastic flows, )Viscosity )Viscosity vs.

3 Temperature, lot variations and injection )Flow )Cruise Control on injection Molding )Two stage )Case )Non-return valve (check ring) & )Nozzle tipsb)Step 2: Optimizing Second Stage, Plastic )Basic )Hydraulic Pressure vs. Melt )Back )Intensification )Pressure )Gate seal vs. )Pressure vs. time )Clamp )Platen )Pressure Loss Documentationc)Step 3: Cooling Rate and )Percent of )Turbulent )Series vs. parallel )Cooling )Infrared )Cycle time optimization studiesd)Step 4: Plastic )The ) )The feed )Barrel vs. melt )Screw components and )How plastics )Back )Screw )How to measure temperaturee)Step 5: Challenge the )When to start saving )Force viscosity )Different resins? )Capability studiesf)Step 6: Test the part; expect issues to )Test ) ) ) )First article inspections (FAI s) )Visual inspectionsg)Do the DOE s Necessary/Correctly )What are the issues, problem(s) clearly defined?

4 List )Possible ) )Factors with respect to four plastic )Do we know the response for any of these )Select Factors (variables) )Machine Set Points vs. Plastic Conditions )DOE check )Screening DOE s to establish Process windowh) )Set up sheet per )Universal Set-up sheet, mold ) Process Monitoring )First )Second )PQ ( Process Performance Qualification; Test production performance of the Process under production conditions)a)Run established Process for production, time 4 24 )Lot )Different )Shift changesb)Run on different machinec)Verify output, Dimensions, function, capability, scrap )Document corrective action and confirme)Evaluate entire system, Molding , secondary operations, labels, and document resultsf)Implement corrective actionsg)Document Process /equipment changesh) Process monitoring variablesi)Obtain customer approval7)Miscellaneousa)Universal Setup Sheetb)Optimization Guidelinesc)Recommended resources and web sitesd)Backgrounde)Evaluatio