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Process Verification and Validation for Additive Manufacturing
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ConfidentialThe presentation is intended for educational purposes only and does not replace independent professional judgment. Statements of fact and opinions expressed are those of the participant individually and, unless expressly stated to the contrary, are not the opinion or position of Johnson & Johnson or its affiliates.
Dan Fritzinger
Global Manager, Instrument Innovation
DePuy-Synthes
Johnson & Johnson
Outline
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Purpose: Present an Overview of Validating a Special Process, and what it means to Additive Manufacturing
Key Take-Aways:• Understand the basics of validation and how it differs from verification• The difference between Design and Manufacturing Verification and Validation• Why AM is considered a special process
A TRUE (funny) STORY…
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QUICK AUDIENCE SURVEY
• Performed Process Validations?
• Performed Process Validations using AM?
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PROCESS VALIDATIONDoes this apply to me?
• Do you need Regulatory clearance in order to sell the device?• Compared to Point-of-Care Printing
• Does your manufacturing process use “Special Processes”?
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• Spoiler Alert- 3D Printing is a Special Process
PROCESS VALIDATION FOR AMBasic Difference SM vs. AM
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Subtractive Manufacturing (SM)
Bar Stock
Screw Machine
Finished Screws
Additive Manufacturing (AM)
Powder
Selective Laser Manuf.
Final Part
PROCESS/DESIGN- VERIFICATION/VALIDATION
XSmartManufacturingSeries.com
Design FeaturesCTQ’s (critical to quality)
CTQ: Critical to Quality
PROCESS- VERIFICATION & VALIDATIONWhat’s the Difference?
No discussion of process validation would be complete without citing the first sentence of 21CFR820.75
OK, now it all makes sense…
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"Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures.“(1)
(1) FDA 21 CFR 820.75(a)
PROCESS- VERIFICATIONLet’s take the easier one first
• There are a number of critical features
Note 1- Must meet ASTM minimum yield strength
• All dimensions can be VERIFIED using conventional inspection methods
• Strength can be VERIFIED with material certification
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PROCESS- VALIDATIONInjection Molding Example
• How do you ensure physical properties of finished part?
• Material certification has limitations
Transformation of material from one state to another
PROCESS VALIDATION
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PROCESS VALIDATION vs. VERIFICATIONDecision Tree
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VERIFYVALIDATE
GHTF: QMS Process Validation Guidance
Elements of Process Validation
OQ Extreme 1 (High)• High temperature• High pressure• Long time
OQ Extreme 2 (Low)• Low temperature• Low pressure• Short time
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INSTALLATION QUALIFICATION
(IQ)
Ensure equipment is installed correctly
PROCESSCHARACTERIZATION
Conduct experiments to understand how input factors affect process
outputs
OPERATION QUALIFICATION
(OQ)
Demonstrate that devices built at
processing window extremes meet device
requirements
PERFORMANCE QUALIFICATION
(PQ)
Demonstrate that devices built at nominal
processing settings consistently meet
device requirements
Elements of Process Validation"Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures.“ (1)
• Protocol
For IQ, OQ, and PQ:
• How it’s being measured
• What’s being tested?
• Acceptance criteria
• Report
• Results
• Pass or Fail
• Deviations
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• What’s being measured?
(1) FDA 21 CFR 820.75(a)
Process Validation for AM
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Map the ProcessFDA Guidance Document: Technical Considerations for Additive Manufactured Medical Devices
01- ORDER RAW MATERIAL
02- RECEIVE & INSPECT RAW MATERIAL
05- PRINT
04- PREPARE BUILD FILE
03- STORE RAW MATERIAL
06- PERFORM POST-PRINTING OPS
10- CLEAN/PASSIVATE
07- SECONDARY OPERATIONS
09- LASER ETCH
08-INSPECT
11- PACKSTERILENONSTERILE
(X’s) Inputs- Raw Mat ’l Spec
(Y’s) Outputs- Purchase Order
(X’s) Inputs- Receiving Procedure- Inspection Procedure
(Y’s) Outputs- Material Approval
(X’s) Inputs- Storage Procedure- Quarantine Area
(Y’s) Outputs- Mat ’l available for use
(Y’s) Outputs- Build File
(X’s) Inputs- 3D CAD Model- .STL File- Procedure
(X’s) Inputs- Build File- Raw Mat ’l- Printing Procedures- Printer
(Y’s) Outputs- Printed Parts
(X’s) Inputs- Equipment to Remove
Support Structure- Removal Procedure
(Y’s) Outputs- Printed Parts
(Y’s) Outputs- Finished Parts
(X’s) Inputs- Printed Parts- CNC Equipment- Surface Finishing Equipment- Procedures
(X’s) Inputs- Finished Parts- Inspection Equipment- Inspection Procedures
(Y’s) Outputs- Approved Parts
(X’s) Inputs- Inspected Parts- Laser Etch Equipment- Laser Etch Procedures
(Y’s) Outputs- Etched Parts
(X’s) Inputs- Etched Parts- Clean/Passivation Equipment- Clean/Etch Procedures
(Y’s) Outputs- Clean/Pass. Parts
(X’s) Inputs- Clean/Pass. Parts- Packaging Materials/Equipment- Packaging Procedures
(Y’s) Outputs- Finished Product Ready to Ship
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Map the ProcessInstallation Qualification (IQ)
ORDER RAW MATERIAL
RECEIVE/INSPECT RAW MATERIAL
PREPARE BUILD FILE
STORE RAW MATERIAL
PERFORM POST-PRINTING STEPS
CLEAN/PASSIVATE
SECONDARY OPERATIONS
LASER ETCH
INSPECT
PACKSTERILENONSTERILE
(X’s) Inputs- Raw Mat ’l Spec
(Y’s) Outputs- Purchase Order
(X’s) Inputs- Receiving Procedure- Inspection Procedure
(Y’s) Outputs- Material Approval
(X’s) Inputs- Storage Procedure- Quarantine Area
(Y’s) Outputs- Mat ’l available for use
(Y’s) Outputs- Build File
(X’s) Inputs- 3D CAD Model- .STL File- Procedure
(X’s) Inputs- Build File- Raw Mat ’l- Printing Procedures- Printer
(Y’s) Outputs- Printed Parts
(X’s) Inputs- Equipment to Remove
Support Structure- Removal Procedure- Cleaning Equipment- Cleaning Procedure
(Y’s) Outputs- Printed Parts
(Y’s) Outputs- Finished Parts
(X’s) Inputs- Printed Parts- CNC Equipment- Surface Finishing Equipment- Procedures
(X’s) Inputs- Finished Parts- Inspection Equipment- Inspection Procedures
(Y’s) Outputs- Approved Parts
(X’s) Inputs- Inspected Parts- Laser Etch Equipment- Laser Etch Procedures
(Y’s) Outputs- Etched Parts
(X’s) Inputs- Etched Parts- Clean/Passivation Equipment- Clean/Etch Procedures
(Y’s) Outputs- Clean/Pass. Parts
(X’s) Inputs- Clean/Pass. Parts- Packaging Materials/Equipment- Packaging Procedures
(Y’s) Outputs- Finished Product Ready to Ship
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PROCESS VALIDATION FOR AMProcess Characterization Process Variable Additive
Manufacturing
Traditional Special
Processes
Fixed or Variable? Fixed or Variable?
Type of Part Variable Fixed
Part Orientation in
Space (i, j, k)
Variable Fixed
Part Location in Space
(x, y, z)
Variable Fixed
Variety of Parts /
Range of Sizes
Variable Fixed
Number of Parts per
Build
Variable Fixed
Proximity of Parts per
Build
Variable Fixed
FDA Guidance Document➢ Process Validation➢ Section 4
➢ Recommends use of test coupons
➢ AM process is more flexible than other special processes
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PROCESS VALIDATION FOR AMProcess Characterization
Two-Part Goal
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Goal #1Define Worst Case Build File(“virtual worst case part”)
Goal #2Identify and Understand How Process Inputs Affect Process
Outputs (CTQ’s)
PROCESS VALIDATION FOR AMProcess CharacterizationGoal #1
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Process Variable Additive
Manufacturing
Traditional Special
Processes
Fixed or Variable? Fixed or Variable?
Type of Part Variable Fixed
Part Orientation in
Space (i, j, k)
Variable Fixed
Part Location in
Space (x, y, z)
Variable Fixed
Variety of Parts /
Range of Sizes
Variable Fixed
Number of Parts per
Build
Variable Fixed
Proximity of Parts
per Build
Variable Fixed
PROCESS VALIDATION FOR AMProcess CharacterizationGoal #1
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Process Variable Additive
Manufacturing
Traditional Special
Processes
Fixed or Variable? Fixed or Variable?
Type of Part Variable Fixed
Part Orientation in
Space (i, j, k)
Variable Fixed
Part Location in
Space (x, y, z)
Variable Fixed
Variety of Parts /
Range of Sizes
Variable Fixed
Number of Parts per
Build
Variable Fixed
Proximity of Parts
per Build
Variable Fixed
PROCESS VALIDATION FOR AMProcess CharacterizationGoal #1
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Process Variable Additive
Manufacturing
Traditional Special
Processes
Fixed or Variable? Fixed or Variable?
Type of Part Variable Fixed
Part Orientation in
Space (i, j, k)
Variable Fixed
Part Location in
Space (x, y, z)
Variable Fixed
Variety of Parts /
Range of Sizes
Variable Fixed
Number of Parts per
Build
Variable Fixed
Proximity of Parts
per Build
Variable Fixed
PROCESS VALIDATION FOR AMProcess CharacterizationGoal #1
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Process Variable Additive
Manufacturing
Traditional Special
Processes
Fixed or Variable? Fixed or Variable?
Type of Part Variable Fixed
Part Orientation in
Space (i, j, k)
Variable Fixed
Part Location in
Space (x, y, z)
Variable Fixed
Variety of Parts /
Range of Sizes
Variable Fixed
Number of Parts per
Build
Variable Fixed
Proximity of Parts
per Build
Variable Fixed
PROCESS VALIDATION FOR AMProcess Characterization:Goal #2- How Process Inputs Affect/Influence the Outputs
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• Worst case build file
• Energy input power and beam size
• Layer thickness
• Raw material reuse- Virgin : reclaimed material
• Chamber temperature, humidity, gas flow rate• Multiple material lots
POST-PRINTING
• Heat treat / stress relief
• Support structure removal
SECONDARY OPERATIONS
• Surface finish
• Other
- Cleaning Equipment/Procedures
PROCESS VALIDATION FOR AMOQ and PQ
OQ Limit 1(OQ High)
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OQ Limit 2(OQ Low)
PQ 1
PQ 2
PQ x
PROCESS VALIDATION FOR AMSummary
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Process Characterization&
Design of Experiments
“Push” the Key Process InputVariables to Identify MainEffects and Interactions
OQ Validation
Stress the Most InfluentialKey Process Input Variables
that will Produce Product at the Upper Limit (OQ High) &
Lower Limit (OQ Low) of the Process
PQ Validation
Run Independent ProductionCampaigns at Nominal Settingsto Demonstrate • Process Stability of Inputs• Process Capability of Outputs
Monitor and Control Process for Ongoing Production
Monitor/Control Key Input Parameters Defined in OQ, e.g.
Laser PowerMonitor/Control Key Output
Parameters
RESOURCESDocumentsTitle 21, section 820.75 of the Code of Federal Regulations (CFR)- www.gpo.govISO 13485 section 7.5.6- www.iso.orgFDA Guidance Document, “Technical Considerations for Additive Manufactured Devices”- www.fda.govFDA Guidance Document, “Design Control Guidance for Medical Device Manufacturers”- www.fda.govGlobal Harmonization Task Force , “Quality Management Systems- Process Validation Guidance”-http://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf
WebsitesUS Food and Drug Administration- www.usfda.govSociety of Manufacturing Engineers www.sme.orgwww.sme.org/medical-additivewww.sme.org/medical-am3dp-workgroupAmerican Society for Testing and Materials (ASTM International)- www.astm.orgThey offer an annual subscription that is a compilation of 119 standards for Additive Manufacturing and Medical Devices
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Questions?
Thank you!*
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Questions
*- A special Thank You to Mariann Sayer and Karen Gasko of DePuy-Synthes for their help in preparing this presentation