Process Verification and Validation for Additive Manufacturing€¦ · for Additive Manufacturing SmartManufacturingSeries.com Powered by Confidential The presentation is intended

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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


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…


QUICK AUDIENCE SURVEY

• Performed Process Validations?

• Performed Process Validations using AM?


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”?


• Spoiler Alert- 3D Printing is a Special Process

PROCESS VALIDATION FOR AMBasic Difference SM vs. AM


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…


"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


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


PROCESS VALIDATION vs. VERIFICATIONDecision Tree


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


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


• What’s being measured?

(1) FDA 21 CFR 820.75(a)

Process Validation for AM


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- 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


Map the ProcessInstallation Qualification (IQ)

ORDER RAW MATERIAL

RECEIVE/INSPECT RAW MATERIAL

PRINT

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


(X’s) Inputs- Equipment to Remove

Support Structure- Removal Procedure- Cleaning Equipment- Cleaning Procedure


(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


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


PROCESS VALIDATION FOR AMProcess Characterization

Two-Part Goal


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


Process Variable Additive

Manufacturing

Traditional Special

Processes



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




Manufacturing

Traditional Special

Processes



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




Manufacturing

Traditional Special

Processes



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




Manufacturing

Traditional Special

Processes



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


PRINT

• 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)


OQ Limit 2(OQ Low)

PQ 1

PQ 2

PQ x

PROCESS VALIDATION FOR AMSummary


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


http://www.gpo.gov/

http://www.iso.org/

http://www.fda.gov/

http://www.fda.gov/

http://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf

http://www.usfda.gov/

http://www.sme.org/

http://www.sme.org/medical-additive

http://www.sme.org/medical-am3dp-workgroup

http://www.astm.org/

Questions?

Thank you!*


Questions

*- A special Thank You to Mariann Sayer and Karen Gasko of DePuy-Synthes for their help in preparing this presentation