ASTM F3604-23

Standard Practice for Validating the Additive Manufacturing (AM) Production Process for Medical Devices Produced Using Laser Powder Bed Fusion

SIGNIFICANCE AND USE
4.1 Overview:  
4.1.1 Assurance of product quality is derived from careful attention to many factors but is not limited to raw material acceptance, software workflow definition, product and process design and control, printing and post processing, equipment and systems installation, maintenance, and in-process and end-product testing.  
4.1.2 By managing these factors, a manufacturer can establish confidence that all finished manufactured units from successive lots will be acceptable and meet lot release criteria.  
4.1.3 The basic principles of quality assurance (QA) have as their goal the production of articles that are fit for their intended use. These principles may be stated as:
4.1.3.1 Quality, safety, and effectiveness shall be designed and built into the product as well as the production process.
4.1.3.2 AM product characteristics all cannot currently be verified after the process without destructive testing and therefore requires validation. Suitable consideration should be designed into the product and controls should be applied to the process during process validation.
4.1.3.3 Critical steps of the production process impacting quality shall be controlled to maximize the probability that the finished product meets all quality and design specifications.  
4.1.4 Process validation is a key element in ensuring that these QA goals are met. Routine end-product testing alone is often not sufficient to assure product quality. Some end-product tests have limited sensitivity. In some cases, destructive testing would be required to show that the manufacturing process is adequate, and in other situations, end-product testing does not reveal all variations that may occur in the product that may have an impact on device performance. However, successfully validating a process may reduce the dependence on intensive in-process and finished product testing. Note that, in most cases, end-product testing plays a major role in supporting QA goals, that is, validati...
SCOPE
1.1 This practice provides an overview of how to perform process validation for medical devices manufactured using PBF/LB/M. The topics that will be covered include machine qualifications, software used in the manufacturing process, the importance of design specification and verification on process validation, and raw materials.  
1.2 This practice also provides recommendations for process characterization, risk management, additive manufacturing (AM) facility qualification, and process control as a prerequisite for qualification activity, including installation qualification/operational qualification/performance qualification (IQ/OQ/PQ).  
1.3 The practice is primarily focused on non-device-specific AM system(s) validation. Additional information may be needed in reference to the performance of the actual device.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

General Information

• Status: Published
• Publication Date: 14-Oct-2023
• Technical Committee: F42 - Additive Manufacturing Technologies
• Drafting Committee: F42.07 - Applications

Overview

ASTM F3604-23 - Standard Practice for Validating the Additive Manufacturing (AM) Production Process for Medical Devices Produced Using Laser Powder Bed Fusion provides essential guidance for manufacturers, engineers, and quality professionals involved in the production of medical devices using laser powder bed fusion (PBF/LB/M). Developed by the ASTM Committee F42 on Additive Manufacturing Technologies, this international standard outlines comprehensive requirements and best practices for process validation to ensure product quality, safety, and regulatory compliance within the additive manufacturing (AM) sector.

Assuring product quality in AM-based medical device manufacturing requires a robust system incorporating raw material control, machine and software qualifications, process design, in-process and end-product testing, and post-processing validation. This standard facilitates confidence in the manufacturing process, reducing reliance on extensive destructive end-product testing, and supporting continuous regulatory and quality objectives.

Key Topics

ASTM F3604-23 addresses several pivotal elements of AM process validation:

• Process Mapping & Characterization
  Comprehensive end-to-end mapping of the AM process to identify steps that require verification and those that require validation, including risk assessment for each process stage.

• Machine Qualification (IQ/OQ/PQ)
  Guidance on installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for non-device-specific AM systems, ensuring consistency in process and output.

• Software Workflow Validation
  Ensures all digital phases, including data preparation, slicing, and machine interfacing, are controlled and validated for errors, traceability, and data integrity.

• Raw Material Control
  Covers selection, characterization, storage, and traceability of feedstock materials (metal powders) to maintain consistent performance and quality.

• Risk Management
  Application of risk analysis and mitigation processes-aligned with ISO 14971-for identifying, evaluating, and controlling potential failure modes and process variables.

• Quality Assurance Integration
  Stresses building quality, safety, and effectiveness into both the AM process and final product, requiring rigorous documentation, ongoing monitoring, and integration with a comprehensive quality management system (QMS).

Applications

ASTM F3604-23 is highly relevant in the following contexts:

• Medical Device Manufacturing
  Facilitates regulatory acceptance and robust quality assurance in the production of patient-critical implants, surgical tools, and custom devices made via powder bed fusion.

• Additive Manufacturing Facility Qualification
  Used by manufacturers to qualify new or existing AM systems and facilities as fit for producing medical devices, ensuring that environmental and operational controls meet industry standards.

• Regulatory Compliance
  Supports conformance with global regulatory frameworks, such as FDA 21 CFR Part 820 and ISO 13485, by establishing traceable and reproducible validation activities.

• Process Improvement Programs
  Enables continuous improvement through data-driven validation and risk management methods, identifying key variables and optimizing both product and process controls for consistent quality.

Related Standards

To implement ASTM F3604-23 effectively, familiarity with the following related standards is recommended:

• ASTM F2971 – Practice for Reporting Data for Test Specimens Prepared by Additive Manufacturing
• ASTM F3049 – Guide for Characterizing Properties of Metal Powders Used for AM Processes
• ISO 13485 – Medical Devices Quality Management Systems
• ISO 14971 – Application of Risk Management to Medical Devices
• ISO/ASTM 52900 – Additive Manufacturing – General Principles – Terminology
• ISO/ASTM 52920 – Quality Assurance Processes at AM Centers
• ISO/ASTM 52930 – Qualification Principles (IQ/OQ/PQ) of PBF-LB Equipment
• 21 CFR Part 820 – FDA Quality System Regulation

By aligning with ASTM F3604-23 and these complementary standards, manufacturers can create a validated and repeatable AM production environment, supporting patient safety, product performance, and regulatory acceptance in medical device manufacturing.

Standards Content (Sample)

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F3604 − 23
Standard Practice for
Validating the Additive Manufacturing (AM) Production
Process for Medical Devices Produced Using Laser Powder
Bed Fusion
This standard is issued under the fixed designation F3604; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
This practice provides recommendations to perform process validation in which medical devices are
manufactured using powder bed fusion by laser beam (PBF-LB/M). Areas of interest for process
validation are machine qualifications, software used in the manufacturing process, the importance of
design specification and verification on process validation, and raw materials.
1. Scope 2. Referenced Documents
1.1 This practice provides an overview of how to perform 2.1 ASTM Standards:
process validation for medical devices manufactured using F2971 Practice for Reporting Data for Test Specimens Pre-
PBF/LB/M. The topics that will be covered include machine pared by Additive Manufacturing
qualifications, software used in the manufacturing process, the F3049 Guide for Characterizing Properties of Metal Pow-
importance of design specification and verification on process ders Used for Additive Manufacturing Processes
validation, and raw materials. F3456 Guide for Powder Reuse Schema in Powder Bed
Fusion Processes for Medical Applications for Additive
1.2 This practice also provides recommendations for pro-
Manufacturing Feedstock Materials
cess characterization, risk management, additive manufactur-
2.2 ISO Standards:
ing (AM) facility qualification, and process control as a
ISO 9712 Non-destructive Testing—Qualification and Cer-
prerequisite for qualification activity, including installation
tification of NDT Personnel
qualification/operational qualification/performance qualifica-
ISO 13485 Medical Devices—Quality Management
tion (IQ/OQ/PQ).
Systems—Requirements for Regulatory Purposes
1.3 The practice is primarily focused on non-device-specific
ISO 14971 Medical Devices—Application of Risk Manage-
AM system(s) validation. Additional information may be
ment to Medical Devices
needed in reference to the performance of the actual device.
2.3 ISO/ASTM Standards:
1.4 This standard does not purport to address all of the
52900 Additive Manufacturing—General Principles—
safety concerns, if any, associated with its use. It is the
Terminology
responsibility of the user of this standard to establish appro-
52902 Additive manufacturing—Test artifacts—Geometric
priate safety, health, and environmental practices and deter-
capability assessment of additive manufacturing systems
mine the applicability of regulatory limitations prior to use.
52907 Additive manufacturing—Feedstock materials—
1.5 This international standard was developed in accor-
Methods to characterize metallic powders
dance with internationally recognized principles on standard-
52910 Standard Guidelines for Design for AM
ization established in the Decision on Principles for the
52911-1 Additive manufacturing—Design—Part 1: Laser-
Development of International Standards, Guides and Recom-
based powder bed fusion of metals
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
For referenced ASTM or ISO/ASTM standards, visit the ASTM website,
www.astm.org, or contact ASTM Customer Service at [e-mail]. For
This practice is under the jurisdiction of ASTM Committee F42 on Additive Annual Book of ASTM Standards volume information, refer to the standard’s
Manufacturing Technologies and is the direct responsibility of Subcommittee Document Summary page on the ASTM website.
F42.07 on Applications. Available from International Organization for Standardization (ISO), ISO
Current edition approved Oct. 15, 2023. Published February 2024. DOI: Central Secretariat, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva,
10.1520/F3604-23. Switzerland, https://www.iso.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F3604 − 23
52911-2 Additive manufacturing—Design—Part 2: Laser- equipment adhere to the manufacturer’s approved specification
based powder bed fusion of polymers and the recommendations of the supplier of the equipment are
52913-1 Additive manufacturing—Feedstock materials— suitably considered.
Part 1 Parameters for characterization of powder flow 3.2.6.1 Discussion—Consideration should be given to ISO/
properties
ASTM 52930.
52915 Specification for additive manufacturing file format
3.2.7 machine fleet variation, n—variations within multiple
(AMF) Version 1.2
machines of the same model.
52920 Standard specification for quality assurance processes
3.2.8 process operational qualification, n—establishing by
at AM centers
objective evidence that process control limits have been
52930 Additive manufacturing—Qualification principles—
sufficiently challenged and result in outputs that meet all
Installation, operation, and performance (IQ/OQ/PQ) of
predetermined requirements.
PBF-LB equipment
3.2.9 process performance qualification, n—establishing by
52931 Standard guideline for use of metallic materials
objective evidence that the process, under anticipated
52933 Standard specification on indoor air quality manage-
conditions, consistently produces a product that meets all
ment
predetermined requirements.
52950 Additive manufacturing—General principles—
Overview of data processing
3.2.10 process re-validation, n—establishing by objective
2.4 ISO/DIS Standard: evidence that the process under anticipated conditions consis-
ISO/DIS 14644-9 Cleanrooms and associated controlled tently produces a product that meets all predetermined require-
environments—Part 9: classification of surface particles ments once specific changes that could sufficiently change a
cleanliness product’s performance have occurred.
2.5 Federal Standards:
3.2.11 process validation, n—establishing by objective evi-
21 CFR Part 11 Electronic Records, Electronic Signatures
dence that a process can produce a result or product meeting its
21 CFR Part 820 Quality System Regulation
predetermined requirements, for example, part cleaning.
3.2.11.1 Discussion—Consideration should be given to the
3. Terminology
difference between machine types, fleet of one or more
machines versus a single machine for process validation.
3.1 Definitions—Standard additive manufacturing (AM) ter-
minology is defined in ISO/ASTM 52900. For the purposes of
3.2.12 process validation protocol, n—document stating
this guide, the definitions in 3.2 apply. The International
how validation will be conducted, including test parameters,
Organization for Standardization (ISO) and the International
product characteristics, manufacturing equipment, feedstock,
Electrotechnical Commission (IEC) maintain terminological
and decision points on what constitutes acceptable test results.
databases for use in standardization at the following addresses:
3.2.13 product verification, n—confirmation by examination
ISO online browsing platform available at https://www.iso.org/
and provision of objective evidence that the specified product
obp and IEC Electropedia available at http://
requirements have been fulfilled, for example, part dimensions.
www.electropedia.org/.
3.2.13.1 Discussion—Verification should include product
3.2 Definitions of Terms Specific to This Standard:
performance testing for worse-case process and material con-
3.2.1 build interruption, n—unplanned delay during the AM
figuration(s).
cycle that halts the general progression of the process.
3.2.14 production process, n—encompasses the end-to-end
3.2.2 build pause, n—longer than typical dwell time spacing
AM process and associated post processing to manufacture a
between layers and may be planned as part of the print job or
finished medical device.
the automatic machine control function, for example, to allow
3.2.15 raw material, n—as-received powder material and
powder transfer.
blend used to produce the final mechanical and physical
3.2.3 calibration, n—configuration and verification of all
properties of the device.
critical sensors, accessories, and instruments against control
3.2.16 risk, n—combination of the probability of occurrence
standards defined by original equipment manufacturer (OEM)
of harm and the severity of that harm.
guidance.
3.2.16.1 Discussion—This definition is derived from ISO
3.2.4 critical to quality, CTQ, n—attribute or feature that is
13485:2016 and differs from the definition of “risk” in ISO
critical to the overall quality of the device or process.
9000:2015.
3.2.5 factory acceptance test, n—system acceptance test
3.2.17 risk analysis, n—a listing of all the hazards associ-
performed at OEM facility.
ated with process and the level of severity, occurrence and
3.2.6 installation qualification, n—establishing by objective
detection for each risk and associated failure mode.
evidence that all key aspects of the installation process
3.2.18 risk assessment, n—overall process of risk analysis
associated with both the printing equipment and ancillary
and risk evaluation.
3.2.19 risk management, n—systematic application of man-
agement policies, procedures and practices aimed at analyzing,
Available from U.S. Government Publishing Office (GPO), 732 N. Capitol St.,
NW, Washington, DC 20401, http://www.gpo.gov. evaluating, controlling, and monitoring risk.
F3604 − 23
3.2.19.1 Discussion—This definition is derived from ISO cases, end-product testing plays a major role in supporting QA
13485:2016. goals, that is, validation and end-product testing are not
mutually exclusive.
3.2.20 site acceptance test, n—series of documented proce-
4.1.5 Key process variables should be monitored and docu-
dures and tests agreed between the equipment supplier and
mented using statistical process control where applicable.
equipment purchaser with results meeting predetermined re-
Analysis of the data collected from monitoring should establish
quirements.
the potential variability of process parameters for individual
3.2.20.1 Discussion—The site acceptance test is performed
production runs to ensure that a process is within acceptable
after installation of the machine at the final production loca-
control limits and the equipment can consistently produce the
tion. This should include facility and environmental conditions
product within specification.
assessment, material characterization, environment health and
4.2 Preliminary Considerations:
safety assessment, equipment computer systems qualification,
training of production personnel, and operations. 4.2.1 A manufacturer should evaluate all factors that affect
product quality through appropriate documented process char-
3.2.21 software workflow, n—manufacturing software used
acterization.
during the manufacturing process.
4.2.2 Risk management and an analysis file shall be created
3.2.22 special process, n—a process whereby the resulting
in line with ISO 14971. These factors may vary considerably
output cannot be verified by subsequent monitoring or mea-
among different products, manufacturing technologies, and
surement.
facilities. No single approach to process validation will be
appropriate and complete in all cases; however, the following
3.3 Abbreviations:
quality steps should be undertaken.
3.3.1 LIMS, n—Laboratory Information Management Sys-
4.2.3 All pertinent aspects of the production processes that
tem
have an impact on device design (product’s end use) should be
3.3.2 MES, n—Manufacturing Execution System
considered during process validation. These aspects include,
but are not necessarily limited to, performance, reliability, and
4. Significance and Use
stability. Performance limits and variation should be estab-
4.1 Overview: lished for each characteristic acceptance criteria and expressed
4.1.1 Assurance of product quality is derived from careful in readily measurable terms. Once a product specification is
attention to many factors but is not limited to raw material defined it is important that any changes to it be made in
acceptance, software workflow definition, product and process accordance with documented change control procedures and
design and control, printing and post processing, equipment the device history file.
and systems installation, maintenance, and in-process and
end-product testing.
5. Elements of Process Validation
4.1.2 By managing these factors, a manufacturer can estab-
5.1 General:
lish confidence that all finished manufactured units from
5.1.1 Process validation shall be considered when a new
successive lots will be acceptable and meet lot release criteria.
product is introduced or there is a critical change in the
4.1.3 The basic principles of quality assurance (QA) have as
production process that may affect any or all the product’s
their goal the production of articles that are fit for their
dimensional, material characteristics, and device functionality.
intended use. These principles may be stated as:
5.1.2 The following are considered as pre-requisites to
4.1.3.1 Quality, safety, and effectiveness shall be designed
process validation:
and built into the product as well as the production process.
5.1.2.1 Process mapping
4.1.3.2 AM product characteristics all cannot currently be
5.1.2.2 Risk assessment
verified after the process without destructive testing and
5.1.2.3 Control Plans
therefore requires validation. Suitable consideration should be
5.1.3 The following are considered as key elements of
designed into the product and controls should be applied to the
process validation:
process during process validation.
5.1.3.1 Process master validation planning (MVP)
4.1.3.3 Critical steps of the production process impacting
5.1.3.2 Process characterization
quality shall be controlled to maximize the probability that the
5.1.3.3 Software workflow validation
finished product meets all quality and design specifications.
5.1.3.4 Equipment Validation
4.1.4 Process validation is a key element in ensuring that (1) Installation qualification (IQ)
these QA goals are met. Routine end-product testing alone is 5.1.3.5 Process Validation
often not sufficient to assure product quality. Some end-product (1) Operational qualification (OQ)
tests have limited sensitivity. In some cases, destructive testing (2) Performance qualification (PQ)
would be required to show that the manufacturing process is 5.1.4 It is essential that the validation documentation is
adequate, and in other situations, end-product testing does not properly maintained and fully traceable in accordance with ISO
reveal all variations that may occur in the product that may 13485 and 21 CFR Part 11. For ongoing production, it is
have an impact on device performance. However, successfully important to adequately record or monitor or both facility and
validating a process may reduce the dependence on intensive process variables defined during the risk assessment and
in-process and finished product testing. Note that, in most validation as well as any critical changes to the process. An
F3604 − 23
example of the full AM workflow (see Fig. 1) and impact on of the end-to-end software workflow, and therefore, it is critical
final device quality should be considered when assessing that system controls are established at each stage of the product
individual process steps. life cycle and the workflow impact on the final product quality
is established.
5.2 Process Validation Pre-Requisites:
5.2.3 Risk Management and Analysis:
5.2.1 Overview—The personnel involved in the steps below
should be a good cross functional team of personnel involved 5.2.3.1 A risk management and analysis file shall be created
in the AM process to ensure all perspectives are included.
in accordance with ISO 14971. Process and design failure
5.2.2 Process Mapping: mode and effects analysis (FMEA), or other risk analysis tools,
5.2.2.1 Full end to end AM process mapping is required to
should link characteristics of the production process that
define process steps to be covered for risk assessment. influence medical device performance (dimensional/material
5.2.2.2 The output from the process mapping will define
characteristics and functionality).
which process steps can be verified and which process steps
5.2.3.2 Risk assessments are living documents and should
need to be validated.
be updated after process validation. Risk assessments should
(1) See Terminology section for verification / validation.
also be reviewed on a periodic basis.
5.2.2.3 Process steps that cannot be fully verified will need
5.2.3.3 The risk assessment may be based on hypothesized
to be validated. To help determine when a process “cannot be
risk or historical data, or both. Historical data should be used
fully verified,” the following guidelines may be considered:
wherever possible.
(1) Routine end-product tests have insufficient sensitivity
5.2.4 Control Plans:
to verify the validated performance of the finished devices.
5.2.4.1 Control plans are an output from risk assessment.
(2) Clinical or destructive testing would be required to
The risk assessment identifies high risk process steps related to
show that the manufacturing process has produced the desired
high severity, high occurrence, low detection, or the resulting
result or product.
severity X occurrence X detection score. The control plan is
(3) Routine end-product tests do not reveal all variations in
meant to control the process and ensure the process produces
device performance that may occur in the finished devices.
quality parts that meet the customer requirements.
(4) Process capability is unknown and device features
challenge the process repeatability. 5.2.4.2 When assessing software workflow controls, it is
5.2.2.4 Software workflow is critical to the AM device file important to consider the following:
preparation (for example, lattice generation, supports, slice (1) Relevant risks and controls for each individual step and
hatch), production, MES, data collection, and final perfor- their impact on final device quality.
mance. Multiple file conversions and translation steps from (2) Digital error stack throughout the end-to-end workflow.
digital to printable forms can impact product quality, data (3) Verification steps required when validation is not pos-
integrity, and traceability. Manual intervention is a major part sible.
FIG. 1 Example of an Additive Manufacturing Workflow
F3604 − 23
(4) Routine end-product tests do not reveal all variations in 5.4.1.2 Any equipment that does not need validation shall
device performance that may occur in the finished devices and, be documented and justified as to why validation is not needed,
therefore, may require a worse case combination of digital
for example hand tools used in manufacturing or test, callipers,
stack-up error to demonstrate true design window and end-
etc.
product performance.
5.4.2 Installation Qualification (IQ):
(5) Highlight and establish controls on manual operations
5.4.2.1 Pre-Requisites:
when human error can impact device performance.
(1) The following items must be completed before execu-
5.2.4.3 Control plans should also be periodically reviewed
tion of an IQ protocol:
and updated. This may include by not limited to the following:
(a) The equipment is located in its final location.
(1) Implementation of corrective actions against the cus-
(b) The IQ protocol and supporting documentation must
tomer complaints, when applicable.
be approved before starting execution of the IQ protocol.
(2) When there is any change that occurs affecting
(c) All personnel executing the IQ protocol shall be
products, production process, measurements, supply chain, and
trained to the validation plan and IQ protocol prior to execu-
failure mode effect analysis (FMEA).
tion.
(3) At a defined frequency set as per customer requirement
5.4.2.2 General:
or based on risk analysis.
(1) Installation qualification studies establish confidence
5.3 Validation Planning:
that the process equipment and ancillary systems are capable of
5.3.1 Validation planning should result in a documented
consistently operating within established limits and tolerances.
master validation plan (MVP). This should include the follow-
After process equipment is designed or selected, it should be
ing elements:
evaluated and tested to verify that it can operate satisfactorily
5.3.1.1 A process flowchart containing all validated and
within the operating limits required by the process in a factory
verified steps.
acceptance test. This phase of validation includes examination
of equipment design; determination of calibration, environ-
5.3.1.2 Equipment Validation Strategy: A list of all equip-
mental conditions, maintenance, and adjustment requirements;
ment that needs validation. Equipment validation is done per
section 5.4. and identifying critical equipment features and configuration
management of software workflow that could affect the process
5.3.1.3 Software Workflow Validation: Required when com-
and product. Information obtained from these studies should be
puters or automated data-processing systems are used as part of
used to establish written procedures covering equipment
the production or quality system in line with regulatory
calibration, maintenance, monitoring, and control.
guidance (for example, 21 CFR 820.70(i)).
(2) In assessing the suitability of a given piece of
5.3.1.4 Process Validation Strategy:
equipment, it is usually insufficient to rely solely upon the
(1) This includes identification of processes that can be
representations of the equipment supplier or experience in
verified and processes that will need to be validated.
producing similar product. Sound theoretical and practical
(a) Processes that can be verified do not need special
engineering principles and considerations are the first step in
validation as the output of the process step can be verified.
the assessment with respect the product functionality, material
(b) Process validation is required when the results of a
and dimensional characteristics, and functionality. It is impor-
process cannot be fully verified by subsequent inspection and
tant that equipment qualification represent production
testing [for example, 21 CFR 820.75(a)]. In most instances,
conditions, including those that are "worst-case" situations.
this includes the test methods used to assure a product complies
These conditions shall be defined by the user of the equipment.
with key specifications (that is, dimensional and material
(3) Tests and challenges should be repeated with statistical
characteristics and functionality).
significance to assure reliable and meaningful results. All
(2) Special processes should be identified, and appropriate
acceptance criteria shall be met during the test or challenge. If
level of consideration given. This includes software workflow
validation. any test or challenge shows that the equipment does not
perform within its specifications, an evaluation should be
5.3.1.5 Adequate controls within the quality management
performed to identify the root cause of the failure. Corrections
system (QMS) should be in place for all sub-tier suppliers.
should be made, and additional test runs performed as needed
5.3.1.6 Nonconformance procedures should be established
to verify that the equipment performs within specifications in
for the production process.
the production setting. The observed variability of the equip-
5.3.1.7 All validation protocols, product criteria, and pro-
ment between and within runs can be used as a basis for
cess acceptance criteria should be agreed upon and finalized
determining the overall process window for the subsequent
during the planning stage.
operational and performance qualification studies of the pro-
5.4 Equipment Validation:
cess.
5.4.1 General:
5.4.2.3 Equipment Design Validation and Installation:
(1) Systems Acceptance Testing—System acceptance test-
5.4.1.1 A list of all equipment (manufacturing and test
equipment) shall be made and be part of the MVP. This list will ing should be completed and documented during the installa-
tion in the production setting. Systems acceptance testing may
form the basis on which equipment installation qualifications
will be needed. include:
F3604 − 23
(a) Factory acceptance testing (FAT) performed at the (iii) All utility supplies to be assessed and quality limits
OEM factory before delivery. to be set (for example, argon gas moisture content and purity).
(b) Site acceptance testing (SAT) performed following (3) Procedural Control—As part of the installation
the installation activity at the customer site by the OEM. qualification, the user should establish proper documented
(c) Examine equipment design and locate supplied control of the AM equipment and supporting equipment. Such
documentation, prints, drawings, and manuals, including soft- written instructions may include the following and should be
ware configuration documentation where applicable. documented within the installation qualification:
(d) The user should generate or locate a spare parts list (a) Powder bed manufacture and build preparation.
with guidance from the OEM and in line with the maintenance (b) Machine set up, shut down, and general operations
schedule. procedures.
(2) Installation Conditions—A documented assessment for (c) Cleanliness of build plate, chamber, and optics. ISO/
humidity, temperature, and other environmental controls DIS 14644-9, Part 9 to be used where applicable.
(vibration, load bearing, and ventilation) for the machine (d) Build plate removal.
location should take place with respect to ISO/ASTM 52931. (e) Traceability.
Facility safety assessment should also account for relevant (f) Powder handling and lot traceability.
regional and global standards. Recommended environmental (g) Powder reuse schema and ancillary equipment quali-
conditions and limits shall be provided by the equipment fication.
manufacturer. In ISO/ASTM 52920, an overview of qualifica- (h) System configuration management.
tion principles for industrial additive manufacturing sites is (i) Nonconforming material in case of build interruption
also provided. Air quality should account for recommendations or build anomaly.
given in ISO/ASTM 52933. Verification that the facility (j) File preparation.
environmental monitoring and controls are sufficient should be (k) Control of digital workflow and data translation where
fully documented and is the responsibility of the user. Any not digitized.
modifications or deviations from the recommended environ- (l) Support structure removal and post processing.
mental controls by the equipment manufacturer should be (m) Conditions on when re-validation of the equipment is
supported through appropriate characterization. All procedures required. See Section 7 for more details.
and equipment used to monitor the environmental conditions (n) Is the equipment portable / moveable without re-
should be recorded in the installation qualification (IQ) report. validation.
The following considerations should be made and documented: (4) Software Controls—Software should be validated as
(a) Humidity and temperature shall each be measured in per section 5.4.3. Software used for file preparation and
at least one representative location in the vicinity of the operation of the AM equipment should be characterized and
equipment. Additional location measurements for humidity and controlled with the following considerations:
temperature shall be taken if they have an impact on the (a) The user should have a documented procedure for
product performance. Instruments shall be calibrated configuration management to ensure that software versions are
periodically, and the calibration records maintained. controlled and recorded on manufacturing build records.
(b) Powder storage and handling conditions shall be (b) Software updates should be controlled following a
considered, and appropriate limits set in line with product and written procedure and assessment to product performance and
process characteristics, functionality, and safety. when re-validation is required.
(c) The surrounding work area shall have sufficient space (c) Data links, recipe management, and change control
to perform the processing and any associated activities includ- procedures to be defined in line with Product Lifecycle
ing maintenance; location of equipment shall allow for ad- Management (PLM) requirements to satisfy 21 CFR Part 11
equate servicing, ventilation, and safety. requirements.
(d) OEMs are responsible for providing facilities guides (d) In-situ monitoring technology and data logging to be
before install. The user is responsible for meeting facility qualified and linked to the PLM system and QMS where
requirements before install of the equipment. applicable.
(e) Due consideration should be given to the use of inert (5) Calibration of metal powder bed fusion machines and
gas and static electricity during facility commissioning. Verify subsystems equipment and process variable calibration and
that all utilities are conforming. controlled with the following considerations:
(f) Determine machine requirements based on informa- (a) Establish calibration, cleaning, maintenance,
tion that shall be provided by the machine manufacturer. The adjustment, performance tests, and expected repair procedures
OEM should be consulted for specific system facility require- (including schedules). Calibration schedules of instruments
ments before installation. These may include: and measurement devices used either within the process or as
(i) Allowable limits on environmental factors such as part of the calibration of the system shall be determined.
vibration, load-bearing surfaces, ventilation, space Procedures should be in place to ensure compliance to the
requirements, and supplied utilities such as power, compressed calibration system. Specific recalibration intervals depend on
air, and inert gas. several factors, including:
(ii) Calibrated equipment that has a measuring function (i) Accuracy requirements of the product. Consideration
and the calibration records maintained. to be given to ISO/ASTM 52902.
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(ii) Requirements set by supplier contract, quality (2) Any deviations and resolutions as result of the IQ
system, or regulation. execution.
(3) Training records for the Validation Plan and IQ protocol
(iii) Inherent stability of the specific instrument or
for all personnel involved in the execution.
device.
(4) Calibration information for the validated equipment
(iv) External and environmental factors that may affect
and for all equipment used in the validation.
the stability.
(5) Records of FAT and SAT.
(b) Complete qualification and documented check to be
(6) Equipment software validation reports as applicable.
included in the installation qualification for the following
(7) Evaluation of system performance to the machine
items:
specification. Performance testing to establish a baseline per-
(i) Critical sensors to be verified
formance of the AM system. This can be in line with product
(ii) Optics calibration (focus, power, scanner accuracy,
requirements.
and XY positional calibration)
(8) The report approved and controlled as part of the QMS
(iii) Pressure, flow, and seal testing
process.
(iv) Filter checks
(v) Regional environmental health and safety (EHS) and 5.5 Process Validation:
design safety checks
5.5.1 Pre-Requisites—A completed design and process risk
(vi) Critical alarms
assessment should be done before starting process validation.
(vii) Moving parts Completed risk assessment are required so that sampling plans
(viii) Ancillary equipment can be assessed properly per the associated risks.
(ix) Recoating system 5.5.2 Overview:
(x) Complete qualification job linked to desired material
5.5.2.1 The personnel involved in the steps below should be
and dimensional CTQs of the product application.
a good cross functional team of personnel involved in the AM
(6) Preventive Maintenance: process to ensure all perspectives are included.
(a) Establish preventative maintenance. The OEM should
5.5.2.2 Roles across the process chain shall be defined and
provide guidance to frequency, content, and tools needed for
personnel fulfilling these roles shall be qualified according to
preventative maintenance. Procedures should be in place to
their task quality objectives in accordance with ISO/ASTM/
establish a preventative maintenance program. The procedure DIS 52920, if applicable, and existing standards (for example,
should ensure that records of maintenance are duly recorded those being developed in ISO/ASTM Joint Group 74). This
and stored, and risk analysis is performed for any unplanned qualification of personnel shall be documented and available
maintenance. for assessment. Each role should be conducted by suitable
technical staff with demonstrable technological understanding.
(b) Maintenance plans may include, and are not limited
This includes knowledge about currently available AM
to, the following considerations:
standards, sound expertise of the relevant process category
(i) Power supply
(according to ISO/ASTM 52900), and its QA aspects. Typical
(ii) Optical to mechanical alignment
personnel roles and responsibilities along the AM-related
(iii) Laser cooling equipment
process chain are:
(iv) Filter replacement
(1) AM Designer (for metal, see ISO/ASTM 52937)—The
(v) Cooling water conductivity and top-up levels
responsibilities are to verify the part requirements and to
(vi) Laser output using a calibrated instrument
perform data preparation.
(vii) Laser beam profile
(2) AM Coordinator (see ISO/ASTM 52935)—For process
(viii) Optical components including focus, scan field,
development and maintaining process during operation.
power, and relative position
(3) Machine Operator (for metal, see ISO/ASTM 52926-1,
(ix) Recoater arm and wiper blades
-2, -3, -4, and -5)—The responsibilities are to manage feed-
(x) Machine ways and bearings
stock and carry out AM machine-related activities).
(xi) Machine interlocks and safety checks
(4) Test Personnel—For non-destructive testing, see ISO
(xii) Z-axis travel
9712. For non-destructive testing, personnel should be quali-
(xiii) Inert gas supply and output
fied to the part manufacturer’s local qualification process.
(xiv) Compressed air supply
(5) Quality Engineer—The responsibilities include to
(xv) Pumps
check the maintenance of the systems to perform.
(xvi) Door seal and leak test
(6) Maintenance Personnel—The responsibilities are to
(xvii) Sieving system
carry out machine cleaning operations, maintenance, and repair
(xviii) Purge check.
operations as per machine manufacturer prescriptions and
5.4.3 Reporting Information to Consider for Equipment
trainings and record maintenance history.
Validation:
5.5.2.3 Procedures and monitoring activities should include
5.4.3.1 The following items shall be included in the Equip-
specific details of process parameters and ensure that the
ment Validation / IQ report: validated state is maintained. If at any point the device is
(1) Executed IQ report. The report shall be filled out per
pushed to an unknown or inadequate state based on risk
Good Manufacturing Procedures (GMP). assessment (without valid statistical verification tasks or a
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robust performance data set to reference for the machine) and (c) Chemistry
dimensional, material, and functional does not conform to (d) Contamination within formed material
design intent, then revalidation may be needed. (e) Unsatisfactory surface finish or roughness or both;
5.5.3 Process Characterization: and
5.5.3.1 Engineering studies should be undertaken when
(f) Inadequate product functionality.
process limits are unknown. Appropriate statistical methods
5.5.3.5 Raw material considerations for process
should be deployed to define process limits in line with product
characterization—Documented characterization should be
requirements. All worse-case production process combinations
completed and account for the following factors:
should be addressed during characterization including feed-
(1) Clearly stated and controlled starting/receiving condi-
stock re-use, software workflow impact on final device char-
tion in line with ISO/ASTM 52907/52913.
acteristics and functionality, machine fleet variation, and long-
(2) Powder storage and facility qualification
term process variation.
(3) Powder characterization per Guide F3049 where appli-
5.5.3.2 Specific Considerations for Process Characterization
cable:
are key process input and output variables.
(a) Size determination
5.5.3.3 The following variables are deemed to impact the
(b) Morphology
quality of the output and shall be controlled and monitored. For
(c) Flow characteristics
product performance qualification, the following variables
(d) Chemical composition
should be evaluated for monitoring or controlling or both along
(e) Density
with frequency of activity:
(f) Sampling
(1) Beam power, spot size, and exposure time
(4) Documented controls and guidance on handling and
(2) Scan strategy and speed
compaction
(3) Layer thickness
(5) Defined powder recycling and re-use strategy in line
(4) Hatching strategy
Guide F3456
(5) Process gas parameters, for example, purity, pressure,
(6) Traceability and powder lot tracking
and flow rate
(7) Lot release to production
(6) Build platform material, condition, and preparation
(8) Monitoring of powder quality and link to material
(7) Build platform preheat temperature
performance.
(8) Recoater blade or roller condition/wear
5.5.3.6 Software workflow considerations for process char-
(9) Build platform location
acterization:
(10) Packing density of the plate
(1) Documented characterization should be completed and
(11) Part spacing
account for the following factors:
(12) Orientation
(a) File format conversions
(13) Support structures
(b) Model resolution and translation
(14) Equipment condition
(c) Slicing
(15) Ambient environmental conditions (for example, tem-
(d) Optic exposure settings
perature and humidity)
(e) Scaling and offsets
(16) Build process environmental conditions (for example,
(f) Support structure design
temperature, pressure, and atmospheric)
(g) Part modification for processing
(17) Feedstock condition:
(h) Part placement
(a) Powder lot change and
(i) Part orientation
(b) Content of recycled powder such as chemical
(j) Equipment software controls
constituency, particle size distribution, and morphology. Fur-
(k) Computer systems validatio
ther consideration in 5.5.3.5.
(l) Process parameters and environmental controls
5.5.3.4 Possible Output Variance—The following variances
(m) Part identification and traceability
in the output of the full production process should be docu-
(n) Documented change control
mented with respect to the parameters outlined in 5.6.1 and
(o) Timestamping and access controls
consideration given to:
(p) Identify security or corruption risks
(1) Failed build or unplanned stoppage
(2) As an output of process characterization, sufficient
(2) Lack of fusion or keyhole defects
processing parameters should be determined, and associated
(3) Excessive residual stresses leading to warpage, crack-
product acceptance criteria should be defined.
ing or delamination, or reduced device performance.
5.5.4 Software Workflow Validation:
(4) Inconsistency of part and feature dimensions.
(5) Inconsistency or increased variability of material prop- 5.5.4.1 General—Software workflow is critical to the AM
erties from established and historical capability linked to device file preparation, production, and final performance.
product performance. (1) Multiple file conversions and translation steps from
(a) Microstructure/cross-linkage digital to printable forms can impact product quality, data
(b) Mechanical integrity, and traceability.
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(2) Manual intervention is a major part of the end-to-end (1) Device design control (for example, 21 CFR 820.30) is
software workflow, and therefore, it is critical that system outside the scope of this document. However, process valida-
controls are established at each stage of the product life cycle
tion should consider the effects of product design, design
and the workflow impact on the final product quality is
verification, and design changes on process validation proce-
established. dure. Considerations should be made to the following aspects.
(3) Systems such as MES, LIMS, training software are also
(a) Product features or unique geometries due to process
important software systems to validate.
limitations / capabilities.
5.5.4.2 A full digital workflow mapping should take place (b) Material properties and achievable requirements for
before validation. Full end-to-end mapping should include all the chosen production process.
elements, including process software versions, design controls, (c) Documented design risk assessment and Design Fail-
change control procedure, file modification, conversion for ure Mode and Effect Analysis (DFMEA) as respect to failure
each step, data transfer procedures, MES, and LIMS. modes and severity of those failure modes. Reference ISO/
ASTM 52910, ISO/ASTM 52911-1, and ISO/ASTM 52911-2.
5.5.4.3 Appropriate file management, traceability, digital
(d) When product features or function is tested through
footprint, and cybersecurity are key aspects to consider. ISO/
the use of test coupons, a correlation study should be com-
ASTM 52915 and 52950 can provide guidance on file format
pleted to show the coupon-to-part relationship.
and data processing when considering the digital workflow.
5.5.4.4 The software workflow validation should consider
5.6 Operational Qualification:
the following factors and the potential impact on final device
5.6.1 Pre-Requisites:
performance. Controls should be in place to ensure a validated
(1) The following items must be completed before execu-
state through the lifetime of the product:
tion of an OQ protocol:
(1) File format conversions
(a) The validation plan is approved released.
(2) Model resolution and translation
(b) OQ protocol(s) approved / released.
(3) Slicing
(c) All equipment IQ reports shall be approved / released
(4) Exposure settings
for the process step being validated.
(5) Scaling and offsets
(d) Draft process work instructions (WI) exist. Redlines
(6) Support structure design
for OQ process settings should be made to the WI. It is
(7) Part modification for processing
preferred that work instructions are approved / released.
(8) Part placement
(e) All personnel executing the OQ protocol shall be
(9) Part orientation
trained to the validation plan and OQ protocol prior to
(10) Equipment software controls
execution.
(11) Computer systems validation
(f) All test methods shall be approved / released and
(12) Process parameters and environmental controls
validated prior to any testing required per the OQ protocol.
(13) Part identification and traceability
5.6.2 General:
(14) Documented change control
(15) Timestamping and access controls 5.6.2.1 The purpose of operational qualification is to pro-
(16) Identify any security or corruption risks
vide rigorous testing to demonstrate the effectiveness and
(17) MES
reproducibility of the process at the bounds of the process
(18) LIMS
window as shown in Fig. 2. Process characterization to
determine the key process variables may be a prerequisite to
5.5.4.5 AM technology will have unique software controls
and a unique digital interface. Software validation for equip- the operational qualification. Other times, at the organization’s
discretion and based on internal QMS, process characterization
ment should take place before or as part of the installation
qualification. may be integrated with Operational Qualification. Establishing
(1) A clear differentiation should take place between the the nominal processing window for key variables is a funda-
firmware inputs that are changeable by the device manufacturer mental output of OQ. Therefore, the nominal processing
or as part of machine manufacture. window should not be defined prior to OQ and studies
(2) Hardware calibration, systems configuration, and quali-
performed during OQ should be based on defined ch
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