ASTM G121-18

Standard Practice for Preparation of Contaminated Test Coupons for the Evaluation of Cleaning Agents

SIGNIFICANCE AND USE
5.1 This practice will be suitable to direct the preparation of test coupons with a known amount of contaminant on the surface. A standard test coupon is described and a list of contaminants that have typically been found in oxygen-enriched systems and components is provided.  
5.2 These test coupons shall be used in the evaluation of cleaning agents for oxygen-enriched systems and components. This will permit direct comparison within and between test facilities.  
5.3 Materials used in other fluid handling systems such as nitrogen, helium, hydrogen, gasoline, etc. may also be prepared for evaluation by this practice.
SCOPE
1.1 This practice describes the procedure for the preparation of single- and double-sided contaminated test coupons for the evaluation of cleaning agents. It is applicable for the evaluation of cleaning agents proposed for the cleaning of oxygen equipment, pharmaceutical manufacturing equipment, and medical devices (see Test Method G122 and Guide G127). It also is applicable to other systems where contamination is a concern.  
1.2 Several classes of contaminants/residues most likely to be found in oxygen equipment, pharmaceutical manufacturing equipment, and medical devices are identified. However, if the user of this practice has identified contaminants not included in these classes, such identified contaminants may be substituted for the preparation of the test coupons if appropriate for this test method.  
1.3 Solvent and cleaning agent compatibility with nonmetallic substrates should be verified prior to the preparation of the test coupons. Typical nonmetallic materials utilized in oxygen systems are contained in Guide G63.  
1.4 This practice may involve hazardous materials, operations, and equipment. This practice does not purport to address all of the safety concerns associated with its use. It is the responsibility of whomever uses this practice to consult and 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: 30-Nov-2018
• ICS: 71.100.40 - Surface active agents
• Technical Committee: G04 - Compatibility and Sensitivity of Materials in Oxygen Enriched Atmospheres
• Drafting Committee: G04.02 - Recommended Practices

Relations

• Refers: ASTM E1235-12(2020) - Standard Test Method for Gravimetric Determination of Nonvolatile Residue (NVR) in Environmentally Controlled Areas for Spacecraft
• Effective Date: 01-Apr-2020
• Refers: ASTM E1235-12(2020)e1 - Standard Test Method for Gravimetric Determination of Nonvolatile Residue (NVR) in Environmentally Controlled Areas for Spacecraft
• Effective Date: 01-Apr-2020
• Refers: ASTM E3106-17 - Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation
• Effective Date: 01-Dec-2017
• Refers: ASTM E3106-18 - Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation
• Effective Date: 01-Sep-2018
• Refers: ASTM F331-13(2020) - Standard Test Method for Nonvolatile Residue of Solvent Extract from Aerospace Components (Using Flash Evaporator)
• Effective Date: 01-Apr-2020
• Referred By: ASTM F2847-17 - Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments
• Effective Date: 01-Dec-2018
• Referred By: ASTM G122-20 - Standard Test Method for Evaluating the Effectiveness of Cleaning Agents and Processes
• Effective Date: 01-Dec-2018
• Referred By: ASTM F3127-22 - Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
• Effective Date: 01-Dec-2018
• Referred By: ASTM G144-01(2022) - Standard Test Method for Determination of Residual Contamination of Materials and Components by Total Carbon Analysis Using a High Temperature Combustion Analyzer
• Effective Date: 01-Dec-2018
• Referred By: ASTM D6361/D6361M-98(2020) - Standard Guide for Selecting Cleaning Agents and Processes
• Effective Date: 01-Dec-2018
• Referred By: ASTM E3106-22 - Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation
• Effective Date: 01-Dec-2018
• Referred By: ASTM E3263-22e1 - Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues
• Effective Date: 01-Dec-2018
• Referred By: ASTM F2459-18 - Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis
• Effective Date: 01-Dec-2018
• Referred By: ASTM G126-16(2023) - Standard Terminology Relating to the Compatibility and Sensitivity of Materials in Oxygen Enriched Atmospheres
• Effective Date: 01-Dec-2018
• Referred By: ASTM G131-96(2023)e1 - Standard Practice for Cleaning of Materials and Components by Ultrasonic Techniques
• Effective Date: 01-Dec-2018
• Referred By: ASTM G127-15(2023) - Standard Guide for the Selection of Cleaning Agents for Oxygen-Enriched Systems
• Effective Date: 01-Dec-2018

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: G121 − 18
Standard Practice for
Preparation of Contaminated Test Coupons for the
1
Evaluation of Cleaning Agents
This standard is issued under the fixed designation G121; 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.
1. Scope 2. Referenced Documents
2
2.1 ASTM Standards:
1.1 This practice describes the procedure for the preparation
D1193 Specification for Reagent Water
of single- and double-sided contaminated test coupons for the
E1235 Test Method for Gravimetric Determination of Non-
evaluationofcleaningagents.Itisapplicablefortheevaluation
volatile Residue (NVR) in Environmentally Controlled
of cleaning agents proposed for the cleaning of oxygen
Areas for Spacecraft
equipment, pharmaceutical manufacturing equipment, and
E3106 Guide for Science-Based and Risk-Based Cleaning
medical devices (see Test Method G122 and Guide G127). It
Process Development and Validation
also is applicable to other systems where contamination is a
F303 Practices for Sampling for Particles in Aerospace
concern.
Fluids and Components
1.2 Several classes of contaminants/residues most likely to
F312 Test Methods for Microscopical Sizing and Counting
be found in oxygen equipment, pharmaceutical manufacturing
Particles from Aerospace Fluids on Membrane Filters
equipment, and medical devices are identified. However, if the
F324 Test Method for Nonvolatile Residue of Volatile
user of this practice has identified contaminants not included in
Cleaning Solvents Using the Solvent Purity Meter (With-
3
these classes, such identified contaminants may be substituted
drawn 1987)
for the preparation of the test coupons if appropriate for this
F331 Test Method for Nonvolatile Residue of Solvent Ex-
test method.
tract from Aerospace Components (Using Flash Evapora-
tor)
1.3 Solvent and cleaning agent compatibility with nonme-
F3127 GuideforValidatingCleaningProcessesUsedDuring
tallic substrates should be verified prior to the preparation of
the Manufacture of Medical Devices
the test coupons. Typical nonmetallic materials utilized in
G63 Guide for Evaluating Nonmetallic Materials for Oxy-
oxygen systems are contained in Guide G63.
gen Service
1.4 This practice may involve hazardous materials, G94 Guide for Evaluating Metals for Oxygen Service
operations, and equipment. This practice does not purport to G122 Test Method for Evaluating the Effectiveness of
Cleaning Agents
address all of the safety concerns associated with its use. It is
the responsibility of whomever uses this practice to consult and G127 Guide for the Selection of Cleaning Agents for
Oxygen-Enriched Systems
establish appropriate safety, health, and environmental prac-
4
tices and determine the applicability of regulatory limitations
2.2 ANSI Standard:
prior to use.
B46.1 Surface Texture (Surface Roughness, Waviness, and
1.5 This international standard was developed in accor-
Lay)
dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the
3. Terminology
Development of International Standards, Guides and Recom-
3.1 Definitions:
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
1
This practice is under the jurisdiction of ASTM Committee G04 on Compat- Standards volume information, refer to the standard’s Document Summary page on
ibility and Sensitivity of Materials in Oxygen Enriched Atmospheres and is the the ASTM website.
3
direct responsibility of Subcommittee G04.02 on Recommended Practices. The last approved version of this historical standard is referenced on
Current edition approved Dec. 1, 2018. Published January 2019. Originally www.astm.org.
ɛ1 4
approved in 1993. Last previous edition approved in 2015 as G121 – 98 (2015) . Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
DOI: 10.1520/G0121-18. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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G121 − 18
3.1.1 blank, n—the contamination level of the fluid when by weighing the test coupons before and after application. The
the test coupon is omitted. amount of contaminant applied should be controlled and
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
´1
Designation: G121 − 98 (Reapproved 2015) G121 − 18
Standard Practice for
Preparation of Contaminated Test Coupons for the
1
Evaluation of Cleaning Agents
This standard is issued under the fixed designation G121; 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.
1
ε NOTE—Editorial changes were made throughout in October 2015.
1. Scope
1.1 This practice describes the procedure for the preparation of single- and double-sided contaminated metallic test coupons for
the evaluation of cleaning agents. It is applicable for the evaluation of cleaning agents proposed for the cleaning of
oxygen-enriched systems and components. oxygen equipment, pharmaceutical manufacturing equipment, and medical devices (see
Test Method G122 and Guide G127). It also is applicable to other systems where contamination is a concern.
1.2 Several classes of contaminantscontaminants/residues most likely to be found in oxygen-enriched systems and components
oxygen equipment, pharmaceutical manufacturing equipment, and medical devices are identified. However, if the user of this
practice has identified contaminants not included in these classes, such identified contaminants may be substituted for the
preparation of the test coupons.coupons if appropriate for this test method.
1.3 Preparation of nonmetallic substrates is not addressed, although similar methodology may be used. Solvent and cleaning
agent compatibility with the nonmetallic substratesubstrates should be verified prior to the preparation of the test coupons. Typical
nonmetallic materials utilized in oxygen systems are contained in Guide G63.
1.4 This practice may involve hazardous materials, operations, and equipment. This practice does not purport to address all
of the safety concerns associated with its use. It is the responsibility of whomever uses this practice to consult and establish
appropriate safety safety, health, and healthenvironmental 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.
2. Referenced Documents
2
2.1 ASTM Standards:
D1193 Specification for Reagent Water
E1235 Test Method for Gravimetric Determination of Nonvolatile Residue (NVR) in Environmentally Controlled Areas for
Spacecraft
E3106 Guide for Science-Based and Risk-Based Cleaning Process Development and Validation
F303 Practices for Sampling for Particles in Aerospace Fluids and Components
F312 Test Methods for Microscopical Sizing and Counting Particles from Aerospace Fluids on Membrane Filters
3
F324 Test Method for Nonvolatile Residue of Volatile Cleaning Solvents Using the Solvent Purity Meter (Withdrawn 1987)
F331 Test Method for Nonvolatile Residue of Solvent Extract from Aerospace Components (Using Flash Evaporator)
F3127 Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
G63 Guide for Evaluating Nonmetallic Materials for Oxygen Service
G94 Guide for Evaluating Metals for Oxygen Service
G122 Test Method for Evaluating the Effectiveness of Cleaning Agents
1
This practice is under the jurisdiction of ASTM Committee G04 on Compatibility and Sensitivity of Materials in Oxygen Enriched Atmospheres and is the direct
responsibility of Subcommittee G04.02 on Recommended Practices.
Current edition approved Sept. 1, 2004Dec. 1, 2018. Published October 2015January 2019. Originally approved in 1993. Last previous edition approved in 20102015 as
ɛ1
G121 – 98 (2010)(2015) . DOI: 10.1520/G0121-98R15E01.10.1520/G0121-18.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
The last approved version of this historical standard is referenced on www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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G121 − 18
G127 Guide for the S
...