ASTM G122-20

Standard Test Method for Evaluating the Effectiveness of Cleaning Agents and Processes

SIGNIFICANCE AND USE
5.1 The purpose of these test methods is to define a procedure for evaluating the capability and effectiveness of cleaning agents to remove residues of a compound/product from surrogate surfaces (that is, coupons or beakers) of Materials of Construction. This test method also provides a procedure for determining the compatibility of cleaning agents with the Material of Construction prior to starting tests. Based on the outcome of the testing, suitable cleaning agents may be selected for further cleaning process development (see Guide D6361/D6361M).  
5.2 The potential critical cleaning parameters related to the cleaning agent(s) under study may also be examined using these tests. Potentially critical cleaning parameters include cleaning agent concentration, temperature, time, pH, foaming, type and strength of ultrasonic energy or agitation (if used), and others. These parameters may be varied (for example, using Design of Experiments) to determine their potential optimal settings for actual use.
SCOPE
1.1 This test method covers a procedure for evaluating the effectiveness and capability of cleaning agents to remove contamination to the desired level. This includes removing drug residues from manufacturing equipment and residues from medical devices (Guide E3106), as well as systems for oxygen service.  
1.2 The test coupons/beakers described in this standard provide a representative surface to which contamination can be applied and tested for the ability of a cleaning agent to remove it.  
1.3 This test method is a laboratory scale approximation and the actual effectiveness of a particular cleaning agent depends upon the method (temperature, agitation, concentration, etc.) in which it is used and the characteristics of the article being cleaned, such as size, shape, and material. Final evaluation of the cleaning agent should include testing of actual products and cleaning processes.  
1.4 Units—The values stated in SI units are to be regarded as standard. The values given in parentheses after SI units are provided for information only and are not considered standard.  
1.5 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 safety of each compound on a case-by-case basis.  
1.6 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: 31-Aug-2020
• ICS: 71.100.40 - Surface active agents
• Technical Committee: G04 - Compatibility and Sensitivity of Materials in Oxygen Enriched Atmospheres
• Drafting Committee: G04.01 - Test Methods

Relations

• Refers: ASTM D6361/D6361M-98(2020) - Standard Guide for Selecting Cleaning Agents and Processes
• Effective Date: 01-Apr-2020
• Refers: ASTM G93/G93M-19 - Standard Guide for Cleanliness Levels and Cleaning Methods for Materials and Equipment Used in Oxygen-Enriched Environments
• Effective Date: 01-Oct-2019
• Refers: ASTM G121-18 - Standard Practice for Preparation of Contaminated Test Coupons for the Evaluation of Cleaning Agents
• Effective Date: 01-Dec-2018
• Refers: ASTM E3106-18 - Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation
• Effective Date: 01-Sep-2018
• Refers: ASTM E3106-17 - Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation
• Effective Date: 01-Dec-2017
• Refers: ASTM D6361/D6361M-98(2015) - Standard Guide for Selecting Cleaning Agents and Processes
• Effective Date: 01-Jun-2015
• Refers: ASTM D6317-15 - Standard Test Method for Low Level Determination of Total Carbon, Inorganic Carbon and Organic Carbon in Water by Ultraviolet, Persulfate Oxidation, and Membrane Conductivity Detection
• Effective Date: 01-May-2015
• Refers: ASTM E177-14 - Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
• Effective Date: 01-May-2014
• Refers: ASTM E691-13 - Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
• Effective Date: 01-May-2013
• Refers: ASTM E177-13 - Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
• Effective Date: 01-May-2013
• Refers: ASTM E691-11 - Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
• Effective Date: 01-Nov-2011
• Refers: ASTM E177-10 - Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
• Effective Date: 01-Oct-2010
• Refers: ASTM D6361/D6361M-98(2010)e1 - Standard Guide for Selecting Cleaning Agents and Processes
• Effective Date: 01-Jun-2010
• Refers: ASTM E177-08 - Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
• Effective Date: 01-Oct-2008
• Refers: ASTM E691-08 - Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
• Effective Date: 01-Oct-2008

Overview

ASTM G122-20: Standard Test Method for Evaluating the Effectiveness of Cleaning Agents and Processes establishes procedures for assessing how well cleaning agents remove contaminants from surrogate surfaces. This standard is crucial for industries that require a high degree of cleanliness, such as pharmaceutical manufacturing, medical device production, and systems intended for oxygen service. It defines a laboratory-scale method to quantify cleaning effectiveness, helping users make informed decisions for process development and regulatory compliance while minimizing contamination risks.

Key Topics

• Cleaning Agent Evaluation: The standard provides a framework to test both aqueous and non-aqueous cleaning agents on surfaces similar to actual equipment (test coupons and beakers), determining their ability to remove specific residues.
• Critical Cleaning Parameters: Variables such as concentration, temperature, pH, agitation (ultrasonic or mechanical), and exposure time are identified as critically influencing the cleaning process. These can be systematically varied to find optimal cleaning conditions.
• Material Compatibility: The procedure includes initial testing to verify that the cleaning agents are compatible with the materials of construction, whether metals or non-metals, ensuring that no corrosion, oxidation, or damage occurs.
• Quantitative Assessment: Effectiveness is measured using gravimetric and analytical techniques, such as mass loss or Total Organic Carbon analysis. The Cleaning Effectiveness Factor (CEF) indicates the fraction of contaminant removed, while residual contamination is determined per unit surface area.
• Documentation and Validation: The method emphasizes thorough documentation, including all cleaning parameters, mass measurements, and statistical evaluation, which supports validation and regularity reporting requirements.

Applications

ASTM G122-20 is widely used to:

• Pharmaceutical Equipment Cleaning: Ensures equipment used in drug manufacturing is free of cross-contamination, supporting compliance with Good Manufacturing Practice (GMP).
• Medical Device Processing: Assesses and verifies that cleaning protocols for medical devices remove potentially harmful residues, contributing to patient safety.
• Oxygen System Preparation: Validates that equipment and components used in oxygen-enriched environments are adequately cleaned to prevent reactions, reducing the risk of fire or explosion.
• Process Development: Supports method development by allowing users to compare cleaning agents and protocols under controlled laboratory conditions, facilitating optimization before implementing at scale.
• Regulatory Compliance: Demonstrates control over cleaning processes as required by key industry regulators and internal quality systems.

Related Standards

Several standards are referenced or closely associated with ASTM G122-20 to provide guidance on adjacent aspects of cleaning validation and material compatibility:

• ASTM D6361/D6361M: Guide for Selecting Cleaning Agents and Processes
• ASTM G121: Practice for Preparation of Contaminated Test Coupons for Evaluation of Cleaning Agents
• ASTM G127: Guide for Selection of Cleaning Agents for Oxygen-Enriched Systems
• ASTM E3106: Guide for Science-Based and Risk-Based Cleaning Process Development and Validation
• ASTM D1193: Specification for Reagent Water (for preparing cleaning solutions)
• ASTM G93/G93M: Guide for Cleanliness Levels and Cleaning Methods for Oxygen-Enriched Environments

Practical Value

Implementing ASTM G122-20 enables organizations to:

• Objectively compare cleaning agents and methods for specific residues and substrates.
• Identify optimal cleaning conditions (concentration, temperature, agitation, etc.) based on data.
• Ensure equipment and surfaces are cleaned to desired levels-critical for product quality and safety.
• Document and validate cleaning processes for regulatory inspections and audits.
• Reduce the risk of contamination, corrosion, or material degradation by confirming compatibility before full-scale use.

By adopting this standardized method, industries can enhance product integrity, comply with international regulatory expectations, and foster continuous process improvement in cleaning operations.

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: G122 − 20
Standard Test Method for
Evaluating the Effectiveness of Cleaning Agents and
Processes
This standard is issued under the fixed designation G122; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
Many products, systems, and manufacturing equipment require a high degree of cleanliness. For
example, many medical devices must be cleaned (the terms clean, cleaned, or cleaning are used
intentionally and do not imply disinfect, disinfecting, or disinfected) of residues that may cause
problemswhentheycomeincontactwithpatients.Gaseousandliquidoxygensystemsmustbeclean,
particularly of hydrocarbons, to avoid the potential hazard of a reaction and subsequent fire or
explosion. Pharmaceutical manufacturing equipment must be cleaned to prevent product cross
contamination from residues. Cleaning agents need to be identified and selected based on their
effectivenesstoachievecleaningofthesystem,product,ormanufacturingequipment.Theremayalso
be other considerations, such as chlorinated solvents that have been used to clean systems and
equipment that must be free of hydrocarbons and other contaminants and environmental concerns
dictate that suitable replacements are needed.
This test method presents a procedure that may be used to evaluate candidate aqueous or
non-aqueous cleaning agents for use in cleaning products, systems, or equipment, including medical
devices, systems for oxygen service, and drug manufacturing equipment.
1. Scope 1.4 Units—The values stated in SI units are to be regarded
as standard. The values given in parentheses after SI units are
1.1 This test method covers a procedure for evaluating the
providedforinformationonlyandarenotconsideredstandard.
effectiveness and capability of cleaning agents to remove
1.5 This standard does not purport to address all of the
contamination to the desired level. This includes removing
safety concerns, if any, associated with its use. It is the
drug residues from manufacturing equipment and residues
responsibility of the user of this standard to establish appro-
from medical devices (Guide E3106), as well as systems for
priate safety, health, and environmental practices and deter-
oxygen service.
mine the safety of each compound on a case-by-case basis.
1.2 The test coupons/beakers described in this standard
1.6 This international standard was developed in accor-
providearepresentativesurfacetowhichcontaminationcanbe
dance with internationally recognized principles on standard-
applied and tested for the ability of a cleaning agent to remove
ization established in the Decision on Principles for the
it.
Development of International Standards, Guides and Recom-
1.3 Thistestmethodisalaboratoryscaleapproximationand
mendations issued by the World Trade Organization Technical
the actual effectiveness of a particular cleaning agent depends
Barriers to Trade (TBT) Committee.
uponthemethod(temperature,agitation,concentration,etc.)in
which it is used and the characteristics of the article being
2. Referenced Documents
cleaned, such as size, shape, and material. Final evaluation of
2.1 ASTM Standards:
thecleaningagentshouldincludetestingofactualproductsand
D1193Specification for Reagent Water
cleaning processes.
D6317Test Method for Low Level Determination of Total
Carbon, Inorganic Carbon and Organic Carbon in Water
This test method is under the jurisdiction of ASTM Committee G04 on
Compatibility and Sensitivity of Materials in Oxygen EnrichedAtmospheres and is
the direct responsibility of Subcommittee G04.01 on Test Methods. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Sept. 1, 2020. Published September 2020. Originally contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
ε1
approved in 1993. Last previous edition approved in 2015 as G122–96(2015) . Standards volume information, refer to the standard’s Document Summary page on
DOI: 10.1520/G0122-20. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
G122 − 20
by Ultraviolet, Persulfate Oxidation, and Membrane Con- cleaning agent concentration, agitation, etc.) found during
ductivity Detection actual cleaning as much as possible. Cleaning may be per-
D6361/D6361MGuide for Selecting Cleaning Agents and formed using a cleaning tank with or without ultrasonic
Processes agitation,elevatedtemperature,orothercleaningenhancement
E177Practice for Use of the Terms Precision and Bias in features and may depend on the manufacturer’s instructions.
ASTM Test Methods Cleaning methods may include Immersion models, Cascading
E691Practice for Conducting an Interlaboratory Study to Flow models, Clean-In-Place (CIP) models, etc.The effective-
Determine the Precision of a Test Method nessofthecleaningprocessisrepresentedasCEF,thecleaning
E3106Guide for Science-Based and Risk-Based Cleaning effectivenessfactor,thefractionofthecontaminantremovedas
Process Development and Validation determined by gravimetric or other quantitative techniques. A
G93/G93MGuide for Cleanliness Levels and Cleaning controlcouponisusedtoaccountforanycorrosionormaterial
Methods for Materials and Equipment Used in Oxygen- removaleffectsduetothecleaningagent/process,ortoaccount
Enriched Environments for the normal Loss on Drying due to the contaminant’s water
G121Practice for Preparation of Contaminated Test Cou- or volatile content, unless this has been tested for previously.
pons for the Evaluation of Cleaning Agents
G127Guide for the Selection of Cleaning Agents for
5. Significance and Use
Oxygen-Enriched Systems
5.1 The purpose of these test methods is to define a
procedure for evaluating the capability and effectiveness of
3. Terminology
cleaning agents to remove residues of a compound/product
3.1 Definitions:
from surrogate surfaces (that is, coupons or beakers) of
3.1.1 cleanability, n—relative difficulty for cleaning a piece
Materials of Construction. This test method also provides a
of equipment, product, or device.
procedure for determining the compatibility of cleaning agents
3.1.2 cleaning agent, n—an agent used to support the
with the Material of Construction prior to starting tests. Based
removal of a contaminant from equipment surfaces or other
on the outcome of the testing, suitable cleaning agents may be
critical objects (such as a medical device).
selected for further cleaning process development (see Guide
3.1.3 cleaning effectiveness factor (CEF), n—the fraction of D6361/D6361M).
contaminantremoved,orremaining,fromaninitiallycontami-
5.2 The potential critical cleaning parameters related to the
nated test coupon and determined by gravimetric or other
cleaning agent(s) under study may also be examined using
analytical techniques (for example, Total Organic Carbon
these tests. Potentially critical cleaning parameters include
analysis, etc.).
cleaning agent concentration, temperature, time, pH, foaming,
3.1.4 residual contamination, R ,n—the absolute mass of
C typeandstrengthofultrasonicenergyoragitation(ifused),and
contaminant remaining after the cleaning process and ex-
others. These parameters may be varied (for example, using
pressed in micrograms per square centimetre of area or
Design of Experiments) to determine their potential optimal
optionally as milligrams per square foot.
settings for actual use.
3.1.5 surface roughness, R ,n—the arithmetic average
A
deviation of the surface profile from the centerline, normally 6. Apparatus
reported in micrometers or micro inches.
6.1 Materials:
3.1.6 test beaker, n—a variant of a test coupon in that the
6.1.1 Test Coupon/Beaker, prepared in accordance with
configuration is similar to a laboratory beaker and the process
Practice G121.
residue under study is deposited on the inner walls or bottom.
6.1.2 Control Coupon/Beaker—This is uncontaminated and
3.1.7 test coupon, n—representative surface that is typically
issubjectedtotheidenticalcleaningprocedureasthecontami-
a rectangular piece of a material of construction on which a
nated coupons and serves to evaluate corrosion and erosion of
known amount of a compound is deposited to simulate a
the test coupons.
process residue.
6.1.3 Cleaning Agent, prepared according to the manufac-
3.1.8 visual inspection, n—processofusingthehumaneye,
turer’s instructions. If the CleaningAgent is used after dilution
alone or in conjunction with various aids, as the sensing
with water, Specification D1193 Type I to IV water shall be
mechanism from which judgments may be made about the
usedforpreparingaqueoussolutionsorpreparedwithwaterof
condition of the surface to be inspected.
the purity used in the actual cleaning.
4. Summary of Test Methods 6.2 Equipment:
6.2.1 Cleaning Tank, of sufficient size to conduct a number
4.1 These test methods provide quantitative results as to the
of evaluations simultaneously. Testing is enhanced by having
ability of a specific cleaning agent/process for removing
automatic temperature and time controls.Acleaning tank with
selected contaminants from standard coupons. The coupons
ultrasonics may be used.
usedfortestingarepreparedinaccordancewithPracticeG121.
To achieve results and data of the highest relevance, the 6.2.2 Balance, accuracy to 0.1 mg. However, 0.01 mg
method should be a close model of the cleaning system used accuracy is desirable to detect contamination levels
2 2
thatcanapproximatetheconditions(forexample,temperature, of10mg⁄m (1mg⁄ft ) or less.
G122 − 20
6.2.3 Beaker Holder—A device to support beakers in the study if MOC compatibility or the contaminant’s normal Loss
ultrasonic cleaner tank such that the beakers do not contact the on Drying has not already been determined as described above
bottom and sides of the tank. or unless prior testing indicates this is unnecessary.
NOTE 1—Due to pharmaceutical regulations, all Materials of Construc-
7. Material Compatibility Testing
tion must be "non-reactive and non-additive" for use in drug manufacture
and have typically already been approved for use.
7.1 Initial Determination of Material Compatibility—The
first step in using this guide is to determine the compatability
8.2 Indicate the masses of coupons in grams as MXy where
ofthematerial,ormaterialsoftheparts,beingcleanedwiththe
X is the coupon designation (number, letter, or name) and y =
cleaning agent(s) (see Guide G127).This will provide material
1 indicates a clean coupon,y=2 indicates a contaminated
compatibility test data required to ensure the cleaner will not
coupon, andy=3 indicates a coupon after cleaning.
damage the parts being cleaned. It is important to note that
8.3 Designate one coupon/beaker as the control to undergo
alloys behave differently than pure metals and different alloys
cleaning without contamination (if used).
behave differently than other alloys; therefore, specific alloys
8.4 Measure the mass of the control and test coupons/
must be utilized when conducting these compatibility tests.
beakers (recording them as MX1 as previously defined).
Non-metallic materials (for example, plastics) may also have
compatibility issues with cleaners and this should be consid-
8.5 Contaminate the test coupons in accordance with Prac-
ered as well. If data are not available on a specific alloy with
tice G121.
aspecificcleaner,thesedatamustbedevelopedpriortotheuse
8.6 Measure the mass of all contaminated test coupons
of the cleaner. This can be performed by exposing the
(recording them as MX2 as previously defined).
Coupon/Beaker of different Materials of Construction to the
8.7 Process the control coupon in the test cleaning solution
cleaning agent(s) to determine their compatibility prior to
separately from the contaminated test coupons.
running any cleaning agent studies.
8.8 The contaminated test coupons can be processed in
7.2 Validation of Procedure—Examine the control coupons
independent beakers held in the cleaning tank or as a batch in
to determine whether they lost mass (such as might occur if
a single beaker.
there was corrosion, incompatibility or oxidation occurring, if
the coupons were dissolving, or if the standard cleaning
8.9 Clean the test and control coupons in
...

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: G122 − 96 (Reapproved 2015) G122 − 20
Standard Test Method for
Evaluating the Effectiveness of Cleaning Agents and
Processes
This standard is issued under the fixed designation G122; 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.
ε NOTE—Editorial correction made in October 2015.
INTRODUCTION
Many systems products, systems, and manufacturing equipment require a high degree of
cleanliness. For example, gaseous and many medical devices must be cleaned (the terms clean,
cleaned, or cleaning are used intentionally and do not imply disinfect, disinfecting, or disinfected) of
residues that may cause problems when they come in contact with patients. Gaseous and liquid oxygen
systems must be clean, particularly of hydrocarbons, to avoid the potential hazard of a reaction and
subsequent fire or explosion. Typically, chlorinated solvents Pharmaceutical manufacturing equipment
must be cleaned to prevent product cross contamination from residues. Cleaning agents need to be
identified and selected based on their effectiveness to achieve cleaning of the system, product, or
manufacturing equipment. There may also be other considerations, such as chlorinated solvents that
have been used to clean systems and equipment that must be free of hydrocarbons and other
contaminants. Environmental contaminants and environmental concerns dictate that suitable replace-
ments are needed. This test method presents a procedure that may be used to evaluate candidate
aqueous or non aqueous cleaning agents.
This test method presents a procedure that may be used to evaluate candidate aqueous or
non-aqueous cleaning agents for use in cleaning products, systems, or equipment, including medical
devices, systems for oxygen service, and drug manufacturing equipment.
1. Scope
1.1 This test method covers a procedure for evaluating the effectiveness and capability of cleaning agents and processes to remove
contamination to the desired level. This includes removing drug residues from manufacturing equipment and residues from medical
devices (Guide E3106), as well as systems for oxygen service.
1.2 The test coupons coupons/beakers described in this standard provide a relatively rough representative surface to which
contamination can easily adhere.be applied and tested for the ability of a cleaning agent to remove it.
1.3 The capability This test method is a laboratory scale approximation and the actual effectiveness of a particular cleaning agent
depends upon the method by (temperature, agitation, concentration, etc.) in which it is used and the characteristics of the article
being cleaned, such as size, shape, and material. Final evaluation of the cleaning agent should include testing of actual products
and production process.cleaning processes.
This test method 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 G04.01 on Test Methods.
Current edition approved Oct. 1, 2015Sept. 1, 2020. Published October 2015September 2020. Originally approved in 1993. Last previous edition approved in 20082015
ε1
as G122 – 96 (2008).(2015) . DOI: 10.1520/G0122-96R15E01.10.1520/G0122-20.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
G122 − 20
1.4 Units—The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information
only.after SI units are provided for information only and are not considered standard.
1.5 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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.safety of each compound on a case-by-case Specific precautionary statements
are given in basis.Note 2.
1.6 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
2.1 ASTM Standards:
D1193 Specification for Reagent Water
D6317 Test Method for Low Level Determination of Total Carbon, Inorganic Carbon and Organic Carbon in Water by
Ultraviolet, Persulfate Oxidation, and Membrane Conductivity Detection
D6361/D6361M Guide for Selecting Cleaning Agents and Processes
E177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods
E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
G94E3106 Guide for Evaluating Metals for Oxygen ServiceScience-Based and Risk-Based Cleaning Process Development and
Validation
G93/G93M Guide for Cleanliness Levels and Cleaning Methods for Materials and Equipment Used in Oxygen-Enriched
Environments
G121 Practice for Preparation of Contaminated Test Coupons for the Evaluation of Cleaning Agents
G127 Guide for the Selection of Cleaning Agents for Oxygen-Enriched Systems
2.2 ANSI Standard:
D46.1 Surface Texture (Surface Roughness, Waviness, Lay)
3. Terminology
3.1 Definitions:
3.1.1 cleanability, n—relative difficulty for cleaning a piece of equipment, product, or device.
3.1.2 cleaning agent, n—an agent used to support the removal of a contaminant from equipment surfaces or other critical objects
(such as a medical device).
3.1.3 cleaning effectiveness factor (CEF), n—the fraction of contaminant removed removed, or remaining, from an initially
contaminated test coupon and determined by gravimetric techniques.or other analytical techniques (for example, Total Organic
Carbon analysis, etc.).
3.1.4 residual contamination, R ,n—the absolute mass of contaminant remaining after the cleaning process and expressed in
cC
milligramsmicrograms per square centimetre of area or optionally as milligrams per square foot.
3.1.5 surface roughness, R ,n—the arithmetic average deviation of the surface profile from the centerline, normally reported in
A
micrometres.micrometers or micro inches.
3.1.6 test beaker, n—a variant of a test coupon in that the configuration is similar to a laboratory beaker and the process residue
under study is deposited on the inner walls or bottom.
3.1.7 test coupon, n—representative surface that is typically a rectangular piece of a material of construction on which a known
amount of a compound is deposited to simulate a process residue.
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.
G122 − 20
3.1.8 visual inspection, n— process of using the human eye, alone or in conjunction with various aids, as the sensing mechanism
from which judgments may be made about the condition of the surface to be inspected.
4. Summary of Test MethodMethods
4.1 ThisThese test method providesmethods provide quantitative results as to the ability of a specific cleaning agent/process for
removing selected contaminants from standard coupons. The coupons used for testing are prepared in accordance with Practice
G121. Cleaning is To achieve results and data of the highest relevance, the method should be a close model of the cleaning system
used that can approximate the conditions (for example, temperature, cleaning agent concentration, agitation, etc.) found during
actual cleaning as much as possible. Cleaning may be performed using a cleaning tank with or without ultrasonic agitation,
elevated temperature, or other cleaning enhancement features and depends may depend on the manufacturer’s instructions.
manufacturer’s instructions. Cleaning methods may include Immersion models, Cascading Flow models, Clean-In-Place (CIP)
models, etc. The effectiveness of the cleaning process is represented as CEF, the cleaning effectiveness factor, that is the fraction
of the contaminant removed as determined by gravimetric or other quantitative techniques. A control coupon is used to account
for any corrosion or material removal effects due to the cleaning agent/process.agent/process, or to account for the normal Loss
on Drying due to the contaminant’s water or volatile content, unless this has been tested for previously.
5. Significance and Use
5.1 The purpose of thisthese test methodmethods is to define a procedure for evaluating the capability and effectiveness of cleaning
agents to clean metallic coupons. remove residues of a compound/product from surrogate surfaces (that is, coupons or beakers)
of Materials of Construction. This test method also provides a procedure for determining the compatibility of cleaning agents with
the Material of Construction prior to starting tests. Based on the outcome of the testing, suitable cleaning agents may be selected
for cleaning in general and forfurther cleaning process development (see Guide D6361/D6361Moxygen service in particular.).
5.2 The potential critical cleaning parameters can be changed and the test method can be repeated. The usual related to the cleaning
agent(s) under study may also be examined using these tests. Potentially critical cleaning parameters include cleaning agent
concentration, temperature, and time; time, pH, foaming, type and strength of ultrasonic energy or agitation, if used, and
others.agitation (if used), and others. These parameters may be varied (for example, using Design of Experiments) to determine
their potential optimal settings for actual use.
NOTE 1—Usual cleaning parameters are based on the manufacturer’s recommendations.
6. Apparatus
6.1 Materials:
6.1.1 Test Coupon,Coupon/Beaker, prepared in accordance with Practice G121. The mass of the coupon is approximately 30 to
45 g but will vary significantly for each selected material. Typical materials used in oxygen systems are described in Guide G94.
6.1.2 Control Coupon—Coupon/Beaker—This is uncontaminated and is subjected to the identical cleaning procedure as the
contaminated coupons and serves to evaluate corrosion anderosion and erosion of the test coupons.
6.1.3 Cleaning Agent, prepared according to the manufacturer’s instructions. If the Cleaning Agent is used after dilution with
water, Specification D1193 Type II I to IV water shall be used for preparing aqueous solutions. solutions or prepared with water
of the purity used in the actual cleaning.
6.2 Equipment:
6.2.1 Cleaning Tank, A vessel of sufficient size to conduct a number of evaluations simultaneously. Testing is enhanced by having
automatic temperature and time controls. A cleaning tank with ultrasonics may be used.
6.2.2 Balance, accuracy to 0.1 mg. However, 0.01 mg accuracy is desirable to detect contamination levels of of 10 mg 10 mg/m⁄m
(1 (1 mg mg/ft⁄ft ) or less.
6.2.3 Beaker Holder—A device to support beakers in the ultrasonic cleaner tank such that the beakers do not contact the bottom
and sides of the tank.
G122 − 20
7. Test Procedure
7.1 Prepare a minimum of six test coupons by Practice G121.
7.2 Indicate the masses of coupons in grams as MXy where X is the coupon designation (number, letter, or name) and y = 1
indicates a clean coupon, y = 2 indicates a contaminated coupon and y = 3 indicates a coupon after cleaning.
7.3 Designate one coupon as the control coupon to undergo cleaning without contamination.
7.4 Measure the mass of the control and test coupons (recording them as MX1 as previously defined).
7.5 Contaminate five test coupons in accordance with Practice G121.
7.6 Measure the mass of all contaminated test coupons (recording them as MX2 as previously defined).
7.7 Process the control coupon in the test cleaning solution separately from the contaminated test coupons.
7.8 The contaminated test coupons can be processed in independent beakers held in the cleaning tank or as a batch in a single
beaker.
7.9 Clean the test and control coupons in the candidate cleaning agent by the manufacturer’s procedure or selected procedure.
7.9.1 Prepare the cleaning agent in accordance with the manufacturer’s recommendations.
7.9.2 Select beakers of suitable size to accommodate the test coupons and fit the beaker holder.
7.9.3 Wash the beakers thoroughly with a solution of liquid, surface-active cleaning agent in hot water and rinse with type II water.
7.9.4 Fill the beakers with the cleaning agent solution to a level that will ensure the test coupons are submerged.
7.9.5 Fill the cleaning tank to its operating level with the transfer fluid and preheat to desired test temperature.
7.9.6 Place the beakers in the beaker holder in the tank so that the liquid levels in the tank and beakers are approximately equal.
7.9.7 Allow the temperatures of the tank fluid and cleaning agent in the beakers to equilibrate at the desired temperature.
7.9.8 Suspend the test coupons and control coupon in the cleaning agent, using a wire hook of the same material as the coupon
or a compatible material. Position the coupons such that they do not touch the beaker or one another.
7.9.9 Begin agitation or sonication in the cleaning process and start the timer.
7.9.10 Upon completing the required cleaning time, discontinue the agitation or sonication, and remove the coupons from the
cleaning agent.
7.9.11 Rinse the test coupon in accordance with the manufacturer’s recommendations.
7.9.12 Allow the suspended coupons to dry overnight or in a forced convection oven for one hour.
NOTE 2—Warning: Do not place test coupons directly in the oven after application of the solution containing the contaminant. A fire may result if the
solvent is flammable or rapid evaporation of the solvent may cause spattering of the contaminant thereby reducing the amount of contaminant on the test
coupon. It is recommended that the test coupons be air dried until no traces of a liquid phase are visible.
7.9.13 Determine the final mass of each test coupon (recording them as MX3 as previously defined), including the control coupon.
G122 − 20
7. Material Compatibility Testing
7.1 Initial Determination of Material Compatibility—The first step in using this guide is to determine the compatability of the
material, or materials of the parts, being cleaned with the cleaning agent(s) (see Guide G127). This will provide material
compatibility test data required to ensure the cleaner will not damage the parts being cleaned. It is important to note that alloys
behave differently than pure metals and different alloys behave differently than other alloys; therefore, specific alloys must be
utilized when conducting these compatibility tests. Non-metallic materials (for example, plastics) may also have compatibility
issues with cleaners and this should be considered as well. If data are not available on a specific alloy with a specific cleaner, these
data must be deve
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