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

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
1
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
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
1
This test method is under the jurisdiction of ASTM Committee G04 on
Compatibility and Sensitivity of Materials in Oxygen EnrichedAtmospheres and is
2
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
1

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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 cleani
...

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
1
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.
1
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.
1
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
1

---------------------- Page: 1 ----------------------
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 T
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