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.
ASTM G122-20 Referenced Document
ASTM D1193 Standard Specification for Reagent Water
ASTM D6317 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
ASTM D6361/D6361M Standard Guide for Selecting Cleaning Agents and Processes
ASTM E177 Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
ASTM E3106 Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation*, 2022-11-01 Update
ASTM E691 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM G121 Standard Practice for Preparation of Contaminated Test Coupons for the Evaluation of Cleaning Agents
ASTM G127 Standard Guide for the Selection of Cleaning Agents for Oxygen Systems
ASTM G93/G93M Standard Guide for Cleanliness Levels and Cleaning Methods for Materials and Equipment Used in Oxygen-Enriched Environments
ASTM G122-20 history
2020ASTM G122-20 Standard Test Method for Evaluating the Effectiveness of Cleaning Agents and Processes
1996ASTM G122-96(2015)e1 Standard Test Method for Evaluating the Effectiveness of Cleaning Agents
1996ASTM G122-96(2008) Standard Test Method for Evaluating the Effectiveness of Cleaning Agents
1996ASTM G122-96(2002) Standard Test Method for Evaluating the Effectiveness of Cleaning Agents
1996ASTM G122-96 Standard Test Method for Evaluating the Effectiveness of Cleaning Agents