ASTM E1891-21
Standard Guide for Determination of a Survival Curve for Antimicrobial Agents Against Selected Microorganisms and Calculation of a D-Value and Concentration Coefficient

Standard No.

ASTM E1891-21

Release Date

2021

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM E1891-21

Scope

1.1 This guide covers the methods for determining the death rate kinetics expressed as D-values. These values can be derived from the construction of a kill curve (or survivor curve) or by using other procedures for determining the number of survivors after exposure to antimicrobial chemicals or formulations. Options for calculations will be presented as well as the method for calculation of a concentration coefficient. 1.1.1 The test methods are designed to evaluate antimicrobial agents in formulations to define a survivor curve and to subsequently calculate a D-value. The tests are designed to produce data and calculate values that provide basic information of the rate-of-kill of antimicrobial formulations tested against single, selected microorganisms. In addition, calculated D-values from survivor curves from exposure at different dilutions of antimicrobial can be used to show the effect of dilution by calculation of the concentration exponent, η (2). D-value determination assumes the ideal of first-order killing reactions that are reflected in a straight-line reduction in count where a count-versus-time plot is done. The goal here is not to determine the time at which no survivors are found, but to determine a standard value that can be used in processing and exposure determinations or used to estimate dilutions. 1.1.2 As an example of potential use of kill curve data, the published FDA, OTC Tentative Final Monograph for HealthCare Antiseptic Drug Products, Proposed Rule, June 17, 1994 has suggested the testing of topically applied antimicrobial products using survival curve (or kill curve) calculations. The methods described in this guide are applicable to these products, but adjustments such as the use of antifoaming agents when the reaction mixture is stirred may be necessary to counteract the presence of detergents in many formulations. Frequently the sampling for these tests is done after very short intervals of exposure to the formulation, such as 30 and 60 s. This methodology also has been applied to preservative testing of antimicrobial ingredients in more complex cosmetic formulations (5). 1.2 The test methods discussed should be performed only by those trained in microbiological techniques. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 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. 1 This guide is under the jurisdiction of ASTM Committee E35 on Pesticides, Antimicrobials, and Alternative Control Agents and is the direct responsibility of Subcommittee E35.15 on Antimicrobial Agents. Current edition approved Oct. 1, 2021. Published October 2021. Originally approved in 1997. Last previous edition approved in 2015 as E1891 – 10a(2015). DOI: 10.1520/E1891-21. 2 The boldface numbers given in parentheses refer to a list of references at the end of the text. E1891 − 21 2 2. Referenced Documents

ASTM E1891-21 Referenced Document

• ASTM D5259 Standard Test Method for Isolation and Enumeration of Enterococci from Water by the Membrane Filter Procedure
• ASTM D5465 Standard Practice for Determining Microbial Colony Counts from Waters Analyzed by Plating Methods
• ASTM E2756 Standard Terminology Relating to Antimicrobial and Antiviral Agents

ASTM E1891-21 history

• 2021 ASTM E1891-21 Standard Guide for Determination of a Survival Curve for Antimicrobial Agents Against Selected Microorganisms and Calculation of a D-Value and Concentration Coefficient
• 2015 ASTM E1891-10a(2015) Standard Guide for Determination of a Survival Curve for Antimicrobial Agents Against Selected Microorganisms and Calculation of a D-Value and Concentration Coefficient
• 2010 ASTM E1891-10a Standard Guide for Determination of a Survival Curve for Antimicrobial Agents Against Selected Microorganisms and Calculation of a D-Value and Concentration Coefficient
• 2010 ASTM E1891-10 Standard Guide for Determination of a Survival Curve for Antimicrobial Agents Against Selected Microorganisms and Calculation of a D-Value and Concentration Coefficient
• 1997 ASTM E1891-97(2002) Standard Guide for Determination of a Survival Curve for Antimicrobial Agents Against Selected Microorganisms and Calculation of a D-Value and Concentration Coefficient
• 1997 ASTM E1891-97 Standard Guide for Determination of a Survival Curve for Antimicrobial Agents Against Selected Microorganisms and Calculation of a D-Value and Concentration Coefficient