ASTM-E2839 Standard Practice for Production and Storage of Spores of C. difficile for Use in Efficacy Evaluation of Antimicrobial Agents

ASTM-E2839 - 2021 EDITION - CURRENT
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Standard Practice for Production and Storage of Spores of C. difficile for Use in Efficacy Evaluation of Antimicrobial Agents
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Scope

1.1 This practice specifies the procedures for producing and storing standardized suspensions of Clostridioides difficile spores for the evaluation of the sporicidal activity of antimicrobial formulations using the Quantitative Method for Testing Antimicrobial Agents against Spores of C. difficile on Hard, Non-porous Surfaces or other procedures.

1.2 This practice may involve hazardous materials, chemicals, and microorganisms and should be performed only by persons with formal training in microbiology.

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.

Significance and Use

5.1 This practice describes a procedure for preparing and storing a suspension of C. difficile spores that meets the following acceptance criteria: (1) spore titer of approximately 5.0×108 spores/mL, (2) spore purity of 95 %, and (3) a mean log10 reduction (LR) value >5.0 for 3 carriers exposed to 5000 ppm and a mean LR of <3.0 for 3 carriers exposed to 1500 ppm sodium hypochlorite. These acceptance criteria are necessary in order to use the spore suspension to evaluate the performance of antimicrobial formulations using Test Method E3218.

Keywords

Clostridioides difficile; Clostridium difficile; density gradient medium; spore production; spore purity; spore qualification; sporicidal efficacy testing;

To find similar documents by ASTM Volume:

11.05 (Pesticides and Alternative Control Agents; Environmental Assessment; Hazardous Substances and Oil Spill Response)

To find similar documents by classification:

07.100.99 (Other standards related to microbiology)

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Document Number

ASTM-E2839-21

Revision Level

2021 EDITION

Status

Current

Modification Type

Revision

Publication Date

July 8, 2021

Document Type

Practice

Page Count

7 pages

Committee Number

E35.15