1.1 This test method describes the production and semipurification of C. difficile spores (also called endospores) primarily for use in testing the sporicidal activities of environmental surface disinfectants (E2111; E2197); such spores can also be used to study their structure, chemistry, and germination. 1.2 While this test method is based on the use of 500-mL volumes of the liquid culture medium in an anaerobic incubator, anaerobic jars with smaller volumes of the same medium can also be used. 1.3 It is the responsibility of the investigator to determine whether Good Laboratory Practice (GLP) regulations are required and to follow them when appropriate (40 CFR, Part 160 for EPA submissions and 21 CFR; Part 58 for FDA submissions). 1.4 This test method may involve hazardous materials, chemicals, and microorganisms and should be performed only by persons with formal training in microbiology. 1.5 This standard does not purport to address all safety concerns, if any, associated with its use. It is the responsibility of the user of this practice to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
The U.S. Environmental Protection Agency (EPA) now requires that any product claiming activity against this organism shall use high numbers of its spores with a certain minimum level of purity. The test method being proposed is designed to meet those requirements. The spores produced could also be used to investigate their structure, composition, and germination characteristics.
Keywordsanaerobic spore-former; Clostridium difficile; enzymatic purification; liquid medium for spore production; sporicidal activity
The title and scope are in draft form and are under development within this ASTM Committee.Back to Top
Ballot Item Approved as E2895-2013 and Pending Publication