ASTM E1482-23
Standard Practice for Use of Gel Filtration Columns for Cytotoxicity Reduction and Neutralization

Standard No.

ASTM E1482-23

Release Date

2023

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM E1482-23

Scope

1.1 This practice is intended to be used to reduce the cytotoxic level of the virus-test product mixture prior to assaying for viral infectivity. It is used in conjunction with evaluations of the virucidal efficacy of disinfectant solutions, wipes, trigger sprays, or pressurized disinfectant spray products intended for use on inanimate, nonporous environmental surfaces. This practice may also be used in the evaluation of hygienic handwashes/handrubs, or for other special applications. The practice may be employed with all viruses and host systems. NOTE 1—Gel filtration columns may impact virus titer and their use should be taken into consideration when selected for use. 1.2 This practice should be performed only by persons trained in virology techniques. 1.3 This practice utilizes gel filtration technology. The effectiveness of the practice is dependent on the ratio of gel bed volume to sample size and uniformity in the preparation of columns as well as the conditions of centrifugation. The effectiveness of this practice is maximized by investigator practice and experience with gel filtration techniques. 1.4 This practice will aid in the reduction, but not necessarily elimination, of test product toxicity while preserving the titer of the input virus. 1.5 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 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. 1.7 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 E1482-23 Referenced Document

• ASTM E1052 Standard Test Method for Efficacy of Antimicrobial Agents Against Viruses in Suspension
• ASTM E1053 Standard Test Method for Efficacy of Virucidal Agents Intended for Inanimate Environmental Surfaces
• ASTM E2756 Standard Terminology Relating to Antimicrobial and Antiviral Agents

ASTM E1482-23 history

• 2023 ASTM E1482-23 Standard Practice for Use of Gel Filtration Columns for Cytotoxicity Reduction and Neutralization
• 2017 ASTM E1482-12(2017) Standard Practice for Use of Gel Filtration Columns for Cytotoxicity Reduction and Neutralization
• 2012 ASTM E1482-12 Standard Practice for Use of Gel Filtration Columns for Cytotoxicity Reduction and Neutralization
• 2004 ASTM E1482-04 Standard Test Method for Neutralization of Virucidal Agents in Virucidal Efficacy Evaluations
• 1992 ASTM E1482-92(2004) Standard Test Method for Neutralization of Virucidal Agents in Virucidal Efficacy Evaluations
• 1992 ASTM E1482-92(1998) Standard Test Method for Neutralization of Virucidal Agents in Virucidal Efficacy Evaluations