ASTM E2614-15(2020)e1 PDF

1.1 This guide identifies important factors to consider when selecting a disinfectant for use in a cleanroom or similar controlled environment and recommends test methods suitable for evaluating disinfectants. The proper selection of disinfecting agent combined with qualification testing is a key element of a successful disinfection program. Regulatory guidance such as United States Pharmacopoeia Chapter <1072>, “Disinfectants and Antiseptics” and the FDA Guidance for Industry, “Sterile Drug Products Produced by Aseptic Processing-Current Good Manufacturing Practice” address the necessity of disinfectant effectiveness testing but do not clearly define acceptable test methods.

1.2 An understanding of microbiology and microbiological techniques is essential. Knowledge in the following areas is recommended: microorganisms, antimicrobial products (disinfectants, sporicides, and decontamination agents), the chemistry of disinfection, mechanism of activity of disinfectants on cells, application procedures, cleanroom surfaces, and environmental conditions within a cleanroom. This information is available in several published texts listed in the bibliography.

1.3 The theoretical basis for disinfectant activity is not addressed in this guide. An understanding of the effect of disinfectant concentration on microbial reduction (concentration exponent) and kinetics is desirable in determining the use-dilution of different disinfectants and in using dilution to neutralize a disinfectant for efficacy testing. USP chapter <1072> provides further information on this topic.

1.4 This guide is written for the cleanroom environment, although many of the principles outlined in this standard are applicable to manufacturing and processing environments outside of the cleanroom.

1.5 Evaluation of disinfectants for biofilm control is outside the scope of this document.

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.