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ASTM E 2614 : 2015 : REDLINE

Current
Current

The latest, up-to-date edition.

Standard Guide for Evaluation of Cleanroom Disinfectants
Available format(s)

PDF

Language(s)

English

Published date

05-01-2015

CONTAINED IN VOL. 11.05, 2016 Describes 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.

1.1This 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.

1.2An 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.

1.3The 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.

1.4This 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.

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

Committee
E 35
DocumentType
Redline
Pages
7
PublisherName
American Society for Testing and Materials
Status
Current

ASTM E 2315 : 2016 : REDLINE Standard Guide for Assessment of Antimicrobial Activity Using a Time-Kill Procedure
BS EN 1650 : 2008 CHEMICAL DISINFECTANTS AND ANTISEPTICS - QUANTITATIVE SUSPENSION TEST FOR THE EVALUATION OF FUNGICIDAL OR YEASTICIDAL ACTIVITY OF CHEMICAL DISINFECTANTS AND ANTISEPTICS USED IN FOOD, INDUSTRIAL, DOMESTIC AND INSTITUTIONAL AREAS - TEST METHOD AND REQUIREMENTS (PHASE 2, STEP 1)
BS EN 1276:2009 Chemical disinfectants and antiseptics . Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional areas. Test method and requirements (phase 2, step 1)
BS EN 13704:2002 Chemical disinfectants. Quantitative suspension test for the evaluation of sporicidal activity of chemical disinfectants used in food, industrial, domestic and institutional areas. Test method and requirements (phase 2, step 1)
ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
BS EN 13697:2001 Chemical disinfectants and antiseptics. Quantitative non-porous surface test for the evaluation of bactericidal and/or fungicidal activity of chemical disinfectants used in food, industrial, domestic and institutional areas. Test method and requirements without mechanical action (phase 2/step 2)
BS EN 1040:2005 Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of basic bactericidal activity of chemical disinfectants and antiseptics. Test method and requirements (phase 1)

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