ASTM E2614-15
(Guide)Standard Guide for Evaluation of Cleanroom Disinfectants
Standard Guide for Evaluation of Cleanroom Disinfectants
SIGNIFICANCE AND USE
5.1 Requirements for aseptic processing areas include readily cleanable floors, walls, and ceilings that have smooth, non-porous surfaces; particle, temperature, and humidity controls; and cleaning and disinfecting procedures to produce and maintain aseptic conditions. These controls, combined with careful and thorough evaluation of the chemical agents used for the cleaning and disinfection program, should lead to achieving the specified cleanliness standards and control of microbial contamination of products. Qualification of disinfectants in pharmaceutical, biotechnology, medical device facilities, and associated controlled environments, along with validation of the cleaning and disinfection process, is subject to scrutiny by regulatory agencies.
5.2 An effective cleaning and disinfection program in aseptic processing areas of a Good Manufacturing Practice (GMP) - regulated facility is critical to assure product quality. Manufacturers are held to a high standard when it comes to product sterility, and regulatory agencies increasingly request validation data to support sanitization and disinfection procedures. Regulatory authorities expect evidence of the effectiveness of disinfection agents against environmental microorganisms isolated from the facility. The FDA Guideline for Aseptic Processing states, “The suitability, efficacy, and limitations of disinfecting agents and procedures should be assessed. The effectiveness of these disinfectants and procedures should be measured by their ability to ensure that potential contaminants are adequately removed from surfaces.”7
5.3 Basic knowledge regarding the effectiveness of different chemical agents against vegetative bacteria, fungi, and spores will aid in selecting chemical agents.
5.4 An understanding of test methods used to assess disinfectant effectiveness is important. Most methods are adaptable, allowing the user to customize the methods to their specific requirements.
SCOPE
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 , “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 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.
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Designation: E2614 − 15
Standard Guide for
1
Evaluation of Cleanroom Disinfectants
This standard is issued under the fixed designation E2614; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2. Referenced Documents
2
1.1 This guide identifies important factors to consider when
2.1 ASTM Standards:
selecting a disinfectant for use in a cleanroom or similar
E2111 Quantitative Carrier Test Method to Evaluate the
controlled environment and recommends test methods suitable
Bactericidal,Fungicidal,Mycobactericidal,andSporicidal
for evaluating disinfectants. The proper selection of disinfect-
Potencies of Liquid Chemicals
ing agent combined with qualification testing is a key element
E2197 Quantitative Disk Carrier Test Method for Determin-
ofasuccessfuldisinfectionprogram.Regulatoryguidancesuch
ing Bactericidal, Virucidal, Fungicidal, Mycobactericidal,
as United States Pharmacopoeia Chapter <1072>, “Disinfec-
and Sporicidal Activities of Chemicals
tants and Antiseptics” and the FDA Guidance for Industry,
E2315 Guide for Assessment of Antimicrobial Activity Us-
“Sterile Drug Products Produced by Aseptic Processing–Cur-
ing a Time-Kill Procedure
rent Good Manufacturing Practice” address the necessity of
3
2.2 BSI Standards:
disinfectant effectiveness testing but do not clearly define
BS EN 1040 Chemical disinfectants and antiseptics. Quan-
acceptable test methods.
titative suspension test for the evaluation of basic bacte-
1.2 An understanding of microbiology and microbiological
ricidal activity of chemical disinfectants and antiseptics.
techniques is essential. Knowledge in the following areas is
Test method and requirements (phase 1)
recommended: microorganisms, antimicrobial products
BS EN 1276 Chemical disinfectants and antiseptics. Quan-
(disinfectants, sporicides, and decontamination agents), the
titative suspension test for the evaluation of bactericidal
chemistry of disinfection, mechanism of activity of disinfec-
activity of chemical disinfectants and antiseptics used in
tants on cells, application procedures, cleanroom surfaces, and
food, industrial, domestic and institutional areas. Test
environmental conditions within a cleanroom. This informa-
method and requirements (phase 2, step 1)
tion is available in several published texts listed in the
BS EN 1650 Chemical disinfectants and antiseptics. Quan-
bibliography.
titative suspension test for the evaluation of fungicidal or
yeasticidal activity of chemical disinfectants and antisep-
1.3 The theoretical basis for disinfectant activity is not
tics used in food, industrial, domestic and institutional
addressed in this guide. An understanding of the effect of
areas. Test method and requirements (phase 2, step 1)
disinfectant concentration on microbial reduction (concentra-
BS EN 13704 Chemical disinfectants. Quantitative suspen-
tion exponent) and kinetics is desirable in determining the
sion test for the evaluation of sporicidal activity of
use-dilution of different disinfectants and in using dilution to
chemical disinfectants used in food, industrial, domestic
neutralize a disinfectant for efficacy testing. USP chapter
and institutional areas. Test method and requirements
<1072> provides further information on this topic.
(phase 2, step 1)
1.4 This guide is written for the cleanroom environment,
BS EN 13697 Chemical disinfectants and antiseptics. Quan-
although many of the principles outlined in this standard are
titative non-porous surface test for the evaluation of
applicable to manufacturing and processing environments
bactericidal and/or fungicidal activity of chemical disin-
outside of the cleanroom.
fectantsusedinfood,industrial,domesticandinstitutional
1.5 Evaluation of disinfectants for biofilm control is outside areas. Test method and requirements without mechanical
the scope of this document. action (phase 2, step 2)
1 2
This specification is under the jurisdiction of ASTM Committee E35 on For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Pesticides, Antimicrobials, and Alternative Control Agents and is under the direct contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
responsibility of Subcommittee E35.15 on Antimicrobial Agents. Standards volume information, refer to the standard’s Document Summary page on
CurrenteditionapprovedMay1,2015.PublishedJuly2015.Originallyapproved the ASTM website.
3
in 2008. Last previous edition approved in 2008 as E2614–08. DOI: 10.1520/ Available from British Standards Institute (BSI), 389 Chiswick High Rd.,
E2614-15. London W4 4AL, U.K., http://www.bsi-glo
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: E2614 − 08 E2614 − 15
Standard Guide for
1
Evaluation of Cleanroom Disinfectants
This standard is issued under the fixed designation E2614; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
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 agentsagent
combined with in-house qualification testing is a key element toof a successful disinfection program. Recent publications of
regulatory guidance/standards such asRegulatory guidance such as United States Pharmacopoeia Chapter <1072>, “Disinfectants
and Antiseptics” in the United States Pharmacopoeia address the issue of disinfectant testing but there is very little published
guidance on what criteria and test methods should be used for selection and efficacy testing of disinfectants that will be used in
cleanrooms and controlled environments. 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), and 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 Although the information in this This guide is written for the cleanroom environment, although many of the principles
outlined in this standard are applicable to manufacturing/processing manufacturing and processing environments outside of the
cleanroom.
1.5 Evaluation of disinfectants for biofilm control is outside the scope of this document. The reader is referred to Guide E1427.
1.6 The values state in inch-pound units are to be regarded as standard. No other units of measurement are included in this
standard.
2. Referenced Documents
2
2.1 ASTM Standards:
E1427 Guide for Selecting Test Methods to Determine the Effectiveness of Antimicrobial Agents and Other Chemicals for the
3
Prevention, Inactivation and Removal of Biofilm (Withdrawn 2009)
E2111 Quantitative Carrier Test Method to Evaluate the Bactericidal, Fungicidal, Mycobactericidal, and Sporicidal Potencies of
Liquid Chemicals
E2197 Quantitative Disk Carrier Test Method for Determining Bactericidal, Virucidal, Fungicidal, Mycobactericidal, and
Sporicidal Activities of Chemicals
E2315 Guide for Assessment of Antimicrobial Activity Using a Time-Kill Procedure
1
This specification is under the jurisdiction of ASTM Committee E35 on Pesticides, Antimicrobials, and Alternative Control Agents and is under the direct responsibility
of Subcommittee E35.15 on Antimicrobial Agents.
Current edition approved April 1, 2008May 1, 2015. Published May 2008July 2015. Originally approved in 2008. Last previous edition approved in 2008 as E2614–08.
DOI: 10.1520/E2614-08.10.1520/E2614-15.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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E2614 − 15
2.2 Other Standard:BSI Standards:
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United States Pharmacopeia 30, Chapter <1072> Disinfectants and Antiseptics, May 1, 2007
5
AOAC, Chapter 6, 15th Edition Offici
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