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ASTM E2614-08

(Guide)

Standard Guide for Evaluation of Cleanroom Disinfectants

Standard Guide for Evaluation of Cleanroom Disinfectants

SIGNIFICANCE AND USE
Requirements for aseptic processing areas include readily cleanable floors, walls, and ceilings that have smooth, non-porous surfaces; particulate, temperature, and humidity controls; and cleaning and disinfecting procedures to produce and maintain aseptic conditions. These conditions 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. In recent years, the use of disinfectants in pharmaceutical, biotechnology, medical device facilities, and associated controlled environments has been the subject of scrutiny by regulatory agencies.
An effective cleaning and disinfection program in aseptic processing areas of a Good Manufacturing Practice (GMP) facility is critical to assure the quality of the products. Manufacturers are being held to a high standard when it comes to product sterility and regulatory agencies are increasingly asking for validation data to support sanitization and disinfection procedures. Regulatory authorities now expect evidence of the efficacy of disinfection agents against environmental isolates. 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.”6  
Basic knowledge regarding the effectiveness of different chemical agents against vegetative bacteria, fungi, and spores will aid in selecting chemical agents.
A good 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 agents combined with in-house qualification testing is a key element to a successful disinfection program. Recent publications of regulatory guidance/standards such as 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.  
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 guide is written for the cleanroom environment, many of the principles outlined in this standard are applicable to manufacturing/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 E 1427.
1.6 The values state in inch-pound units are to be regarded as st...

General Information

Status
Historical
Publication Date
31-Mar-2008
ICS
13.040.35 - Cleanrooms and associated controlled environments
Technical Committee
E35 - Pesticides, Antimicrobials, and Alternative Control Agents
Drafting Committee
E35.15 - Antimicrobial Agents
Current Stage
Ref Project

Relations

Replaced By
ASTM E2614-15 - Standard Guide for Evaluation of Cleanroom Disinfectants
Effective Date
01-May-2015
Referred By
ASTM D8219-19 - Standard Guide for Cleaning and Disinfection at a Cannabis Cultivation Center
Effective Date
01-Apr-2008
Referred By
ASTM D8270-23b - Standard Terminology Relating to Cannabis
Effective Date
01-Apr-2008
Referred By
ASTM E3106-22 - Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation
Effective Date
01-Apr-2008

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ASTM E2614-08 - Standard Guide for Evaluation of Cleanroom Disinfectants
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: E2614 − 08
StandardGuide 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 1.6 The values state in inch-pound units are to be regarded
as standard. No other units of measurement are included in this
1.1 This guide identifies important factors to consider when
standard.
selecting a disinfectant for use in a cleanroom or similar
controlled environment and recommends test methods suitable
2. Referenced Documents
for evaluating disinfectants. The proper selection of disinfect-
2
ingagentscombinedwithin-housequalificationtestingisakey 2.1 ASTM Standards:
E1427 Guide for Selecting Test Methods to Determine the
element to a successful disinfection program. Recent publica-
tions of regulatory guidance/standards such as Chapter Effectiveness of Antimicrobial Agents and Other Chemi-
cals for the Prevention, Inactivation and Removal of
<1072>, “Disinfectants and Antiseptics” in the United States
3
Pharmacopoeia address the issue of disinfectant testing but Biofilm (Withdrawn 2009)
E2111 Quantitative Carrier Test Method to Evaluate the
there is very little published guidance on what criteria and test
methods should be used for selection and efficacy testing of Bactericidal,Fungicidal,Mycobactericidal,andSporicidal
Potencies of Liquid Chemicals
disinfectants that will be used in cleanrooms and controlled
environments. E2197 Quantitative Disk Carrier Test Method for Determin-
ing Bactericidal, Virucidal, Fungicidal, Mycobactericidal,
1.2 An understanding of microbiology and microbiological
and Sporicidal Activities of Chemicals
techniques is essential. Knowledge in the following areas is
E2315 Guide for Assessment of Antimicrobial Activity Us-
recommended: microorganisms, antimicrobial products
ing a Time-Kill Procedure
(disinfectants,sporicides,anddecontaminationagents),andthe
2.2 Other Standard:
chemistry of disinfection, mechanism of activity of disinfec-
United States Pharmacopeia 30, Chapter <1072> Disinfec-
tants on cells, application procedures, cleanroom surfaces, and
4
tants and Antiseptics, May 1, 2007
environmental conditions within a cleanroom. This informa-
AOAC, Chapter 6, 15th Edition Official Methods of Analy-
tion is available in several published texts listed in the
sis ofAOAC International, Chapter 6: Disinfectants, 15th
bibliography.
5
ed, 1990
1.3 The theoretical basis for disinfectant activity is not
AOAC Chapter 6, 17th Edition Official Methods ofAnalysis
addressed in this guide. An understanding of the effect of
ofAOACInternational,Chapter6:Disinfectants,17thed.,
disinfectant concentration on microbial reduction (concentra-
5
2000
tion exponent) and kinetics is desirable in determining the
BS EN 1040 Chemical Disinfectants andAntiseptics—Basic
use-dilution of different disinfectants and in using dilution to
6
Bactericidal Activity
neutralize a disinfectant for efficacy testing. USP chapter
BS EN 1276 Chemical disinfectants and antiseptics—
<1072> provides further information on this topic.
Quantitative Suspension Test for the Evaluation of Bacte-
1.4 Although the information in this guide is written for the
ricidalActivity of Chemical Disinfectants andAntiseptics
cleanroom environment, many of the principles outlined in this
standard are applicable to manufacturing/processing environ-
ments outside of the cleanroom.
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
1.5 Evaluation of disinfectants for biofilm control is outside
Standards volume information, refer to the standard’s Document Summary page on
the scope of this document. The reader is referred to Guide
the ASTM website.
3
E1427.
The last approved version of this historical standard is referenced on
www.astm.org.
4
Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville,
1
This specification is under the jurisdiction of ASTM Committee E35 on MD 20852-1790, http://www.usp.org.
5
Pesticides, Antimicrobials, and Alternative Control Agents and is under the direct Available from AOAC International, 481 North Frederick Ave., Suite 500,
responsibility of Subcommittee E35.15Antimicrobial Agents. Gaithersburg, Maryland 20877-2417, http://www.aoac.org.
6
Current edition approved April 1, 2008. Published May 2008. DOI: 10.1520/ Available from British Standards Institute (BSI), 389 Chiswick High Rd.,
E2614-08. London W4 4AL, U.K., http://www.bsi-global.com.
Copyright © ASTM International, 100 Barr Harbor Drive,
...

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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.  
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4.1 This practice identifies methods for cleaning and maintaining controlled areas and clean rooms as defined by ISO 14644-1 and ISO 14644-2. Cleaning procedures are described, and cleaning frequency for different classes of facility are given. Compliance with this practice will make it easier and more likely that the required level of facility cleanliness will be maintained. A cleaner facility also will help to protect flight hardware from contamination and should reduce the frequency for cleaning flight hardware. This practice does not discuss operation and operational procedures for cleanrooms and controlled areas. Other documents such as IEST-RP-CC026 and Practice E2352 provide recommended practices for operating cleanrooms and controlled areas.
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1.1 This practice covers the procedures to be followed for the initial cleaning and normal maintenance of cleanrooms and controlled areas. This practice is applicable to aerospace clean areas where both particles and molecular films (NVR) must be controlled.  
1.2 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.  
1.3 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.  
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Standard Practice for Selecting, Preparing, Exposing, and Analyzing Witness Surfaces for Measuring Particle Deposition in Cleanrooms and Associated Controlled Environments

SIGNIFICANCE AND USE
5.1 This practice provides a standard approach to measuring particle deposition, or fallout, in cleanrooms and other controlled environments. It is based on the use of a witness surface to collect particles that deposit from the surrounding environment and subsequently sizing and counting the particles by conventional methods. Several options are introduced, with limitations and guidelines for selecting the best choice for the intended application.  
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1.1 This practice is intended to assist in the selection, preparation, exposure, and analysis of witness surfaces for the purpose of characterizing particle deposition rates in cleanrooms and associated controlled environments, particularly for aerospace applications.  
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1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
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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.  
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This practice specifies the basic requirements, procedures, and practices for operating aerospace cleanrooms and controlled environments and the precautions associated with the facility and equipment used. This practice covers the requirements for operational systems, appropriate cleanroom clothing, authorized work personnel, stationary equipments, materials and mobile equipments, proper cleanroom operations, correct cleaning methods, and critical surfaces.
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Standard Guide for Ecological Considerations for the Use of Oil Spill Dispersants in Freshwater and Other Inland Environments, Lakes and Large Water Bodies

SIGNIFICANCE AND USE
3.1 This guide is meant to aid response teams who may use it during spill response planning and spill events.  
3.2 This guide should be adapted to site specific circumstance.
SCOPE
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1.3 This is a general guide only. Oil, as used in this guide, includes crude oils and refined petroleum products. Differences between individual dispersants or between different oil products are not considered. The dispersibility of the oil with the chosen dispersant should be evaluated.  
1.4 The guide is organized by habitat type, for example, small ponds and lakes, rivers and streams, and land. It considers the use of dispersants primarily to protect habitats from impact (or to minimize impacts).  
1.5 This guide applies only to freshwater and other inland environments. It does not consider the direct application of dispersants to subsurface waters.  
1.6 In making dispersant use decisions, appropriate government authorities should be consulted as required by law.  
1.7 This guide does not address getting regulatory approval.  
1.8 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.9 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.  
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4.1 This test method establishes a selected set of conditions of temperature, relative humidity and rate of evaporation of the environment to which a mortar specimen of stated composition shall be subjected for a specified period of time during which its change in length is determined and designated “drying shrinkage.”  
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