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ASTM E2042/E2042M-09

(Practice)

Standard Practice for Cleaning and Maintaining Controlled Areas and Clean Rooms

Standard Practice for Cleaning and Maintaining Controlled Areas and Clean Rooms

SIGNIFICANCE AND USE
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 E 2352 provide recommended practices for operating cleanrooms and controlled areas.
SCOPE
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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

Status
Historical
Publication Date
31-Mar-2009
ICS
13.040.35 - Cleanrooms and associated controlled environments
Technical Committee
E21 - Space Simulation and Applications of Space Technology
Drafting Committee
E21.05 - Contamination
Current Stage
Ref Project

Relations

Replaces
ASTM E2042-04 - Standard Practice for Cleaning and Maintaining Controlled Areas and Clean Rooms
Effective Date
01-Apr-2009

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ASTM E2042/E2042M-09 - Standard Practice for Cleaning and Maintaining Controlled Areas and Clean RoomsASTM E2042/E2042M-09 - Standard Practice for Cleaning and Maintaining Controlled Areas and Clean Rooms
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ASTM E2042/E2042M-09 - Standard Practice for Cleaning and Maintaining Controlled Areas and Clean Rooms
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Standards Content (Sample)

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: E2042/E2042M − 09
StandardPractice for
Cleaning and Maintaining Controlled Areas and Clean
1
Rooms
ThisstandardisissuedunderthefixeddesignationE2042/E2042M;thenumberimmediatelyfollowingthedesignationindicatestheyear
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 E2352 Practice for Aerospace Cleanrooms and Associated
Controlled Environments—Cleanroom Operations
1.1 This practice covers the procedures to be followed for
F24 Test Method for Measuring and Counting Particulate
the initial cleaning and normal maintenance of cleanrooms and
Contamination on Surfaces
controlled areas. This practice is applicable to aerospace clean
F25 Test Method for Sizing and Counting Airborne Particu-
areas where both particles and molecular films (NVR) must be
late Contamination in Cleanrooms and Other Dust-
controlled.
Controlled Areas
1.2 Units—The values stated in either SI units or inch-
F50 Practice for Continuous Sizing and Counting of Air-
pound units are to be regarded separately as standard. The
borne Particles in Dust-Controlled Areas and Clean
values stated in each system may not be exact equivalents;
Rooms Using Instruments Capable of Detecting Single
therefore,eachsystemshallbeusedindependentlyoftheother.
Sub-Micrometre and Larger Particles
Combining values from the two systems may result in non-
3
conformance with the standard.
2.2 IEST Standards:
1.3 This standard does not purport to address all of the IEST-RP-CC007 Testing ULPA Filters
safety concerns, if any, associated with its use. It is the
IEST-RP-CC016 The Rate of Deposition of Nonvolatile
responsibility of the user of this standard to establish appro-
Residue in Cleanrooms
priate safety and health practices and determine the applica-
IEST-RP-CC0018 Cleanroom Housekeeping and Monitor-
bility of regulatory limitations prior to use.
ing Procedures
IEST-RP-CC003 Garment System Considerations for Clean-
2. Referenced Documents
rooms and Other Controlled Environments
2
2.1 ASTM Standards:
IEST-RP-CC026 Cleanroom Operations
D1193 Specification for Reagent Water
IEST-STD-CC1246D Product Cleanliness Levels and Con-
4
E1234 Practice for Handling, Transporting, and Installing
tamination Control Program
Nonvolatile Residue (NVR) Sample Plates Used in Envi-
5
2.3 US Federal Standards:
ronmentally Controlled Areas for Spacecraft
FED-STD-209E Airborne Particulate Cleanliness Classes in
E1235 Test Method for Gravimetric Determination of Non-
6
Cleanrooms and Clean Zones
volatile Residue (NVR) in Environmentally Controlled
TT-I-735 Isopropyl Alcohol
Areas for Spacecraft
5
O-A-51 Acetone
E1549 Specification for ESD Controlled Garments Required
5
in Cleanrooms and Controlled Environments for Space-
2.4 US Department of Defense Standards:
craft for Non-Hazardous and Hazardous Operations
MIL-D-16791 Detergents, General Purpose (Liquid, Non-
E1560 Test Method for Gravimetric Determination of Non-
Ionic)
volatile Residue From Cleanroom Wipers
1 3
This practice is under the jurisdiction of ASTM Committee E21 on Space Available from Institute of Environmental Science and Technology (IEST),
Simulation andApplications of Space Technology and is the direct responsibility of 5005 Newport Dr., Suite 506, Rolling Meadows, IL 60008-3841.
4
Subcommittee E21.05 on Contamination. IEST-STD-CC1246D replaced MIL-STD-1246.
5
Current edition approved April 1, 2009. Published April 2009. Originally Available from Superintendent of Documents, US Government Printing Office,
approved in 1999. Last previous edition approved in 2004 as E2042 – 04. DOI: Washington, DC 20402.
6
10.1520/E2042_E2042M-09. Cancelled Nov. 29, 2001 and replaced with ISO 14644-1 and 14644-2.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or FED-STD-209E may be used by mutual agreement between buyer and seller.
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Available from U.S. Government Printing Office, Superintendent of Documents,
Standards volume information, refer to the standard’s Document Summary page on 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401. FS209E
the ASTM website. cleanroom classes are given for reference in parentheses after the ISO classes.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E2042/E2042M − 09
7
2.5 International Standards: 3.1.5 cleanroom, operational, n—a cleanroom in normal
ISO 14644-1 Cleanrooms and Associated Controlled operation, with all services functioning and with equipment
Environments—Part 1: Classification of Air Cleanliness and per
...

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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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5.1 This test method provides for accurate and reproducible enumeration of particles and fibers released from a wiper immersed in a cleaning solution with moderate mechanical stress applied. When performed correctly, this counting test method is sensitive enough to quantify very low levels of total particle and fiber burden. The results are accurate and not influenced by artifact or particle size limitations. A further advantage to this technique is that it allows for morphological as well as X-ray analysis of individual particles.
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Standard Practice for Design and Construction of Aerospace Cleanrooms and Contamination Controlled Areas

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4.1 This practice describes and defines factors to be taken into consideration when designing and fabricating a cleanroom or controlled area that is used for aerospace operations and fabrication. Following the suggestions herein should provide a facility that is more capable of meeting performance requirements and that will offer protection against contamination for objects fabricated and processed in such a facility.
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1.1 The purpose of this practice is to provide design and construction guidelines for contamination controlled facilities used in the assembly and integration of aerospace hardware. The guidelines herein are intended to ensure that the facilities, when used properly, will meet the cleanliness requirements of aerospace hardware and processes. The objective is to limit contamination due to the deposition of particulate and molecular contaminants on flight hardware surfaces.  
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5.1 This practice is not intended to advocate or discourage use of any particular test method. It is intended for information only, and to provide a useful guide for further detailed study, test, and evaluation of cleanroom materials and products.
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ASTM E2042/E2042M-09(2021)(Practice)
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SIGNIFICANCE AND USE
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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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.  
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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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