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ASTM E2352-04(2010)

(Practice)

Standard Practice for Aerospace Cleanrooms and Associated Controlled Environments-Cleanroom Operations

Standard Practice for Aerospace Cleanrooms and Associated Controlled Environments-Cleanroom Operations

ABSTRACT
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.
SCOPE
1.1 This practice specifies basic requirements, procedures, and practices for operating aerospace cleanrooms and controlled environments and precautions associated with the facility and equipment used.  
1.2 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-2010
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 E2352-04 - Standard Practice for Aerospace Cleanrooms and Associated Controlled Environments-Cleanroom Operations
Effective Date
01-Apr-2010
Replaced By
ASTM E2352-19 - Standard Practice for Aerospace Cleanrooms and Associated Controlled Environments—Cleanroom Operations
Effective Date
01-May-2019
Referred By
ASTM E2042/E2042M-09(2021) - Standard Practice for Cleaning and Maintaining Controlled Areas and Clean Rooms
Effective Date
01-Apr-2010

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ASTM E2352-04(2010) - Standard Practice for Aerospace Cleanrooms and Associated Controlled Environments-Cleanroom OperationsASTM E2352-04(2010) - Standard Practice for Aerospace Cleanrooms and Associated Controlled Environments-Cleanroom Operations
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ASTM E2352-04(2010) - Standard Practice for Aerospace Cleanrooms and Associated Controlled Environments-Cleanroom Operations
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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: E2352 − 04 (Reapproved 2010)
Standard Practice for
Aerospace Cleanrooms and Associated Controlled
1
Environments—Cleanroom Operations
This standard is issued under the fixed designation E2352; 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 E1731 Test Method for Gravimetric Determination of Non-
volatile Residue from Cleanroom Gloves
1.1 This practice specifies basic requirements, procedures,
E2042 Practice for Cleaning and Maintaining Controlled
and practices for operating aerospace cleanrooms and con-
Areas and Clean Rooms
trolled environments and precautions associated with the
E2088 Practice for Selecting, Preparing, Exposing, andAna-
facility and equipment used.
lyzing Witness Surfaces for Measuring Particle Deposi-
1.2 This standard does not purport to address all of the
tion in Cleanrooms and Associated Controlled Environ-
safety concerns, if any, associated with its use. It is the
ments
responsibility of the user of this standard to establish appro-
E2217 Practice for Design and Construction of Aerospace
priate safety and health practices and determine the applica-
Cleanrooms and Contamination Controlled Areas
bility of regulatory limitations prior to use.
F25 Test Method for Sizing and CountingAirborne Particu-
late Contamination in Cleanrooms and Other Dust-
2. Referenced Documents
Controlled Areas
2
2.1 ASTM Standards:
F50 Practice for Continuous Sizing and Counting of Air-
D737 Test Method for Air Permeability of Textile Fabrics
borne Particles in Dust-Controlled Areas and Clean
E595 Test Method for Total Mass Loss and Collected Vola-
Rooms Using Instruments Capable of Detecting Single
tile Condensable Materials from Outgassing in a Vacuum
Sub-Micrometre and Larger Particles
Environment
F51 Test Method for Sizing and Counting Particulate Con-
E1216 Practice for Sampling for Particulate Contamination
taminant In and On Clean Room Garments
by Tape Lift
F318 Practice for Sampling Airborne Particulate Contami-
E1234 Practice for Handling, Transporting, and Installing
nation in Cleanrooms for Handling Aerospace Fluids
Nonvolatile Residue (NVR) Sample Plates Used in Envi-
3
2.2 Government Standards:
ronmentally Controlled Areas for Spacecraft
Federal Standard 209E Airborne Particulate Cleanliness
E1235 Test Method for Gravimetric Determination of Non-
Classes in Cleanroom and Clean Zones (cancelled Nov.
volatile Residue (NVR) in Environmentally Controlled
29, 2001)
Areas for Spacecraft
NASA-STD-6001, Test #7 Flammability, Odor, Offgassing
E1549 Specification for ESD Controlled Garments Required
and Compatibility Requirements and Test Procedures for
in Cleanrooms and Controlled Environments for Space-
Materials in Environments That Support Combustion
craft for Non-Hazardous and Hazardous Operations
2.3 Other Technical Society Standards:
E1559 Test Method for Contamination Outgassing Charac-
IEST-RP-CC003 Garments Required in Cleanrooms and
teristics of Spacecraft Materials
4
Controlled Environments
E1560 Test Method for Gravimetric Determination of Non-
IEST-RP-CC004 Evaluating Wiping Materials Used in
volatile Residue From Cleanroom Wipers
4
Cleanrooms and Other Controlled Environments
4
IEST-RP-CC005 Cleanroom Gloves and Finger Cots
IEST-RP-CC018 Cleanroom Housekeeping—Operating and
1
This practice is under the jurisdiction of ASTM Committee E21 on Space
4
Monitoring Procedures
Simulation andApplications of Space Technology and is the direct responsibility of
Subcommittee E21.05 on Contamination.
Current edition approved April 1, 2010. Published May 2010. Originally
approved in 2004. Last previous edition approved in 2004 as E2352 – 04. DOI:
3
10.1520/E2352-04R10. AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401.
4
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Available from Institute of Environmental Sciences and Technology (IEST),
Standards volume information, refer to the standard’s Document Summary page on Arlington Place One, 2340 S.Arlington Heights Rd., Suite 100,Arlington Heights,
the ASTM website. IL 60005-4516, http://www.iest.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E2352 − 04 (2010)
IEST-RP-CC020 Substrates and Forms for Documentation 3.1.1 airlock—intermediate room or area that is normally
4
in Cleanrooms ventilated and used to minimize the t
...

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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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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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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.  
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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.  
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