ASTM E2312-11(2019)

Standard Practice for Tests of Cleanroom Materials

SIGNIFICANCE AND USE
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.
SCOPE
1.1 This practice identifies test methods used to evaluate the properties of various materials and products used in cleanrooms and for cleanroom construction.  
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

General Information

• Status: Published
• Publication Date: 30-Jun-2019
• ICS: 13.040.35 - Cleanrooms and associated controlled environments
• Technical Committee: E21 - Space Simulation and Applications of Space Technology
• Drafting Committee: E21.05 - Contamination

Relations

• Replaces: ASTM E2312-11 - Standard Practice for Tests of Cleanroom Materials
• Effective Date: 01-Jul-2019
• Refers: ASTM E2090-12(2020) - Standard Test Method for Size-Differentiated Counting of Particles and Fibers Released from Cleanroom Wipers Using Optical and Scanning Electron Microscopy
• Effective Date: 01-Apr-2020
• Refers: ASTM E1234-12(2020) - Standard Practice for Handling, Transporting, and Installing Nonvolatile Residue (NVR) Sample Plates Used in Environmentally Controlled Areas for Spacecraft
• Effective Date: 01-Apr-2020
• Refers: ASTM E1235-12(2020)e1 - Standard Test Method for Gravimetric Determination of Nonvolatile Residue (NVR) in Environmentally Controlled Areas for Spacecraft
• Effective Date: 01-Apr-2020
• Refers: ASTM E1235-12(2020) - Standard Test Method for Gravimetric Determination of Nonvolatile Residue (NVR) in Environmentally Controlled Areas for Spacecraft
• Effective Date: 01-Apr-2020
• Refers: ASTM E2217-12(2019) - Standard Practice for Design and Construction of Aerospace Cleanrooms and Contamination Controlled Areas
• Effective Date: 01-Dec-2019
• Refers: ASTM E1560-18 - Standard Test Method for Gravimetric Determination of Nonvolatile Residue From Cleanroom Wipers
• Effective Date: 01-Nov-2018
• Refers: ASTM E1731-11(2018) - Standard Test Method for Gravimetric Determination of Nonvolatile Residue from Cleanroom Gloves
• Effective Date: 01-Nov-2018
• Refers: ASTM E1234-12 - Standard Practice for Handling, Transporting, and Installing Nonvolatile Residue (NVR) Sample Plates Used in Environmentally Controlled Areas for Spacecraft
• Effective Date: 01-Nov-2012
• Refers: ASTM E1235-12 - Standard Test Method for Gravimetric Determination of Nonvolatile Residue (NVR) in Environmentally Controlled Areas for Spacecraft
• Effective Date: 01-Nov-2012
• Refers: ASTM F739-12 - Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact
• Effective Date: 01-Sep-2012
• Refers: ASTM E2217-12 - Standard Practice for Design and Construction of Aerospace Cleanrooms and Contamination Controlled Areas
• Effective Date: 01-Apr-2012
• Refers: ASTM E2090-12 - Standard Test Method for Size-Differentiated Counting of Particles and Fibers Released from Cleanroom Wipers Using Optical and Scanning Electron Microscopy
• Effective Date: 01-Apr-2012
• Refers: ASTM E1560-11e1 - Standard Test Method for Gravimetric Determination of Nonvolatile Residue From Cleanroom Wipers
• Effective Date: 01-Dec-2011
• Refers: ASTM E1560-11 - Standard Test Method for Gravimetric Determination of Nonvolatile Residue From Cleanroom Wipers
• Effective Date: 01-Dec-2011

Overview

ASTM E2312-11(2019), Standard Practice for Tests of Cleanroom Materials, provides guidance on identifying and selecting relevant test methods to evaluate the properties of materials and products used in cleanrooms and for cleanroom construction. Published by ASTM International, this practice is informational in nature and serves as a comprehensive reference for professionals involved in contamination control, materials testing, and cleanroom product evaluation. It is designed to inform users about available test methods and assist in the further analysis, study, and validation of cleanroom components.

Key Topics

• Scope and Purpose

  • Outlines test methods for the evaluation of garments, wipers, gloves, swabs, surfaces, and construction materials in cleanroom environments.
  • Focuses on properties critical for contamination control, such as particulate release, non-volatile residue (NVR), microorganism contamination, electrostatic discharge (ESD), chemical compatibility, outgassing, and more.
  • Encourages users to consider all applicable tests to fully assess cleanroom material suitability.

• Test Methods Guidance

  • Lists referenced standard test methods from ASTM and IEST (Institute of Environmental Sciences and Technology) to measure:
    • Particle generation and fiber release
    • Non-volatile residue (NVR) and extractables
    • Microbial contamination potential
    • Chemical resistance and barrier performance
    • Outgassing properties
    • ESD characteristics
    • Design and construction criteria for controlled environments

• Safety and Compliance

  • Emphasizes the user’s responsibility for implementing appropriate safety, health, and environmental practices.
  • Reminds users to verify regional regulatory limitations and compliance needs before selecting and applying tests.

• Reporting and Evaluation

  • Recommends detailed record-keeping, including material identification, source, part numbers, test methods used, and results.
  • Suggests comparing data across product lots or manufacturers to assess consistency and performance.
  • No pass/fail criteria are specified; users determine acceptability based on comparative results and specific facility requirements.

Applications

ASTM E2312 is a valuable tool for multiple stakeholders in cleanroom technology, contamination control, and quality assurance:

• Cleanroom Designers and Engineers

  • Select appropriate materials based on contamination potential under standardized tests.
  • Ensure compatibility and longevity of cleanroom constructions.

• Manufacturers of Cleanroom Products

  • Validate products like garments, gloves, wipers, and other consumables through recognized testing practices.
  • Benchmark new materials against industry standards for compliance and marketing purposes.

• Quality Assurance and Regulatory Compliance

  • Use as a reference for developing testing protocols, procurement specifications, and validation processes.
  • Support documentation needs for audits and certification in industries such as pharmaceuticals, semiconductors, aerospace, and biotechnology.

• Research and Development

  • Guide for evaluating candidate materials and improving contamination control properties before product introduction.

Related Standards

Users of ASTM E2312-11(2019) may also reference the following commonly cited standards to complement their cleanroom material testing programs:

• ASTM E1560 - Gravimetric Determination of Non-volatile Residue from Cleanroom Wipers
• ASTM E1731 - Gravimetric Determination of Non-volatile Residue from Cleanroom Gloves
• ASTM E2088 - Measuring Particle Deposition in Cleanrooms
• ASTM E2090 - Counting Particles and Fibers Released from Cleanroom Wipers
• ASTM F25 – Sizing and Counting Airborne Particulate Contamination
• IEST RP-CC003, CC004, CC005 - Best practices for garments, wipers, and gloves in cleanroom environments
• ANSI/AAMI/ISO 11137 – Sterilization of Health Care Products Radiation

For further information and the latest updates on these standards, visit ASTM International and the IEST.

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Relevant Keywords: cleanroom materials testing, ASTM E2312, contamination control, cleanroom evaluation, non-volatile residue, ESD, outgassing, product testing, cleanroom standard, materials properties

Standards Content (Sample)

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: E2312 − 11 (Reapproved 2019)
Standard Practice for
Tests of Cleanroom Materials
This standard is issued under the fixed designation E2312; 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 E1560 Test Method for Gravimetric Determination of Non-
volatile Residue From Cleanroom Wipers
1.1 This practice identifies test methods used to evaluate the
E1731 Test Method for Gravimetric Determination of Non-
properties of various materials and products used in clean-
volatile Residue from Cleanroom Gloves
rooms and for cleanroom construction.
E2088 Practice for Selecting, Preparing, Exposing, andAna-
1.2 This standard does not purport to address all of the
lyzing Witness Surfaces for Measuring Particle Deposi-
safety concerns, if any, associated with its use. It is the
tion in Cleanrooms and Associated Controlled Environ-
responsibility of the user of this standard to establish appro-
ments
priate safety, health, and environmental practices and deter-
E2090 Test Method for Size-Differentiated Counting of
mine the applicability of regulatory limitations prior to use.
Particles and Fibers Released from Cleanroom Wipers
1.3 This international standard was developed in accor-
Using Optical and Scanning Electron Microscopy
dance with internationally recognized principles on standard-
E2217 Practice for Design and Construction of Aerospace
ization established in the Decision on Principles for the
Cleanrooms and Contamination Controlled Areas
Development of International Standards, Guides and Recom-
F25 Test Method for Sizing and Counting Airborne Particu-
mendations issued by the World Trade Organization Technical
late Contamination in Cleanrooms and Other Dust-
Barriers to Trade (TBT) Committee.
Controlled Areas
F51 Test Method for Sizing and Counting Particulate Con-
2. Referenced Documents
taminant In and On Clean Room Garments
2.1 ASTM Standards:
F739 Test Method for Permeation of Liquids and Gases
E595 Test Method for Total Mass Loss and Collected Vola-
Through Protective Clothing Materials Under Conditions
tile Condensable Materials from Outgassing in a Vacuum
of Continuous Contact
Environment 3
2.2 IEST Standards:
E1216 Practice for Sampling for Particulate Contamination
IESTRP-CC003 Garment System Considerations for Clean-
by Tape Lift
rooms and Other Controlled Environments
E1234 Practice for Handling, Transporting, and Installing
IEST RP-CC004 Evaluating Wiping Materials Used in
Nonvolatile Residue (NVR) Sample Plates Used in Envi-
Cleanrooms and Other Controlled Environments
ronmentally Controlled Areas for Spacecraft
IEST RP-CC005 Gloves and Finger Cots Used in Clean-
E1235 Test Method for Gravimetric Determination of Non-
rooms and Other Controlled Environments
volatile Residue (NVR) in Environmentally Controlled
IEST RP-CC020 Substrates and Forms for Documentation
Areas for Spacecraft
in Cleanrooms
E1549 Specification for ESD Controlled Garments Required
IEST RP-CC022 Electrostatic Charge in Cleanrooms and
in Cleanrooms and Controlled Environments for Space-
Other Controlled Environments
craft for Non-Hazardous and Hazardous Operations
2.3 Others:
E1559 Test Method for Contamination Outgassing Charac-
ANSI/AAMI/ISO 11137 Sterilization of Health Care Prod-
teristics of Spacecraft Materials
ucts Radiation Part 1
1 3. Terminology
This practice is under the jurisdiction of ASTM Committee E21 on Space
Simulation andApplications of Space Technology and is the direct responsibility of
3.1 Definitions:
Subcommittee E21.05 on Contamination.
Current edition approved July 1, 2019. Published July 2019. Originally approved
in 2004. Last previous edition approved in 2011 as E2312 – 11. DOI: 10.1520/
E2312-11R19. Available from Institute of Environmental Sciences and Technology (IEST),
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Arlington Place One, 2340 S. Arlington Heights Rd., Suite 100, Arlington Heights,
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM IL 60005-4516, http://www.iest.org.
Standards volume information, refer to the standard’s Document Summary page on Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E2312 − 11 (2019)
3.1.1 ESD—electrostatic discharge, the transfer of electro- rooms. A brief description and some of the features of the
static charge between bodies that have different electric poten- various tests are also given to aid interested users in selecting
tial. the test or groups of tests that have the ability to meet their
needs for evaluating existing and candidate cleanroom prod-
3.1.2 fiber—particlehavinganaspect(length-to-width)ratio
ucts.
of 10 or more.
4.2 Table 1 lists the tests suggested to measure specific
3.1.3 microorganism—living organism of microscopic size
properties of various cleanroom materials and products.Where
capable of growth and reproduction. Examples include
no test is presently listed it is probable that a test will be
bacteria, yeasts, and molds.
required and must be identified or developed if none exist at
3.1.4 non-volatile residue (NVR)—that quantity of molecu-
present.
lar matter remaining after the filtration of a solvent containing
contaminants and evaporation of the solvent at a specified
5. Significance and Use
temperature.
5.1 This practice is not intended to advocate or discourage
3.1.5 outgassing—evolution of volatile components from an
use of any particular test method. It is intended for information
item exposed to elevated temperature, normally in vacuum.
only, and to provide a useful guide for further detailed study,
3.1.6 particle—small piece of matter with defined physical
test, and evaluation of cleanroom materials and products.
bou
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