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ASTM E2312-04

(Practice)

Standard Practice for Tests of Cleanroom Materials

Standard Practice for Tests of Cleanroom Materials

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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

Status
Historical
Publication Date
31-Mar-2004
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

Replaced By
ASTM E2312-11 - Standard Practice for Tests of Cleanroom Materials
Effective Date
01-Jan-2011

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ASTM E2312-04 - Standard Practice for Tests of Cleanroom MaterialsASTM E2312-04 - Standard Practice for Tests of Cleanroom Materials
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ASTM E2312-04 - Standard Practice for Tests of Cleanroom Materials
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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:E2312–04
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 E2090 Test Method for Size-Differentiated Counting of
Particles and Fibers Released from Cleanroom Wipers
1.1 This practice identifies test methods used to evaluate the
Using Optical and Scanning Electron Microscopy
properties of various materials and products used in clean-
E2217 Practice for Design and Construction of Aerospace
rooms and for cleanroom construction.
Cleanrooms and Contamination Controlled Areas
1.2 This standard does not purport to address all of the
F25 Test Method for Sizing and CountingAirborne Particu-
safety concerns, if any, associated with its use. It is the
late Contamination in Cleanrooms and Other Dust-
responsibility of the user of this standard to establish appro-
Controlled Areas
priate safety and health practices and determine the applica-
F51 Test Method for Sizing and Counting Particulate Con-
bility of regulatory limitations prior to use.
taminant In and On Clean Room Garments
2. Referenced Documents
F739 Test Method for Permeation of Liquids and Gases
through Protective Clothing Materials under Conditions of
2.1 ASTM Standards:
Continuous Contact
E595 Test Method for Total Mass Loss and Collected
2.2 IEST Standards:
Volatile Condensable Materials from Outgassing in a
IEST RP-CC003 Garment System Considerations for
Vacuum Environment
Cleanrooms and Controlled Environments
E1216 Practice for Sampling for Particulate Contamination
IEST RP-CC004 Evaluating Wiping Materials Used in
by Tape Lift
Cleanrooms
E1234 Practice for Handling, Transporting, and Installing
IEST RP-CC005 Gloves and Finger Cots Used in Clean-
Nonvolatile Residue (NVR) Sample Plates Used in Envi-
rooms and Other Controlled Environments
ronmentally Controlled Areas for Spacecraft
IEST RP-CC020 Substrates and Forms for Documentation
E1235 Test Method for Gravimetric Determination of Non-
in Cleanrooms
volatile Residue (NVR) in Environmentally Controlled
IEST RP-CC022 Electrostatic Charge in Cleanrooms and
Areas for Spacecraft
Other Controlled Environments
E1549 Specification for ESD Controlled Garments Re-
quired in Cleanrooms and Controlled Environments for
3. Terminology
Spacecraft for Non-Hazardous and Hazardous Operations
3.1 Definitions:
E1559 Test Method for Contamination Outgassing Charac-
3.1.1 ESD—electrostatic discharge, the transfer of electro-
teristics of Spacecraft Materials
static charge between bodies that have different electric poten-
E1560 Test Method for Gravimetric Determination of Non-
tial.
volatile Residue From Cleanroom Wipers
3.1.2 fiber—particle having an aspect (length-to-width) ra-
E1731 Test Method for Gravimetric Determination of Non-
tio of 10 or more.
volatile Residue from Cleanroom Gloves
3.1.3 microorganism—living organism of microscopic size
E2088 Practice for Selecting, Preparing, Exposing, and
capable of growth and reproduction. Examples include bacte-
Analyzing Witness Surfaces for Measuring Particle Depo-
ria, yeasts, and molds.
sition in Cleanrooms and Associated Controlled Environ-
3.1.4 non-volatile residue (NVR)—that quantity of molecu-
ments
lar matter remaining after the filtration of a solvent containing
contaminants and evaporation of the solvent at a specified
This practice is under the jurisdiction of ASTM Committee E21 on Space
temperature.
SimulationandtheApplicationsofSpaceTechnologyandisthedirectresponsibility
3.1.5 outgassing—evolution of volatile components from
of Subcommittee E21.05 on Contamination.
Current edition approved Apr. 1, 2004. Published April 2004. DOI: 10.1520/ an item exposed to elevated temperature, normally in vacuum.
E2312-04.
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 Available from Institute of Environmental Sciences and Technology (IEST),
the ASTM website. 5005 Newport Dr., Suite 506, Rolling Meadows, IL 60008-3841.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
E2312–04
3.1.6 particle—small piece of matter with defined physical possible hazards and suggest means to minimize them. If toxic
boundaries. or other hazardous materials are identified, they must be
handled properly per the reference documents.
4. Summary of Practice
7. Procedure
4.1 A number of tests for materials and products used in
cleanrooms or to fabricate cleanrooms have been issued by 7.1 Table 1 lists the types of materials and cleanroom
various organizations such asASTM and IEST.The purpose of
products of present interest and recommends the test methods
this practice is to identify test methods used to determine the to be used to evaluate these materials. Where several tests are
properties of various materials and products used in clean-
listed, it is suggested that all of them be considered at least
rooms. A brief description and some of the features of the initially to evaluate the product and allow properties to be
various tests are also given to aid interested users in selec
...

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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 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.  
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