iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
ASTM

ASTM E2352-19

(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, 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-Apr-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
Current Stage
Ref Project

Relations

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 D737-04(2016) - Standard Test Method for Air Permeability of Textile Fabrics
Effective Date
01-Jul-2016
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 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 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 E2217-12(2019) - Standard Practice for Design and Construction of Aerospace Cleanrooms and Contamination Controlled Areas
Effective Date
01-Dec-2019
Referred By
ASTM E2042/E2042M-09(2021) - Standard Practice for Cleaning and Maintaining Controlled Areas and Clean Rooms
Effective Date
01-May-2019

Buy Standard

ASTM E2352-19 - Standard Practice for Aerospace Cleanrooms and Associated Controlled Environments—Cleanroom OperationsASTM E2352-19 - Standard Practice for Aerospace Cleanrooms and Associated Controlled Environments—Cleanroom Operations
PreviousNext
Standard
ASTM E2352-19 - Standard Practice for Aerospace Cleanrooms and Associated Controlled Environments—Cleanroom Operations
English language
14 pages
sale 15% off
Preview
sale 15% off
Preview
REDLINE ASTM E2352-19 - Standard Practice for Aerospace Cleanrooms and Associated Controlled Environments—Cleanroom OperationsREDLINE ASTM E2352-19 - Standard Practice for Aerospace Cleanrooms and Associated Controlled Environments—Cleanroom Operations
PreviousNext
Standard
REDLINE ASTM E2352-19 - Standard Practice for Aerospace Cleanrooms and Associated Controlled Environments—Cleanroom Operations
English language
14 pages
sale 15% off
Preview
sale 15% off
Preview

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: E2352 − 19
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 E1549 Specification for ESD Controlled Garments Required
in Cleanrooms and Controlled Environments for Space-
1.1 This practice specifies basic requirements, procedures,
craft for Non-Hazardous and Hazardous Operations
and practices for operating aerospace cleanrooms and con-
E1559 Test Method for Contamination Outgassing Charac-
trolled environments and precautions associated with the
teristics of Spacecraft Materials
facility and equipment used.
E1560 Test Method for Gravimetric Determination of Non-
1.2 This standard does not purport to address all of the
volatile Residue From Cleanroom Wipers
safety concerns, if any, associated with its use. It is the
E1731 Test Method for Gravimetric Determination of Non-
responsibility of the user of this standard to establish appro-
volatile Residue from Cleanroom Gloves
priate safety, health, and environmental practices and deter-
E2042 Practice for Cleaning and Maintaining Controlled
mine the applicability of regulatory limitations prior to use.
Areas and Clean Rooms
1.3 This international standard was developed in accor-
E2088 Practice for Selecting, Preparing, Exposing, andAna-
dance with internationally recognized principles on standard-
lyzing Witness Surfaces for Measuring Particle Deposi-
ization established in the Decision on Principles for the
tion in Cleanrooms and Associated Controlled Environ-
Development of International Standards, Guides and Recom-
ments
mendations issued by the World Trade Organization Technical
E2217 Practice for Design and Construction of Aerospace
Barriers to Trade (TBT) Committee.
Cleanrooms and Contamination Controlled Areas
F25 Test Method for Sizing and CountingAirborne Particu-
2. Referenced Documents
late Contamination in Cleanrooms and Other Dust-
2
2.1 ASTM Standards:
Controlled Areas
D737 Test Method for Air Permeability of Textile Fabrics
F50 Practice for Continuous Sizing and Counting of Air-
E595 Test Method for Total Mass Loss and Collected Vola-
borne Particles in Dust-Controlled Areas and Clean
tile Condensable Materials from Outgassing in a Vacuum
Rooms Using Instruments Capable of Detecting Single
Environment
Sub-Micrometre and Larger Particles
E1216 Practice for Sampling for Particulate Contamination
F51 Test Method for Sizing and Counting Particulate Con-
by Tape Lift
taminant In and On Clean Room Garments
E1234 Practice for Handling, Transporting, and Installing
F318 Practice for Sampling Airborne Particulate Contami-
Nonvolatile Residue (NVR) Sample Plates Used in Envi-
nation in Cleanrooms for Handling Aerospace Fluids
ronmentally Controlled Areas for Spacecraft 3
(Withdrawn 2013)
E1235 Test Method for Gravimetric Determination of Non- 4
2.2 Government Standards:
volatile Residue (NVR) in Environmentally Controlled
Federal Standard 209E Airborne Particulate Cleanliness
Areas for Spacecraft
Classes in Cleanroom and Clean Zones (cancelled Nov.
29, 2001)
1
This practice is under the jurisdiction of ASTM Committee E21 on Space
NASA-STD-6001, Test #7 Flammability, Odor, Offgassing
Simulation andApplications of Space Technology and is the direct responsibility of
and Compatibility Requirements and Test Procedures for
Subcommittee E21.05 on Contamination.
Materials in Environments That Support Combustion
CurrenteditionapprovedMay1,2019.PublishedJuly2019.Originallyapproved
in 2004. Last previous edition approved in 2010 as E2352 – 04(2010). DOI:
10.1520/E2352-19.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or The last approved version of this historical standard is referenced on
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM www.astm.org.
4
Standards volume information, refer to the standard’s Document Summary page on AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
the ASTM website. 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E2352 − 19
2.3 Other Technical Society Standards: 3.1.3 cross-over bench—bench that is used as an aid to
IEST-RP-CC003 Garments
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: E2352 − 04 (Reapproved 2010) E2352 − 19
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
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 safety, health, and healthenvironmental 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.
2. Referenced Documents
2
2.1 ASTM Standards:
D737 Test Method for Air Permeability of Textile Fabrics
E595 Test Method for Total Mass Loss and Collected Volatile Condensable Materials from Outgassing in a Vacuum
Environment
E1216 Practice for Sampling for Particulate Contamination by Tape Lift
E1234 Practice for Handling, Transporting, and Installing Nonvolatile Residue (NVR) Sample Plates Used in Environmentally
Controlled Areas for Spacecraft
E1235 Test Method for Gravimetric Determination of Nonvolatile Residue (NVR) in Environmentally Controlled Areas for
Spacecraft
E1549 Specification for ESD Controlled Garments Required in Cleanrooms and Controlled Environments for Spacecraft for
Non-Hazardous and Hazardous Operations
E1559 Test Method for Contamination Outgassing Characteristics of Spacecraft Materials
E1560 Test Method for Gravimetric Determination of Nonvolatile Residue From Cleanroom Wipers
E1731 Test Method for Gravimetric Determination of Nonvolatile Residue from Cleanroom Gloves
E2042 Practice for Cleaning and Maintaining Controlled Areas and Clean Rooms
E2088 Practice for Selecting, Preparing, Exposing, and Analyzing Witness Surfaces for Measuring Particle Deposition in
Cleanrooms and Associated Controlled Environments
E2217 Practice for Design and Construction of Aerospace Cleanrooms and Contamination Controlled Areas
F25 Test Method for Sizing and Counting Airborne Particulate Contamination in Cleanrooms and Other Dust-Controlled Areas
F50 Practice for Continuous Sizing and Counting of Airborne Particles in Dust-Controlled Areas and Clean Rooms Using
Instruments Capable of Detecting Single Sub-Micrometre and Larger Particles
F51 Test Method for Sizing and Counting Particulate Contaminant In and On Clean Room Garments
F318 Practice for Sampling Airborne Particulate Contamination in Cleanrooms for Handling Aerospace Fluids (Withdrawn
3
2013)
1
This practice is under the jurisdiction of ASTM Committee E21 on Space Simulation and Applications of Space Technology and is the direct responsibility of
Subcommittee E21.05 on Contamination.
Current edition approved April 1, 2010May 1, 2019. Published May 2010July 2019. Originally approved in 2004. Last previous edition approved in 20042010 as E2352
– 04.04(2010). DOI: 10.1520/E2352-04R10.10.1520/E2352-19.
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 Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
The last approved version of this historical standard is referenced on www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E2352 − 19
4
2.2 Government Standards:
Federal Standard 209E Airborne Particulate Cleanliness Classes in Cleanroom and Clean Zones (cancelled Nov. 29, 2001)
NASA-STD-6001, Test #7 Flammability, Odor, Offgassing and Compatibility Requirements and Test Procedures for Materials
in Environments That Support Combustion
2.3 Other Technical Society Standards:
5
IEST-RP-CC003 Garments
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

This May Also Interest You

ASTM
ASTM E2042/E2042M-09(2021)(Practice)
Standard Practice for Cleaning and Maintaining Controlled Areas and Clean Rooms

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.
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 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.

  • Standard
    9 pages
    English language
    sale 15% off
ASTM
ASTM E2088-06(2021)(Practice)
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.  
5.2 This practice is applicable across numerous industries including aerospace, microelectronics, and pharmaceuticals.
SCOPE
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.  
1.2 Requirements may be defined in terms of particle size distribution and count, percent area coverage, or product performance criteria such as optical transmission or scatter. Several choices for witness surfaces are provided.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 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.  
1.5 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.

  • Standard
    5 pages
    English language
    sale 15% off
ASTM
ASTM E2090-12(2020)(Test Method)
Standard Test Method for Size-Differentiated Counting of Particles and Fibers Released from Cleanroom Wipers Using Optical and Scanning Electron Microscopy

SIGNIFICANCE AND USE
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.
SCOPE
1.1 This test method covers testing all wipers used in cleanrooms and other controlled environments for characteristics related to particulate cleanliness.  
1.2 This test method includes the use of computer-based image analysis and counting hardware and software for the counting of densely particle-laden filters (see 7.7 – 7.9). While the use of this equipment is not absolutely necessary, it is strongly recommended to enhance the accuracy, speed, and consistency of counting.  
1.3 The values stated in SI units are to be regarded as the standard.  
1.4 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.  
1.5 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.

  • Standard
    11 pages
    English language
    sale 15% off
ASTM
ASTM E2217-12(2019)(Practice)
Standard Practice for Design and Construction of Aerospace Cleanrooms and Contamination Controlled Areas

SIGNIFICANCE AND USE
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.
SCOPE
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.  
1.2 One cleanliness classification of a facility is the airborne particle concentrations in accordance with ISO 14644-1 and 14644-2. Airborne particle concentrations in accordance with FED-STD-209E are included for reference. This simple classification is inadequate to describe a facility that will support the assembly and integration of spacecraft. The extended duration of hardware exposure during fabrication and testing, the sensitivity of the hardware to hydrocarbons and other molecular contaminants, and the changing requirements during assembly and integration must be considered in addition to the airborne particle concentrations.  
1.3 The guidelines specified herein are intended to provide facilities that will effectively restrict contaminants from entering the facility, limit contamination generated by and within the facility, and continuously remove airborne contaminants generated during normal operations. Some items of support hardware, such as lifting equipment, stands, and shoe cleaners, are addressed since these items are often purchased and installed with the facility and may require accommodation in the design of the facility.  
1.4 Active filtration of molecular contaminants (such as hydrocarbons, silicones, and other chemicals) is discussed. Such active filtration of molecular contaminants may be required for the processing of highly sensitive optical devices, especially infrared and cryogenic sensors. Control of microbiological contamination is not included although HEPA (High Efficiency Particulate Air) filtration will provide some control of airborne bacteria, spores, and other viable contaminants that are typically carried on particles of sizes 0.3 μm and larger. Control of radioactive contamination and accommodation of very hazardous materials such as propellants, strong acids or caustics, or carcinogens are not addressed.  
1.5 No facility will compensate for excessive contamination generated inside the facility. In addition to an effective facility design, the user must also institute a routine maintenance program (see Practice E2042) for the facility, and personnel and operational disciplines that limit the transfer of contaminants through entry doors and contaminant generation inside the facility.  
1.6 This practice only addresses guidelines for contamination control in facility design. It must be implemented in compliance with all mandatory government and regulatory building and safety codes. References to related cleanroom standards and U.S. building codes and standards may be found in IEST-RP-CC012.  
1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.7.1 The values given in parentheses are provided for information only and are not considered standard.  
1.8 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 det...

  • Standard
    14 pages
    English language
    sale 15% off
ASTM
ASTM E2312-11(2019)(Practice)
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.

  • Standard
    3 pages
    English language
    sale 15% off
ASTM
ASTM E2042/E2042M-09(2021)(Practice)
Standard Practice for Cleaning and Maintaining Controlled Areas and Clean Rooms

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.
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 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.

  • Standard
    9 pages
    English language
    sale 15% off
ASTM
ASTM E2088-06(2021)(Practice)
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.  
5.2 This practice is applicable across numerous industries including aerospace, microelectronics, and pharmaceuticals.
SCOPE
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.  
1.2 Requirements may be defined in terms of particle size distribution and count, percent area coverage, or product performance criteria such as optical transmission or scatter. Several choices for witness surfaces are provided.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 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.  
1.5 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.

  • Standard
    5 pages
    English language
    sale 15% off
ASTM
ASTM E2090-12(2020)(Test Method)
Standard Test Method for Size-Differentiated Counting of Particles and Fibers Released from Cleanroom Wipers Using Optical and Scanning Electron Microscopy

SIGNIFICANCE AND USE
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.
SCOPE
1.1 This test method covers testing all wipers used in cleanrooms and other controlled environments for characteristics related to particulate cleanliness.  
1.2 This test method includes the use of computer-based image analysis and counting hardware and software for the counting of densely particle-laden filters (see 7.7 – 7.9). While the use of this equipment is not absolutely necessary, it is strongly recommended to enhance the accuracy, speed, and consistency of counting.  
1.3 The values stated in SI units are to be regarded as the standard.  
1.4 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.  
1.5 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.

  • Standard
    11 pages
    English language
    sale 15% off
ASTM
ASTM E2614-15(2020)e1(Guide)
Standard Guide for Evaluation of Cleanroom Disinfectants

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.  
5.4 An 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 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.  
1.6 This international standard was developed in accordance with internationally recognized principles on standar...

  • Guide
    5 pages
    English language
    sale 15% off
ASTM
ASTM E2217-12(2019)(Practice)
Standard Practice for Design and Construction of Aerospace Cleanrooms and Contamination Controlled Areas

SIGNIFICANCE AND USE
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.
SCOPE
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.  
1.2 One cleanliness classification of a facility is the airborne particle concentrations in accordance with ISO 14644-1 and 14644-2. Airborne particle concentrations in accordance with FED-STD-209E are included for reference. This simple classification is inadequate to describe a facility that will support the assembly and integration of spacecraft. The extended duration of hardware exposure during fabrication and testing, the sensitivity of the hardware to hydrocarbons and other molecular contaminants, and the changing requirements during assembly and integration must be considered in addition to the airborne particle concentrations.  
1.3 The guidelines specified herein are intended to provide facilities that will effectively restrict contaminants from entering the facility, limit contamination generated by and within the facility, and continuously remove airborne contaminants generated during normal operations. Some items of support hardware, such as lifting equipment, stands, and shoe cleaners, are addressed since these items are often purchased and installed with the facility and may require accommodation in the design of the facility.  
1.4 Active filtration of molecular contaminants (such as hydrocarbons, silicones, and other chemicals) is discussed. Such active filtration of molecular contaminants may be required for the processing of highly sensitive optical devices, especially infrared and cryogenic sensors. Control of microbiological contamination is not included although HEPA (High Efficiency Particulate Air) filtration will provide some control of airborne bacteria, spores, and other viable contaminants that are typically carried on particles of sizes 0.3 μm and larger. Control of radioactive contamination and accommodation of very hazardous materials such as propellants, strong acids or caustics, or carcinogens are not addressed.  
1.5 No facility will compensate for excessive contamination generated inside the facility. In addition to an effective facility design, the user must also institute a routine maintenance program (see Practice E2042) for the facility, and personnel and operational disciplines that limit the transfer of contaminants through entry doors and contaminant generation inside the facility.  
1.6 This practice only addresses guidelines for contamination control in facility design. It must be implemented in compliance with all mandatory government and regulatory building and safety codes. References to related cleanroom standards and U.S. building codes and standards may be found in IEST-RP-CC012.  
1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.7.1 The values given in parentheses are provided for information only and are not considered standard.  
1.8 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 det...

  • Standard
    14 pages
    English language
    sale 15% off