iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
ASTM

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

Buy Standard

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
PreviousNext
Standard
ASTM E2352-04(2010) - 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)


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
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
2.1 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-
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
Controlled Environments
E1560 Test Method for Gravimetric Determination of Non-
IEST-RP-CC004 Evaluating Wiping Materials Used in
volatile Residue From Cleanroom Wipers
Cleanrooms and Other Controlled Environments
IEST-RP-CC005 Cleanroom Gloves and Finger Cots
IEST-RP-CC018 Cleanroom Housekeeping—Operating and
This practice is under the jurisdiction of ASTM Committee E21 on Space
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:
10.1520/E2352-04R10. AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
For referenced ASTM standards, visit the ASTM website, www.astm.org, or 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401.
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
E2352 − 04 (2010)
IEST-RP-CC020 Substrates and Forms for Documentation 3.1.1 airlock—intermediate room or area that is normally
in Cleanrooms ventilated and used to minimize the transfer of airborne
IEST-RP-CC022 Electrostatic Charge in Cleanrooms and contamination from one area to another. The airlock is main-
Other Controlled Environments tained at a lower air pressure than the cleanroom and a higher
IEST-RP-CC026 Cleanroom Operations pressure than the outside area.
IEST-RP-CC027 Personnel Practices and Procedures in
3.1.2 changing room—room where people using a clean-
Cleanrooms and Controlled Environments
room may change into or out of cleanroom clothing.
IEST-RP-CC0016 Recommended Practice for the Rate of
4 3.1.3 cross-over bench—bench that is used as an aid to
Deposition of Nonvolatile Residue in Cleanrooms
changingofcleanroomclothingandwhichprovidesabarrierto
JIS B9923 Methods for Sizing and Counting Particle Con-
5 the tracking of floor contamination.
taminants in and on Clean Room Garments
3.1.4 fiber—particlehavinganaspect(length-to-width)ratio
JIS B9926 Test Methods for Dust Generation from Moving
Mechanisms of 10 or more.
JACA Number 14C Guidance for Operation of Clean
3.1.5 non-unidirectional airflow—air distribution where the
Rooms
supply air entering the room mixes with the internal air by
2.4 International Standards:
means of induction.
ISO 14644-1 Cleanrooms and Associated Controlled
3.1.5.1 Discussion—This type of air distribution results in
Environments—Part 1: Classification of Air Cleanliness
dilution of the particle concentration.
ISO 14644-2 Cleanrooms and Associated Controlled
3.1.6 operational—condition where the installation is func-
Environments—Part 2: Specifications for Testing and
tioning in the specified manner, with the personnel present and
Monitoring to Prove Continued Compliance with ISO
7 working in the manner agreed upon.
14644-1
ISO 14644-3 Cleanrooms and Associated Controlled 3.1.7 operator—person working in the cleanroom perform-
Environments—Part 3: Metrology and Test Methods ing production work or carrying out process procedures.
ISO 14644-4 Cleanrooms and Associated Controlled
3.1.8 particle—small piece of matter with defined physical
Environments—Part 4: Design, Construction, and Start-
boundaries.
up
3.1.9 personnel—persons entering the cleanroom for any
ISO/AWI 14644-6 Cleanrooms and Associated Controlled
7 purpose, but typically operators.
Environments—Part 6: Terms and Definitions
ISO 14644-7 Cleanrooms and Controlled Environments— 3.1.10 stationary equipment—large equipment that cannot
be easily moved.
Part 7: Separative Devices
ISO 7730 Moderate Thermal Environments—Determination
3.1.11 unidirectional airflow—air flow which has a singular
of the PMV and PPD Indices and Specification of the
direction of flow and may or may not contain uniform
Conditions for Thermal Comfort
velocities of air flow along parallel lines. Formerly known as
ISO 9237 Textiles—Determination of Permeability of Fab-
laminar airflow.
rics to Air
ISO 11092 Textiles—Physiological Effects—Measurement
4. Requirements
of Thermal and Water-Vapour Resistance Under Steady-
4.1 Operational Systems:
State Conditions (Sweating Guarded-Hotplate Test)
4.1.1 General—The air cleanliness class required shall be
EN 1149-1 (1994) Protective Clothing—Electrostatic
determined before the facility is certified or used initially.
Properties—Part 1 Surface Resistivity (Test Methods and
Operations may be performed in a controlled area if the
Requirements)
products are not sensitive to contamination, or if they will be
CEI IIEC 1025:1990 Fault Tree Analysis (FTA)
cleanedadequatelyduringlatersteps.Normallyoperationswill
CEI IIEC 812:1985 Analysis Techniques for System
be performed in a cleanroom of at least class 8 or cleaner per
Reliability—Procedure for Failure Mode and Effective
ISO 14644-1 (class 100 000 or cleaner per FED-STD-209E).
Analysis (FMEA)
4.1.2 A set of risk factors, appropriate for the use of the
3. Terminology
specificcleanroom,shallidentifytheareaswherethereisarisk
ofcontaminationtotheprocess.Impropercontrolofthecritical
3.1 Definitions:
elements of an operational cleanroom can pose a risk to the
5 cleanliness of the cleanroom and the quality of the product. A
AvailablefromJapanIndustrialStandards(JIS),1-3-1Kasumigaseki,Chiyoda-
ku, Tokyo, 100-8901, Japan.
risk assessment must be done and plans formulated to remedy
Available from Japan Air Cleaning Association (JACA), Tomoe-Ya Building
out-of-control situations. A method for monitoring these risks
No. 2-14, 1-Chome, Uchi-Kanda, Chiyoda-ku, Tokyo, 101, Japan.
shall be instituted so that action can be taken when conditions
Available from International Organization for Standardization (ISO), 1, ch. de
are outside of specifications. The following list identifies some
la Voie-Creuse, Case postale 56, CH-1211, Geneva 20, Switzerland, http://
www.iso.ch.
of the risks that may prove important. Cleanroom parameters
Available from European Committee for Standardization (CEN), 36 rue de
including heating, ventilation and air conditioning, pressure
Stassart, B-1050, Brussels, Belgium, http://www.cenorm.be.
differential, temperature, humidity, air change rates, and filters,
International Electrotechnical Commission, Case postale 131, 1211 Geneva 20,
Switzerland. are discussed in ISO 14644-2, ISO 14644-3, and ISO 14644-4.
E2352 − 04 (2010)
TABLE 1 Minimum Requirements for Air Cleanliness Classes and Operations Constraints
Operation or Controls Class 4 Class 5 Class 6 Class 7 Class 8 Class 8.5
Wear garments including hair and beard covers Required Required Required Required Required No beard or hair covers
Enter via ante room with air shower or air lock Required Required Required Optional Optional No
No cosmetics or similar products worn Required Required Required Required Required No
Sanding, grinding, machining prohibited Required Required Required Controlled Controlled Controlled
Particle counts taken continuously Required Required Required Required Opt. Weekly
Temperature and humidity recorded continuously Required Required Required Required Opt. Daily
Wear gloves even when not handling products Required Required Required Required Opt. Opt.
Pre-clean all equipment before entry, verify clean Required Required Required Required Req. Opt.
Clean working surfaces twice daily Required Required Required Required Daily No
Remove trash and waste daily Required Required Required Required Preferred No
Personnel trained and certified for cleanliness level Required Required Required Required Required Required
4.1.2.1 Table1givestherecommendedaircleanlinessclass, (7) Maintenance procedures,
personnelpractices,andoperationalcontrolsfordifferenttypes (8) Cleanroom testing and monitoring,
of cleanroom and controlled area operations. Examples of (9) Proper behavior in a cleanroom,
methods used for determining and managing these factors (10) Work processes and technologies employed,
include: (11) Safety and emergency responses, and
(1) HAZOP (HACCP Principles and Applications, per (12) Corrective actions if there are operational failures
HACCP Principles and Applications), such as exceeding allowed particle counts or temperature.
(2) HACCP (Hazard Analysis Critical Control Point), 4.1.3.2 Different types of personnel require training in
(3) FMEA (Failure Mode Effects Analysis) per CEI IIEC different areas. For example, visitors need not be trained in
1025,FMEA:FailureModesandEffectAnalysis, andFailure maintenance, testing, monitoring, or corrective actions. Failure
12,13
Mode Effect Analysis: FMEA from Theory to Execution, to properly train anyone entering, using, or maintaining the
(4) FTA (Fault Tree Analysis) per EN 1149-1, and facility will compromise the effectiveness of the cleanroom.
(5) Evaluation of sensitivity of the products and equipment 4.1.4 Courses taken and passed for certification must be
in the cleanroom or controlled area to the effects of identified. A concise, comprehensive system that documents
contamination,andtheeaseandcostofcleaningthoseproducts the training progression and level of each individual should be
and removing contamination products. used. Each job and set of jobs or responsibilities should be
4.1.3 A system for training and certifying personnel in identified by the management team. This system should be
cleanroom procedures is required. Provide a method for easily accessible to management and periodically reviewed.
monitoring compliance to procedures. All personnel must be Basicdocumentationshouldincludecoursecontents,personnel
trained and certified with regard to their responsibilities and identification information, training and certification dates, and
how those responsibilities affect the clean environment. Per- schedules for retraining at future intervals.
sonnel shall be recertified every two years.The training should 4.1.5 A set of procedures shall be documented to describe
ensure that each of the following groups of personnel is how the cleanroom systems are to be operated, maintained,
educated and trained appropriately: operators, technicians, repaired, and monitored. See ISO 14644—Part 4. Factors that
engineers and scientists, supervisors and managers, facilities may influence the operation or environmental quality of the
personnel, contractors, field service personnel, and visitors. cleanroom may include the following:
4.1.3.1 Recordsshallbemaintainedtoprovideevidencethat 4.1.5.1 Entry,exit,andmovementproceduresforequipment
all personnel have received proper training in the following and personnel,
areas: 4.1.5.2 Installation of equipment,
(1) How the cleanroom works (design, airflow, equipment 4.1.5.3 Cleaning techniques and methodology,
used, and air filtration), 4.1.5.4 Contamination generation from personnel or equip-
(2) Cleanroom standards, ment operation,
(3) Sources of contamination and how to avoid or control 4.1.5.5 Generation of heat, humidity, and electrostatic
them, charge,
(4) Hygiene and permitted and prohibited personal care 4.1.5.6 Service, maintenance, and repair of equipment and
products, facilities,
(5) Cleaning op
...

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 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 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 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 E2352-19(Practice)
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.

  • Standard
    14 pages
    English language
    sale 15% off
  • Standard
    14 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 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 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 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