ASTM E2352-04

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-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

Relations

• Replaced By: ASTM E2352-04(2010) - Standard Practice for Aerospace Cleanrooms and Associated Controlled Environments-Cleanroom Operations
• Effective Date: 01-Apr-2010
• Referred By: ASTM E2042/E2042M-09(2021) - Standard Practice for Cleaning and Maintaining Controlled Areas and Clean Rooms
• Effective Date: 01-Apr-2004

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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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
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 E2042 Practice for Cleaning and Maintaining Controlled
Areas and Clean Rooms
1.1 This practice specifies basic requirements, procedures,
E2088 Practice for Selecting, Preparing, Exposing, and
and practices for operating aerospace cleanrooms and con-
Analyzing Witness Surfaces for Measuring Particle Depo-
trolled environments and precautions associated with the
sition in Cleanrooms and Associated Controlled Environ-
facility and equipment used.
ments
1.2 This standard does not purport to address all of the
E2217 Practice for Design and Construction of Aerospace
safety concerns, if any, associated with its use. It is the
Cleanrooms and Contamination Controlled Areas
responsibility of the user of this standard to establish appro-
F25 Test Method for Sizing and CountingAirborne Particu-
priate safety and health practices and determine the applica-
late Contamination in Cleanrooms and Other Dust-
bility of regulatory limitations prior to use.
Controlled Areas
2. Referenced Documents F50 Practice for Continuous Sizing and Counting of Air-
borne Particles in Dust-ControlledAreas and Clean Rooms
2.1 ASTM Standards:
Using Instruments Capable of Detecting Single Sub-
D737 Test Method for Air Permeability of Textile Fabrics
Micrometre and Larger Particles
E595 Test Method for Total Mass Loss and Collected
F51 Test Method for Sizing and Counting Particulate Con-
Volatile Condensable Materials from Outgassing in a
taminant In and On Clean Room Garments
Vacuum Environment
F318 Practice for Sampling Airborne Particulate Contami-
E1216 Practice for Sampling for Particulate Contamination
nation in Cleanrooms for Handling Aerospace Fluids
by Tape Lift
2.2 Government Standards:
E1234 Practice for Handling, Transporting, and Installing
Federal Standard 209E Airborne Particulate Cleanliness
Nonvolatile Residue (NVR) Sample Plates Used in Envi-
Classes in Cleanroom and Clean Zones (cancelled Nov.
ronmentally Controlled Areas for Spacecraft
29, 2001)
E1235 Test Method for Gravimetric Determination of Non-
NASA-STD-6001, Test #7 Flammability, Odor, Offgassing
volatile Residue (NVR) in Environmentally Controlled
and Compatibility Requirements and Test Procedures for
Areas for Spacecraft
Materials in Environments That Support Combustion
E1549 Specification for ESD Controlled Garments Re-
2.3 Other Technical Society Standards:
quired in Cleanrooms and Controlled Environments for
IEST-RP-CC003 Garments Required in Cleanrooms and
Spacecraft for Non-Hazardous and Hazardous Operations
Controlled Environments
E1559 Test Method for Contamination Outgassing Charac-
IEST-RP-CC004 Evaluating Wiping Materials Used in
teristics of Spacecraft Materials
Cleanrooms and Other Controlled Environments
E1560 Test Method for Gravimetric Determination of Non-
IEST-RP-CC005 Cleanroom Gloves and Finger Cots
volatile Residue From Cleanroom Wipers
IEST-RP-CC018 Cleanroom Housekeeping—Operating
E1731 Test Method for Gravimetric Determination of Non-
and Monitoring Procedures
volatile Residue from Cleanroom Gloves
IEST-RP-CC020 Substrates and Forms for Documentation
in Cleanrooms
IEST-RP-CC022 Electrostatic Charge in Cleanrooms and
This practice is under the jurisdiction of ASTM Committee E21 on Space
Other Controlled Environments
SimulationandtheApplicationsofSpaceTechnologyandisthedirectresponsibility
of Subcommittee E21.05 on Contamination.
Current edition approved Apr. 1, 2004. Published April 2004. DOI: 10.1520/
E2352-04.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401.
Standards volume information, refer to the standard’s Document Summary page on Available from Institute of Environmental Sciences and Technology (IEST),
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Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
E2352–04
IEST-RP-CC026 Cleanroom Operations tained at a lower air pressure than the cleanroom and a higher
IEST-RP-CC027 Personnel Practices and Procedures in pressure than the outside area.
Cleanrooms and Controlled Environments
3.1.2 changing room—room where people using a clean-
IEST-RP-CC0016 Recommended Practice for the Rate of
room may change into or out of cleanroom clothing.
Deposition of Nonvolatile Residue in Cleanrooms
3.1.3 cross-over bench—bench that is used as an aid to
JIS B9923 Methods for Sizing and Counting Particle Con-
changingofcleanroomclothingandwhichprovidesabarrierto
taminants in and on Clean Room Garments
the tracking of floor contamination.
JIS B9926 Test Methods for Dust Generation from Moving
3.1.4 fiber—particle having an aspect (length-to-width) ra-
Mechanisms
tio 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
working in the manner agreed upon.
14644-1
3.1.7 operator—person working in the cleanroom perform-
ISO 14644-3 Cleanrooms and Associated Controlled
7 ing production work or carrying out process procedures.
Environments—Part 3: Metrology and Test Methods
3.1.8 particle—small piece of matter with defined physical
ISO 14644-4 Cleanrooms and Associated Controlled
boundaries.
Environments—Part 4: Design, Construction, and Start-
3.1.9 personnel—persons entering the cleanroom for any
up
purpose, but typically operators.
ISO/AWI 14644-6 Cleanrooms and Associated Controlled
Environments—Part 6: Terms and Definitions 3.1.10 stationary equipment—large equipment that cannot
ISO 14644-7 Cleanrooms and Controlled Environments— be easily moved.
Part 7: Separative Devices
3.1.11 unidirectional airflow—air flow which has a singular
ISO 7730 Moderate Thermal Environments—
direction of flow and may or may not contain uniform
Determination of the PMV and PPD Indices and Specifi-
velocities of air flow along parallel lines. Formerly known as
cation of the Conditions for Thermal Comfort
laminar airflow.
ISO 9237 Textiles—Determination of Permeability of Fab-
rics to Air
4. Requirements
ISO 11092 Textiles—Physiological Effects—Measurement
4.1 Operational Systems:
of Thermal and Water-Vapour Resistance Under Steady-
4.1.1 General—The air cleanliness class required shall be
State Conditions (Sweating Guarded-Hotplate Test)
determined before the facility is certified or used initially.
EN 1149-1 (1994) Protective Clothing—Electrostatic
Operations may be performed in a controlled area if the
Properties—Part 1 Surface Resistivity (Test Methods and
8 products are not sensitive to contamination, or if they will be
Requirements)
cleanedadequatelyduringlatersteps.Normallyoperationswill
CEI IIEC 1025:1990 Fault Tree Analysis (FTA)
be performed in a cleanroom of at least class 8 or cleaner per
CEI IIEC 812:1985 Analysis Techniques for System
ISO 14644-1 (class 100 000 or cleaner per FED-STD-209E).
Reliability—Procedure for Failure Mode and Effective
4.1.2 A set of risk factors, appropriate for the use of the
Analysis (FMEA)
specificcleanroom,shallidentifytheareaswherethereisarisk
ofcontaminationtotheprocess.Impropercontrolofthecritical
3. Terminology
elements of an operational cleanroom can pose a risk to the
3.1 Definitions:
cleanliness of the cleanroom and the quality of the product. A
3.1.1 airlock—intermediate room or area that is normally
risk assessment must be done and plans formulated to remedy
ventilated and used to minimize the transfer of airborne
out-of-control situations. A method for monitoring these risks
contamination from one area to another. The airlock is main-
shall be instituted so that action can be taken when conditions
are outside of specifications. The following list identifies some
of the risks that may prove important. Cleanroom parameters
AvailablefromJapanIndustrialStandards(JIS),1-3-1Kasumigaseki,Chiyoda- including heating, ventilation and air conditioning, pressure
ku, Tokyo, 100-8901, Japan.
differential, temperature, humidity, air change rates, and filters,
Available from Japan Air Cleaning Association (JACA), Tomoe-Ya Building
are discussed in ISO 14644-2, ISO 14644-3, and ISO 14644-4.
No. 2-14, 1-Chome, Uchi-Kanda, Chiyoda-ku, Tokyo, 101, Japan.
4.1.2.1 Table1givestherecommendedaircleanlinessclass,
Available from International Organization for Standardization (ISO), 1 rue de
Varembé, Case postale 56, CH-1211, Geneva 20, Switzerland.
personnel practices, and operational controls for different types
Available from European Committee for Standardization (CEN), 36 rue de
of cleanroom and controlled area operations. Examples of
Strassart, B-1050, Brussels, Belgium.
methods used for determining and managing these factors
International Electrotechnical Commission, Case postale 131, 1211 Geneva 20,
Switzerland. include:
E2352–04
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
(1) HAZOP (HACCP Principles and Applications, per (12)Correctiveactionsifthereareoperationalfailuressuch
HACCP Principles and Applications), 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 contami- identified. A concise, comprehensive system that documents
nation, and the ease and cost of cleaning those products and the training progression and level of each individual should be
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 operations and handling of products,
4.1.5.7 Cleanliness of process materials and utilities deliv-
(6) Cleanroom clothing and changing procedures,
ery systems,
(7) Maintenance procedures,
4.1.5.8 Testing and monitoring the facility,
(8) Cleanroom testing and monitoring,
4.1.5.9 Routine environmental contaminating factors (air-
(9) Proper behavior in a cleanroom,
flows, airborne particles, outgassing, haz
...