1、Designation: E2352 04 (Reapproved 2010)Standard Practice forAerospace Cleanrooms and Associated ControlledEnvironmentsCleanroom Operations1This standard is issued under the fixed designation E2352; the number immediately following the designation indicates the year oforiginal adoption or, in the cas
2、e of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This practice specifies basic requirements, procedures,and practices for operating aerospac
3、e cleanrooms and con-trolled environments and precautions associated with thefacility and equipment used.1.2 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and
4、 health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D737 Test Method for Air Permeability of Textile FabricsE595 Test Method for Total Mass Loss and CollectedVolatile Condensable Materials from Outgassing in aVacuum Env
5、ironmentE1216 Practice for Sampling for Particulate Contaminationby Tape LiftE1234 Practice for Handling, Transporting, and InstallingNonvolatile Residue (NVR) Sample Plates Used in Envi-ronmentally Controlled Areas for SpacecraftE1235 Test Method for Gravimetric Determination of Non-volatile Residu
6、e (NVR) in Environmentally ControlledAreas for SpacecraftE1549 Specification for ESD Controlled Garments Re-quired in Cleanrooms and Controlled Environments forSpacecraft for Non-Hazardous and Hazardous OperationsE1559 Test Method for Contamination Outgassing Charac-teristics of Spacecraft Materials
7、E1560 Test Method for Gravimetric Determination of Non-volatile Residue From Cleanroom WipersE1731 Test Method for Gravimetric Determination of Non-volatile Residue from Cleanroom GlovesE2042 Practice for Cleaning and Maintaining ControlledAreas and Clean RoomsE2088 Practice for Selecting, Preparing
8、, Exposing, andAnalyzing Witness Surfaces for Measuring Particle Depo-sition in Cleanrooms and Associated Controlled Environ-mentsE2217 Practice for Design and Construction of AerospaceCleanrooms and Contamination Controlled AreasF25 Test Method for Sizing and Counting Airborne Particu-late Contamin
9、ation in Cleanrooms and Other Dust-Controlled AreasF50 Practice for Continuous Sizing and Counting of Air-borne Particles in Dust-Controlled Areas and Clean RoomsUsing Instruments Capable of Detecting Single Sub-Micrometre and Larger ParticlesF51 Test Method for Sizing and Counting Particulate Con-t
10、aminant In and On Clean Room GarmentsF318 Practice for Sampling Airborne Particulate Contami-nation in Cleanrooms for Handling Aerospace Fluids2.2 Government Standards:3Federal Standard 209E Airborne Particulate CleanlinessClasses in Cleanroom and Clean Zones (cancelled Nov.29, 2001)NASA-STD-6001, T
11、est #7 Flammability, Odor, Offgassingand Compatibility Requirements and Test Procedures forMaterials in Environments That Support Combustion2.3 Other Technical Society Standards:IEST-RP-CC003 Garments Required in Cleanrooms andControlled Environments4IEST-RP-CC004 Evaluating Wiping Materials Used in
12、Cleanrooms and Other Controlled Environments4IEST-RP-CC005 Cleanroom Gloves and Finger Cots4IEST-RP-CC018 Cleanroom HousekeepingOperatingand Monitoring Procedures4IEST-RP-CC020 Substrates and Forms for Documentationin Cleanrooms41This practice is under the jurisdiction of ASTM Committee E21 on Space
13、Simulation and Applications of Space Technology and is the direct responsibility ofSubcommittee E21.05 on Contamination.Current edition approved April 1, 2010. Published May 2010. Originallyapproved in 2004. Last previous edition approved in 2004 as E2342 04. DOI:10.1520/E2352-04R10.2For referenced
14、ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from U.S. Government Printing Office Superintendent of Documents,7
15、32 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401.4Available from Institute of Environmental Sciences and Technology (IEST),Arlington Place One, 2340 S. Arlington Heights Rd., Suite 100, Arlington Heights,IL 60005-4516, http:/www.iest.org.1Copyright ASTM International, 100 Barr Harbor Driv
16、e, PO Box C700, West Conshohocken, PA 19428-2959, United States.IEST-RP-CC022 Electrostatic Charge in Cleanrooms andOther Controlled Environments4IEST-RP-CC026 Cleanroom Operations4IEST-RP-CC027 Personnel Practices and Procedures inCleanrooms and Controlled Environments4IEST-RP-CC0016 Recommended Pr
17、actice for the Rate ofDeposition of Nonvolatile Residue in Cleanrooms4JIS B9923 Methods for Sizing and Counting Particle Con-taminants in and on Clean Room Garments5JIS B9926 Test Methods for Dust Generation from MovingMechanisms5JACA Number 14C Guidance for Operation of CleanRooms62.4 International
18、 Standards:ISO 14644-1 Cleanrooms and Associated ControlledEnvironmentsPart 1: Classification of Air Cleanliness7ISO 14644-2 Cleanrooms and Associated ControlledEnvironmentsPart 2: Specifications for Testing andMonitoring to Prove Continued Compliance with ISO14644-17ISO 14644-3 Cleanrooms and Assoc
19、iated ControlledEnvironmentsPart 3: Metrology and Test Methods7ISO 14644-4 Cleanrooms and Associated ControlledEnvironmentsPart 4: Design, Construction, and Start-up7ISO/AWI 14644-6 Cleanrooms and Associated ControlledEnvironmentsPart 6: Terms and Definitions7ISO 14644-7 Cleanrooms and Controlled En
20、vironmentsPart 7: Separative Devices7ISO 7730 Moderate Thermal EnvironmentsDetermination of the PMV and PPD Indices and Specifi-cation of the Conditions for Thermal Comfort7ISO 9237 TextilesDetermination of Permeability of Fab-rics to Air7ISO 11092 TextilesPhysiological EffectsMeasurementof Thermal
21、and Water-Vapour Resistance Under Steady-State Conditions (Sweating Guarded-Hotplate Test)7EN 1149-1 (1994) Protective ClothingElectrostaticPropertiesPart 1 Surface Resistivity (Test Methods andRequirements)8CEI IIEC 1025:1990 Fault Tree Analysis (FTA)9CEI IIEC 812:1985 Analysis Techniques for Syste
22、mReliabilityProcedure for Failure Mode and EffectiveAnalysis (FMEA)93. Terminology3.1 Definitions:3.1.1 airlockintermediate room or area that is normallyventilated and used to minimize the transfer of airbornecontamination from one area to another. The airlock is main-tained at a lower air pressure
23、than the cleanroom and a higherpressure than the outside area.3.1.2 changing roomroom where people using a clean-room may change into or out of cleanroom clothing.3.1.3 cross-over benchbench that is used as an aid tochanging of cleanroom clothing and which provides a barrier tothe tracking of floor
24、contamination.3.1.4 fiberparticle having an aspect (length-to-width) ra-tio of 10 or more.3.1.5 non-unidirectional airflowair distribution where thesupply air entering the room mixes with the internal air bymeans of induction.3.1.5.1 DiscussionThis type of air distribution results indilution of the
25、particle concentration.3.1.6 operationalcondition where the installation is func-tioning in the specified manner, with the personnel present andworking in the manner agreed upon.3.1.7 operatorperson working in the cleanroom perform-ing production work or carrying out process procedures.3.1.8 particl
26、esmall piece of matter with defined physicalboundaries.3.1.9 personnelpersons entering the cleanroom for anypurpose, but typically operators.3.1.10 stationary equipmentlarge equipment that cannotbe easily moved.3.1.11 unidirectional airflowair flow which has a singulardirection of flow and may or ma
27、y not contain uniformvelocities of air flow along parallel lines. Formerly known aslaminar airflow.4. Requirements4.1 Operational Systems:4.1.1 GeneralThe air cleanliness class required shall bedetermined before the facility is certified or used initially.Operations may be performed in a controlled
28、area if theproducts are not sensitive to contamination, or if they will becleaned adequately during later steps. Normally operations willbe performed in a cleanroom of at least class 8 or cleaner perISO 14644-1 (class 100 000 or cleaner per FED-STD-209E).4.1.2 A set of risk factors, appropriate for
29、the use of thespecific cleanroom, shall identify the areas where there is a riskof contamination to the process. Improper control of the criticalelements of an operational cleanroom can pose a risk to thecleanliness of the cleanroom and the quality of the product. Arisk assessment must be done and p
30、lans formulated to remedyout-of-control situations. A method for monitoring these risksshall be instituted so that action can be taken when conditionsare outside of specifications. The following list identifies someof the risks that may prove important. Cleanroom parametersincluding heating, ventila
31、tion and air conditioning, pressuredifferential, temperature, humidity, air change rates, and filters,are discussed in ISO 14644-2, ISO 14644-3, and ISO 14644-4.4.1.2.1 Table 1 gives the recommended air cleanliness class,personnel practices, and operational controls for different typesof cleanroom a
32、nd controlled area operations. Examples ofmethods used for determining and managing these factorsinclude:5Available from Japan Industrial Standards (JIS), 1-3-1 Kasumigaseki, Chiyoda-ku, Tokyo, 100-8901, Japan.6Available from Japan Air Cleaning Association (JACA), Tomoe-Ya BuildingNo. 2-14, 1-Chome,
33、 Uchi-Kanda, Chiyoda-ku, Tokyo, 101, Japan.7Available from International Organization for Standardization (ISO), 1, ch. dela Voie-Creuse, Case postale 56, CH-1211, Geneva 20, Switzerland, http:/www.iso.ch.8Available from European Committee for Standardization (CEN), 36 rue deStassart, B-1050, Brusse
34、ls, Belgium, http:/www.cenorm.be.9International Electrotechnical Commission, Case postale 131, 1211 Geneva 20,Switzerland.E2352 04 (2010)2(1) HAZOP (HACCP Principles and Applications, perHACCP Principles and Applications),10(2) HACCP (Hazard Analysis Critical Control Point),(3) FMEA (Failure Mode Ef
35、fects Analysis) per CEI IIEC1025, FMEA: Failure Modes and EffectAnalysis,11and FailureMode Effect Analysis: FMEA from Theory to Execution,12,13(4) FTA (Fault Tree Analysis) per EN 1149-1, and(5) Evaluation of sensitivity of the products and equipmentin the cleanroom or controlled area to the effects
36、 of contami-nation, and the ease and cost of cleaning those products andremoving contamination products.4.1.3 A system for training and certifying personnel incleanroom procedures is required. Provide a method formonitoring compliance to procedures. All personnel must betrained and certified with re
37、gard to their responsibilities andhow those responsibilities affect the clean environment. Per-sonnel shall be recertified every two years. The training shouldensure that each of the following groups of personnel iseducated and trained appropriately: operators, technicians,engineers and scientists,
38、supervisors and managers, facilitiespersonnel, contractors, field service personnel, and visitors.4.1.3.1 Records shall be maintained to provide evidence thatall personnel have received proper training in the followingareas:(1) How the cleanroom works (design, airflow, equipmentused, and air filtrat
39、ion),(2) Cleanroom standards,(3) Sources of contamination and how to avoid or controlthem,(4) Hygiene and permitted and prohibited personal careproducts,(5) Cleaning operations and handling of products,(6) Cleanroom clothing and changing procedures,(7) Maintenance procedures,(8) Cleanroom testing an
40、d monitoring,(9) Proper behavior in a cleanroom,(10) Work processes and technologies employed,(11) Safety and emergency responses, and(12) Corrective actions if there are operational failures suchas exceeding allowed particle counts or temperature.4.1.3.2 Different types of personnel require trainin
41、g indifferent areas. For example, visitors need not be trained inmaintenance, testing, monitoring, or corrective actions. Failureto properly train anyone entering, using, or maintaining thefacility will compromise the effectiveness of the cleanroom.4.1.4 Courses taken and passed for certification mu
42、st beidentified. A concise, comprehensive system that documentsthe training progression and level of each individual should beused. Each job and set of jobs or responsibilities should beidentified by the management team. This system should beeasily accessible to management and periodically reviewed.
43、Basic documentation should include course contents, personnelidentification information, training and certification dates, andschedules for retraining at future intervals.4.1.5 A set of procedures shall be documented to describehow the cleanroom systems are to be operated, maintained,repaired, and m
44、onitored. See ISO 14644Part 4. Factors thatmay influence the operation or environmental quality of thecleanroom may include the following:4.1.5.1 Entry, exit, and movement procedures for equipmentand personnel,4.1.5.2 Installation of equipment,4.1.5.3 Cleaning techniques and methodology,4.1.5.4 Cont
45、amination generation from personnel or equip-ment operation,4.1.5.5 Generation of heat, humidity, and electrostaticcharge,4.1.5.6 Service, maintenance, and repair of equipment andfacilities,4.1.5.7 Cleanliness of process materials and utilities deliv-ery systems,4.1.5.8 Testing and monitoring the fa
46、cility,4.1.5.9 Routine environmental contaminating factors (air-flows, airborne particles, outgassing, hazardous gas, vibration,electrostatic charges, and molecular contamination),4.1.5.10 Personnel and material flow,4.1.5.11 Emergency and planned shutdowns,4.1.5.12 Facility expansion and modificati
47、on,4.1.5.13 Frequency of monitoring the results,4.1.5.14 Compatibility and selection of fabrication and en-vironmental control equipment,4.1.5.15 Waste and trash disposal,4.1.5.16 Storage of equipment and supporting supplies inthe cleanroom,10HACCP Principles and Applications, edited by Merle D. Pie
48、rson and DonaldA. Corlett, Jr., Chapman these can be in a locker or in the room, and4.2.7.4 Bins or storage slots. Clothing elements may requirephysical separation when stored together in bins or slots.Launderable or disposable bags can be used to help avoidcross-contamination.4.2.8 Cleanroom clothi
49、ng (clean packaged or dirty) shall notbe removed beyond the confines of the storage area andcleanroom or changing room except for laundering purposes.Cleanroom garments shall not be worn in uncontrolled areas oroutside of the cleanroom and changing room.4.2.9 Cleanroom clothing shall be put on and removed sothat the spread of contamination is avoided or minimized.Dress from the top down, and do not drag cleanroom garmentson the floor. Cleanroom personnel will change into cleanroomclothing in the changing area or airlock, before proceeding intoa cleanr
