1、Designation: E 2352 04Standard Practice forAerospace Cleanrooms and Associated ControlledEnvironmentsCleanroom Operations1This standard is issued under the fixed designation E 2352; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, t
2、he year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This practice specifies basic requirements, procedures,and practices for operating aerospace cleanrooms an
3、d 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 health practic
4、es and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D 737 Test Method for Air Permeability of Textile FabricsE 595 Test Method for Total Mass Loss and CollectedVolatile Condensable Materials from Outgassing in aVacuum EnvironmentE 121
5、6 Practice for Sampling for Surface Particulate Con-tamination by Tape LiftE 1234 Practice for Handling, Transporting and InstallingNonvolatile Residue NVR Plates Used in EnvironmentallyControlled Areas for SpacecraftE 1235 Test Method for Gravimetric Determination of Non-volatile Residue (NVR) in E
6、nvironmentally ControlledAreas for SpacecraftE 1549 Specification for ESD Controlled Garments Re-quired in Cleanrooms and Controlled Environments forSpacecraft for Non-Hazardous and Hazardous OperationsE 1559 Test Method for Contamination Outgassing Charac-teristics of Spacecraft MaterialsE 1560 Tes
7、t Method for Gravimetric Determination of Non-volatile Residue from Cleanroom WipersE 1731 Test Method for Gravimetric Determination of Non-volatile Residue for Cleanroom GlovesE 2042 Practice for Cleaning and Maintaining ControlledAreas and CleanroomsE 2088 Practice for Selecting, Preparing, Exposi
8、ng, andAnalyzing Witness Surfaces for Measuring ParticulateDeposition in Cleanrooms and Associated Controlled En-vironmentsE 2217 Practice for Design and Construction of AerospaceCleanrooms and Contamination Controlled AreasF 25 Test Method for Sizing and Counting Airborne Par-ticulate Contamination
9、 in Cleanrooms and Other Dust-Controlled Areas Designated for Electronic and SimilarApplicationsF 50 Practice for Continuous Sizing and Counting AirborneParticulate Contamination in Dust-Controlled Areas andCleanrooms Using Instruments Capable of DetectingSingle Sub-Micrometer and Larger ParticlesF
10、51 Test Method for Sizing and Counting ParticulateContamination in Non- Cleanroom GarmentsF 318 Practice for Sampling Airborne Particulate Contami-nation in Cleanrooms for Handling Aerospace Fluids2.2 Government Standards:3Federal Standard 209E Airborne Particulate CleanlinessClasses in Cleanroom an
11、d Clean Zones (cancelled Nov.29, 2001)NASA-STD-6001, Test #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 Environm
12、ents4IEST-RP-CC004 Evaluating Wiping Materials Used inCleanrooms and Other Controlled Environments4IEST-RP-CC005 Cleanroom Gloves and Finger Cots4IEST-RP-CC018 Cleanroom HousekeepingOperatingand Monitoring Procedures4IEST-RP-CC020 Substrates and Forms for Documentationin Cleanrooms4IEST-RP-CC022 Ele
13、ctrostatic Charge in Cleanrooms andOther Controlled Environments41This practice is under the jurisdiction of ASTM Committee E21 on SpaceSimulation and the Applications of Space Technology and is the direct responsibilityof Subcommittee E21.05 on Contamination.Current edition approved Apr. 1, 2004. P
14、ublished April 2004.2For referenced 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
15、Office Superintendent of Documents,732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401.4Available from Institute of Environmental Sciences and Technology (IEST),5005 Newport Dr., Suite 506, Rolling Meadows, IL 60008-3841.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, Wes
16、t Conshohocken, PA 19428-2959, United States.IEST-RP-CC026 Cleanroom Operations4IEST-RP-CC027 Personnel Practices and Procedures inCleanrooms and Controlled Environments4IEST-RP-CC0016 Recommended Practice for the Rate ofDeposition of Nonvolatile Residue in Cleanrooms4JIS B 9923 Methods for Sizing a
17、nd Counting ParticleContaminants in and on Clean Room Garments5JIS B 9926 Test Methods for Dust Generation from MovingMechanisms5JACA Number 14C Guidance for Operation of CleanRooms62.4 International Standards:ISO 14644-1 Cleanrooms and Associated ControlledEnvironmentsPart 1: Classification of Air
18、Cleanliness7ISO 14644-2 Cleanrooms and Associated ControlledEnvironmentsPart 2: Specifications for Testing andMonitoring to Prove Continued Compliance with ISO14644-17ISO 14644-3 Cleanrooms and Associated ControlledEnvironmentsPart 3: Metrology and Test Methods7ISO 14644-4 Cleanrooms and Associated
19、ControlledEnvironmentsPart 4: Design, Construction, and Start-up7ISO/AWI 14644-6 Cleanrooms and Associated ControlledEnvironmentsPart 6: Terms and Definitions7ISO 14644-7 Cleanrooms and Controlled EnvironmentsPart 7: Separative Devices7ISO 7730 Moderate Thermal EnvironmentsDetermination of the PMV a
20、nd PPD Indices and Specifi-cation of the Conditions for Thermal Comfort7ISO 9237 TextilesDetermination of Permeability of Fab-rics to Air7ISO 11092 TextilesPhysiological EffectsMeasurementof Thermal and Water-Vapour Resistance Under Steady-State Conditions (Sweating Guarded-Hotplate Test)7EN 1149-1
21、(1994) Protective ClothingElectrostaticPropertiesPart 1 Surface Resistivity (Test Methods andRequirements)8CEI IIEC 1025:1990 Fault Tree Analysis (FTA)9CEI IIEC 812:1985 Analysis Techniques for SystemReliabilityProcedure for Failure Mode and EffectiveAnalysis (FMEA)93. Terminology3.1 Definitions:3.1
22、.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 than the cleanroom and a higherpressure than the outside area.3.1.2 changing roomroom where people us
23、ing 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 contamination.3.1.4 fiberparticle having an aspect (length-to-width) ra-tio of 10 or more.3.1.5 non-u
24、nidirectional 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 particle concentration.3.1.6 operationalcondition where the installation is func-tioning in the speci
25、fied 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 particlesmall piece of matter with defined physicalboundaries.3.1.9 personnelpersons entering the cleanroom
26、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 may not contain uniformvelocities of air flow along parallel lines. Formerly known aslaminar airflow.4.
27、 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 area if theproducts are not sensitive to contamination, or if they will becleaned adequately during l
28、ater 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 the use of thespecific cleanroom, shall identify the areas where there is a riskof contamination to t
29、he 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 plans formulated to remedyout-of-control situations. A method for monitoring these risksshall be insti
30、tuted 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, ventilation and air conditioning, pressuredifferential, temperature, humidity, air change rates, and filters
31、,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 and controlled area operations. Examples ofmethods used for determining and managing these factorsincl
32、ude: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, Uchi-Kanda, Chiyoda-ku, Tokyo, 101, Japan.7Available from International Organization for Standardiza
33、tion (ISO), 1 rue deVaremb, Case postale 56, CH-1211, Geneva 20, Switzerland.8Available from European Committee for Standardization (CEN), 36 rue deStrassart, B-1050, Brussels, Belgium.9International Electrotechnical Commission, Case postale 131, 1211 Geneva 20,Switzerland.E2352042(1) HAZOP (HACCP P
34、rinciples and Applications, perHACCP Principles and Applications),10(2) HACCP (Hazard Analysis Critical Control Point),(3) FMEA (Failure Mode Effects Analysis) per CEI IIEC1025, FMEA: Failure Modes and Effect Analysis,11and FailureMode Effect Analysis: FMEA from Theory to Execution,12,13(4) FTA (Fau
35、lt Tree Analysis) per EN 1149-1, and(5) Evaluation of sensitivity of the products and equipmentin the cleanroom or controlled area to the effects of contami-nation, and the ease and cost of cleaning those products andremoving contamination products.4.1.3 A system for training and certifying personne
36、l incleanroom procedures is required. Provide a method formonitoring compliance to procedures. All personnel must betrained and certified with regard to their responsibilities andhow those responsibilities affect the clean environment. Per-sonnel shall be recertified every two years. The training sh
37、ouldensure that each of the following groups of personnel iseducated and trained appropriately: operators, technicians,engineers and scientists, supervisors and managers, facilitiespersonnel, contractors, field service personnel, and visitors.4.1.3.1 Records shall be maintained to provide evidence t
38、hatall personnel have received proper training in the followingareas:(1) How the cleanroom works (design, airflow, equipmentused, and air filtration),(2) Cleanroom standards,(3) Sources of contamination and how to avoid or controlthem,(4) Hygiene and permitted and prohibited personal careproducts,(5
39、) Cleaning operations and handling of products,(6) Cleanroom clothing and changing procedures,(7) Maintenance procedures,(8) Cleanroom testing and monitoring,(9) Proper behavior in a cleanroom,(10) Work processes and technologies employed,(11) Safety and emergency responses, and(12) Corrective actio
40、ns if there are operational failures suchas exceeding allowed particle counts or temperature.4.1.3.2 Different types of personnel require training indifferent areas. For example, visitors need not be trained inmaintenance, testing, monitoring, or corrective actions. Failureto properly train anyone e
41、ntering, using, or maintaining thefacility will compromise the effectiveness of the cleanroom.4.1.4 Courses taken and passed for certification must beidentified. A concise, comprehensive system that documentsthe training progression and level of each individual should beused. Each job and set of job
42、s or responsibilities should beidentified by the management team. This system should beeasily accessible to management and periodically reviewed.Basic documentation should include course contents, personnelidentification information, training and certification dates, andschedules for retraining at f
43、uture intervals.4.1.5 A set of procedures shall be documented to describehow the cleanroom systems are to be operated, maintained,repaired, and monitored. See ISO 14644Part 4. Factors thatmay influence the operation or environmental quality of thecleanroom may include the following:4.1.5.1 Entry, ex
44、it, 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 Contamination generation from personnel or equip-ment operation,4.1.5.5 Generation of heat, humidity, and electrostaticcharge,4.1.5.6 Service, maintenance, and
45、 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 facility,4.1.5.9 Routine environmental contaminating factors (air-flows, airborne particles, outgassing, hazardous gas, vibration,electrostatic charges, and
46、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 modification,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
47、 trash disposal,4.1.5.16 Storage of equipment and supporting supplies inthe cleanroom,10HACCP Principles and Applications, edited by Merle D. Pierson 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 se
48、paration when stored together in bins or slots.Launderable or disposable bags can be used to help avoidcross-contamination.4.2.8 Cleanroom clothing (clean packaged or dirty) shall notbe removed beyond the confines of the storage area andcleanroom or changing room except for laundering purposes.Clean
49、room 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 cleanroom. Minimize contamination of the cleanroom cloth-ing while putting it on and removing it to ensure thatcontamination is not spread from the changing area. Seve
