IEST RP-CC026 2-2004 CLEANROOM OPERATIONS (Second printing).pdf

1、INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY Contamination Control Division Recommended Practice 026.2 IEST-RP-CC026.2 Cleanroom Operations INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY Arlington Place One 2340 S. Arlington Heights Road, Suite 100 Arlington Heights, IL 60005-4516 Phone: (

2、847) 981-0100 Fax: (847) 981-4130 E-mail: iestiest.org Web: www.iest.org 2 Copyrighted material INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY IEST-RP-CC026.2 IEST-RP-CC026.2 INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY Copyrighted material 3 This Recommended Practice is published by the I

3、NSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY to advance the technical and engineering sciences. Its use is entirely voluntary, and determination of its applicability and suitability for any particular use is solely the responsibility of the user. This Recommended Practice was prepared by and is

4、 under the jurisdiction of Working Group 026 of the IEST Con-tamination Control Division. Copyright 2004 by the INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY Second printing, September 2004 Validated August 2008 ISBN 978-1-877862-97-7 PROPOSAL FOR IMPROVEMENT: The Working Groups of the INSTITUT

5、E OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY are continually working on improvements to their Recommended Practices and Reference Documents. Suggestions from those who use these documents are welcome. If you have a suggestion regarding this document, please use the online Proposal for Improvement form

6、 found on the IEST website at www.iest.org/proposal/form.html. INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY Arlington Place One 2340 S. Arlington Heights Road, Suite 100 Arlington Heights, IL 60005-4516 Phone: (847) 981-0100 Fax: (847) 981-4130 E-mail: iestiest.org Web: www.iest.org 4 Copyrigh

7、ted material INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY IEST-RP-CC026.2 IEST-RP-CC026.2 INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY Copyrighted material 5 Cleanroom Operations IEST-RP-CC026.2 CONTENTS SECTION 1 SCOPE AND LIMITATIONS 7 2 REFERENCES 7 3 TERMS AND DEFINITIONS 8 4 BACKGRO

8、UND AND PURPOSE 8 5 ANCILLARY OPERATIONS 9 6 METHODS FOR VERIFYING CLEANLINESS. 13 FIGURE 1 CONTINUOUS FLOWING DUCT METHOD 15 2 TEST CHAMBER SCHEMATIC FOR RESERVOIR METHOD 17 3 RELATIVE PARTICLE CONCENTRATION IN THE RESERVOIR DURING THE RESERVOIR TEST METHOD 17 APPENDIX A BIBLIOGRAPHY 23 6 Copyright

9、ed material INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY IEST-RP-CC026.2 IEST-RP-CC026.2 INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY Copyrighted material 7 INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY Contamination Control Division Recommended Practice 026.2 Cleanroom Operations I

10、EST-RP-CC026.2 1 SCOPE AND LIMITATIONS This Recommended Practice (RP) provides guidance for maintaining the integrity of the cleanroom during ancillary operations. 1.1 Scope Ancillary operations include: a) Preparation of supplies and materials b) Modification of the facility c) Installation and rep

11、air of equipment Procedures are given for verifying the cleanliness of the equipment, the workstation, and the area, follow-ing these ancillary operations. 1.2 Limitations This Recommended Practice does not address the effect of contamination from the equipment or facil-ity upon the product under ma

12、nufacture, nor does it specify limits of acceptance for operational condi-tions. It does, however, recommend standard termi-nology for specifying desired limits. 2 REFERENCES The following documents are incorporated into this Recommended Practice to the extent specified herein. Users should apply th

13、e most recent editions of the references. 2.1 Standards and recommended practices ASTM-D3154-00 Standard Test Method for Average Velocity in a Duct (Pitot Tube Method) ASTM-F24: Standard Method for Measuring and Counting Particulate Contamination on Surfaces IEST-RP-CC003: Garment System Considerati

14、ons for Cleanrooms and Other Controlled Environments IEST-RP-CC004: Evaluating Wiping Materials Used in Cleanrooms and Other Controlled Environments IEST-RP-CC005: Gloves and Finger Cots Used in Cleanrooms and Other Controlled Environments IEST-RP-CC012: Considerations in Cleanroom De-sign IEST-RP-C

15、C018: Cleanroom HousekeepingOper-ating and Monitoring Procedures ISO 14644-1 Cleanrooms and associated controlled environmentsPart 1: Classification of air cleanliness 2.2 Sources ASTM American Society for Testing and Materials 100 Barr Harbor Drive West Conshohocken, Pennsylvania 19428-2959 USA www

16、.astm.org IEST Institute of Environmental Sciences and Technology 2340 S. Arlington Heights Road, Suite 100 Arlington Heights, IL 60005-4516 USA www.iest.org ISO U.S. Member Body for document orders: IEST 2340 S. Arlington Heights Road, Suite 100 Arlington Heights, IL 60005-4516 USA www.iest.org 8 C

17、opyrighted material INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY IEST-RP-CC026.2 Outside the US: Documents available from representative ISO member body organization 3 TERMS AND DEFINITIONS The following terms have special meaning in the con-text of this Recommended Practice. ancillary Subordi

18、nate, subsidiary, auxiliary, or supplemental activities required to start up or maintain production or process activity. adhesion A molecular force that is exerted across the surface of contact between unlike liquids and solids, or solids and solids, and which resists their separation. airlock An in

19、termediate room or area that is normally venti-lated and used to minimize the transfer of airborne contamination from one area to another. clean zone A defined space in which the concentration of air-borne particles is controlled to specified limits. cleanroom A room in which the air supply, air dis

20、tribution, fil-tration of air supply, materials of construction, pres-sure gradients, and operating procedures are regulated to control airborne particle concentrations to meet established air cleanliness levels, as defined by ISO 14644-1. cleaning agent A liquid that has the ability to aid in remov

21、ing contami-nants from surfaces, usually by dissolution, reducing surface tension, or neutralizing electrostatic charge, or by both reducing surface tension and neutralizing elec-trostatic charge. Cleaning agents can also be disinfectants. To be accept-able for use in cleanrooms and other environmen

22、tally controlled areas, cleaning agents should be chemically and physically compatible with the process or product, or both, and should not themselves contribute measura-bly to the overall burden of contamination. classes of air cleanliness Airborne particle concentration levels as defined by ISO 14

23、644-1. contaminant Any unwanted substance present on a surface. contamination The act or result of deposition of contaminants on a surface. housekeeping maintenance Functions performed to preserve the specified cleanli-ness of a cleanroom or clean zone. modification Making of a limited change in som

24、ething. particle A solid or liquid object that, as a general rule, meas-ures from 1 nm to 1 mm. particle burden The number of particles in the relevant size range that can be found on a given surface. pass-through An opening in a wall between two rooms through which something (such as materials) may

25、 be passed. prep area (decontamination area) A preparation cleanroom or clean zone that typically is less clean than the operational cleanroom and in which preliminary cleaning procedures are performed. primary surface A surface that is in direct contact with the product. residue Any contaminant rem

26、aining on a surface after it has been cleaned. secondary surface A surface that is not in contact with the product, but which indirectly affects the product. viable particle A particle capable of reproduction. 4 BACKGROUND AND PURPOSE New cleanrooms and the production and service equipment they cont

27、ain are installed and commis-sioned by specialists under controlled and near ideal conditions. Inevitably, however, routine maintenance, modifications, and replacements will be made to both the room and equipment during their operating life. All cleanroom operations, therefore, must be con-ducted in

28、 accordance with correct procedures if cleanroom integrity is to be maintained at all times. This RP provides both general and detailed methods for the continuing operation of a cleanroom to assure its integrity and is intended for use as a basis for pre-paring standard operating procedures (SOP) fo

29、r any cleanroom. IEST-RP-CC026.2 INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY Copyrighted material 9 5 ANCILLARY OPERATIONS 5.1 Considerations in planning and preparation for ancillary operations a) The proper planning and preparation of tasks that may be a source of contamination should inclu

30、de the procedures and precautions required to control (or limit) these risks. A detailed protocol should include the following considerations (refer to IEST-RP-CC012): Mission statement (goals and strategy) Collection and analysis of facts (parameters requiring control) Contamination control guideli

31、nes Life safety Environmental issues Personnel entry and exit requirements Critical material flows Security and access control Special requirements b) Better maintenance of equipment and support facilities can often be achieved by providing easy ac-cess for repair and replacement purposes. Major ser

32、v-ice equipment should be located outside the process floor footprint. The extensive requirements of clean-room facilities for support maintenance are often un-derestimated. In many cases, a separate cleanroom facility is required. c) Redundancy in critical equipment or systems may be justifiable in

33、 cleanroom projects to ensure continuous operation and control of the room. Costs associated with redundant systems should be evalu-ated in relation to the risk of lost product and exten-sive cleanroom restart and qualification costs. d) Flexibility to facilitate future expansion and change should b

34、e considered in the design of clean-room projects. The following is a partial list of fea-tures that may enhance cleanroom flexibility: Additional air recirculation units to accom-modate future increases of air volume Zone design that will facilitate the rear-rangement of any zone with minimal inter

35、-ruption of adjacent zones or the total system Location of the distribution of services (such as utilities) in proximity to the equipment so that the desired level of access is facilitated Location of service mains outside the process floor and placement of branch connections to serve equipment, thu

36、s easing process line modification Location of support services outside the process floor e) Certain ancillary operations, such as the follow-ing, may require certain precautions: Major work on the room structure (walls, floors, ceilings) requiring a total shutdown Minor work on the room structure t

37、hat does not require a shutdown Equipment entry and installation (planned tooling or plug-in) Replacement of individually ducted HEPA or ULPA filters Replacement of HEPA or ULPA filters in a pressurized plenum system Light changeouts Equipment removal (decommissioning and exit procedures) 5.2 Servic

38、e equipment and supplies for ancillary operations All tools, equipment, and supplies used in the clean-room should be clean (consistent with the requirements of the product and process) and, if applicable, steril-ized or disinfected prior to entry into the cleanroom. Equipment designated for cleanro

39、om service should be restricted to this use. Examples of such equipment and supplies may include but are not limited to those with the following characteristics: 5.2.1 Vacuum cleaning systems Vacuum cleaning systems may be central plant vac-uum systems with attachments or portable vacuum cleaners wi

40、th HEPA filtered exhaust (dry-wet, or dry type). 5.2.2 Adhesive roll mops Adhesive roll mops are mops that utilize an adhesive contact surface to remove particles. 5.2.3 Cleanroom wipers Refer to IEST-RP-CC004. 5.2.4 Stepladders Stepladders may be fiberglass-reinforced, plastic, aluminum, or stainle

41、ss steel. 5.2.5 Cleanroom apparel Cleanroom apparel should be compatible with the product cleanliness requirements, the process being used to meet these requirements, and the cleanroom classification. Refer to IEST-RP-CC003 and IEST-RP-CC005. 10 Copyrighted material INSTITUTE OF ENVIRONMENTAL SCIENC

42、ES AND TECHNOLOGY IEST-RP-CC026.2 5.2.6 Water Water may be filtered tap, distilled, reverse osmosis, deionized, or other water suitable for injection. 5.2.7 Cleaning agents Cleaning agents include water, aqueous solutions of nonionic detergents, and certain organic solvents or disinfectants. Aerosol

43、 sprays are usually not accept-able for cleanroom use. NOTE: Toxic or corrosive substances need spe-cial handling precautions, tools, and disposal procedures. 5.2.8 Wet mops Wet mops may have heads constructed of foam, ny-lon, or low-linting material, and handles constructed of stainless steel, alum

44、inum, reinforced plastic, or their equivalent. 5.2.9 Repair tools Repair tools may include a variety of hand tools, such as screwdrivers, wrenches, and pliers, made of top quality (i.e., minimum-shedding or minimum-particle-generating) materials. Stainless steel tools are pre-ferred whenever possibl

45、e. Tools should be dedicated to cleanroom use only, if possible. NOTE: Power-driven tools such as drills or mo-torized screwdrivers should only be used in clean-rooms if no alternatives are available. In the event they are used, special precautions are required to minimize particulate contamination

46、from metal filings and so forth. 5.2.10 Portable instruments Any portable instruments such as meters, power sup-plies, oscilloscopes, and so forth, should be made of top-quality, minimum-shedding or minimum-particle-generating materials, and, whenever possible, should be designed for use in a cleanr

47、oom. 5.2.11 Clean film (plastic sheeting) Clean plastic film may be used as a temporary cover-ing or partitioning provided it meets the specified limits for release of contaminants such as, but not limited to, particles and volatile compounds (VOCs). Clean film is film manufactured of polyvinyl chlo

48、ride (vinyl, or PVC), polytetrafluoroethylene (PTFE) (e.g., Teflon), polyethylene (poly, or PE), polychloro-trifluoroethylene (PCTFE) (e.g., Aclar), or other ma-terial cleaned in FCC level 1 or 2, which is consistent with Class A as defined by IEST-RP-CC003. 5.2.12 Tape Adhesive film used to attach

49、and secure clean film to provide a barrier between zones of differing cleanli-ness levels. 5.2.13 Barriers A system of hard walls, soft walls, or partitions, used to provide a cleanliness zone around a work area or a process area. 5.2.14 Decontamination area Defined space for the removal of visible contamination. 5.3 Safety considerations Some cleaning agents may require special storage, handling, and disposal procedures. The appropriate procedures and restrictions may be found in the Ma-terial Safety Data Sheet (MSDS)