IEST RP-CC018 4-2007 CLEANROOM HOUSEKEEPING OPERATING AND MONITORING PROCEDURES.pdf

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1、INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY Contamination Control Division Reco ended Practice 018.4 IEST-RP-C018.4 Cleanrom Housekeping: Operating and Monitoring Procedures INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY Arlington Place One 2340 S. Arlington Heights Road, Suite 10 Arlingt

2、on Heights, IL 6005-4516 Phone: (847) 981-010 Fax: (847) 981-4130 E-mail: iestiest.org Web: ww.iest.org 2 Copyrighted material INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY IEST-RP-C018.4 This Recomended Practice is published by the INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY to advance

3、the technical and enginering sciences. Its use is entirely voluntary, and determination of its aplicability and suitability for any particular use is solely the responsibility of the user. This Recomended Practice was prepared by and is under the jurisdiction of Working Group 018 of the IEST Con-tam

4、ination Control Division. Copyright 207 by the INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY First printing, October 207 ISBN 978-0-9787868-3-0 PROPOSAL FOR IMPROVEMENT: The Working Groups of the INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY are continualy working on improvements to their

5、Recomended Practices and Reference Documents. Sugestions from those who use these documents are welcome. If you have a sugestion regarding this document, please use the online Proposal for Improvement form found on the IEST website at ww.iest.org/proposal/form.html. INSTITUTE OF ENVIRONMENTAL SCIENC

6、ES AND TECHNOLOGY Arlington Place One 2340 S. Arlington Heights Road, Suite 10 Arlington Heights, IL 6005-4516 Phone: (847) 981-010 Fax: (847) 981-4130 E-mail: iestiest.org Web: ww.iest.org IEST-RP-C018.4 INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY Copyrighted material 3 Cleanroom Housekeping

7、: Operating and Monitoring Procedures IEST-RP-C018.4 CONTENTS SECTION 1 SCOPE AND LIMITATIONS.5 2 REFERENCES5 3 TERMS AND EFINITIONS.6 4 BACKGROUND6 5 PROCEDURES.7 6 TEST METHODS14 FIGURE 1 RECOMENDED WIPING SEQUENCE10 2 WAL-CLEANING STROKE METHOD10 3 FLOR-CLEANING STROKE METHOD1 4 CLEANING CHECKLIS

8、T.13 5 WIPING SUB-ASEMBLY18 6 CAMERA ND UV LIGHT SUB-ASEMBLY.19 TABLE 1 CLEANING FREQUENCY FOR ISO CLAS 5 CLEANROM.13 2 APLICATION OF TEST METHODS ACORDING TO TYPE OF CONTAMINATION.14 A1 EFECT OF PARTICLE SIZE ON ADHESION TO SURFACE24 APPENDIX A PARTICLE ADHESION AND REMOVAL.23 B BIBLIOGRAPHY26 4 Co

9、pyrighted material INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY IEST-RP-C018.4 IEST-RP-C018.4 INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY Copyrighted material 5 INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY Contamination Control Division Recommended Practice 018.4 Cleanroom Houseke

10、ping: Operating and Monitoring Procedures IEST-RP-C018.4 1 SCOPE AND LIMITATIONS 1.1 Scope This Recomended Practice (RP) provides guidance for maintaining a cleanrom at the level for which it was designed. This document is intended as a guide for establishing apropriate housekeping procedures es-sen

11、tial for the overal contamination control program of the cleanrom. In adition, test procedures are pro-vided for use in establishing the frequency of house-keping and monitoring the efectivenes of the housekeping. The test methods also are designed to help determine apropriate levels of surface clea

12、nlines for specific cleanroms. 1.2 Limitations This RP does not specify aceptance limits, but does provide standard terminology for specifying desired limits. NOTE: References to “cleanrom” in this document are to be construed, where apropriate, as including clean zones and clean-air devices. 2 REFE

13、RENCES The cited editions of the folowing documents are in-corporated into this RP to the extent specified herein. Users are encouraged to investigate the posibility of aplying the most recent editions of the references. 2.1 American Society for Testing and Materials (ASTM) ASTM F24-04: Standard Met

14、hod for Measuring and Counting Particulate Contamination on Surfaces 2.2 Institute of Environmental Sciences and Technology (IEST) IEST-RP-C03.3: Garment System Considerations in Cleanroms and Other Controled Environments IEST-RP-C04.3: Evaluating Wiping Materials Used in Cleanroms and Other Control

15、ed Environments IEST-RP-C05.3: Gloves and Finger Cots Used in Cleanroms and Other Controled Environments IEST-RP-C07.1: Testing ULPA Filters 2.3 International Organization for Standardization (ISO) ISO 1464-1:199 Cleanroms and asociated con-troled environmentsPart 1: Clasification of air cleanlines

16、2.4 United States Pharmacopeia (USP) USP30-NF25: The United States Pharmacopeia and National Formulary 2.5 Sources and Addresses ASTM American Society for Testing and Materials 10 Bar Harbor Drive West Conshohocken, PA 19428-2959 USA Phone: 610-832-9585 Fax: 610-832-955 Web: ww.astm.org 6 Copyrighte

17、d material INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY IEST-RP-C018.4 IEST Institute of Environmental Sciences and Technology Arlington Place One 2340 S. Arlington Heights Rd., Ste. 10 Arlington Heights, IL 6005-4516 USA Phone: 847- 981-010 Fax: 847-981-4130 Web: ww.iest.org ISO In the US, do

18、cuments may be ordered from: IEST Arlington Place One 2340 S. Arlington Heights Rd., Ste. 10 Arlington Heights, IL 6005-4516 USA ww.iest.org Outside the US: Documents available from represen-tative ISO member body organization USP United States Pharmacopeia 12601 Twinbrok Parkway Rockvile, MD 20852-

19、1790 USA Phone: 301-81-066 Fax: 301-816-8148 Web: ww.usp.org 3 TERMS AND EFINITIONS adhesion The force exerted acros a surface of contact betwen liquids and solids, or solids and solids, that resists their separation. clases of air cleanlines The airborne particle concentration levels defined by ISO

20、 1464-1. cleaning agent Any liquid that has the ability to aid in the removal of surface contamination, is compatible with the product and proces, and does not contribute substantialy to the contamination of the cleanrom. cleanrom A rom in which the air filtration, air distribution, utilities, mater

21、ials of construction, equipment, and operating procedures are specified and regulated to control airborne particle concentrations to met ap-propriate airborne particulate cleanlines clasifica-tions, as defined by ISO 1464-1. clean zone A defined space in which the concentration of air-borne particle

22、s is controled to specified limits. contamination The result of the adition of contaminants to a mate-rial or to any surface within a clean zone. filter A device used to remove particulate mater or impuri-ties from a fluid (gas or liquid) flowing through it. filter, high-eficiency particulate air (H

23、EPA) A throwaway, extended-medium, dry-type filter in a rigid frame, having a minimum particle-colection eficiency of 9.97% (that is, a maxi-mum particle penetration of 0.03%) for 0.3-m particles of thermaly generated dioctyl phthalate (DOP) or specified alternative aerosol. filter, ultralow-penetra

24、tion air (ULPA) A throwaway, extended-medium, dry-type filter in a rigid frame, having a minimum particle-colection eficiency of 9.99% (that is, a maximum particle penetration of 0.01%) for particles in the size range of 0.1 to 0.2 m, when tested in acordance with the methods of IEST-RP-C07. houseke

25、ping, cleanrom Maintenance or cleaning performed to preserve the specified cleanlines of a cleanrom. particle An object that is solid, liquid, or both, usualy be-twen 1 nm and 1 m in size. particle burden The number of particles in the relevant size range per unit area of surface. primary surface A

26、surface that is in direct contact with the product. residue Any substance remaining on a surface after the sur-face has ben cleaned. secondary surface A surface that is not in contact with the product, but which indirectly afects the product. surface contaminant Any unwanted substance present in or

27、on a surface. viable particle A particle capable of reproduction; a living organism. 4 BACKGROUND 4.1 History The methods and techniques presented in this RP originated from the initial meting for this RP and from industry standards at that time. Some of the methods were based on studies that had be

28、n per-formed by universities and aerospace, semiconductor, IEST-RP-C018.4 INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY Copyrighted material 7 and pharmaceutical companies. Round-robin testing (industry testing of the methods by al clases and types of cleanroms) was done for the initial publica

29、-tion of the RP. Previous revisions aded one flor and one wal clean-ing technique. The proposal to ad these techniques was based on particle removal eficiency studies pub-lished by the University of Arizona in Tucson and microbial removal eficiency studies published by Re-search Triangle Institute.

30、The comite had direct oversight on the 25 companies that participated in the 6-month comparison testing of both wal and flor techniques. The results were reviewed, and the new methods were incorporated in the RP. 4.2 Particles on surfaces: adhesion and removal Mechanisms by which particles are held

31、to surfaces in a cleanrom include London-van der Wals forces (the dominant mechanism when surfaces are not weted), electrostatic forces (which usualy are smal if the fa-cility has ben properly shielded), and capilary adhe-sion. Removal of particles is aided by the use of a liquid because such usage

32、decreases the London-van der Wals forces by several orders of magnitude, dis-sipates electrostatic forces, and, if a surfactant is pre-sent in the liquid, decreases capilary adhesion through a lowering of surface tension. Ionic surfactants alter surface electrical potentials and thus also can reduce

33、 electrical forces. Liquids also per-mit beter coupling of the mechanical energy used dur-ing cleaning, as wel as provide an oportunity for the removal of soluble contaminants through disolution. Individual submicrometer particles are extremely difi-cult to remove, and even an optimum cleaning proce

34、-dure wil not completely eliminate submicrometer particles from cleanrom surfaces (se Bowling, Ap-pendix B). It is likely that only those particles larger than 5 m wil be significantly afected by the cleaning procedures presented in this RP. Se Apendix A for a detailed discusion of particle adhesion

35、 and removal. 4.3 Validation of cleaning If cleaning is being undertaken by or for a manufactur-ing proces, where the control of viable organisms is critical (e.g. pharmaceutical, biologic, or medical de-vices manufacturing), the cleaning wil probably be under the control of a regulatory agency such

36、 as the United States Fod and Drug Administration (FDA), in which case the validation of cleaning is esential. The formal FDA definition of such validation in Guideline on General Principles of Proces Validation can be sumarized as: “Establishing documented evidence which pro-vides a high degre of a

37、surance that a specific cleaning proces wil consistently produce a product result meting its predetermined specifications and quality atributes.” Validation, usualy undertaken as a project prior to ful-scale operation, starts with the creation of a Vali-dation Master Plan. Most often, the plan conta

38、ins thre sections: strategy, protocols, and evaluation. “Strat-egy,” or the design phase, sets out the objectives and specifies the results to be achieved. Results are speci-fied as permited residual limits. “Protocols” covers the implementation stage and specifies how the goals wil be achieved. “Ev

39、aluation” describes the means and methods, either visual or sampling and analytical tests, that wil be used to analyze the results of the proces. Sampling techniques should be able to colect con-tamination, the residues, in a form that is detectable by the analytical methods of choice. That choice w

40、il de-pend on the sampling site, the nature and properties of the residues, and the type of facility and its equipment. 5 PROCEDURES 5.1 Housekeeping equipment and supplies Al tols, equipment, and suplies used for maintain-ing the cleanlines of the cleanrom should be selected carefuly for the intend

41、ed cleanrom. Equipment should be constructed of non-sheding materials that can be easily maintained in a clean condition. Such materials may include reinforced plastic or fiberglas, powder-coated stel, anodized or hard-coated alumi-num, stainles stel, or other aproved materials. Equipment utilizing

42、casters should have polyurethane or other non-maring whel surfaces. If sterilization or disinfection is required then, equipment and tols should be constructed of stainles stel or other resil-ient materials. The folowing sections list recomended suplies and equipment for use in housekeping. It shoul

43、d be noted that this list is not al-inclusive. The responsible person should select equipment and suplies that are compati-ble with the cleanrom, cleanrom surfaces, the prod-uct, and related proceses. 8 Copyrighted material INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY IEST-RP-C018.4 5.1.1 Vacu

44、um cleaning system A central plant vacum (wet or dry) with atachments, or a portable vacum cleaner with HEPA/ULPA-filtered exhaust and acesories. 5.1.2 Tacky rol mop A cleaning tol, resembling a paint roler, that removes particles by means of a removable or renewable adhe-sive contact surface. 5.1.3

45、 Mop bucket A receptacle with a wringer or squezing device made of plastic or stainles stel with single, dual, or triple compartments. 5.1.4 Wet mop A mop that has a head constructed of foam, nylon, or low-linting material and handles constructed of stain-les stel, aluminum, reinforced plastic, or a

46、n equiva-lent material. In general, recomended laboratory practices are designed to promote the quality and validity of al laboratory measurements using standard practices and procedures. It is expected that users of IEST-RP-C04 wil folow recomended laboratory practices in the measurement of wiper c

47、haracteristics. 5.1.5 Cleanroom wiper Dry wipera cleanrom wiper selected in acordance with the recomendations of IEST-RP-C04. The wiper may be used with water or other cleaning agents or solvents as dictated by the cleaning aplication. Pre-saturated wiperscleanrom wipers that are pre-packaged in a s

48、pecified cleaning solution or solvent. 5.1.6 Stepladder Comon foldingconstructed of non-contaminating materials such as aluminum, stainles stel, or fiber-glas-reinforced plastic. Typical safety regulations prohibit the use of the top two steps. Generaly, the user must hold onto the lader with one ha

49、nd while performing a cleaning task with the other. These lad-ders are generaly the lightest types of stepladers and easiest to position in tight work areas. Folding platformsimilar to a comon folding vari-ety except that the frame extends beyond the uper-most step to provide a handhold. The upermost step provides a wide, stable platform that alows the user to safely stand and work comfortably. These laders are generaly a litle heavier than comon folding laders and have a slightly wider stance in tight work areas. Fixed platforma movable, rigid staircase