IEST RP-CC027 2-2006 PERSONNEL PRACTICES AND PROCEDURES IN CLEANROOMS AND CONTROLLED ENVIRONMENTS.pdf

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1、INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY Contamination Control Division Reco ended Practice 027.2 IEST-RP-C027.2 Personel Practices and Procedures in Cleanroms and Controled Environments INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY Arlington Place One 2340 S. Arlington Heights Road,

2、Suite 10 Arlington 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-C027.2 IEST-RP-C027.2 INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY Copyrighted material 3 Th

3、is Recomended Practice is published by the INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY to advance 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 R

4、ecomended Practice was prepared by and is under the jurisdiction of Working Group 027 of the IEST Con-tamination Control Division. Copyright 206 by the INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY First printing, April 206 ISBN 978-0-9747313-7-7 PROPOSAL FOR IMPROVEMENT: The Working Groups of

5、the INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY are continualy working on improvements to their 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 Improvem

6、ent form found on the IEST website at ww.iest.org/proposal/form.html. INSTITUTE OF ENVIRONMENTAL SCIENCES 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 4 Copyr

7、ighted material INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY IEST-RP-C027.2 IEST-RP-C027.2 INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY Copyrighted material 5 Personnel Practices and Procedures in Cleanrooms and Controlled Environments IEST-RP-C027.2 CONTENTS SECTION 1 SCOPE AND LIMITATI

8、ONS7 2 REFERENCES7 3 TERMS AND EFINITIONS8 4 BACKGROUND AND PURPOSE9 5 PROCEDURES10 TABLE 1 EXAMPLES OF A TRAINING MATRIX AND AN INDIVIDUAL TRAINING RECORD.12 FIGURE 1 GENERIC CHANGE ROM LAYOUT15 2 LEANING RAIL DESIGN.17 6 Copyrighted material INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY IEST-

9、RP-C027.2 IEST-RP-C027.2 INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY Copyrighted material 7 INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY Contamination Control Division Recommended Practice 027.2 Personnel Practices and Procedures in Cleanrooms and Controlled Environments IEST-RP-C027.2

10、1 SCOPE AND LIMITATIONS 1.1 Scope This Recomended Practice (RP) provides a basis for establishing personel procedures and the develop-ment of training programs for cleanroms and other contamination controled environments. 1.2 Limitations This RP does not provide the specialized information neded for

11、 operations requiring control of living mi-crobial contaminants. A wide range of design options, equipment, protocols, and procedures can be combined to acomplish con-tamination control objectives consistent with the apli-cation. This document details many of those options, but it is up to the user

12、to determine the suitability and aplicability to his or her requirements. 2 REFERENCES The folowing documents are incorporated into this RP to the extent specified herein. Users should aply the most recent editions of the references. 2.1 International Organization for Standardization (ISO) ISO 1464-

13、1 Cleanroms and asociated controled environmentsPart 1: Clasification of air cleanlines ISO 1464-5 Cleanroms and asociated controled environmentsPart 5: Operations 2.2 Institute of Environmental Sciences and Technology (IEST) IEST-RP-C03: Garment System Considerations for Cleanroms and Other Control

14、ed Environments IEST-RP-C05: Gloves and Finger Cots Used in Cleanroms and Other Controled Environments IEST-RP-C07: Testing ULPA Filters IEST-RP-C018: Cleanrom HousekepingOperat-ing and Monitoring Procedures IEST-RP-C026: Cleanrom Operations IEST-STD-C1246: Product Cleanlines Levels And Contaminatio

15、n Control Program 2.3 Sources and addresses IEST Institute of Environmental Sciences and Technology 2340 S. Arlington Heights Road, Suite 10 Arlington Heights, IL 6005-4516, USA Phone: 847-981-010 Fax: 847-981-4130 ww.iest.org ISO In the U.S.: Documents available from IEST 2340 S. Arlington Heights

16、Road, Suite 10 Arlington Heights, IL 6005-4516, USA ww.iest.org Outside the U.S.: Documents available from represen-tative ISO member body organization 8 Copyrighted material INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY IEST-RP-C027.2 3 TERMS AND EFINITIONS building shoes A dedicated pair of s

17、hoes worn by cleanrom per-sonel within the defined areas of the change rom, cleanrom, and peripheral suport areas to limit tracking in external contamination on stret shoes. building suit An undergarment made of 10% polyester or other synthetic fabrics, normaly similar to a two-piece joging suit wit

18、h either a pulover or zip-up top. It is worn over personal underwear and under the clean-rom garment. change rom A facility contiguous to the cleanrom to provide for the control of the pasage of personel; doning, dofing, and storage of aparel; and storage of related suplies. clas (airborne particula

19、te) The cleanlines clas as defined by ISO 1464-1. cleanrom A rom in which the concentration of airborne parti-cles is controled and which contains one or more clean zones. comfort suit Se building suit. contaminant Any unwanted substance present in or on a material or any surface within a clean zone

20、. contamination The result of the adition of contaminants to a mate-rial or to any surface within a clean zone. controled environment An environment in which parameters, such as tem-perature, presure, humidity, and contaminant level, are controled within specified limits. dofing or degowning The act

21、 of removing cleanrom garments in a con-troled maner to prevent damage and unecesary contamination of the garments. doning or gowning The procedures folowed while puting on the gar-ment system in a precise, prescribed order and man-ner to avoid compromising the cleanlines and functionality of the co

22、ntamination controling protec-tive garment system. doning gloves An extra pair of gloves worn to protect gowning sys-tem components from coming into direct contact with the hand to prevent the transfer of skin oil and flakes. May be worn over work gloves during gowning or used alone for gowning and

23、replaced by work gloves after completion of the gowning procedure. electrostatic discharge (ESD) The transfer of electrostatic charge betwen two bod-ies that have diferent electrostatic potentials. garments, cleanrom Specialy designed items of clothing that are worn to prevent or reduce the dispersi

24、on of contaminants that may be shed or released by personel. Examples of such aparel include coverals, fotwear, shoe covers, gloves, and head covers. garment system The entire set of clothing and consumable items used to enclose the wearer and contain sources of human-borne and human-generated conta

25、mination. These items include beard covers, boufants (hair nets), face masks, hods, garments (including coverals, shirts, pants, frocks or smocks), cleanrom shoes, safety shoes, shoe covers, cleanrom bots (or boties), glove liners, and gloves. HEPA (high-eficiency particulate air) filter An extended

26、-medium, dry-type filter in a rigid frame, when tested at rated airflow having a minimum parti-cle colection eficiency of 9.97% for 0.3-m mas median diameter particles of DOP when tested in acordance with MIL-STD-282. housekeping, cleanrom Maintenance or cleaning performed to preserve the specified

27、cleanlines of a cleanrom. micrometer (m) A unit of measurement of length equal to one mil-lionth of a meter (aproximately 0.003937 inch). particle counter, airborne An instrument for continuous counting of airborne particles larger than a given threshold size. The sens-ing means may be optical, elec

28、trical, aerodynamic, etc. pre-gowning The required procedures betwen entering the build-ing and entering the change rom to begin the gown-ing procedure. procesing, garment Procedures performed to met cleanlines and usabil-ity specifications for aparel and acesories for use in a controled environment

29、. shoe cleaner, mechanical An electricaly operated device that contains rotating or oscilating brushes and a vacum colection system. IEST-RP-C027.2 INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY Copyrighted material 9 When a shoe or bot is placed into the device and slowly moved fore and aft, th

30、e brushes help to remove dust and dirt from the tops, botoms, and sides of the shoe, while the vacum system colects and contains the dirt. shoe cover A disposable or reusable cover worn over stret shoes within defined boundaries of the change rom, clean-rom, and suport area to minimize the transfer

31、of contamination from stret shoes. tack mat A disposable or washable flor mat with a sticky surface which, when steped upon, removes particles from the portion of the shoe or bot sole with which it comes in contact. ULPA (ultra-low-penetration air) filter A throwaway, extended-medium, dry-type filte

32、r in a rigid frame, having a minimum particle-colection eficiency of 9.99% (that is, a maximum particle penetration of 0.01%) when tested in acordance with the methods of IEST-RP-C07. wipe-down station A facility provided in a change rom for the cleaning of materials that are going to be brought int

33、o the cleanrom. 4 BACKGROUND AND PURPOSE Most cleanroms ned people to perform tasks aso-ciated with the operations being performed. Even fuly automated operations require personel to tend or service automated systems. People and their stret clothing generate contamination, therefore an efec-tive con

34、tamination control system should be adopted to minimize the risks to the product, proces yields, or the cleanrom environment. Also, because activi-ties within the cleanrom can cary in, generate, stir up, or transfer contamination from place to place within the cleanrom, a system of operational proto

35、-cols should be developed, enforced, and monitored to maintain the proper controls. ISO 1464-5 identifies the basic requirements for adresing these opera-tional isues. These normative requirements should be adresed to asure a minimaly thorough opera-tional cleanrom program. This RP serves as a guide

36、 for developing a program to manage contamination caused by or asociated with the people, proceses, and toling in the cleanrom. Contamination may be generated by the people or the activities they perform, or may be transported into the clean environment with the materials brought into it. Programs f

37、or the control of personel-generated con-tamination are complex. In this document, the subjects often overlap. In some areas, there is deliberate redun-dancy betwen two sections. The reader wil find the most specific and detailed information under the topic heading for a particular subject. However,

38、 related sub-ject areas are included in the general discusions when these subject areas are pertinent to or have an efect on the main topic. References to sections of this document that provide more thorough coverage are included. This RP provides a general description of the elements esential to a

39、contamination control program as wel as specific procedures for minimizing human-sourced contamination. The rationale behind the procedures and elements is discused. The intent is to inform the user while asisting with the preparation of compo-nents of the program. This document specifies com-monly

40、acepted procedures and recomendations, and also points out considerations that should be made for a thorough and sucesful program. Because there is a wide variety of degres of cleanli-nes for cleanroms (and diferences in potential con-taminants from which clean environments should protect products),

41、 some aspects of the procedures wil be to stringent for some aplications, while insufi-cient for others. A program should be expected to have a significant amount of individuality. What works wel for one company or industry may not be aceptable in others because of factors such as local culture, fac

42、ility constraints, large work forces, and government regulations. The user is responsible for chosing the elements and degre of compliance that best suit the specific situa-tion. In some cases, the advice of a contamination con-trol consultant may be sought. The science of contamination control is c

43、ontinuously evolving. Users are encouraged to find improved methods for controling contamination apropriate for their neds and to share these with the contamination control comunity. It is helpful to use data or experiments to evaluate whether a procedure is necesary or efective. Test methods are be

44、yond the scope of this document. It should be noted that there are several references available that provide a thorough background on con-tamination control theories, practices, and considera-tions. These references may be found in the text of this document and should be consulted when the user re-q

45、uires more detailed information. 10 Copyrighted material INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY IEST-RP-C027.2 5 PROCEDURES 5.1 Hiring This section provides guidelines for determining the suitability of personel to enter and to work within cleanroms. These guidelines include physical, me

46、ntal, and job skils demed necesary to help ensure people selected to work in a cleanrom wil not cause undue product contamination and can cope with the restric-tions necesarily imposed by gowning and work prac-tices required in a controled environment. Use of these guidelines wil help ensure that su

47、itable personel are chosen for cleanrom tasks, that they wil be content, and that “people contamination” wil be minimized. 5.1.1 Implementation a) The responsibility for determining personel suit-ability should be asumed by human resource per-sonel aware of the necesary physical, mental, and job ski

48、ls required for the task as identified by the cleanrom anager. b) Whenever posible, potential cleanrom employ-es should be given a cleanrom tour as part of the interview proces. Candidates can be observed for comitment and suitability to work in the cleanrom, including their ability to comprehend in

49、structions. A tour wil help candidates new to cleanrom work decide whether they can tolerate the confinement of cleanrom atire and wil help verify that the corect sizes of cleanrom garments exist in inventory prior to the new employes first workday. 5.1.2 Physical characteristics This section provides special physical and medical criteria for screning potential cleanrom personel. a) Smoker hiring policySmoking is not permited in manufacturing cleanroms or change rom areas or in any area where smoking may adversely afect product quality or personel health by