IEST RP-CC032 1-2009 FLEXIBLE PACKAGING MATERIALS FOR USE IN CLEANROOMS AND OTHER CONT ENV.pdf
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1、 Institute of Environmental Sciences and Technology IEST-RP-C032.1 Contamination Control Division Recoended Practice 032.1 Flexible Packaging Materials for Use in Cleanroms and Other Controled Environments Arlington Place One 2340 S. Arlington Heights Road, Suite 10 Arlington Heights, IL 6005-4516 P
2、hone: (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-C032.1 This Recomended Practice is published by the Institute of Environmental Sciences and Technology to advance the technical and engineri
3、ng sciences. Use of this document 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 032 of the IEST Con-tamination Contr
4、ol Division. Copyright 209 by the Institute of Environmental Sciences and Technology First printing, June 209 ISBN 978-0-9787868-6-1 PROPOSAL FOR IMPROVEMENT: The Working Groups of the Institute of Environmental Sciences and Technology are continualy working on improvements to their Recomended Pract
5、ices and Reference Docu-ments. Sugestions from users of these documents are welcome. If you have a sugestion regarding this docu-ment, please use the online Proposal for Improvement form found on the IEST website at ww.iest.org. Institute of Environmental Sciences and Technology Arlington Place One
6、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-C032.1 Institute of Environmental Sciences and Technology Copyrighted material 3 Flexible Packaging Materials for Use in Cleanroms and Other
7、 Controled Environments IEST-RP-C032.1 CONTENTS SECTION 1 SCOPE AND LIMITATIONS4 2 REFERENCES4 3 TERMS AND EFINITIONS5 4 BACKGROUND AND PURPOSE7 5 DETERMINATION OF PACKAGING REQUIREMENTS.7 6 QUALIFICATION, QUALITY CONTROL, VALIDATION, AND SAMPLING10 TABLE 1 PACKAGING SELECTION BASED ON PROTECTION RE
8、QUIREMENTS.10 APPENDIX A TEST METHODS12 B FLOW CHARTS.19 C BIBLIOGRAPHY21 FIGURE B1 INDUSTRY STRUCTURE AND MATERIAL FLOW CHART19 B2 PLASTIC FILM ANUFACTURING FLOW CHART.20 4 Copyrighted material Institute of Environmental Sciences and Technology IEST-RP-C032.1 Institute of Environmental Sciences and
9、 Technology Contamination Control Division Recoended Practice 032.1 Flexible Packaging Materials for Use in Cleanroms and Other Controled Environments IEST-RP-C032.1 1 SCOPE AND LIMITATIONS 1.1 Scope This Recomended Practice (RP) provides guidance for the selection of flexible packaging materials fo
10、r aplications in cleanroms and other controled envi-ronments. Only packaging that protects the product integrity is discused. 1.2 Limitations This RP does not discus rigid packaging materials. This RP also does not discus packaging procedures or outer packaging required for shiping. Health, safety,
11、and waste stream isues are not adresed. 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. NOTE: There are multiple test methods and proce-dures to identify contamination properties. Users ar
12、e advised to select the method best suited to their products or aplications. Users should establish the physical, electrical, and contamination performance property lev-els neded to secure adequate protection. 2.1 Governmental MIL-STD-3010: Test Procedures for Packaging Materials MIL-STD-3010, Metho
13、d 2065: Puncture Resistance MIL-STD-3010, Method 305: Contact Corosivity FDA 97-4179, Medical Device Quality Systems Man-ual, Section 13: Packaging 2.2 Non-governmental ANSI/ASQ Z1.4: Sampling Procedures and Tables for Inspection by Atributes ASTM D82: Standard Test Method for Tensile Properties of
14、Thin Plastic Sheting ASTM D103: Standard Test Method for Haze and Luminous Transmitance of Transparent Plastics ASTM D3420: Standard Test Method for Pendulum Impact Resistance of Plastic Film ASTM F8: Standard Test Method for Seal Strength of Flexible Barier Materials ASTM F1249: Standard Test Metho
15、d for Water Va-por Transmision Rate Through Plastic Film and Sheting Using a Modulated Infrared Sensor IEST-STD-C1246: Product Cleanlines Levels and Contamination Control Program ISO 1464-1: Cleanroms and asociated controled environmentsPart 1: Clasification of air cleanlines. ISO/EN 1607-1: Packagi
16、ng for Terminaly Steril-ized Medical DevicesPart 1: Requirements for Ma-terials, Sterile Barier Systems and Packaging Systems ISO/EN 1607-2: Packaging for Terminaly Steril-ized Medical DevicesPart 2: Validation Require-ments for Forming, Sealing and Asembly Proceses IEST-RP-C032.1 Institute of Envir
17、onmental Sciences and Technology Copyrighted material 5 2.3 Sources and Adreses AMI Asociation for the Advancement of Medical Instrumentation 110 North Glebe Road, Suite 20 Arlington, VA 2201-4795, USA Phone: 703-525-4890 Fax: 703-276-0793 ww.ami.org ANSI American National Standards Institute 25 Wes
18、t 43rd Stret New York, NY 1036, USA Phone: 212-642-490 Fax: 212-398-023 ww.ansi.org ASTM International (Formerly American Society for Testing and Materials) 10 Bar Harbor Drive West Conshohocken, PA 19428-2959, USA Phone: 610-832-950 Fax: 610-832-955 ww.astm.org ASQ American Society for Quality 60 N
19、orth Plankinton Avenue Milwauke, WI 53203, USA Phone: 80-248-1946 Fax: 414-272-1734 ww.asq.org CEN European Comite for Standardization Avenue Marnix 17 B-100 Brusels, Belgium Phone: 32 2 50 08 1 Fax: 32 2 50 08 19 ww.cenorm.be FDA Fod and Drug Administration Division of Manufacturing and Product Qua
20、lity Ofice of Compliance 560 Fishers Lane Rockvile, MD 20857, USA ww.fda.gov 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 International Organization for Stand
21、ardization 1, ch. de la Voie-Creuse, Case postale 56 CH-121 Geneva 20, Switzerland Phone: +41 2 749 01 1 Fax: +41 2 73 34 30 ww.iso.ch U.S. Member Body for ISO 1464 documents: IEST 2340 S. Arlington Heights Road, Suite 10 Arlington Heights, IL 6005-4516, USA Phone: 847-981-010 Fax: 847-981-4130 ww.i
22、est.org MIL/Q (Military Standards) Standardization Document Order Desk Bldg. #4, Section D 70 Robins Avenue Philadelphia, PA 1911-5098, USA htp:/dodsp.daps.dla.mil/ 3 TERMS AND DEFINITIONS abrasion resistance The ability of a surface to resist wearing due to friction. aliquot One part of a sample th
23、at has ben divided into equal parts. ashing A method for determining the amount of non-carbon components that remains after combustion. AQL Aceptable quality level. Refers to table of inspection by atributes in ANSI/ASQC Z1.4. bag, autoclave A type of polymer bag used in steam sterilization apli-cat
24、ions. Also caled biohazard bags, some are printed with an indicator that changes color when procesed. bag, guseted A bag made with side or botom pleats, with dimen-sions such as 10 4 16 in., or in the case of botom guset, 10 16 4 in. bag, outer (also outside double-bag, dust cover) An aditional laye
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