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
25、r of protective packaging used dur-ing storage and transportation. NOTE: The outer bag is removed in the gowning area and has a les-stringent cleanlines requirement than the iner packaging. bioburden A measure of the number of microrganisms resident on or within products and inanimate objects. A com
26、-mon synonym is microcount. 6 Copyrighted material Institute of Environmental Sciences and Technology IEST-RP-C032.1 chemical degradation The change in materials that ocurs when the materi-als come into contact with chemicals. Degradation may take such forms as sweling, los of tensile strength, defo
27、rmation, or los of abrasion resistance. colony forming unit (CFU) An individual or an agregate of multiple microbial cels, which, when cultivated on solid media, wil develop into a single visual colony. contaminant Any unwanted substance present in or on a material or any surface within a clean zone
28、. electrostatic discharge (ESD) The transfer of electrostatic charge betwen bodies that have diferent electrostatic potentials. electrostatic discharge shield A barier or enclosure that limits the pasage of cur-rent and atenuates an electromagnetic field resulting from an electrostatic discharge. fi
29、lm, gas barier A film designed with either single or multiple layers of films to prevent gas transmision through the film and onto the product. film, moisture barier A film designed with either single or multiple layers of films to prevent moisture transmision through the film and onto the product.
30、gel marks (also known as carbon marks) The result of exposure of molten resin to time and heat that causes the resin to burn. As the burning proces continues, the resin breaks fre, resulting in clear, brown, or black round markings on the material. laminate A material formed by bonding together two
31、or more layers to achieve an efect not otherwise atainable from each of the component layers separately. nonvolatile residue (NVR) Any solid or liquid phase remaining after the evapora-tion of a volatile liquid from a solution. NOTE: NVR is generaly expresed in units of mas per unit of liq-uid. If t
32、he volatile liquid was used to remove soluble contamination from a specific area of surface, the NVR units may be expresed as mas per unit area. outgasing The liberation of a gas from any material other than by change of state. NOTE: Per ISO 14624-3, NASA coined the term “ofgasing” to describe outga
33、sing into the spaceship cabin atmosphere. The term has also ben used in standards for test methods related to materials out-gasing into rom air. However, the physical and chemical proceses for “outgasing” and “ofgasing” are the same. The surounding atmosphere afects the net outgasing rate, but there
34、 is no obvious point where “ofgasing” becomes “outgasing” as the atmospheric presure decreases. particle An object that is solid, liquid, or both, usualy betwen 1 nanometer (nm) and 1 milimeter (m) in size. particle size The aparent maximum linear dimension of a particle in the plane of observation
35、as observed with an optical microscope, or the equivalent diameter of a particle detected by automatic instrumentation. The equivalent diameter is the diameter of a reference sphere having known properties and producing the same response in the sensing instrument as the particle being measured. perm
36、eability A quantitative measure of the ability of a material to transfer mas (solid, liquid, or gaseous) through its pores or capilaries, or both, under the influence of a presure gradient. primary barier A surface that is in direct contact with the product. The primary barier should be as clean as
37、or cleaner than the product it contains. polymer A high-molecular-weight substance, natural or syn-thetic, whose structure can be represented by re-peated smal units. releasable particles Particles present on the surface of a substrate that are readily releasable there from by weting the surface wit
38、h a liquid, but without imparting mechanical en-ergy to the substrate. 3.1 Packaging material abreviations ABS Acrylonitrile butadiene styrene EVA Ethyl vinyl acetate FEP Fluorinated ethylene polypropylene co-polymer HDPE High-density polyethylene HIPS High-impact polystyrene LDPE Low-density polyet
39、hylene LDPE Linear low-density polyethylene MDPE Medium-density polyethylene NY Nylon-polyamide PCTFE Polychlorotrifluoroethylene PE Polyethylene PET Polyethylene terephthalate P Polypropylene PS Polystyrene IEST-RP-C032.1 Institute of Environmental Sciences and Technology Copyrighted material 7 PTF
40、E Polytetrafluoroethylene PU Polyurethane PVC Polyvinyl chloride PVDC Polyvinylidene chloride SBHDPE Spun bond high-density polyethylene 4 BACKGROUND AND PURPOSE 4.1 Background Packaging of products within the contamination-sensitive environment of a cleanrom or other con-troled environment requires
41、 a systematic aproach to achieve the protective environment neded for the product. Packaging aplications in cleanroms are used for protection, handling, and storage of products to ensure preservation of cleanlines. Contamination from improperly chosen packaging can migrate into critical products and
42、 cause product malfunction or damage. The product can react with the packaging, causing damage to the product. 4.2 Purpose This RP provides a structured method for selecting flexible packaging for use with products manufac-tured or procesed in cleanroms and other controled environments. 5 DETERMINAT
43、ION OF PACKAGING REQUIREMENTS Proper packaging should be designed to maintain the cleanlines of products until opened by the intended user. Many requirements should be considered to adres contamination concerns. The folowing par-tial list of considerations is intended as a starting point for making
44、the proper packaging choice. 5.1 General characteristics of product and packaging When chosing materials apropriate for the product being packaged, various packaging properties should be considered along with the specifications and goals to be met. End users of clean, flexible packaging ma-terials (
45、i.e., film or bags) should consider the folow-ing characteristics: Abrasion resistance Biodegradability Chemical reactivity/resistance/compatibility Cleanlines Density ESD protection (static generation and static disipation) Flamability Flexibility Humidity range Ion-fre Moisture bariers oisture per
46、meability (moisture transmision of barier material) Outgasing Sloughing/sheding Opacity Oxygen or gas permeability Porosity Product visibility Sealability Shelf life Sterilization capability Temperature range The folowing product characteristics also should be considered: Configuration ESD sensitivi
47、ty Fragility Quantity Sharp or protruding features Size Sterility Surface texture 5.2 Compatibility of packaged product environment 5.2.1 Chemical compatibility Chemical resistance ratings of packaging materials should be obtained from the manufacturer of the packaging materials. 5.2.2 Material comp
48、atibility Material compatibility may be specific to the industry or aplication. Such requirements are typicaly defined by regulatory standards or industry specifications and standards. The packaging material manufacturer should be consulted for the material compatibility of film or bags used with sp
49、ecific substances or in situa-tions that might cause products to react with the pack-aging materials, including the efects of exposure time, chemical temperature, chemical concentration, mate-rial thicknes, and UV exposure. 5.2.3 Sterilization compatibility Sterilization compatibility is critical, depending on the proces chosen. Requirements are proces apli-cation-specific and ireversible damage may ocur if material compatibility is ignored. Compatibility with th
