1、Designation: F17 13Standard Terminology Relating toFlexible Barrier Packaging1This standard is issued under the fixed designation F17; the number immediately following the designation indicates the year of originaladoption or, in the case of revision, the year of last revision. A number in parenthes
2、es indicates the year of last reapproval. A superscriptepsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This terminology covers the principal terms relating toflexible barrier packaging and its materials. This terminologycontains related definitions and desc
3、riptions of terms used orlikely to be used in flexible barrier packaging standards. Thepurpose of terminology is to promote clear understanding andinterpretation of the standards in which they are used.2. Referenced Documents2.1 ASTM Standards:2D883 Terminology Relating to PlasticsD1129 Terminology
4、Relating to WaterF1349 Test Method for Nonvolatile Ultraviolet (UV) Ab-sorbing Extractables from Microwave SusceptorsF1980 Guide for Accelerated Aging of Sterile Barrier Sys-tems for Medical Devices3. Terminologyaccelerated aginga technique to simulate the effects of timeon a package by subjecting t
5、he product/package system toelevated temperatures in a controlled environment represen-tative of controlled environment storage conditions. Theequivalent time is generally estimated by assuming thedegradation of packaging materials follows the kineticsdescribed by the Arrhenius reaction rate functio
6、n, morediscussion of which is available in Guide F1980.acid foodsfoods that have a natural pH of 4.6 or below.adhesive transfera condition occurring when an adhesive-coated material is peeled away from an opposing material towhich it has been sealed and shows visible evidence of theadhesive being le
7、ft on the opposing material. This evidenceis in the form of an adhesive layer that remains with theopposing material, the adhesive having separated eitheradhesively from the coated web or cohesively within theadhesive itself.asepticas applied to aseptic packaging, synonymous withcommercially sterile
8、.aseptic packagingfilling of a commercially sterilized prod-uct into presterilized containers, followed by hermetic seal-ing in a commercially sterile atmosphere.aseptic presentationintroduction and transfer of a sterileproduct using conditions and procedures that exclude micro-bial contamination.ba
9、rrierany material limiting passage through itself of solids,liquids, semisolids, gases, vapors, or forms of energy such asultraviolet light.barrier materialsspecialized porous or nonporous packag-ing materials that provide environmental protection to thepackage contents as well as protection to the
10、environmentfrom the package contents: (1) gas, vapor, humidity, liquid,microbial, or light resistant materials that control or elimi-nate the amount of those environmental constituents thatpass into or out of a package; (2) a porous materialpreventing the passage of microorganisms that might con-tam
11、inate the contents of the package.biological evaluation test (biotest)a test which involvesexposure of sealed packages to biological indicators and isdesigned to determine the microbiological integrity of apackage under the specific conditions of the test.burst strengtha measure of the internal pres
12、sure necessaryto rupture a package or seal.channelany unimpaired pathway across the entire width ofthe intended seal.coextrusionin flexible barrier materials,(1) a processwhereby two or more plastic streams are forced simultane-ously through one or more shaping orifices to become onecontinuously-for
13、med multilayered structure. (2) Also, theproduct resulting from such a mercial sterility of thermally processed food, the con-dition achieved by application of heat, alone or in combina-tion with other appropriate treatments, to render the food1This terminology is under the jurisdiction ofASTM Commi
14、ttee F02 on FlexibleBarrier Packaging and is the direct responsibility of F02.50 on Package Design andDevelopment.Current edition approved April 15, 2013. Published June 2013. Originallyapproved in 1961. Last previous edition approved in 2012 as F17 12. DOI:10.1520/F0017-13.2For referenced ASTM stan
15、dards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, P
16、A 19428-2959. United States1free of microorganisms capable of growing in the food atnormal nonrefrigerated conditions at which the food is likelyto be held during distribution and storage.conditioningthe exposure of a material to the influence of aprescribed atmosphere for a stipulated period of tim
17、e or untila stipulated relation is reached between material and atmo-sphere.delaminationthe separation of layers in a multilayeredstructure.dispersion coatingin flexible barrier materials,(1) a pro-cess of applying a material, suspended or dispersed in avehicle, to a surface in such a way that a con
18、tinuous,coalesced, adherent layer results when the vehicle liquid(usually water) is evaporated. (2) Also, the product resultingfrom such a process.dual ovenableterms describing a food packaging containerused to prepare food in either a conventional oven or amicrowave oven.environmentally challenging
19、the process of subjecting apackage to extremes of temperature and/or humidity and/orother environmental conditions, with the goal of determiningsensitivities of the package to environmental stresses. Incontrast to accelerated aging, environmental challengingoften includes conditions, or transitions,
20、 or both, of tempera-ture and humidity that equal or exceed those that can beencountered in a package life cycle.extrusion coatingin flexible barrier materials,(1) a processof extrusion whereby a molten extrudate adheres to thesurface of another (solid) material, forming a continuouslayer upon cooli
21、ng. (2)Also, the product resulting from sucha process.flexibleeasily hand-folded, flexed, twisted, and bent.DISCUSSION“Flexible” may be a characteristic of thin barriermaterials, especially when thinner than 125 to 255 m (5 to 10 mils),that are composed of materials that are otherwise classified as
22、“rigid”or “semi-rigid” under the definitions concerning rigidity based onmodulus of elasticity (see Terminology D883). Modulus of elasticity isan inherent property of a material which in conjunction with thicknessdetermines flexibility.flexible packageany package with at least one flexiblecomponent
23、that can be bent back or folded back upon itself.fluoroptic temperature measurementtemperature mea-surement based on the variation in total luminescence of afluoroptic phosphor which has been previously calibratedversus a known temperature standard.food simulanta well-characterized substance used in
24、 placeof food for investigative studies.functional barrierin food packaging, a material that effec-tively restricts passage of solids, liquids, semi-solids, vapors,or forms of energy such as ultraviolet light through itself,across its borders, or interface with another material orsubstance.fusion se
25、ala bond formed by combining two or morematerials through melting or other means so that the joininglayers become indistinguishable at the interface.heat sealthe result of bonding surfaces by controlled appli-cation of heat, pressure, and dwell time.hermetically sealed aseptic containera container t
26、hat isdesigned and intended to be secure against the entry ofmicroorganisms and thereby to maintain the commercialsterility of its contents.hot tackthe property of a heat seal to hold together whenstressed while it is still hot from the sealing operation.laminatea product made by bonding together tw
27、o or morelayers of material or materials. (See also multilayeredstructure)laminationin flexible barrier materials, the process ofpreparing a laminate which consists of two or more flexiblebarriers bonded together (see also laminate).leakany opening in a flexible package that is contrary tointention
28、and either lets contents escape or permits sub-stances to enter.load (water load)an amount of water used to moderate themicrowave radiation absorbed by a susceptor during simu-lated microwave heating tests.low-acid foodany food, other than alcoholic beverages, witha finished equilibrium pH greater t
29、han 4.6 and a wateractivity (aw) greater than 0.85. Tomatoes and tomato prod-ucts having a finished equilibrium pH less than 4.7 are notclassed as low-acid foods.major package defecta defect that is likely to result infailure or reduce significantly the usability of the package forits intended use.m
30、edical deviceany instrument, apparatus, implement,machine, appliance, implant, in vitro reagent or calibrator,software, material, or other related article, intended by themanufacturer to be used, alone or in combination, for one ofmore of the specific purpose(s) of (1) diagnosis, prevention,monitori
31、ng, treatment, or alleviation of a disease; (2)diagnosis, monitoring, treatment, alleviation of or compen-sation for an injury; (3) investigation, replacement, modifi-cation or support of the anatomy or of a physiologicalprocesssupporting or sustaining life; (4) control of con-ception; (5) disinfect
32、ion of medical devices; and (6) provid-ing information for medical purposes by means of in vitroexamination of specimens derived from the human body, andwhich does not achieve its primary intended action in or onthe human body by pharmacological, immunological, ormetabolic means, but which may be as
33、sisted in its functionby such means.microbial barrierproperty of the sterile barrier system thatprevents the ingress and/or egress of microorganisms underspecified conditions.microbiological contamination (of packaged products)theentry of viable microorganisms into a finished package dueto lack of o
34、r loss of package integrity.F17132microbiological package integritythe physical condition ofa finished package, including, but not limited to, the securityof package seals, which ensures the maintenance of thepackage contents in a commercially sterile condition.microwave extraction cella polytetrafl
35、uoroethylene cellused for evaluating microwave active materials. Refer toTest Method F1349 for schematics of cell construction.microwave only food packagea container used to heatfoods only in a microwave oven.microwave susceptorpackaging material that, when placedin a microwave field, is designed to
36、 interact with the fieldand provide substantial heat to the package contents.minor package defecta defect that does not significantlyreduce the usability of the package for its intended purpose,or that is a departure from established standards having littleor no bearing on the effective use of the p
37、ackage.multilayered structurein flexible barrier materials, a struc-ture that consists of two or more continuous layers or pliesof material.DISCUSSIONProcesses such as lamination, coextrusion, extrusioncoating, and solution or dispersion coating can be used to makemultilayered structures. (See also
38、laminate).nonporous packaging materialmaterial which does nothave pores or minute openings to allow volumetric air flow.nonvolatile extractables (1) for purposes of the ASTM testsfor volatile extractables and nonvolatile extractables, non-volatiles shall be defined as those compounds that give moret
39、han 50 % recovery in studies using the applicable nonvola-tile extractables method; (2) in microwave packaging, thosechemical species that are released from microwave foodpackaging under simulated use conditions and are detectedusing an applicable nonvolatile extracables method.packagea container pr
40、oviding protection to a product duringdistribution, storage, retailing, and use.package integritythe physical capability of a given packageto protect its contents with the desired level of protectionover a defined period of service; for example, as a barrier tophysical, microbiological, or chemical
41、challenges.package performancethe ability of the packaging system,including the primary package or sterile barrier system andprotective packaging, to withstand the hazards of handling,distribution, and storage.packaging systemcombination of the sterile barrier systemand protective packaging.peelable
42、 sealthe opening characteristic of forcibly separat-ing two package substrates, which have been joined togetherby a sealing process, without tearing, film fracturing,delamination, or fiber tear of the substrates.porous packaging materiala material used in medicalpackaging which is intended to provid
43、e an environmentaland biological barrier, while allowing sufficient air flow to beused in gaseous sterilization methods (for example, EtO,steam, gas plasma).preformed sterile barrier systemsterile barrier system thatis supplied partially assembled for filling and final closure orsealing (for example
44、, pouches, bags, and open reusablecontainers).protective packaging(1) configuration of materials de-signed to prevent damage to the sterile barrier system and itscontents from the time of their assembly until the point ofuse; (2) any package or configuration of materials thateliminates external fact
45、ors that may adversely affect theform, function, use, or appearance of the product through itsintended packaging life cycle.retortablecapable of withstanding specified thermal pro-cessing in a closed retort at temperatures above 100C.sealthe result of joining surfaces together to form a continu-ous
46、bond without skips or breaks in the pattern, over thecontact surface. For example, surfaces can be joined togetherby the use of adhesives or thermal fusion.seal contaminationforeign matter in the seal area such as,but not limited to, water, grease, or food.seal creepthe reduction in width of a seal
47、due to a forcebeing exerted on it, such as a bulky product, pouchdistortion, or internal air pressure.seal creep resistancea measure of the ability of a sealedpackage or seal to remain intact when subjected to a constantforce.seal integrity(1) characteristics of the seal that ensures thatit maintain
48、s label claim(s), acceptable quality, and ad-equately contains the product; (2) characteristics of the seal,which ensures that it prevents the ingress of microorganismsunder specified conditions.seal strengtha measure of the mechanical strength of thebond between sealed materials of a package.seama
49、noncontinuous joint of two or more surfaces of sheetmaterial such as made by stitching, spot adhesions, orintermittent fusion.solution coatingin flexible barrier materials,(1) a processin which a substrate is covered with a homogeneous solutioncontaining the coating material, followed by removal of the(usually organic) solvent(s). (2) Also, the product resultingfrom such a process.sterilantan agent used to achieve commercial sterility.sterilefree of any viable microorganisms, either active ordormant (Term
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