1、Designation: F 17 07aStandard Terminology Relating toFlexible Barrier Packaging1This standard is issued under the fixed designation F 17; 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 parent
2、heses indicates the year of last reapproval. A superscriptepsilon (e) 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
3、descriptions 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:2D 883 Terminology Relating to PlasticsD 1129 Termin
4、ology Relating to WaterF 1349 Test Method for Nonvolatile Ultraviolet (UV) Ab-sorbing Extractables from Microwave SusceptorsF 1980 Guide for Accelerated Aging of Sterile BarrierSystems for Medical Devices3. Terminologyaccelerated aginga technique to simulate the effects of timeon a package by subjec
5、ting the 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 f
6、unction, morediscussion of which is available in Guide F 1980.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 b
7、eing left 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
8、sterile.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 contamina
9、tion.barrierany 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
10、to the 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
11、con-taminate 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 intern
12、al pressure 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 simulta-neously through one or more shaping orifices to become onecontinuou
13、sly-formed 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 foodfree of microorganisms capable of growing in the
14、food atnormal nonrefrigerated conditions at which the food is likelyto be held during distribution and storage.delaminationthe separation of layers in a multilayeredstructure.1This terminology is under the jurisdiction ofASTM Committee F02 on FlexibleBarrier Packaging and is the direct responsibilit
15、y of F02.50 on Package Design andDevelopment.Current edition approved Sept. 1, 2007. Published October 2007. Originallyapproved in 1961. Last previous edition approved in 2007 as F 17 07.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at servicea
16、stm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.dispersion coatingin flexible barrier materials,(1) a pro-c
17、ess of applying a material, suspended or dispersed in avehicle, to a surface in such a way that a continuous,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 conta
18、inerused to prepare food in either a conventional oven or amicrowave oven.environmentally challengingthe 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.
19、 Incontrast to accelerated aging, environmental challengingoften includes conditions, or transitions, 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 mol
20、ten extrudate adheres to thesurface of another (solid) material, forming a continuouslayer upon cooling. (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 thin
21、ner than 125 to 255 m (5 to 10 mils),that are composed of materials that are otherwise classified as “rigid”or “semi-rigid” under the definitions concerning rigidity based onmodulus of elasticity (see Terminology D 883). Modulus of elasticity isan inherent property of a material which in conjunction
22、 with thicknessdetermines flexibility.flexible packageany package with at least one flexiblecomponent 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 previo
23、usly calibratedversus a known temperature standard.food simulanta well-characterized substance used in 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 ultravi
24、olet light through itself,across its borders, or interface with another material orsubstance.fusion seala 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 contro
25、lled appli-cation of heat, pressure, and dwell time.hermetically sealed aseptic containera container that isdesigned and intended to be secure against the entry ofmicroorganisms and thereby to maintain the commercialsterility of its contents.laminatea product made by bonding together two or morelaye
26、rs 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 and either le
27、ts 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 than 4.6 and a
28、 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.medical device
29、any instrument, apparatus, implement, ma-chine, 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,monitoring, treatme
30、nt, or alleviation of a disease; (2) diag-nosis, monitoring, treatment, alleviation of or compensationfor an injury; (3) investigation, replacement, modification orsupport of the anatomy or of a physiological processsupporting or sustaining life; (4) control of conception; (5)disinfection of medical
31、 devices; and (6) providing informa-tion for medical purposes by means of in vitro examinationof specimens derived from the human body, and which doesnot achieve its primary intended action in or on the humanbody by pharmacological, immunological, or metabolicmeans, but which may be assisted in its
32、function by suchmeans.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 or loss of pack
33、age integrity.microbiological 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 polytetrafluoroethylene celluse
34、d for evaluating microwave active materials. Refer toTest Method F 1349 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 interact with the
35、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 package.F1707a2multi
36、layered 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 laminate).no
37、nvolatile extractables (1) for purposes of the ASTM testsfor volatile extractables and nonvolatile extractables, non-volatiles shall be defined as those compounds that give morethan 50 % recovery in studies using the applicable nonvola-tile extractables method; (2) in microwave packaging, thosechemi
38、cal species that are released from microwave foodpackaging under simulated use conditions and are detectedusing an applicable nonvolatile extracables method.packagea container providing protection to a product duringdistribution, storage, retailing, and use.package integritythe physical capability o
39、f 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 challenges.packaging systemcombination of the sterile barrier systemand protective packaging.peelable sealthe opening char
40、acteristic of forcibly separat-ing two package substrates, which have been joined togetherby a sealing process, without tearing, film fracturing, delami-nation, or fiber tear of the substrates.porous packaging materiala material used in medicalpackaging which is intended to provide an environmentala
41、nd 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, pouches, bags, an
42、d 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 factors that may advers
43、ely 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; for example,surfaces can be joined toget
44、her by the use of adhesives orthermal 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 due to a forcebeing exerted on it, such as a bulky product, pouch distor-tion, or internal air pressure.seal cr
45、eep 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, which ensuresthat it prevents the ingress of microorganisms under speci-fied conditions; (2) characteristics of the seal that ensurestha
46、t it maintains label claim(s), acceptable quality, andadequately contains the product.seal strengtha measure of the mechanical strength of thebond between sealed materials of a package.seama noncontinuous joint of two or more surfaces of sheetmaterial such as made by stitching, spot adhesions, orint
47、ermittent 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
48、 achieve commercial sterility.sterilefree of any viable microorganisms, either active ordormant (Terminology D 1129, D19).sterilization compatibilityattributes of the packaging mate-rial and/or system that allow it to both withstand thesterilization process and attain the required conditions forster
49、ilization within the packaging system.terminal sterilizationprocess whereby product is sterilizedwithin its sterile barrier system.thermal processingthe application of heat to achieve areduced level of microbiological activity.transparentizationan increase in light transmission througha normally opaque material (such as Tyvek) due to effects ofexcessive heat and/or pressure.volatile extractables for purposes of the ASTM tests forvolatile extractables and nonvolatile extractables , volatilesshall be define
