ASTM F17-2012 Standard Terminology Relating to Flexible Barrier Packaging《与软性屏障包装相关的标准术语》.pdf

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1、Designation: F17 08 F17 12Standard 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 pa

2、rentheses 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 to flexible barrier packaging and its materials. This terminologycontains related definitions

3、and descriptions of terms used or likely to be used in flexible barrier packaging standards. The purposeof terminology is to promote clear understanding and interpretation of the standards in which they are used.2. Referenced Documents2.1 ASTM Standards:2D883 Terminology Relating to PlasticsD1129 Te

4、rminology Relating to WaterF1349 Test Method for Nonvolatile Ultraviolet (UV) Absorbing Extractables from Microwave SusceptorsF1980 Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices3. Terminologyaccelerated aginga technique to simulate the effects of time on a package by sub

5、jecting the product/package system to elevatedtemperatures in a controlled environment representative of controlled environment storage conditions. The equivalent time isgenerally estimated by assuming the degradation of packaging materials follows the kinetics described by the Arrhenius reactionrat

6、e function, more discussion 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 to whichit has been sealed and shows visible evidence of the adhesi

7、ve being left on the opposing material. This evidence is in the formof an adhesive layer that remains with the opposing material, the adhesive having separated either adhesively from the coatedweb or cohesively within the adhesive itself.asepticas applied to aseptic packaging, synonymous with commer

8、cially sterile.aseptic packagingfilling of a commercially sterilized product into presterilized containers, followed by hermetic sealing in acommercially sterile atmosphere.aseptic presentationintroduction and transfer of a sterile product using conditions and procedures that exclude microbialcontam

9、ination.barrierany material limiting passage through itself of solids, liquids, semisolids, gases, vapors, or forms of energy such asultraviolet light.barrier materialsspecialized porous or nonporous packaging materials that provide environmental protection to the packagecontents as well as protecti

10、on to the environment from the package contents: (1) gas, vapor, humidity, liquid, microbial, or lightresistant materials that control or eliminate the amount of those environmental constituents that pass into or out of a package;(2) a porous material preventing the passage of microorganisms that mi

11、ght contaminate the contents of the package.biological evaluation test (biotest)a test which involves exposure of sealed packages to biological indicators and is designedto determine the microbiological integrity of a package under the specific conditions of the test.burst strengtha measure of the i

12、nternal pressure necessary to rupture a package or seal.channelany unimpaired pathway across the entire width of the intended seal.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1coextrusionin flexible barrier materials, (1) a process

13、 whereby two or more plastic streams are forced simultaneously throughone or more shaping orifices to become one continuously-formed multilayered structure. (2) Also, the product resulting fromsuch a mercial sterility of thermally processed food, the condition achieved by application of heat, alone

14、or in combination withother appropriate treatments, to render the food free of microorganisms capable of growing in the food at normal nonrefrigeratedconditions at which the food is likely to be held during distribution and storage.conditioningthe exposure of a material to the influence of a prescri

15、bed atmosphere for a stipulated period of time or until astipulated relation is reached between material and atmosphere.delaminationthe separation of layers in a multilayered structure.dispersion coatingin flexible barrier materials, (1) a process of applying a material, suspended or dispersed in a

16、vehicle, to asurface in such a way that a continuous, coalesced, adherent layer results when the vehicle liquid (usually water) is evaporated.(2) Also, the product resulting from such a process.dual ovenableterms describing a food packaging container used to prepare food in either a conventional ove

17、n or a microwaveoven.environmentally challengingthe process of subjecting a package to extremes of temperature and/or humidity and/or otherenvironmental conditions, with the goal of determining sensitivities of the package to environmental stresses. In contrast toaccelerated aging, environmental cha

18、llenging often includes conditions, or transitions, or both, of temperature and humidity thatequal or exceed those that can be encountered in a package life cycle.extrusion coatingin flexible barrier materials, (1) a process of extrusion whereby a molten extrudate adheres to the surface ofanother (s

19、olid) material, forming a continuous layer upon cooling. (2) Also, the product resulting from such a process.flexibleeasily hand-folded, flexed, twisted, and bent.DISCUSSION“Flexible” may be a characteristic of thin barrier materials, especially when thinner than 125 to 255 m (5 to 10 mils), that ar

20、e composed of materialsthat are otherwise classified as “rigid” or “semi-rigid” under the definitions concerning rigidity based on modulus of elasticity (see Terminology D883).Modulus of elasticity is an inherent property of a material which in conjunction with thickness determines flexibility.flexi

21、ble packageany package with at least one flexible component that can be bent back or folded back upon itself.fluoroptic temperature measurementtemperature measurement based on the variation in total luminescence of a fluoropticphosphor which has been previously calibrated versus a known temperature

22、standard.food simulanta well-characterized substance used in place of food for investigative studies.functional barrierin food packaging, a material that effectively restricts passage of solids, liquids, semi-solids, vapors, or formsof energy such as ultraviolet light through itself, across its bord

23、ers, or interface with another material or substance.fusion seala bond formed by combining two or more materials through melting or other means so that the joining layers becomeindistinguishable at the interface.heat sealthe result of bonding surfaces by controlled application of heat, pressure, and

24、 dwell time.hermetically sealed aseptic containera container that is designed and intended to be secure against the entry of microorganismsand thereby to maintain the commercial sterility of its contents.laminatea product made by bonding together two or more layers of material or materials. (See als

25、o multilayered structure)laminationin flexible barrier materials, the process of preparing a laminate which consists of two or more flexible barriersbonded together (see also laminate).leakany opening in a flexible package that is contrary to intention and either lets contents escape or permits subs

26、tances to enter.1 This terminology is under the jurisdiction of ASTM Committee F02 on Flexible Barrier Packaging and is the direct responsibility of F02.50 on Package Design andDevelopment.Current edition approved Aug. 1, 2008Nov. 1, 2012. Published September 2008 November 2012. Originally approved

27、in 1961. Last previous edition approved in 20072008as F17 07a.F17 08. DOI: 10.1520/F0017-08.10.1520/F0017-12.2 For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the s

28、tandards Document Summary page on the ASTM website.F17 122load (water load)an amount of water used to moderate the microwave radiation absorbed by a susceptor during simulatedmicrowave heating tests.low-acid foodany food, other than alcoholic beverages, with a finished equilibrium pH greater than 4.

29、6 and a water activity (aw)greater than 0.85. Tomatoes and tomato products having a finished equilibrium pH less than 4.7 are not classed as low-acidfoods.major package defecta defect that is likely to result in failure or reduce significantly the usability of the package for its intendeduse.medical

30、 deviceany instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software,material, or other related article, intended by the manufacturer to be used, alone or in combination, for one of more of the specificpurpose(s) of (1) diagnosis, prevention, monitoring,

31、 treatment, or alleviation of a disease; (2) diagnosis, monitoring, treatment,alleviation of or compensation for an injury; (3) investigation, replacement, modification or support of the anatomy or of aphysiological processsupporting or sustaining life; (4) control of conception; (5) disinfection of

32、 medical devices; and (6)providing information for medical purposes by means of in vitro examination of specimens derived from the human body, andwhich does not achieve its primary intended action in or on the human body by pharmacological, immunological, or metabolicmeans, but which may be assisted

33、 in its function by such means.microbial barrierproperty of the sterile barrier system that prevents the ingress and/or egress of microorganisms under specifiedconditions.microbiological contamination (of packaged products)the entry of viable microorganisms into a finished package due to lackof or l

34、oss of package integrity.microbiological package integritythe physical condition of a finished package, including, but not limited to, the security ofpackage seals, which ensures the maintenance of the package contents in a commercially sterile condition.microwave extraction cella polytetrafluoroeth

35、ylene cell used for evaluating microwave active materials. Refer to Test MethodF1349 for schematics of cell construction.microwave only food packagea container used to heat foods only in a microwave oven.microwave susceptorpackaging material that, when placed in a microwave field, is designed to int

36、eract with the field andprovide substantial heat to the package contents.minor package defecta defect that does not significantly reduce the usability of the package for its intended purpose, or thatis a departure from established standards having little or no bearing on the effective use of the pac

37、kage.multilayered structurein flexible barrier materials, a structure that consists of two or more continuous layers or plies ofmaterial.DISCUSSIONProcesses such as lamination, coextrusion, extrusion coating, and solution or dispersion coating can be used to make multilayered structures. (See alsola

38、minate).nonvolatile extractables (1) for purposes of the ASTM tests for volatile extractables and nonvolatile extractables, nonvolatilesshall be defined as those compounds that give more than 50 % recovery in studies using the applicable nonvolatile extractablesmethod; (2) in microwave packaging, th

39、ose chemical species that are released from microwave food packaging under simulateduse conditions and are detected using an applicable nonvolatile extracables method.packagea container providing protection to a product during distribution, storage, retailing, and use.package integritythe physical c

40、apability of a given package to protect its contents with the desired level of protection over adefined period of service; for example, as a barrier to physical, microbiological, or chemical challenges.package performancethe ability of the packaging system, including the primary package or sterile b

41、arrier system and protectivepackaging, to withstand the hazards of handling, distribution, and storage.packaging systemcombination of the sterile barrier system and protective packaging.peelable sealthe opening characteristic of forcibly separating two package substrates, which have been joined toge

42、ther by asealing process, without tearing, film fracturing, delamination, or fiber tear of the substrates.porous packaging materiala material used in medical packaging which is intended to provide an environmental and biologicalbarrier, while allowing sufficient air flow to be used in gaseous steril

43、ization methods (for example, EtO, steam, gas plasma).F17 123preformed sterile barrier systemsterile barrier system that is supplied partially assembled for filling and final closure or sealing(for example, pouches, bags, and open reusable containers).protective packaging(1) configuration of materia

44、ls designed to prevent damage to the sterile barrier system and its contentsfrom the time of their assembly until the point of use; (2) any package or configuration of materials that eliminates externalfactors that may adversely affect the form, function, use, or appearance of the product through it

45、s intended packaging life cycle.retortablecapable of withstanding specified thermal processing in a closed retort at temperatures above 100C.sealthe result of joining surfaces together to form a continuous bond without skips or breaks in the pattern, over the contactsurface. For example, surfaces ca

46、n be joined together by 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 due to a force being exerted on it, such as a bulky product, pouch distortion, or internalai

47、r pressure.seal creep resistancea measure of the ability of a sealed package or seal to remain intact when subjected to a constant force.seal integrity(1) characteristics of the seal that ensures that it maintains label claim(s), acceptable quality, and adequatelycontains the product; (2) characteri

48、stics of the seal, which ensures that it prevents the ingress of microorganisms under specifiedconditions.seal strengtha measure of the mechanical strength of the bond between sealed materials of a package.seama noncontinuous joint of two or more surfaces of sheet material such as made by stitching,

49、 spot adhesions, or intermittentfusion.solution coatingin flexible barrier materials, (1) a process in 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 resulting fromsuch a process.sterilantan agent used to achieve commercial sterility.sterilefree of any viable microorganisms, either active or dormant (Terminology D1129, D19).sterile barrier systemminimum package that prevents ingre