ASTM F17-2017 Standard Terminology Relating to Primary Barrier Packaging《初级阻隔性包装相关标准术语》.pdf

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1、Designation: F17 13aF17 17Standard Terminology Relating toFlexiblePrimary 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.Anumber

2、in parentheses indicates the year of last reapproval.Asuperscriptepsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This terminology covers the principal terms relating to flexibleprimary barrier packaging and its materials. This terminologycontains related de

3、finitions and descriptions of terms used or likely to be used in flexibleprimary barrier packaging standards. Thepurpose of terminology is to promote clear understanding and interpretation of the standards in which they are used.1.2 This international standard was developed in accordance with intern

4、ationally recognized principles on standardizationestablished in the Decision on Principles for the Development of International Standards, Guides and Recommendations issuedby the World Trade Organization Technical Barriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2D883 Ter

5、minology Relating to PlasticsD1129 Terminology 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 th

6、e effects of time on a package by subjecting 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 d

7、escribed by theArrhenius reactionrate function, more discussion of which is available in Guide F1980.accumulative pump, na mechanical pump dispenser that accumulates internal pressure by means of a valving-system thatmaintains a high velocity flow of the product no matter what the actuation velocity

8、 that results in a consistent fine mist spray.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 adhesive being left on th

9、e 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 commercially sterile.asep

10、tic 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 microbialcontamination.atomization

11、, nthe separation process of liquid into small particles.1 This terminology is under the jurisdiction of ASTM Committee F02 on FlexiblePrimary Barrier Packaging and is the direct responsibility of F02.50 on Package Designand Development.Current edition approved Aug. 1, 2013June 1, 2017. Published Oc

12、tober 2013July 2017. Originally approved in 1961. Last previous edition approved in 2013 asF17 13.F17 13a. DOI: 10.1520/F0017-13A.10.1520/F0017-17.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standard

13、svolume information, refer to the standards Document Summary page on the ASTM website.This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to

14、adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Consh

15、ohocken, PA 19428-2959. United States1barrierany 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 packa

16、gecontents as well as protection 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 pas

17、sage of microorganisms that might 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.bu

18、rst strengtha measure of the internal pressure necessary to rupture a package or seal.channelany unimpaired pathway across the entire width of the intended seal.clogging, vthe restriction of normal product flow. Most commonly due to product drying in a product flow passage area of themechanical brea

19、k-up system.coextrusionin flexible barrier materials, (1) a process 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 pr

20、ocessed food, the condition achieved by application of heat, alone 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.c

21、onditioningthe exposure of a material to the influence of a prescribed atmosphere for a stipulated period of time or until astipulated relation is reached between material and atmosphere.cross direction (CD)the direction perpendicular to a materials flow through the machine on which the material is

22、beingproduced or processed. Material orientation perpendicular to the flow direction through a machine may have different propertiesthan machine direction. Also known as transverse direction (TD).delaminationthe separation of layers in a multilayered structure.dispersion coatingin flexible barrier m

23、aterials, (1) a process of applying a material, suspended or dispersed in a 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

24、a food packaging container used to prepare food in either a conventional oven 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 t

25、o environmental stresses. In contrast toaccelerated aging, environmental challenging often includes conditions, or transitions, or both, of temperature and humidity thatequal or exceed those that can be encountered in a package life cycle.exit orifice, nthe final passage found in the insert that the

26、 liquid flows through before exiting the dispensing system where thesize of the orifice diameter can determine the size of the spray particles and spray pattern.extrusion coatingin flexible barrier materials, (1) a process of extrusion whereby a molten extrudate adheres to the surface ofanother (sol

27、id) material, forming a continuous layer upon cooling. (2) Also, the product resulting from such a process.fine mist pump, na mechanical pump dispenser that atomizes liquid into a fine mist.An accumulative pump is the most commontype of fine mist pump.flexibleeasily hand-folded, flexed, twisted, and

28、 bent.DISCUSSION“Flexible” may be a characteristic of thin barrier materials, especially when thinner than 125 to 255 m (5 to 10 mils), that are composed of materialsthat are otherwise classified as “rigid” or “semi-rigid” under the definitions concerning rigidity based on modulus of elasticity (see

29、 Terminology D883).Modulus of elasticity is an inherent property of a material which in conjunction with thickness determines flexibility.flexible packageany package with at least one flexible component that can be bent back or folded back upon itself.fluoroptic temperature measurementtemperature me

30、asurement based on the variation in total luminescence of a fluoropticphosphor which has been previously calibrated versus a known temperature standard.F17 172food simulanta well-characterized substance used in place of food for investigative studies.force to actuate (FTA), nthe peak force that corr

31、esponds to the pressure on the finger that a consumer feels upon fully actuatingthe mechanical pump dispenser.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

32、 its borders, or interface with another material or substance.functional compatibility, neffect of physical or chemical interaction between a consumer product and a specific pumpmechanism where problems typically include deformation and degradation of components that result in a lower performance of

33、the mechanical pump dispenser.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 dwell time.hermeticall

34、y 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.hot spot, nthe area of a spray where the product concentration is high which can be visibly seen on a spray pattern as

35、aconcentrated stain on the alcohol-sensitive paper.hot tackthe property of a heat seal to hold together when stressed while it is still hot from the sealing operation.laminatea product made by bonding together two or more layers of material or materials. (See also multilayered structure)laminationin

36、 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 substances to enter.load (water load)an a

37、mount 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 4.6 and a water activity (aw)greater than 0.85. Tomatoes and tomato products havi

38、ng a finished equilibrium pH less than 4.7 are not classed as low-acidfoods.machine direction (MD)the direction parallel to a materials flow through the machine on which the material is being producedor processed. Flow direction through a machine may impart directional properties to a material. Also

39、 called longitudinaldirection (LD).majorpackage defecta defect that is likely to result in failure or reduce significantly the usability of the package for its intendeduse.mechanical break-up unit (MBU), n a design structure found in the insert that forces product to flow in a swirling method forpro

40、ducing specific spray characteristics.mechanical pump dispenser, na small, finger- or hand-actuated, mechanical device used to dispense (spray, stream, or flow)product from a container that may be, generally, held in ones hand.medical deviceany instrument, apparatus, implement, machine, appliance, i

41、mplant, 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, treatment, or alleviation of a disease; (2) diagnosis, monitoring

42、, 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 medical devices; and (6)providing information for medical purpose

43、s 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 in its function by such means.microbial barrierproperty of the st

44、erile 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 loss of package integrity.F17 173microbiological package integrityt

45、he 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 polytetrafluoroethylene cell used for evaluating microwave active materials.

46、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 interact with the field andprovide substantial heat to the pac

47、kage 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 package.multilayered structurein flexible barrier materials, a

48、 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 alsolaminate).nonporous packaging materialmaterial which does not

49、 have pores or minute openings to allow volumetric air flow.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, those chemical species that are released from microwave food packaging under simulateduse conditions and are detected using an applicable nonvolatile extracable