1、Designation: F17 18F17 18aStandard Terminology Relating toPrimary 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 in paren
2、theses 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 primary barrier packaging and its materials. This terminologycontains related definitions and de
3、scriptions of terms used or likely to be used in primary barrier packaging standards. The purposeof 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 internationally recognized pri
4、nciples 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 Terminology Relating to Pla
5、sticsD1129 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 the effects of time on a p
6、ackage 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 described by theArrhenius
7、 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 that results in a consi
8、stent 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 the opposing material. Thi
9、s 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.aseptic packagingfilling of
10、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, nthe separation proces
11、s of liquid into small particles.1 This terminology is under the jurisdiction of ASTM Committee F02 on Primary Barrier Packaging and is the direct responsibility of F02.50 on Package Design andDevelopment.Current edition approved Aug. 15, 2018Oct. 1, 2018. Published August 2018November 2018. Origina
12、lly approved in 1961. Last previous edition approved in 20172018as F17 17.F17 18. DOI: 10.1520/F0017-18.10.1520/F0017-18A.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refe
13、r 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 adequately depict all cha
14、nges 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 Conshohocken, PA 19428-2959. U
15、nited 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 packagecontents as well as pro
16、tection 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 th
17、at 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.burst strengtha measure of
18、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 break-up system.coextrusionin
19、 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 processed food, the conditi
20、on 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.conditioningthe exposure o
21、f 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 beingproduced or processe
22、d. 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 materials, (1) a process o
23、f 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 a food packaging containe
24、r 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 to environmental stresses.
25、 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 liquid flows through bef
26、ore 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 (solid) material, forming a c
27、ontinuous 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 bent.DISCUSSION“Flexible
28、” 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 Terminology D883).Modulu
29、s 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 measurement based on the va
30、riation in total luminescence of a fluoropticphosphor which has been previously calibrated versus a known temperature standard.F17 18a2food simulanta well-characterized substance used in place of food for investigative studies.force to actuate (FTA), nthe peak force that corresponds to the pressure
31、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 its borders, or interfa
32、ce 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 ofthe mechanical pump disp
33、enser.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.hermetically sealed aseptic contain
34、era 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 aconcentrated stain on t
35、he 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 flexible barrier materi
36、als, 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.ahole, void, or defect in the package materia
37、l or mated components of a package capable of passing particulate, aerosols, liquid,or gas from one side (inside or outside) of the package to the other side contrary to intention.load (water load)an amount of water used to moderate the microwave radiation absorbed by a susceptor during simulatedmic
38、rowave 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 having a finished equilibrium pH less than 4.7 are not classed as low-acidfoods.machine direction (MD)t
39、he 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 called longitudinaldirection (LD).majorpackage defecta defect that is likely to result in failure
40、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 forproducing specific spray characteristics.mechanical pump dispenser, na small, finger- or hand-actuated
41、, 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, implant, in vitro reagent or calibrator, software,material, or other related article, intended by th
42、e 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, treatment,alleviation of or compensation for an injury; (3) investigation, replacement, modificat
43、ion 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 purposes by means of in vitro examination of specimens derived from the human body, andwhich does not achi
44、eve 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 sterile barrier system that prevents the ingress and/or egress of microorganisms under specifiedcondi
45、tions.microbiological contamination (of packaged products)the entry of viable microorganisms into a finished package due to lackof or loss of package integrity.F17 18a3microbiological package integritythe physical condition of a finished package, including, but not limited to, the security ofpackage
46、 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. Refer to Test MethodF1349 for schematics of cell construction.microwave only food packagea contain
47、er 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 package contents.minor package defecta defect that does not significantly reduce the usability of the
48、 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 structure that consists of two or more continuous layers or plies ofmaterial.DISCUSSIONProcesses
49、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 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 extr
