ASTM F17-2018 Standard Terminology Relating to Primary Barrier Packaging.pdf

1、Designation: F17 18Standard 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. A number in parenthese

2、s 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 toprimary barrier packaging and its materials. This terminologycontains related definitions and descri

3、ptions of terms used orlikely to be used in primary barrier packaging standards. Thepurpose of terminology is to promote clear understanding andinterpretation of the standards in which they are used.1.2 This international standard was developed in accor-dance with internationally recognized principl

4、es on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2D883 Terminology Relating to Plasti

5、csD1129 Terminology 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 pac

6、kage by subjecting 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 r

7、eaction rate function, morediscussion of which is available in Guide F1980.accumulative pump, na mechanical pump dispenser thataccumulates internal pressure by means of a valving-systemthat maintains a high velocity flow of the product no matterwhat the actuation velocity that results in a consisten

8、t finemist 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 towhich it has been sealed and shows visible evidence of theadhesive being left on the opposing material. This evid

9、enceis 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.aseptic packagingfilling of a commerc

10、ially 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.atomization, nthe separation process of

11、liquid into smallparticles.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

12、as well as protection 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 micr

13、oorganisms that might 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.1This terminolo

14、gy is under the jurisdiction ofASTM Committee F02 on PrimaryBarrier Packaging and is the direct responsibility of F02.50 on Package Design andDevelopment.Current edition approved Aug. 15, 2018. Published August 2018. Originallyapproved in 1961. Last previous edition approved in 2017 as F17 17. DOI:1

15、0.1520/F0017-18.2For referenced ASTM standards, 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

16、 Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendation

17、s issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.1burst strengtha measure of the internal pressure necessaryto rupture a package or seal.channelany unimpaired pathway across the entire width ofthe intended seal.clogging, vthe restriction of normal product flow. Mo

18、stcommonly due to product drying in a product flow passagearea of the mechanical break-up system.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-formed multilayered str

19、ucture. (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 food atnormal nonrefrigerat

20、ed 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 time or untila stipulated relation is reached between material and atmo-sphere.cross direction (CD)the dire

21、ction perpendicular to a mate-rials flow through the machine on which the material isbeing produced or processed. Material orientation perpen-dicular to the flow direction through a machine may havedifferent properties than machine direction. Also known astransverse direction (TD).delaminationthe se

22、paration 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 continuous,coalesced, adherent layer results when the vehicle liquid(usually water) is evaporated

23、. (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 challengingthe process of subjecting apackage to extremes of temperature and/or humidity and/orother envi

24、ronmental conditions, with the goal of determiningsensitivities of the package to environmental stresses. 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

25、package life cycle.exit orifice, nthe final passage found in the insert that theliquid flows through before exiting the dispensing systemwhere the size of the orifice diameter can determine the sizeof the spray particles and spray pattern.extrusion coatingin flexible barrier materials,(1) a processo

26、f extrusion whereby a molten extrudate adheres to thesurface of another (solid) material, forming a continuouslayer upon cooling. (2)Also, the product resulting from sucha process.fine mist pump, na mechanical pump dispenser that atom-izes liquid into a fine mist. An accumulative pump is themost com

27、mon type of fine mist pump.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 “rigid”or “semi-rigid” unde

28、r 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 that can be bent back or fo

29、lded 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 placeof food for investiga

30、tive studies.force to actuate (FTA), nthe peak force that corresponds tothe pressure on the finger that a consumer feels upon fullyactuating the mechanical pump dispenser.functional barrierin food packaging, a material that effec-tively restricts passage of solids, liquids, semi-solids, vapors,or fo

31、rms of energy such as ultraviolet light through itself,across its borders, or interface with another material orsubstance.functional compatibility, neffect of physical or chemicalinteraction between a consumer product and a specific pumpmechanism where problems typically include deformationand degra

32、dation of components that result in a lowerperformance of the mechanical pump dispenser.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 controlled

33、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.hot spot, nthe area of a spray where the product concentra-tion

34、 is high which can be visibly seen on a spray pattern asa concentrated stain on the alcohol-sensitive paper.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 two or morelayers of material or m

35、aterials. (See also multilayeredstructure)F17182laminationin 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 lets contents e

36、scape 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 wateractivit

37、y (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.machine direction (MD)the direction parallel to a materi-als flow through the machine on which the material is beingproduced or processed. Flow direction through a

38、machinemay impart directional properties to a material. Also calledlongitudinal direction (LD).major package defecta defect that is likely to result infailure or reduce significantly the usability of the package forits intended use.mechanical break-up unit (MBU), n a design structurefound in the ins

39、ert that forces product to flow in a swirlingmethod for producing 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 devicea

40、ny 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,monitoring, treatment,

41、 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) disinfection of medical

42、 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 assisted in its

43、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 or loss of pack

44、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

45、d 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 interact with the f

46、ieldand 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.multilayered

47、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).nonporous

48、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 morethan 50 % recovery in

49、 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.output per stroke (OPS), nthe amount of product dispensedwith one complete actuation when measured in terms ofweight (grams) or volume (microliter, milliliters, or ccs).packagea container providing protection to a product duringdistribution, storage, re