1、Designation: F99 07 (Reapproved 2015)Standard Guide forWriting a Specification for Flexible Barrier RollstockMaterials1This standard is issued under the fixed designation F99; the number immediately following the designation indicates the year of originaladoption or, in the case of revision, the yea
2、r of last revision. A number in parentheses indicates the year of last reapproval. A superscriptepsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This guide defines the requirements and considerationsfor flexible barrier materials.1.2 This guide addresses som
3、e critical printing requirementsfor flexible barrier materials.1.3 Guidance is provided on specification requirements andconsiderations for flexible barrier materials intended to bepurchased as rollstock.1.4 If the flexible barrier material is intended to be pur-chased in the form of a pre-made ster
4、ile barrier system, GuideF2559 should be referenced.1.5 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of
5、 regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D4321 Test Method for Package Yield of Plastic FilmF17 Terminology Relating to Flexible Barrier PackagingF88 Test Method for Seal Strength of Flexible BarrierMaterialsF2097 Guide for Design and Evaluation of Primary Flex
6、iblePackaging for Medical ProductsF2203 Test Method for Linear Measurement Using PrecisionSteel RuleF2250 Practice for Evaluation of Chemical Resistance ofPrinted Inks and Coatings on Flexible Packaging Materi-alsF2251 Test Method for Thickness Measurement of FlexiblePackaging MaterialF2475 Guide fo
7、r Biocompatibility Evaluation of MedicalDevice Packaging MaterialsF2559 Guide for Writing a Specification for Sterilizable PeelPouches2.2 TAPPI Standard:3T 437 Dirt in Paper and Paperboard2.3 FDA Document:421 CFR 178 Indirect Food Additives: Adjuvants, ProductionAids, and Sanitizers3. Terminology3.1
8、 DefinitionsFor definitions and terms used in thisguide, see Terminology F17.3.2 Definitions:3.2.1 carbon particlescarbon particles are bits of parentmaterial (resin) that have seen excessive heat in processing.3.2.2 gelssmall particles of resin with higher-than-averagemolecular weight and that appe
9、ar as small, hard glassy par-ticles. Gels are not foreign material and are inherent to manypolymer-based materials.3.2.3 specificationan explicit set of requirements to besatisfied by a material, product, system, or service. Examplesof specifications include, but are not limited to, requirementsfor;
10、 physical, mechanical, or chemical properties, and safety,quality, or performance criteria. A specification identifies thetest methods for determining whether each of the requirementsis satisfied.3.2.4 telescopingtransverse slipping of successive windsof a roll of material so that the edge is conica
11、l rather than flat.4. Summary4.1 This standard provides guidance for writing a specifica-tion for flexible barrier materials. Materials, method ofmanufacture, physical properties, performance requirements,dimensioning, appearance, printing, and labeling are all issuesthat need to be addressed in a f
12、lexible barrier material1This guide is under the jurisdiction of ASTM Committee F02 on FlexibleBarrier Packaging and is the direct responsibility of Subcommittee F02.50 onPackage Design and Development.Current edition approved Oct. 1, 2015. Published October 2015. Originallyapproved in 1976. Last pr
13、evious edition approved in 2011 as F99 07(2011). DOI:10.1520/F0099-07R15.2For 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 A
14、STM website.3Available from Technical Association of the Pulp and Paper Industry (TAPPI),15 Technology Parkway South, Norcross, GA 30092, http:/www.tappi.org.4Available from Food and Drug Administration (FDA), 5600 Fishers Ln.,Rockville, MD 20857, http:/www.fda.gov.Copyright ASTM International, 100
15、Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1specification. Appropriate requirements and test methods aresuggested for preparing a specification.5. Significance and Use5.1 Flexible barrier materials are universally used acrossindustries and produced by a myriad of
16、suppliers. They may bemonolayer materials or complex composite structures.However, even with the diversity of material, there are stillbasic requirements that all flexible barrier materials shouldexhibit.5.2 Flexible barrier material requirements may be dividedinto two categories, initial material q
17、ualification, and routineproduction and receipt requirements to ensure the purchaserreceives exactly what is ordered. While all requirements maybe included in the written specification, initial qualificationtests may only be needed prior to the first order. Routineproduction and receipt requirements
18、 should be adhered to onevery order. Initial qualification requirements are indicatedwith each clause, where applicable.5.3 This guide provides an understanding of the require-ments needed for the manufacture, purchase, and acceptance offlexible barrier materials. Appropriate test methods for com-pl
19、iance are also cited.NOTE 1All test methods for a particular requirement may not be citeddue to specific or unique circumstances. For additional guidance onapplicable methods, refer to Guide F2097.5.4 The specification and its requirements should be mutu-ally agreed to by the supplier and purchaser
20、of the product.This helps ensure that the flexible barrier materials will complywith the specified requirements.6. SpecificationNOTE 2Sufficient requirements should be included to ensure that allbatches, lots, or deliveries conform to the specification. Incorporatingunnecessary requirements into the
21、 specification is likely to increase costand should be avoided.6.1 Material Identification:6.1.1 A brief description of the flexible barrier materialshould be provided. For composite structures, key layers andtheir thickness should be noted.6.1.2 The trade name of the flexible barrier material and t
22、heassociated manufacturer/supplier may be included if desired.6.2 Physical Properties:NOTE 3There are numerous test methods associated with determiningphysical properties of flexible materials. Care should be taken in selectingthe most appropriate test for the users particular application and use. F
23、orguidance in determining which methods to use, refer to Guide F2097.Commonly used test methods have been indicated where appropriate.6.2.1 Thickness (if applicable)the total thickness of theflexible barrier material and associated thickness toleranceshould be identified. (See Test Method F2251.)6.2
24、.2 YieldIf the flexible barrier material is to be pur-chased in weight, the yield should be indicated. (See TestMethod D4321.)6.2.3 Seal StrengthIf applicable, a seal strength should bespecified. This requirement may be a minimum and/or maxi-mum value, a typical value, or in the case of weld sealmat
25、erials, a statement that the material will provide a destruct(material failure) seal. (Test Method F88)NOTE 4Minimum seal strength is typically that which maintainspackage integrity through the processing, handling, and distributionsystems. Maximum seal strength is that which, if exceeded on peelabl
26、eapplications, may result in the perception that the package is too difficultto open or causes fiber tear or delamination between one or more of thebonded substrates. Maximum seal strength does not apply to weld sealapplications.6.2.3.1 The sealing conditions (temperature, pressure, anddwell), and t
27、he product to which the material should be sealedshould be specified.6.2.3.2 Seal strength is generally measured using a tensiletest method such as Test Method F88. Test Method F88indicates three different tail holding methods for the testsample: unsupported, supported 90 (by hand), and supported180
28、. Because the effect of each of these on the results isvaried, consistent use of one technique should be negotiatedwith the supplier and indicated in the specification.6.2.4 Barrier (if applicable)The flexible barrier materialshould provide an appropriate physical barrier (oxygen, watervapor, light,
29、 and so forth) and/or microbial barrier. Thisrequirement should be evaluated during the initial materialqualification and is not typically performed on a routineproduction basis.6.3 Application Requirements (incorporate if applicable):6.3.1 Compatibility with Sterilization ProcessThe flexiblebarrier
30、 material should be compatible with the intended steril-ization process. This requirement should be evaluated duringthe initial material qualification and is not typically performedon a routine production basis.6.3.2 ToxicityThe flexible barrier material should be non-toxic and appropriate for the g
31、iven application (see21 CFR 178 and/or Guide F2475 (intended for medical deviceapplications). This requirement should be evaluated during theinitial material qualification and is not typically performed ona routine production basis.6.3.3 Process/Application Specific RequirementsAny spe-cific process
32、/application requirements should be indicated (forexample, haze, treatment level, and so forth).6.4 Appearance:6.4.1 Cleanliness and Particulate :6.4.1.1 Loose ParticulateLoose particulate should beminimized. The level of particulate inherently present will bedependent upon the packaging material ch
33、osen. Size of par-ticulate is frequently estimated using the Dirt Estimation Chartin TAPPI T 437.6.4.1.2 Embedded ParticulateForeign material that is em-bedded between layers of a laminate or within a film, non-woven, or paper, should be minimized. Size of particulate isfrequently estimated using th
34、e Dirt Estimation Chart in TAPPIT 437. Gels and carbon particles are inherent to many polymer-based materials and should be considered separately fromembedded foreign material particulate.6.4.2 Aesthetics:NOTE 5Visual inspection of flexible barrier materials should bewithout magnification and under
35、normal lighting conditions at a distanceof approximately 30 to 45 cm (12 to 18 in.) and any defects should beF99 07 (2015)2noticeable without an extended inspection time.6.4.2.1 The flexible barrier material should be the colorspecified (for example, white, silver, transparent, translucent).6.4.2.2
36、The degree of scratches, scuffing, discoloration, softwrinkles, or other defects which detract from appearance onvisual inspection should be determined as appropriate for thematerial used.6.4.3 FunctionThe flexible barrier material must be freefrom hard wrinkles that could cause channeling through a
37、 seal,or cuts, holes, or tears which impair functionality.6.5 Rollstock Requirements:6.5.1 Roll WidthThe roll width and tolerance, typically62mm(116 in.) should be specified (Test Method F2203).6.5.2 Core:6.5.2.1 The desired core size should be specified, generally76 mm (3 in.) or 152 mm (6 in.).6.5
38、.2.2 The core type may be specified.6.5.3 Roll DiameterThe maximum roll diameter and/ormaximum weight should be specified. This value is generallybased upon equipment limitations or lifting (weight) restric-tions.6.5.4 Splices:6.5.4.1 The maximum allowable number of splices per rollshould be indicat
39、ed (typically 2 on rolls less than 300 mm (12in.), 3 on rolls with an OD of 300 mm (12 in.) to 500 mm (20in.) and 4 on rolls with an OD of 500 mm (20 in.) or greater).6.5.4.2 If desired, the color and width of the splicing tapemay be indicated and whether the tape should be applied to aspecific side
40、 of the material or to both sides of the material.Style of splice may also be indicated.6.5.5 Wind DirectionIndicated the desired wind direction(for example, sealant in, sealant out). If the item is printed, therewind figure should be specified.6.5.6 TelescopingRolls should be wound with sufficientt
41、ension to prevent telescoping in normal handling. Maximumallowable telescoping is typically 6 mm (14 in.).6.5.7 Roll Edge ProfileMaximum oscillation, peak tovalley, of the edge of the roll may be specified. Maximumallowable oscillation is typically 6 mm (14 in.).6.6 Printing Requirements:6.6.1 The s
42、pecification should indicate whether the copy issurface printed or buried/reverse printed.6.6.2 Repeat RegistrationThe repeat should be indicated.The repeat tolerance is generally specified over an integralnumber of printing cylinder repeats.NOTE 6During the package forming process, the flexible bar
43、riermaterial is under tension and will stretch. This should be taken intoconsideration when developing repeat specifications. The relaxed repeatmeasurement will generally be less than the machine stroke.6.6.3 Chemical Resistance of InkIf the copy is surfaceprinted, any chemical resistance requiremen
44、ts (for example,water, alcohol, and so forth) should be indicated (PracticeF2250). This requirement should be evaluated during the initialmaterial qualification and is not typically performed on aroutine production basis.6.6.4 Ink ColorThe ink color should be specified andconform to agreed upon stan
45、dards.6.6.5 LegibilityThere should be no missing, incorrect, orillegible print.6.6.6 PlacementPlacement and location of print should bespecified. Typical copy to cut tolerance is 63.2 mm (18 in.).NOTE 7Printing should not fall into the seal area. The heat sealingprocess may be affected by the presen
46、ce of ink. Additionally, the sealingprocess may affect the ink and/or print legibility.6.7 Packaging and Package Marking:6.7.1 LabelingEach roll and pallet should be labeled withthe supplier name, supplier lot number, supplier and/or cus-tomer part number, purchase order number, and quantity.6.7.2 P
47、ackagingFlexible barrier materials should be pro-tected from dirt and contamination during shipping.6.8 Supplementary Requirements:6.8.1 Flexible barrier materials should be manufacturedwithin a formal quality system.6.8.2 Traceability of the raw materials used to produce eachlot of flexible barrier
48、 material should be maintained back to thedirect base material supplier.6.8.3 The supplier and customer should agree on howchanges to materials, processes, or sources of supply will behandled once a product is defined and qualified. This istypically documented as an agreement based upon writtenappro
49、vals.7. Keywords7.1 flexible barrier material; roll; rollstock; specificationASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif n
