1、Designation: F 99 07Standard Guide forWriting a Specification for Flexible Barrier RollstockMaterials1This standard is issued under the fixed designation F 99; the number immediately following the designation indicates the year of originaladoption or, in the case of revision, the year of last revisi
2、on. A number in parentheses indicates the year of last reapproval. A superscriptepsilon (e) 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 some critical prin
3、ting 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 sterile barrier sys
4、tem, GuideF 2559 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 regulatory li
5、mitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D 4321 Test Method for Package Yield of Plastic FilmF17 Terminology Relating to Flexible Barrier PackagingF88 Test Method for Seal Strength of Flexible BarrierMaterialsF 2097 Guide for Design and Evaluation of Primary Flex-ible Packag
6、ing for Medical ProductsF 2203 Test Method for Linear Measurement Using Preci-sion Steel RuleF 2250 Practice for Evaluation of Chemical Resistance ofPrinted Inks and Coatings on Flexible Packaging MaterialsF 2251 Test Method for Thickness Measurement of FlexiblePackaging MaterialF 2475 Guide for Bio
7、compatibility Evaluation of MedicalDevice Packaging MaterialsF 2559 Guide for Writing a Specification for SterilizablePeel Pouches2.2 TAPPI Standard:3T 437 Dirt in Paper and Paperboard2.3 FDA Document:421 CFR 178 Indirect FoodAdditives:Adjuvants, ProductionAids, and Sanitizers3. Terminology3.1 Defin
8、itionsFor 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-average molecular weight and that appear as
9、 small, hard glassyparticles. Gels are not foreign material and are inherent tomany polymer-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; physic
10、al, 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 conical rathe
11、r than flat.4. Summary4.1 This standard provides guidance for writing a specifica-tion for flexible barrier materials. Materials, method of manu-facture, physical properties, performance requirements, dimen-sioning, appearance, printing, and labeling are all issues thatneed to be addressed in a flex
12、ible barrier material specification.1This 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 Aug. 1, 2007. Published September 2007. Originallyapproved in
13、 1976. Last previous edition approved in 2001 as F 99 76 (2001).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 websi
14、te.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.1Copyright ASTM International, 100 Barr Har
15、bor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.Appropriate requirements and test methods are suggested forpreparing a specification.5. Significance and Use5.1 Flexible barrier materials are universally used acrossindustries and produced by a myriad of suppliers. They may bem
16、onolayer materials or complex composite structures. How-ever, even with the diversity of material, there are still basicrequirements that all flexible barrier materials should exhibit.5.2 Flexible barrier material requirements may be dividedinto two categories, initial material qualification, and ro
17、utineproduction 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 should be adhered t
18、o 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-pliance are also cited
19、.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 F 2097.5.4 The specification and its requirements should be mutu-ally agreed to by the supplier and purchaser of the product.This
20、 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 specification is l
21、ikely 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 theassociated manufa
22、cturer/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. Forguidance in deter
23、mining which methods to use, refer to Guide F 2097.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 F 2251.)6.2.2 YieldIf the fl
24、exible barrier material is to be pur-chased in weight, the yield should be indicated. (See TestMethod D 4321.)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 sealmaterials, a statem
25、ent 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 peelableapplications, m
26、ay 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 the product to wh
27、ich 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. Because the ef
28、fect 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, and so forth) a
29、nd/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 material should
30、 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 given application
31、 (see21 CFR 178 and/or Guide F 2475 (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/application re
32、quirements 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 chosen. Size of pa
33、r-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 the Dirt Estimatio
34、n 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 normal lighting
35、conditions at a distanceof approximately 30 to 45 cm (12 to 18 in.) and any defects should benoticeable without an extended inspection time.6.4.2.1 The flexible barrier material should be the colorspecified (for example, white, silver, transparent, translucent).F990726.4.2.2 The degree of scratches,
36、 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 seal,or cuts, holes, or
37、 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 F 2203).6.5.2 Core:6.5.2.1 The desired core size should be specified, generally76 mm (3 in.) or 152 mm (6 in.).6.5.2.2 The core type may
38、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 indicated (typically 2 on roll
39、s 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 of the material or to
40、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 sufficienttension to prevent teles
41、coping 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 specification should ind
42、icate 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 barriermaterial is under t
43、ension 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 requirements (for example,water,
44、alcohol, and so forth) should be indicated (PracticeF 2250). This requirement should be evaluated during theinitial material qualification and is not typically performed ona routine production basis.6.6.4 Ink ColorThe ink color should be specified andconform to agreed upon standards.6.6.5 Legibility
45、There 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 presence of ink. Additionall
46、y, 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 PackagingFlexible barri
47、er 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 material should be ma
48、intained 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 writtenapprovals.7. Keywords7.1 fl
49、exible 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 not revised, either reapp
