ASTM_F_34_-_13.pdf

Designation:F3413Standard Practice forConstruction of Test Cell for Liquid Extraction of FlexibleBarrier Materials1This standard is issued under the fixed designation F34;the number immediately following the designation indicates the year of originaladoption or,in the case of revision,the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This practice covers the construction of test cells whichmay be used for the extraction of components from flexiblebarrier materials by suitable extracting liquids,including foodsand food simulating solvents.1.2 The values stated in inch-pound units are to be regardedas standard.The values given in parentheses are mathematicalconversions to SI units that are provided for information onlyand are not considered standard.1.3 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 limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2D1193 Specification for Reagent WaterD4754 Test Method for Two-Sided Liquid Extraction ofPlastic Materials Using FDA Migration Cell2.2 AOAC International Methods of Analysis:Official Method 964.15 Extraction from Flexible BarrierMaterials32.3 Code of Federal Regulations,Title 214The followingregulations cite this standard:21CFR 176.170(d)(3)21CFR 177.1330(e)(4)21CFR 177.1360(b)21CFR 177.1670(b)Appendix VI(b)Cells for Migration Testing,Guidance forIndustry:Preparation of Premarket Submissions for FoodContact Substances:Chemistry Recommendations(2007)3.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 flexible for purpose of this practice,a term applyingonly to those flexible materials which can be inserted in the testcell without affecting their barrier properties.4.Summary of Preactice4.1 This test cell defines the surface area of a flexible barrierstructure that may contribute extractable/leachable substancesto a packaged article.Although stainless steel and othermaterials are cited in the body of the practice,the test cell maybe constructed of any durable material that does not contributeto the extractable content.The test cell should be evaluated forleaks after manufacture.It should be washed of manufacturingor milling fluids that may contribute to the extraction result.4.2 Both pure chemicals as well as food simulants may beused as extracting solvents.FDA regulations usually specifythe extracting fluid of choice,but other solvents may be chosenbased on known or expected effects on the exposed surface.1This practice is under the jurisdiction of ASTM Committee F02 on FlexibleBarrier Packaging and is the direct responsibility of Subcommittee F02.15 onChemical/Safety Properties.Current edition approved April 1,2013.Published June 2013.Originallyapproved in 1963.Last previous edition approved in 2007 as F34 02(2007).DOI:10.1520/F0034-13.2For 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.3This method is available through the Association of Official AnalyticalChemists,International,481 North Frederick Ave.,Suite 500,Gaithersburg,MD20877 or from the AOAC website at www.aoac.org.4Federal Regulations may be purchased from the U.S.Government PrintingOffice Bookstore,710 North Capitol Street,N.W.,Washington,D.C.or may bedownloaded from the internet.The website for the chemistry guidelines documentmay be found at:http:/www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/ucm081818.htmCopyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 4.3 The extractable content is usually measured by gravi-metric analysis after evaporation of the extracting fluid,butother types of analysis may be performed if considered to beappropriate.Some methodologies are cited in the FDA regu-lations.4.4 Unless otherwise specified,the test cell is designed to beused at room temperature and ambient environmental condi-tions.5.Significance and Use5.1 Knowledge of extractives from flexible barrier materialsmay serve many useful purposes.A test cell constructed asdescribed in this practice may be used for obtaining such data.Another test cell has been found equivalent to the onedescribed in this practice.See the appendix for the source ofthe alternate cell.5.2 United States Federal Regulations 21CFR 176.170(d)(3),21CFR 177.1330(e)(4),21CFR 177.1360(b),21CFR177.1670(b),and 21CFR Appendix VI(b)cite this standardpractice as the basis for determining the amount of extractablesfrom the surface of a package or multilayer film or modifiedpaper in contact w