ASTM F34-2013(2018) Standard Practice for Construction of Test Cell for Liquid Extraction of Flexible Barrier Materials.pdf

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1、Designation: F34 13 (Reapproved 2018)Standard 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 r

2、evision, the year 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 practice covers the construction of test cells whichmay be used for the extraction of compon

3、ents 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 a

4、re 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, health, and environmental practices and deter-mine the applicability of regulato

5、ry limitations prior to use.1.4 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organ

6、ization TechnicalBarriers to Trade (TBT) Committee.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 Extractio

7、n 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

8、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

9、. 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 durabl

10、e 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 s

11、olvents. FDA regulations usually specifythe extracting fluid of choice, but other solvents may be chosenbased on known or expected effects on the exposed surface.4.3 The extractable content is usually measured by gravi-metric analysis after evaporation of the extracting fluid, butother types of anal

12、ysis may be performed if considered to beappropriate. Some methodologies are cited in the FDA regu-lations.1This practice is under the jurisdiction of ASTM Committee F02 on PrimaryBarrier Packaging and is the direct responsibility of Subcommittee F02.15 onChemical/Safety Properties.Current edition a

13、pproved Sept. 1, 2018. Published November 2018. Originallyapproved in 1963. Last previous edition approved in 2013 as F34 13. DOI:10.1520/F0034-13R18.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStand

14、ards 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 Regul

15、ations 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/Guidance

16、Documents/FoodIngredientsandPackaging/ucm081818.htmCopyright ASTM International, 100 Barr Harbor 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

17、 Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.14.4 Unless otherwise specified, the test cell is designed to beused at room temperature and ambient environmental cond

18、i-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 th

19、e 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 pa

20、ckage or multilayer film or modifiedpaper in contact with food. In some cases, it is the only practicedefined for this purpose. No alternative detail is given in theregulations for conducting extractions.5.3 Test Method D4754 is not an equivalent to this testmethod. It is for two-sided extraction of

21、 films having the samematerial on both of the exposed surfaces of the film.6. Reagents and Materials6.1 Purity of ReagentsACS (American Chemical Society)reagent grade chemicals shall be used in all tests. Unlessotherwise indicated, it is intended that all reagents shallconform to the specifications

22、of the Committee on AnalyticalReagents of the American Chemical Society, where suchspecifications are available.5Other grades may be used, pro-vided it is first ascertained that the reagent is of sufficientlyhigh purity to permit its use without lessening the accuracy ofthe determination. Good analy

23、tical practice suggests that ablank determination using the extracting solvent and a cell withno sample be run in conjunction with each series of determi-nations Other grades may be used, provided it is first ascer-tained that the reagent is of sufficiently high purity to permit itsuse without lesse

24、ning the accuracy of the determination.6.2 Purity of WaterType IV water; Specification D1193.6.3 n-Heptane, ACS reagent grade.7. Procedure7.1 Construction of Test Cell (Fig. 1, Fig. 2)Assemble asfollows:7.1.1 Two 8 by 1138 by18-in. (203 by 289 by 3.2-mm) No.316 stainless steel plates, degreased.7.1.

25、2 One14 by 112-in. (6.4 by 38-mm) U-shaped virginTFE-fluorocarbon gasket, grooved on both sides as shown.7.1.3 Twelve14 by 1-in. (6.4 by 25.4-mm) stainless steelbolts with wing nuts.7.1.4 One14 by 1 by 8-in. (6.4 by 25.4 by 203-mm)TFE-fluorocarbon gasket plug tapered to provide a tight fit.7.1.5 Six

26、18 by38 by 3-in. (6.4 by 9.5 by 76-mm) plates.NOTE 1The use of stainless steel washers on the outside of each plate(7.1.1) may prevent the cells from leaking.7.2 Pre-Use Conditioning of Test Cell:7.2.1 Wash stainless steel plates and TFE-fluorocarbon gas-kets in aqueous surfactant solution. Rinse wi

27、th reagent waterand dry at 122F (50C). Wash with n-heptane and redistilledacetone.7.2.2 For new TFE-fluorocarbon gaskets, immerse inn-heptane overnight. Rinse gaskets with fresh n-heptane. Drygaskets at 122F (50C).7.3 Use of Test Cell:7.3.1 Place one stainless steel plate of the cell on a flatsurfac

28、e with bolts protruding up through the holes in the plate.Place a prepunched (Note 2) specimen (side to contact liquidup) on the plate with one edge of the specimen aligned with thebottom of the plate, two edges aligned with the sides of theplate, and the bolts passing through the prepunched holes.P

29、lace a TFE-fluorocarbon gasket on the specimen with theouter edges of the gasket aligned with the cell bottom andsides. If desired, place a second prepunched specimen (side tocontact liquid down) on top of the gasket. If only one specimensheet is used for the test, place an inert barrier sheet such

30、asTFE-fluorocarbon or clean foil in place of the second speci-men. Place a second stainless steel plate on top of the assembly.Place wing nuts on the bolts and tighten.NOTE 2Use the cell plate as a template and any suitable sharpinstrument to prepunch the specimen through the bolt holes in the plate

31、.7.3.2 Preheat the assembly (including the TFE-fluorocarbongasket plug) to the test temperature and retighten the nuts sothat the assembly is liquid-tight. The assembly is ready to use.8. Keywords8.1 extractables; flexible barrier materials; food simulatingsolvents; test cells5Reagent Chemicals, Ame

32、rican Chemical Society Specifications , AmericanChemical Society, Washington, DC.F34 13 (2018)2SI Equivalentsin. mm in. mm in. mm116 1.658 15.9 214 5718 3.234 19 3 7614 6.4 1 25.4 8 203932 7112 38 1138 28938 9.5FIG. 1 Test Cell AssemblyF34 13 (2018)3APPENDIX(Nonmandatory Information)X1. AN ALTERNATE

33、 TEST CELL FOR LIQUID EXTRACTIONS OF FLEXIBLE BARRIER MATERIALSX1.1 An alternate test cell has been found to be useful forliquid extractions of flexible barrier materials.6X1.2 The test cell requires less solvent than the original celldescribed in this practice, and maintains an adequate testsurface

34、 area for extractions. Food and Drug Administration(FDA) laboratories have successfully used this cell to performextraction studies of PETE films with both water and Miglyol8127(a fractionated coconut oil) over a temperature range from60 to 120C.8,9X1.3 Reference is made to this cell in the Guidance

35、 forIndustry: Preparation of Premarket Submissions for FoodContact Substances: Chemistry Recommendations (2007).46The test cell is a compression migration cell originally designed at DowChemical Company. There is no manufacturer of these cell systems known to thecommittee. If you are aware of suppli

36、ers, please provide this information to ASTMInternational Headquarters. Your comments will receive careful consideration at ameeting of the responsible technical committee,1which you may attend.7The sole source of supply of Miglyol 812 known to the committee at this timeis Sasol Germany, GmbH, Arthu

37、r-Imhausen-Str 92, 58453 Witten, Germany.Miglyol 812 may be purchased in North America from Peter Cremer, 3117Southside Ave., Cincinnati, OH. Local suppliers may also be found through aninternet search. If you are aware of alternative suppliers, please provide thisinformation to ASTM International H

38、eadquarters. Your comments will receivecareful consideration at a meeting of the responsible technical committee,1whichyou may attend.8Begley, Timothy H., and Hollifield, Henry C., “Food Packaging Made fromRecycled Polymers: Functional Barrier Considerations,” Chapter 36, Plastics,Rubber, and Paper

39、Recycling: A Pragmatic Approach. ACS Symposium Series 609,1995, pp. 445475.9Piringer, O., Begley, T.H., et al.,“ Migration from Food Packaging Containinga Functional Barrier: Mathematical and Experimental Evaluation,” J. Agr. and FoodChem., Vol 46, No. 4, 1998, pp. 15321538.SI Equivalentsin. mm in.

40、mm in. mm18 3.2 1 25.4 714 18414 6.4 214 57 814 21038 9.5 578 149 1212 31758 15.9FIG. 2 Rack for Holding Test CellsF34 13 (2018)4ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard ar

41、e 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

42、revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which yo

43、u may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United

44、 States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org). Permission rights to photocopy the standard may also be secured from the Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ 13 (2018)5