ASTM F34-13(R2018) pdf free download

ASTM F34-13(R2018) pdf free download.Standard Practice for Construction of Test Cell for Liquid Extraction of Flexible Barrier Materials
1. Scope
1.1 This practice covers the construction of test cells which may be used for the extraction of components from flexible barrier materials by suitable extracting liquids, including foods and food simulating solvents. 1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appro- priate safety, health, and environmental practices and deter- mine the applicability ofregulatory 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 the Development of International Standards, Guides and Recom- mendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
4. Summary of Preactice
4.1 This test cell defines the surface area ofa flexible barrier structure that may contribute extractable/leachable substances to a packaged article. Although stainless steel and other materials are cited in the body of the practice, the test cell may be constructed of any durable material that does not contribute to the extractable content. The test cell should be evaluated for leaks after manufacture. It should be washed of manufacturing or milling fluids that may contribute to the extraction result. 4.2 Both pure chemicals as well as food simulants may be used as extracting solvents. FDA regulations usually specify the extracting fluid ofchoice, but other solvents may be chosen based 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, but other types of analysis may be performed if considered to be appropriate. Some methodologies are cited in the FDA regu- lations.
5. Significance and Use
5.1 Knowledge ofextractives from flexible barrier materials may serve many useful purposes. A test cell constructed as described in this practice may be used for obtaining such data. Another test cell has been found equivalent to the one described in this practice. See the appendix for the source of the alternate cell. 5.2 United States Federal Regulations 21CFR 176.170 (d)(3), 21CFR 177.1330 (e)(4), 21CFR 177.1360 (b), 21CFR 177.1670 (b), and 21CFR Appendix VI (b) cite this standard practice as the basis for determining the amount ofextractables from the surface of a package or multilayer film or modified paper in contact with food. In some cases, it is the only practice defined for this purpose. No alternative detail is given in the regulations for conducting extractions. 5.3 Test Method D4754 is not an equivalent to this test method. It is for two-sided extraction of films having the same material on both of the exposed surfaces of the film.
6. Reagents and Materials
6.1 Purity ofReagents—ACS (American Chemical Society) reagent grade chemicals shall be used in all tests. Unless otherwise indicated, it is intended that all reagents shall conform to the specifications of the Committee on Analytical Reagents of the American Chemical Society, where such specifications are available. 5 Other grades may be used, pro- vided it is first ascertained that the reagent is of sufficiently high purity to permit its use without lessening the accuracy of the determination. Good analytical practice suggests that a blank determination using the extracting solvent and a cell with no 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 ofsufficiently high purity to permit its use without lessening the accuracy of the determination. 6.2 Purity ofWater—Type IV water; Specification D1193. 6.3 n-Heptane, ACS reagent grade.