ASTM_F_1929_-_15.pdf

Designation:F192915Standard Test Method forDetecting Seal Leaks in Porous Medical Packaging by DyePenetration1This standard is issued under the fixed designation F1929;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This test method defines materials and procedures thatwill detect and locate a leak equal to or greater than a channelformed by a 50 m(0.002 in.)wire in package edge sealsformed between a transparent material and a porous sheetmaterial.A dye penetrant solution is applied locally to the sealedge to be tested for leaks.After contact with the dye penetrantfor a specified time,the package is visually inspected for dyepenetration.1.2 Three dye application methods are covered in this testmethod:injection,edge dip,and eyedropper.1.3 These test methods are intended for use on packageswith edge seals formed between a transparent material and aporous sheet material.The test methods are limited to porousmaterials which can retain the dye penetrant solution andprevent it from discoloring the seal area for a minimum of 5seconds.Uncoated papers are especially susceptible to leakageand must be evaluated carefully for use with each test method.1.4 These test methods require that the dye penetrantsolution have good contrast to the opaque packaging material.1.5 The values are stated in International System of Units(SI units)and English units.Either is to be regarded asstandard.1.6 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:2F17 Terminology Relating to Flexible Barrier Packaging2.2 ANSI Standards:3Z1.4 Sampling Procedures and Tables for Inspection byAttributes3.Terminology3.1 wickingthe migration of a liquid into the body of afibrous material.This is distinct from a leak as defined inTerminology F17.3.2 dye penetrantan aqueous solution of a dye and asurfactant designed to penetrate and indicate a defect locationin the time prior to the onset of wicking which could mask itspresence.3.3 channelrefer to definition in F17.4.Significance and Use4.1 Harmful biological or particulate contaminants mayenter the medical package through leaks.These leaks arefrequently found at seals between package components of thesame or dissimilar materials.Leaks may also result from apinhole in the packaging material.4.2 It is the objective of this test method to visually observethe presence of channel defects by the leakage of dye throughthem.4.3 This dye penetrant procedure is applicable only toindividual leaks in a package seal.The presence of a number ofsmall leaks,as found in porous packaging material,whichcould be detected by other techniques,will not be indicated.4.4 There is no general agreement concerning the level ofleakage that is likely to be deleterious to a particular package.However,since these tests are designed to detect leaks,components that exhibit any indication of leakage are normallyrejected.4.5 These procedures are suitable to verify and locateleakage sites.They are not quantitative.No indication of leaksize can be inferred from these tests.The methods are usuallyemployed as a pass/fail test.4.6 The dye solution will wick through any porous materialover time,but usually not within the maximum time suggested.1This test method is under the jurisdiction ofASTM Committee F02 on FlexibleBarrier Packagingand is the direct responsibility of Subcommittee F02.40 onPackage Integrity.Current edition approved Oct.1,2015.Published December 2015.Originallyapproved in 1998.Last previous edition approved in 2012 as F1929 12.DOI:10.1520/F1929-15.2For 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.3Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 If wicking does occur,it may be verified by observing theporous side of the subject seal area.The dye will havediscolored the surface of the material.Refer to Appendix X1for details on wicking and guidance on the observance of falsepositives.5.Apparatus5.1 Means of breaching one of the packaging materials suchas a small knife.(Method A)5.2 Dye Dispenser,such as an eyedropper or syringe forinjection of the dye penetrant solution.(Method A)5.3 Dye Solution Container.(Method B)5.4 Scissors or other cutting instrument.(Method B)5.5 Eye