1、Designation: F1886/F1886M 09 (Reapproved 2013)F1886/F1886M 16Standard Test Method forDetermining Integrity of Seals for Flexible Packaging byVisual Inspection1This standard is issued under the fixed designation F1886/F1886M; the number immediately following the designation indicates the yearof origi
2、nal adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval.A superscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This test method covers the determination of channels in the pac
3、kage seal down to a width of 75 m 0.003 in. with a60100 % probability (see Section 8).1.1.1 The ability to visually detect channel defects in package seals is highly dependent on the size of channel, the degree ofcontrast from sealed and unsealed areas, the amount and type of adhesive between the tw
4、o package layers, reflecting light angle,types of material used, the use of magnification, and the inspectors level of training and experience.1.2 This test method is applicable to packages with at least one transparent side so that the seal area may be clearly viewed.1.3 The values stated in either
5、 SI units or inch-pound units are to be regarded separately as standard. The values stated in eachsystem may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from thetwo systems may result in non-conformance with the standard.1.4 This standa
6、rd does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibilityof the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatorylimitations prior to use.2. Referenced Documents2.1 ASTM
7、Standards:2F17 Terminology Relating to Flexible Barrier Packaging3. Terminology3.1 For terminology related to flexible barrier packaging, see Terminology F17.4. Summary of Test Method4.1 This test method provides a qualitative (accept/reject) visual inspection method to evaluate the appearance chara
8、cteristicsof unopened, intact seals in order to determine the presence of defects that may affect the integrity of the package.5. Significance and Use5.1 Seal attributes can be linked directly to a number of variables in process parameters, equipment, or material, as well asenvironmental (room tempe
9、rature and relative humidity). Visual seal characteristics and defects can provide evidence of packageintegrity and production sealing problems.5.2 Visual seal defects often will be the first indication of heat sealing process variation. They also will indicate a lack of, orpotential compromise to,
10、package integrity after physical package performance testing.6. Apparatus6.1 Illuminant, lighting arrangements to give about 540 lumens/m2 50 fc of white light or daylight on the specimens.6.2 Indelible Marking Pen.1 This test method is under the jurisdiction of ASTM Committee F02 on FlexiblePrimary
11、 Barrier Packaging and is the direct responsibility of Subcommittee F02.40 onPackage Integrity.Current edition approved Aug. 1, 2013Oct. 1, 2016. Published September 2013October 2016. Originally approved in 1998. Last previous edition approved in 20092013as F1886/F1886M 09.F1886/F1886M 09(2013). DOI
12、: 10.1520/F1886_F1886M-09R13.10.1520/F1886_F1886M-16.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.This doc
13、ument is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as
14、 appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States17. Procedure7.1 Visual acuity shall be such that the ins
15、pection of the seal may be performed at a distance of 30 to 45 cm 12 to 18 in.NOTE 1Magnification devices, such as eyeloops, may be used as an analytical tool to characterize identified seal defects.7.2 Inspect the entire sealed area of the package for completeness and uniformity.NOTE 2Different pac
16、kage sizes and shapes may require differing lengths of time to adequately inspect the entire seal perimeter.Any time requirementassociated with visual inspection should allow for complete seal inspection.NOTE 3Some packaging materials and adhesives may fluoresce under ultraviolet light. Viewing the
17、seal area in a UV light box will enhance thesealed-to-unsealed area contrast, and provide for easier defect identification.7.3 Identify and record any part of the seal where channels appear. Mark the location of the channels.NOTE 4All other assessed defects seal characteristics noted (refer to Appen
18、dix X1) should be categorized according to user defined accept/rejectcriteria. Define the actions to be taken in the event defects seal characteristics are detected during normal production runs.7.4 Record the number and location of channels identified on each package.NOTE 5If confirmation of channe
19、ls or incomplete seal areas in peelable packages is necessary, hand peel such suspected package completelyseparating the two material components and inspect the seal area of the transferred adhesive for the same incomplete seal attributes as the unopenedpackage. Care should be taken to ensure a smoo
20、th continuous peeling motion so as not to cause any extraneous attributes. Heat seals should be cooledto ambient conditions before peeling open to allow for adhesive bonding to the opposite substrate to occur.In some instances, a channel or unsealed area may be observed only after the package is pee
21、led open. Adhesive transfer is a qualitative measure ofa materials ability to release the coating rather than conclusive evidence that the seal has not been made. It is possible to have continuous seal integritybut fail to give complete transfer. This is because the coating may have a stronger affin
22、ity for the substrate on which it is coated rather than the one towhich it is sealed. In such cases, an additional physical seal integrity test may be required to confirm if it is an unsealed area.8. Precision and Bias38.1 Around robin study was conducted in 1997, which included ten laboratories, fo
23、ur package types, and two different channelsizes randomly produced with 75 m 0.003 in. and 125 m 0.005 in. diameter wire. The negative control consists of the sametype packages produced with no channels. The four different types of packages are:8.1.1 Open pouchclear film/coated paper;8.1.2 Open pouc
24、hclear film/uncoated TYVEK4;8.1.3 Sealed blisterblue tinted blister/coated TYVEK; and,8.1.4 Open end pouchclear film/clear film (clear seal).8.2 The results of this study are pass or fail; therefore, the data is binomial with an expected average of np and an expectedvariance of npq where n is the nu
25、mber of samples, p is the probability of an incorrect evaluation, and q is the probability of a correctevaluation. A statistical analysis of the data by means of a contingency table show significant differences between all factorspresented in the tables at a confidence level of better than 99 %. The
26、 results are presented in Tables 1-4.8.3 A pass/fail test method has no bias.9. Keywords9.1 channels; minimum seal width; spotty seals; sterile package integrity; visual seal inspection3 Supporting data have been filed at ASTM International Headquarters and may be obtained by requesting Research Rep
27、ort RR:F02-1013.4 TYVEK is a trademark of Dupont, Wilmington DE.TABLE 1 Percent Incorrect by LaboratoryLab SamplesInspectedIncorrectAnalysisPercent (%)Incorrect1 117 0 0.002 117 24 20.513 117 5 4.274 117 17 14.535 117 5 4.276 117 12 10.267 117 9 7.698 117 18 15.389 117 26 22.2210 117 10 8.55F1886/F1
28、886M 162APPENDIX(Nonmandatory Information)X1. VISUAL SEALAPPEARANCE CHARACTERISTICS AND PROBABLE CAUSESX1.1 This appendix will serve to review some of the common seal appearance characteristics that may occur and some commonreasons for that occurrence. Specifications for these seal characteristics n
29、eed to be established by individual organizations for theirspecific product and package styles. Each requirement should be established with appropriate rationale and necessary supportingdocumentation.X1.2 Unsealed AreasAn unsealed area occurs when a heat seal is never made to the package or when a s
30、eal has been made toa package and is later ruptured. Causes to this problem include misalignment of package to seal bar or platen, misalignment ofthe seal bar or platen to the mating seal surface, foreign matter underneath the seal bar or platen preventing a seal, or damage tothe seal bar or platen
31、that prevents the seal. There also can be foreign contamination on the packaging materials that prevents aseal from being made. Seal rupture can occur due to internal or external forces placed on the seal due to sterilization conditions,weight of product, stressful handling of the package, and so fo
32、rth.The visual characteristics of a package that has never been sealedversus one that has been sealed, and subsequently opened, are very different, and depend on the material substrates beingexamined.X1.3 Nonhomogeneous or Undersealed AreasThis occurs when a heat seal is made, and may not have adequ
33、ate strength dueto incorrect process parameters, such as temperature, pressure, or dwell. Insufficient sealing temperature either too much, too little,or unevenly applied pressure; too short a process time; or, excessive material thickness variation are some of the conditions thatmay cause seals to
34、appear to be spotty or mottled. A spotty or mottled appearance may be a function of the adhesive properties,as well. This attribute may be in varying degrees of severity and should be categorized based on appearance and whether packageintegrity can be maintained. Often it is easier to see this type
35、of defect under a magnifying light or UV light box.TABLE 2 Percent Incorrect by MaterialMaterialSamplesInspectedIncorrectAnalysisPercent (%)IncorrectFilm paper 300 14 4.67Film TYVEK 300 38 12.67PETG/TYVEK 290 59 20.34Film/film 280 15 5.36TABLE 3 Percent Incorrect by Defect TypeDefect TypeSamplesInsp
36、ectedIncorrectAnalysisPercent(%) IncorrectNo channels 370 20 5.4175 m channel 400 83 20.75125 m channel 400 23 5.75TABLE 4 Percent Correct by Material and Defect TypeMaterial Defect TypeSamplesInspectedCorrectAnalysisPercent (%)CorrectFilm/paper none 100 97 9775 m 100 89 89125 m 100 100 100Film/TYVE
37、K none 100 97 9775 m 100 69 69125 m 100 96 96PETG/TYVEK none 90 88 9875 m 100 60 60125 M 100 83 83Film/film none 80 68 8575 m 100 99 99125 m 100 98 98F1886/F1886M 163X1.4 Oversealed AreasA combination of too much heat, pressure, or dwell time may cause oversealing to the point that it maycause packa
38、ging components to melt and become brittle and susceptible to cracking. When TYVEK spunbonded polyolefin or asimilar porous material is one of the substrates, this condition often is seen as a transparent or translucent seal where the materialfibers are fused.This may become evident through an evalu
39、ation for pinholes or cracks along the seal.Another result of oversealingmay be a spotty or incomplete looking seal where, in this case, the heat seal adhesive is overheated and flows into the porous fiberstructure of the material.X1.5 Narrow SealsThis may occur either during the sealing process or
40、as a result of seal creep or partial rupture of the seal dueto environmental stresses. Misalignment of the package under the sealing die, skewed packaging components, bulging product, ormisalignment of cutters/slitters during the trimming operation are a few causes that may occur during the sealing
41、process. Sealcreep may be a result of the sterilization process or stressed seals at temperature extremes. Impact also may cause the seals topartially rupture. The width of package seals need to be compared to individually defined specification limits to ensure the packagewill maintain its integrity
42、 through the expected sterilization, handling, and distribution systems.X1.6 Channels This is seen as an unsealed pathway across the entire width of the intended seal. Causes for channels have beendiscussed above in X1.2.X1.7 Wrinkles/Foldovers/Cracks Foldovers occur when a material is folded over p
43、rior to the seal being formed. In somesituations the seal may be of adequate strength to form a complete seal. In other situations there may not be adequate strength, anda channel results. Wrinkles and cracks occur after a seal is formed and are caused by the handling of the package. Generally, this
44、occurs with flexible substrates. These too can result in a channel through the entire seal. These types of characteristics often arehard to judge by visual inspection alone and need to be further evaluated by alternate means such as dye penetration.X1.8 Tears/Pinholes These typically occur within th
45、e material substrates, rather than the seal itself. Visual inspection may ormay not detect tears or pinholes. Further evaluation may be required if visual inspection is not adequate to determine acceptability.Light box inspection or physical package integrity tests may be appropriate.ASTM Internatio
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