1、Designation:F209604 Designation: F2096 11Standard Test Method forDetecting Gross Leaks in Medical Packaging by InternalPressurization (Bubble Test)1This standard is issued under the fixed designation F2096; the number immediately following the designation indicates the year oforiginal adoption or, i
2、n 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 covers the detection of gross leaks in medical packaging. Method
3、sensitivity is down to 250 m (0.010in.) with an 81 % probability (see Section 11). This test method may be used for tray and pouch packages.1.2 The sensitivity of this test method has not been evaluated for use with porous materials other than spunbonded polyolefinor with nonporous packaging.1.3 Thi
4、s test method is destructive in that it requires entry into the package to supply an internal air pressure1.4 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.1.5 This standard does not purport to address all of the safety con
5、cerns, 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 Standards:2D1898Practice for Sampling of PlasticsF13
6、27Terminology Relating to Barrier Materials for Medical Packaging 17 Terminology Relating to Flexible Barrier Packaging3. Terminology3.1 DefinitionsGeneral terms relating to barrier materials for medical packaging are found in Terminology F1327F17.3.2 Definitions of Terms Specific to This Standard:3
7、2.1 breathing point pressure, npressure at which permeation of air through the porous material begins.34. Summary of Test Method4.1 The package is inflated underwater to a predetermined pressure. The package is then observed for a steady stream of airbubbles indicating a failure area.4.2 The sensit
8、ivity of this test method is dependent on the differential pressure and method of pressurization. Establishment ofa test pressure for each package material/size is critical for obtaining repeatable results (see Annex A1 for the procedure onestablishing test pressure). Inadequate pressurization of th
9、e package can significantly reduce the sensitivity of this test method.Higher differential pressures will increase the test sensitivity. However, excessive pressurization of the package may rupture sealsor cause misinterpretation of bubble patterns emanating from porous packaging. This may result in
10、 an erroneous conclusionregarding the presence or absence of package defects. While not required, use of a bleed-off control valve in line with the pressuremonitoring device, will aid in stabilizing the test pressure, and help eliminate excessive pressurization of the package (see Fig. 1).4.3 Two di
11、fferent test methods are presented for the testing of porous and nonporous packaging. The key difference betweenthe test methods (as described in Annex A1) is in allowing time for the water to saturate the porous material.1This test method is under the jurisdiction of ASTM Committee F02 on Flexible
12、Barrier Packaging and is the direct responsibility of Subcommittee F02.40 on PackageIntegrity.Current edition approved Jan. 3, 2006. Published June 2004. Originally approved in 2001. Last previous edition approved in 2002 as F2096021. DOI: 10.1520/F2096-04.Current edition approved Dec. 15, 2011. Pub
13、lished February 2012. Originally approved in 2001. Last previous edition approved in 2004 as F2096 04. DOI:10.1520/F2096-11.2For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information,
14、refer to the standards Document Summary page on the ASTM website.3All porous packaging by definition will permit the passage of air. At a given internal pressure it will therefore exhibit an emanating stream of air bubbles dependent onthe pore size. A stream of bubbles identified at a lower internal
15、 pressure than the breathing pressure point may indicate a defect in the packaging.1This document 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 ad
16、equately depict all changes accurately, ASTM recommends that users consult prior editions as 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 Conshoh
17、ocken, PA 19428-2959, United States.5. Significance and Use5.1The internal pressurization test method provides a practical way to examine packages for gross leaks, which may render theproduct non-sterile.5.1 The internal pressurization test method provides a practical way to examine packages for gro
18、ss leaks.5.2 This test method is extremely useful in a test laboratory environment where no common package material/size exists.5.3 This test method may apply to very large or long packages, whichpackages that do not fit into any other package integritytest method apparatus.5.4 This test method may
19、be used as a means to evaluate package integrity. Package integrity is crucial to consumer safety sinceheat sealed packages are designed to provide a contamination free andor sterile environment, or both, to the product.5.5 This test method may be used to detect substrate holes and channels.6. Appar
20、atus6.1 Pressure Delivery System, with pressure monitoring gage, and bleed-off control valve, capable of delivering air at a pressureof 0-50 mbar (0-20 in. H2O).6.2 Device for Puncturing Package, (for example, small slotted screwdriver or other appropriate device) to allow insertion ofair source and
21、 pressure monitoring device. , device to allow insertion of air source and pressure monitoring device.6.3 Water Container, adequate to cover the test specimen with approximately one (1) in. of H2O. , adequate to cover the testspecimen with approximately 25.4 mm (1 in.) of water.NOTE 1It may be benef
22、icial for observation of the test specimen and for interpretation of results to perform the testing in a water container that hasat least one transparent side.7. Sampling7.1The number of test specimens shall be chosen to permit an adequate determination of representative performance. PracticeD1898 p
23、rovides guidance for test speciman selection.FIG. 1 Sample Test ApparatusF2096 1127.1 The number of test specimens shall be chosen to permit an adequate determination of representative performance.8. Conditioning8.1 No special conditioning of the specimen is required.9. ProcedureNOTE1The 2The establ
24、ishment of a test pressure in accordance with Annex A1 must be performed prior to initiating the test procedure. must beperformed prior to initiating the test procedure. It is recommended that a sample test set-up be provided.9.1 Test Method AProcedure for Nonporous Packaging:9.1.1 Create a hole in
25、the package using a puncturing device (for example, small slotted screwdriver or other appropriate device)for inserting the air source and pressure monitor into the control sample. Create the hole as close wherever it is most efficient tothe center of observe defects without obscuring any pre-existi
26、ng defects or creating defects in the inner package as possible. duringthe puncturing process. The hole size should allow insertion of the air source and pressure monitor with minimal air leakage. Usetape or a rubber disk as a septum over the puncture site to seal the insertion site if necessary.9.1
27、2 Insert the air source and pressure monitor into the test specimen. Submerge the package under water approximately one(1) 1 in. under water. Start airflow into the package.NOTE2It 3It may be helpful to use a fixture to keep the entire package submerged at the proper depth.9.1.3 Adjust the airflow
28、and bleed-off valve as necessary to slowly inflate the package to a value equal to or greater than theminimum test pressure as established in accordance with Annex A1. Adjust the bleed-off valve and pressure regulator as necessaryto maintain constant pressure.9.1.4Thoroughly inspect the package for
29、a constant stream of bubbles indicating a specific area of failure (seal channels,pinholes, cracks, tears, and so forth). Inspection time will vary depending on package size.9.1.4 Thoroughly inspect one side of the package facing upwards for a constant stream of bubbles indicating a specific area of
30、failure (seal channels, pinholes, cracks, tears, and so forth). Then repeat the process by rotating the package 180 so the oppositeside of the package is facing upwards. Inspection time will vary depending on package size.9.1.5 Remove the package from water and mark any observed area(s) of failure.9
31、2 Test Method BProcedure for Porous Packaging:9.2.1 Apply blocking agent to samples if required in accordance with A1.1.2.4.9.2.2 Create a hole in the package using a puncturing device (for example, small slotted screwdriver or other appropriate device)for inserting the air source and pressure moni
32、tor into the control sample. Create the hole as close wherever it is most efficient tothe center of observe defects without obscuring any pre-existing defects or creating defects in the inner package as possible. duringthe puncturing process. The hole size should allow insertion of the air source an
33、d pressure monitor with minimal air leakage. Usetape or a rubber disk as a septum over the puncture site to seal the insertion site if necessary.9.2.3 Insert the air source and pressure monitor into the package. Submerge the package approximately 25.4 mm (1 in.) underwater approximately 1 in.with th
34、e porous part of the package in the up position (if one side is porous) and hold for a minimumof 5 s. Start the airflow into the package.NOTE3It 4It may be helpful to use a fixture to keep the entire package submerged at the proper depth.9.2.4 Adjust the airflow and bleed-off valve as necessary to s
35、lowly inflate the package to a value equal to or greater than theminimum test pressure as established in accordance with Annex A1. Adjust the bleed-off valve and pressure regulator as necessaryto maintain constant pressure.9.2.5Thoroughly inspect the package for a constant stream of bubbles indicati
36、ng a specific area of failure (seal channels,pinholes, cracks, tears, and so forth). Inspection time will vary depending on package size.9.2.5 Thoroughly inspect the porous side of the package facing upwards for a constant stream of bubbles indicating a specificarea of failure (seal channels, pinhol
37、es, cracks, tears, and so forth). Then repeat this process by rotating the package 180 so theopposite side of the package is facing upwards. Inspection time will vary depending on package size.TABLE 1 Percent Correct by Laboratory and Defect TypeDefect TypePouch TrayLaboratoryNoDefects125-mChannel25
38、0-mChannel125-mPuncture250-mPunctureNoDefects125-mPuncture250-mPuncturePercent Correctby Laboratory1 100 100 90 60 80 100 40 90 82.502 100 70 90 50 60 90 10 100 71.253 80 20 80 60 80 90 60 80 68.754 100 70 90 0 0 100 60 100 65.005 80 20 100 0 30 100 20 90 55.00Percent Correctby Defect92 56 90 34 50
39、96 38 92F2096 113NOTE 5For packages that may be susceptible to premature deterioration from extended exposure to water, rotation of the package is optional.However, thorough inspection of both surfaces of the package is required.9.2.6 Remove the package from the water and mark any observed area(s) o
40、f failure.10. Report10.1 Report the following information:10.1.1Date, time, location, and operators name.10.1.2Package type, size, material, and traceable identification numbers.10.1.3Description of package preparation including presence of any product in package.10.1.4Established defect size used t
41、o establish the test sensitivity, test pressure, and use of any blocking agent.10.1.5Number of test packages, approximate inspection time per package, number of packages exhibiting leaks, and location ofeach leak.10.1.1 Date and operators name or initials.10.1.2 Package type and any applicable trace
42、able identification numbers.10.1.3 Established defect size used to establish the test sensitivity, test pressure, and use of any blocking agent.10.1.4 Number of test packages, number of packages that passed, number of packages exhibiting leaks, and location of eachleak10.1.5 Record the instrument us
43、ed to create the opening of the package.11. Precision and Bias11.1 A round-robin study was conducted in 2000, which included 5 laboratories, two package types, and two defect types. Thedefects consisted of a channel through the seal area on the pouch samples and a puncture through the porous materia
44、l, on both thetray and pouch samples. All defect sample groups were created with a 125-m (0.005 in.) and 250-m (0.010 in.) wire. The firstpackage type consisted of a 4 by 6-in. heat-sealed pouch, made from a combination clear film and uncoated Tyvek.4The secondpackage type consisted of a 3 by 5-in.
45、thermoformed polycarbonate tray, heat-sealed with an adhesive zone coated Tyvek. Thenegative controls consisted of the same packages produced with no defects. For each specimen set, 15 samples were produced, 10with defects, and 5 controls with no defect. The results are presented in Table 1 and the
46、corresponding graph in Fig. 2.11.2 The analysis of the testing process is by means of logistic regression. The computations were performed in SAS, version8.1. The y-axis is the probability of rejecting a part, and the x-axis is the nominal defect size. The results of this analysis indicatethat there
47、 is an 81 % probability of rejecting a package with a defect size of 250 m. There is also an 11 % probability of rejectinga package with no defects.11.3 Pass/fail tests have no bias.12. Keywords12.1 bubble test; internal pressurization; package integrity4Tyvek is a registered trademark of Dupont and
48、 has been found satisfactory for this purpose.FIG. 2 Probability of Rejection-Combined Laboratory ResultsF2096 114ANNEX(Mandatory Information)A1. ESTABLISHMENT OF TEST PRESSUREA1.1 This test method uses a control sample with a known defect for establishing the test pressure for the package material/
49、size.A known defect is created in the package surface. The package is submerged in water and inflated to a pressure where air bubblesare observed emanating from the defect. This is considered the minimum test pressure for the given package. Inadequatepressurization of the package can significantly reduce the sensitivity of the test method. Higher differential pressures will increasethe test sensitivity. However, excessive pressurization of the package may rupture seals or cause misinterpretation of bubblepatterns emanating from porous packaging. This
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