5.1 This test provides a rapid means of evaluating tendencies for package seal failure when the package is exposed to a pressure differential. Pressure differentials may occur during such processes as sterilization and transportation. This test method provides an indicator of the burst strength of a package, where the burst will normally occur in one or more areas of the seal. An indicator of the minimum burst strength may be of importance to the package manufacturer and end user in ensuring adequate package integrity. This test method cannot provide a measure of package seal uniformity. This test method also cannot provide an evaluation of overall package integrity or the burst strength of areas of the package that contact the surface of the restraining plates used. This test method should be combined with other methods of evaluating overall package integrity, uniformity of the package seal, or opening functionality, if so required.
5.2 This test frequently is used to quickly evaluate package seal strength during the manufacturing process and at various stages of the package''s life cycle.
5.3 If correlations between pieces of test equipment are to be made it is important that all parameters of the test be equivalent. Typical parameters can include, but are not limited to the package size, material, type and configuration of seal, rate of air flow into the package, pressure detection sensing mechanism and sensitivity (machine response to pressure drop), position of test article, rigidity of restraining plates, and distance between restraining plates. See Appendix X2 for further information.
5.4 This test may not necessarily provide correlation with package seal strength as typically measured using Test Methods F1140 or F88 (or equivalents).
1.1 These test methods cover the procedure for determining the minimum burst strength of a seal placed around the perimeter of a flexible package as it is internally pressurized and enclosed within restraining plates.
1.2 The test methods described herein are functionally similar to Test Methods F1140 with the exception of the use of restraining plates. Test Methods F1140 describes methods of burst testing that do not include the use of restraining plates and are suitable to determine a packages general ability to withstand pressurization stresses. Under Test Methods F1140 the stresses are not distributed uniformly to all areas of the package seal. Under unrestrained conditions the stress on the package is highest at the middle of the pouch where it inflates to the packages maximum diameter; therefore, Test Methods F1140 may not reliably detect the weakest area of the seal.
1.3 The burst test internal......
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