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Significance and Use
5.1 These test methods provide a rapid, simple to apply method to detect small leaks in flexible package seals or walls at the leak rate level of greater than 1 × 10−4 sccs, thus providing a measure of package integrity. Porous barrier film packages made non-porous with an impermeable film forming coating may demonstrate lateral leakage through the barrier material. Verification of leakage differences from background leakage must be included in validation methods. The use of calibrated hole sizes or orifices may be appropriate to determine leakage sensitivity or barrier integrity for these materials.
5.2 While theoretical leak rate sensitivity can be established by calculation, the test measurement is in pressure units and the measuring instrument must be calibrated, certified, and verified with these units.
5.3 The pressure decay method of leak testing is a physical measure of package integrity. When testing medical packaging which must conform to ISO 11607–1: 2006 standards, it may necessary to verify the results of the pressure decay test method with other sterile package integrity test methods.
5.4 Test Method A allows packages to be pressurized without restraint. In Test Method A the pouch, tray, or other type package will contain a volume of air defined by its mechanical configuration and its ability to resist internal pressure applied. This test method requires that the package reach a stable volume configuration (stop stretching) to make a measurement.
5.5 Test Method B allows the use of rigid restraining plates against the walls of the package to limit its volume and stabilize the package volume.
1.1 These test methods cover the measurement of leaks in nonporous film, foil, or laminate flexible pouches and foil-sealed trays, which may be empty or enclose solid product. If product is enclosed, seals or surfaces cannot be in contact with water, oils, or other liquid.
1.2 These test methods will detect leaks at a rate of 1 × 10−4 sccs (standard cubic centimetres per second) or greater, in flexible packages. The limitation of leak rate is dependent on package volume as tested.
1.3 The following test methods are included:
1.3.1 Test Method A—Pressure Decay Leak Test for Flexible Packages Without Restraining Plates
1.3.2 Test Method B—Pressure Decay Leak Test for Flexible Packages With Restraining Plates
1.4 These test methods are destructive in that they require entry into the package to supply an internal pressure of gas, typically air or nitrogen, although other gases may be used. The entry connection into the flexible package must be leak-tight.
1.5 For porous packages, see 9.3.
1.6 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 appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
D4332 Practice for Conditioning Containers, Packages, or Packaging Components for Testing
E177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods
E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
F17 Terminology Relating to Flexible Barrier Packaging
Other DocumentANSI/AAMI/ISO 1160 Packaging for Terminally Sterilized Medical Devices--Part 1: Requirements for Materials, Sterile Barrier Systems, and Packaging Systems Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
ICS Number Code 19.060 (Mechanical testing); 55.040 (Packaging materials and accessories)