Test methods for sterile medical device package—Part 9:Burst testing of flexible package seals using internal air pressurization weight restraining plates
Test methods for sterile medical device package
— Part 9: Burst testing of flexible package seals using internal air pressurization within restraining plates
1 Scope
The test method specified in this part of YY/T 0681 specifies the method to inspect the minimum bursting strength at the periphery seal of the flexible package, which is placed in the restraining plate and internally pressurized.
This test is only applicable to flexible packages with sealed peripheries (usually referred to pouch). Especially applicable to packaging which seal has peelable characteristics (the contents are taken out after being peeled off by the end user).
It is suggested that users of this method pay special attention to the possibility of designing and manufacturing restraining plate clamps. See Informative Annex C for details about pressure factors and structural design considerations.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
YY/T 0681.2 Test methods for sterile medical device package — Part 2: Seal strength of flexible barrier materials
YY/T 0681.3 Test methods for sterile medical device package — Part 3: Internal pressurization failure resistance of unrestrained packages
3 Terms and definitions
For the purposes of this standard, the following terms and definitions apply.
3.1
flexible package or pouch
package that at least one sealing material on the package is a flexible structure (such as paper, polyethylene, etc.)
3.2
restraining plates
rigid plate which contacts and limits the expansion of the package surface when the package is pressurized
4 Summary of test method
4.1 Inflate air pressure into the test package on one apparatus until the package ruptures burst. In most cases, the burst occurs at one or more areas of the seal. Inflating and pressurizing equipment is required to keep the internal pressure increase before the seal is broken. In the process of pressurization, the package shall be placed between two rigid parallel plates (restraining plates) to limit the distension and deformation of the package, but leave the sealed peripheral area unrestrained. A sensor inserted inside the package detects the internal pressure when the package breaks. According to the application situation, this test method needs to use two kinds of restraining plates, which are described as follows:
4.1.1 Open packaging configuration: used for package with three peripheries sealed and the fourth side open. This configuration is often used in the production of preformed packages. See Figure 1 for operating instructions of this configuration.
4.1.2 Closed package configuration: used for package with four sides sealed. This configuration is often used to test the seal of the package in a completely sealed state. See Figure 2 for operating instructions of this configuration.
5 Significance and use
5.1 This test provides a quick assessment method for evaluating the sealing failure trend of package under differential pressure. Differential pressure may occur during the processes of sterilization and transportation. This test method is used to measure the bursting strength of the sealed area of package (i.e., bursting often occurs in one or several sealed areas). The minimum bursting strength value of the sealed area may be very important for the package manufacturer and the end user to ensure proper package integrity. This test method cannot provide a measurement for the uniformity of package seal. This test method cannot be used to evaluate the integrity of the whole package, that is, it cannot evaluate the bursting strength of the contact part between the package and the restraining plate. If necessary, this test method should be used in combination with other assessment methods of the whole package integrity, uniformity of package sealing or opening performance.
Foreword i
Introduction ii
1 Scope
2 Normative references
3 Terms and definitions
4 Summary of test method
5 Significance and use
6 Apparatus
7 Sampling
8 Conditioning
9 Procedure
10 Report
Annex A (Normative) Recommendations for determining the gap distance between restraining plates
Annex B (Informative) Factors influencing test results between laboratories
Annex C (Informative) Precision and bias of the test methods
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