YY∕T 0681.5 Sterile medical device packaging internal pressure method to detect gross leakage (bubble method)

This part of YY/T 0681 covers the inspection of gross leakage in medical packaging
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The detection probability of the method sensitivity for pore diameters above 250 μm is 81% (see Appendix B)
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This test method can be used for tray and combination bag packaging.
The internal pressure method is used to detect gross leakage as an important means to evaluate the tightness of sterile medical device packaging.
This method is very useful in the laboratory environment for the inspection of uncommon packaging materials and packaging specifications.
, for very large or long packages that are not suitable for use with any other test instrument for testing package integrity
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Test method 1.
Test principle: The package is inflated under water to a predetermined pressure, and then the continuous flow of air bubbles showing the damage of the package is observed
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2.
Test sensitivity control The sensitivity of this test method depends on the differential pressure and pressurization method
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Determining the test pressure for each packaging material and size is the key to obtaining reproducible results
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Improper pressurization of the package can significantly reduce the sensitivity of this experimental method
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Increasing the differential pressure will increase the test sensitivity
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However, charging too high a pressure can lead to seal cracking or ejection of air bubbles in the breathable material and confusion with defective air bubbles, which may lead to misjudgment of the results
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A pressure limiting valve can be used in lines with pressure monitoring devices to help prevent excessive pressure on the packaging
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3.
Test methods Two different test methods are given for breathable and non-breathable materials
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The main difference between the two methods is the soak time given to the breathable material
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4.
Test instrument 4.
Instrument selection: LT-03A leak and seal strength tester 5.
Test process: 1.
Non-breathable packaging test (1) Use a perforator to punch a hole in the packaging
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The perforation should be located as far as possible in the center of the package
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The holes should be sized to allow insertion of the air source and pressure detector to minimize air leakage
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If necessary, seal the insertion site with tape and a rubber pad as an occluder at the piercing site
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(2) Insert the air source and pressure monitor into the test sample
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Submerge the package about 2.
5cm under water
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Apply air to the package and slowly inflate the package greater than or equal to the minimum test pressure
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(3) Inspect the entire package for the flow of air bubbles showing damaged areas.
The inspection time depends on the size of the package.
(4) Remove the package from the water and mark all observed damaged areas
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2.
Breathable packaging test The breathable packaging and non-breathable packaging procedures are the same, the difference is that the breathable packaging material should apply a barrier agent to the sample, and the packaging should be immersed in water for at least 5s before applying air
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