YY/T 0681.5-2010 English PDF (YYT0681.5-2010)

This Part of YY/T 0681 covers the inspection of gross leaks in medical packaging. The sensitivity of the method has a detection probability of 81% for pore sizes above 250 ??m (see Annex B). This test method can be used for pallet and multi-bag packaging. This test method evaluates sensitivity only for spunbond polyolefin or non-breathable packaging. The sensitivity of other packages with gas permeable materials is not evaluated. This method is a destructive test. In the test, it is necessary to inject air into the package to form internal pressure.

YY/T 0681.5-2010
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.080.40
C 31
Test methods for sterile medical device package - Part 5:
Detecting gross leaks in medical packaging by internal
pressurization (bubble test)
ISSUED ON: DECEMBER 27, 2010
IMPLEMENTED ON: JUNE 01, 2012
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 4
4 Summary of test method ... 4
5 Meaning and application ... 5
6 Instruments ... 5
7 Sampling ... 6
8 State adjustment ... 6
9 Procedure ... 6
10 Report ... 8
Annex A (normative) Determination of test pressure ... 9
Annex B (informative) Precision and bias ... 12
Test methods for sterile medical device package - Part 5:
Detecting gross leaks in medical packaging by internal
pressurization (bubble test)
1 Scope
This Part of YY/T 0681 covers the inspection of gross leaks in medical packaging. The sensitivity of the method has a detection probability of 81% for pore sizes above 250 μm (see Annex B). This test method can be used for pallet and multi-bag packaging. This test method evaluates sensitivity only for spunbond polyolefin or non-breathable packaging. The sensitivity of other packages with gas permeable materials is not evaluated.
This method is a destructive test. In the test, it is necessary to inject air into the package to form internal pressure.
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. GB/T 2918, Plastics - Standard atmospheres for conditioning and testing 3 Terms and definitions
For the purposes of this document, the following terms and definitions apply. 3.1 breathing point pressure
The pressure at which gas begins to pass through a porous material2.
4 Summary of test method
4.1 The package is inflated underwater to a pre-determined pressure. Then observe a 2 All breathable materials are permeable to air. Whether a continuous flow of bubbles is emitted at a given internal air pressure depends on the material pore size. Bubble flow identified at internal pressures below the breathing point pressure can indicate a defect in the package.
continuous stream of bubbles showing a broken package.
4.2 The sensitivity of this test method depends on the differential pressure and the method of pressurization. Determination of the test pressure for each packaging material and size is key to obtaining reproducible results (see Annex A for procedures for determining the test pressure). Improper pressurization of the packaging will significantly reduce the sensitivity of the test method. Increasing the differential pressure will increase the test sensitivity. But inflating to too high a pressure can cause the seal to crack or air bubbles to be ejected from the breathable material to be confused with defective air bubbles. This could lead to erroneous conclusions about the existence of defects. A pressure limiting valve can be used in the line with pressure monitoring device (this helps to stabilize the test pressure). It helps prevent excessive pressure on the package (see Figure 1).
4.3 Two different test methods are given for breathable and non-breathable materials. The main difference between the two methods (as described in Annex A) is that the soak-through times are given for breathable materials.
5 Meaning and application
5.1 This internal pressurization test method provides a test method for detecting gross leaks on a package that would render it non-sterile. Gross leaks on the packaging will not guarantee product sterility. This internal pressure test method provides a practical way to check for gross leaks on packaging.
5.2 This test method is useful for the inspection of unusual packaging materials and pack sizes in a laboratory environment.
5.3 This test method can be applied to very large or long packages. Such packages are not suitable for use with any other testing apparatus for testing package integrity. 5.4 This test method may be used as a means of evaluating package integrity. Since heat-sealed packaging is designed to provide a contamination-free and sterile environment for the product, packaging integrity is critical to consumer safety. 6 Instruments
6.1 Pressure-applying system (as shown in Figure 1): it has a pressure monitoring instrument and a pressure limiting valve, which can provide an air pressure of 0~5 kPa. 6.2 Package piercer (such as a small slotted screwdriver or other suitable device): so that the air source and pressure monitoring device can be inserted.
6.3 Water container: suitable for submerging the test sample for about 2.5 cm. sample. The perforation shall be located in the center of the package as much as possible. The hole size shall be able to allow insertion of the air source and pressure monitor and minimize air leakage. If necessary, seal the insertion site with tape and a rubber pad as an occluder at the perforation site.
9.1.2 Insert the air source and pressure monitor into the test sample. Submerge the package approximately 2.5 cm under water. Apply air to the package.
NOTE 2: Using a limiter that keeps the package at the proper depth will facilitate testing. 9.1.3 Adjust gas and pressure limiting valves if necessary. Slowly inflate the package to a pressure greater than or equal to the minimum test pressure determined in accordance with Annex A. If necessary, adjust the pressure limiting valve and pressure regulator to maintain constant pressure.
9.1.4 Inspect air bubble flow in areas showing damage (channels in seals, pinholes, ruptures, tears, etc.) throughout the package. The inspection time depends on the size of the package.
9.1.5 Remove the package from water. Mark all observed damaged areas.
9.2 Test method B -- Procedure for breathable packaging
9.2.1 If necessary, apply a barrier to the sample according to A.1.2.4. 9.2.2 Use a perforator (such as a small slotted screwdriver or other suitable device) to punch a hole in the package, so as to insert the air source and pressure monitor into the sample. The perforation shall be located in the center of the package as much as possible. The hole size shall be able to allow insertion of the air source and pressure monitor and minimize air leakage. If necessary, seal the insertion site with tape and a rubber pad as an occluder at the perforation site.
9.2.3 Insert the air source and pressure monitor into the package. Submerge the package about 2.5 cm under water and keep it for at least 5 s. Apply air to the package. NOTE 3: Using a limiter will help keep the entire package at the proper depth. 9.2.4 Adjust gas and pressure limiting valves if necessary. Slowly inflate the package to a pressure greater than or equal to the minimum test pressure determined in accordance with Annex A. If necessary, adjust the pressure limiting valve and pressure regulator to maintain constant pressure.
9.2.5 Inspect air bubble flow in areas showing damage (channels in seals, pinholes, ruptures, tears, etc.) throughout the package. The inspection time depends on the size of the package.
9.2.6 Remove the package from water. Mark all observed damaged areas.
Annex A
(normative)
Determination of test pressure
A.1 Overview
This test method uses a control sample of known defects to determine the test pressure for packaging materials and specifications. Create a known defect in the surface of the package. Submerge the package under water. Inflate it to the pressure at which bubbles can be observed at the defect. This is considered the minimum test pressure for the package. Improper pressurization will significantly reduce the sensitivity of this test method. Increasing the differential pressure will increase the test sensitivity. However, if the pressure difference is too large, it will cause the seal to crack or bubbles to appear from the breathable material and be confused with the bubbles from the defect. This could lead to erroneous conclusions about whether there is a defect.
It is noticed in the feasibility study that before the package is submerged, positive pressure gas is introduced into the test sample, at which time the pressure of air passing through the breathable material (breathing point pressure) is very small. Conduct a study specifically to determine the effect of water penetration on the breathing point pressure of Tyvek material. Positive pressure gas is introduced into the test sample prior to immersion in water. When the package is immersed in water at a depth of 2.5 cm, the breathing point pressure is about 1 kPa ~ 1.25 kPa (10.2 cmH2O ~ 12.7 cmH2O). Another test sample is immersed in water at a depth of 2.5 cm for at least 5 s before introducing positive pressure gas into the package. The breathing point pressure is increased to about 2.3 kPa (23.4 cmH2O). When the test is then repeated on the package forming the known defect, the pressure at which the defect is observed shall be 1.25 kPa (12.7 cmH2O). Whether the gas is introduced before or after immersion does not affect the observed defect pressure. However, when the gas is introduced before immersion, the defect may not be detected because the air will pass through the Tyvek. A.2 Determination of test pressure for non-air-permeable packaging
A.2.1 Create a known defect on the control sample (the ideal sensitivity of this method is no more than 250 μm). Circle the defect with a marker. Record the size of the defect for reporting purposes.
A.2.2 Use a piercer (such as a small slotted screwdriver) to punch a hole in the package for inserting the gas source and pressure monitor into the control sample. The perforation shall be as central as possible in the package. The size of the hole shall be able to insert the air source and pressure monitor and make the air leakage to a minimum. If necessary, seal the insertion site with tape and a rubber pad as an occluder over the puncture site. The location of the hole shall not interfere with the defects made according to A.2.1.
A.2.3 Insert the air source and pressure monitor into the control sample. Immerse the sample in water to a depth of 2.5 cm. Introduce gas into the control sample. A.2.4 Adjust gas. Adjust the pressure limiting valve if necessary. Gradually inflate the control sample until bubbles appear at the defect point. Record this pressure. This pressure shall serve as the minimum test pressure. Increasing the differential pressure will increase the test sensitivity. However, if the pressure difference is too large, it will cause the seal to crack.
A.3 Determination of test pressure for air-permeable packaging materials A.3.1 Create a known defect on the control sample (the ideal sensitivity of this method is no more than 250 μm). Circle the defect with a marker. Record the size of the defect for reporting purposes.
A.3.2 Use a perforator (such as a small slotted screwdriver) to punch a hole in the package, so as to insert the gas source and pressure monitor into the control sample. The perforation shall be as central as possible in the package. The size of the hole shall be able to insert the air source and pressure monitor and make the air leakage to a minimum. If necessary, seal the insertion site with tape and a rubber pad as an occluder over the puncture site. The location of the hole shall not interfere with the defects made according to A.3.1.
A.3.3 Insert the air source and pressure monitor into the control sample. Immerse the sample in water to a depth of 2.5 cm. Keep at least 5 s. Introduce gas into the control sample.
A.3.4 Adjust gas and pressure limiting valves if necessary. Gradually inflate the control sample until bubbles appear at the defect point.
NOTE: If the breathable material begins to breathe before defects are observed, apply a barrier agent3 to the breathable material. Repeat A.3.3 and A.3.4. In addition, carry out A.3.5. The purpose of adding a barrier agent is to reduce the pore size of the breathable material, thereby increasing the internal test pressure. This may help the user to check for known defects. The type, amount and method of applying the barrier (e.g., by hand) can have a significant impact on the physical and chemical properties of the breathable material. Therefore, the range of respiratory point pressure may be very large. For inspection of known defects, it is recommended to use a minimum amount of barrier agent.
A.3.5 Report the pressure reading. This pressure shall serve as the minimum test pressure. Increasing the differential pressure will increase the test sensitivity. However, if the pressure difference is too large, it will cause the seal to crack or bubbles to appear 3 Alcare Foaming Alcohol Hand Cleaner has been proven to effectively increase the breathing pressure point of breathable materials.