The use of packaging materials with excellent barrier properties can effectively extend the shelf life of articles, broaden the storage environment, and provide more convenience for storage and transportation. Therefore, barrier materials have been widely applied in recent years. The gas permeability test method of the material can be divided into two types: differential pressure method and equal pressure method. The test methods are different, and the impact on the test data cannot be completely eliminated. Due to the lack of understanding of the barrier detection methods for materials, current drug package companies are less concerned with the choice of test methods when purchasing barrier devices. In order to improve the comparability of the test data for the same gas permeability test of China's pharmaceutical packaging materials, the Food and Drug Administration of China in 2003 formulated the YBB00082003 "Gas Permeability Measurement Method" to regulate the detection method of pharmaceutical packaging materials, becoming a drug package. A guide for selecting a gas permeability testing device in the field. YBB00082003 "Gas Permeability Measurement" provides two test methods: * differential pressure method and second method electricity analysis method. The following will be introduced separately.
1. The differential pressure method* method differential pressure method is formulated in accordance with the national standard GB1038-2000. The test principle is to separate the low-pressure chamber and the high-pressure chamber by using a film or a sheet, and the high- and low-pressure chambers respectively have a pressure measuring device, and the high-pressure chamber is filled with a test gas of about 0.1 MPa, and the volume of the low-pressure chamber is known, after the test is sealed. The vacuum pump is used to draw the air in the low pressure chamber to a value close to zero, and the pressure increment Δp of the low pressure chamber is measured by a pressure gauge to determine the amount of gas in the test gas from the high pressure chamber to the low pressure chamber as a function of time. However, the initial stage in which the gas permeation rate changes over time should be excluded. After entering the test phase, when the pressure difference of the low pressure chamber is kept constant at the same time interval, the stable penetration of the gas is achieved, and the gas permeation amount and gas permeability coefficient can be calculated according to the formula given in the standard, and the unit thereof It is: cm3/m2·24h·0.1MPa. It is important to note that at the beginning of the test, the entire venting chamber needs to be evacuated to below 27 kPa and degassed continuously. The differential pressure method can simultaneously detect the gas permeability coefficient of the material, the diffusion coefficient of the detection gas in the material, and the solubility coefficient of the material to the gas, and can be used for detecting various common inorganic gases such as oxygen, nitrogen, carbon dioxide and air. In the drafting instructions of YBB00082003, it is pointed out that the formulation of the *method pressure difference method is based on GB/T1038-2000 "Test method for the penetration of plastic film and sheet gas - differential pressure method", and compares the method descriptions of the two standards. It can be seen that the content requirements are basically the same, and GB/T1038-2000 is more complete than YBB00082003, so it can be considered that the implementation of GB/T1038-2000 can fully meet the requirements of the YBB00082003* law. Of course, it should be noted that compared with the international standard for measuring the gas permeability of the differential pressure method, ASTM D1434, ISO15105-1, ISO2556:2001, etc., although the description of the operating rules of GB/T1038-2000 is not perfect, but The requirements for testing and various indicators during the test are fully consistent with international standards. For example, for the vacuum side of the test chamber, ASTM D1434-82 (2003) requires less than 26Pa, and ISO2556:2001 and GB/T1038-2000 require no more than 27Pa.
2. The electricity analysis method YYB00082003 has established a power analysis method based on the preservation of the differential pressure method in the establishment of the standard method, which is the second method in the standard. The coulometric method, which is the sensor method, is one of the methods of isostatic testing. The test principle is to use a medicinal film or sheet to separate the permeate chamber into two separate airflow systems, one for the active test gas (which can be pure oxygen or a mixture of oxygen) and the other for active drying. Nitrogen, the pressure on both sides of the sample is equal, but the partial pressure of oxygen is different. Under the effect of the difference in oxygen concentration, oxygen is transmitted through the membrane and sent to the oxygen sensor by the nitrogen gas. The oxygen sensor accurately measures the amount of oxygen carried in the nitrogen stream. To calculate the oxygen transmission rate of the material. The commonly used unit of oxygen permeation measured directly by coulometry is cm3/m2·d. This type of equipment needs to be calibrated using a standard membrane prior to testing and to determine the calibration factor of the equipment. The test principle of the differential pressure method and the electric quantity analysis method are different. The test conditions are different, and the unit of the test result is different. Therefore, the uncorrected raw data obtained by the two methods is theoretically not comparable, but by using The comparable performance of the test results after standard film calibration is improved. In addition, the data of the coulometric method can be traced to the differential pressure method, which is clearly stated in the ASTM D3985-05 standard: "Limited statistical data on correlations with Test Method D1434 method. Among them, ASTMD1434 is the differential pressure test standard. The sensors used in the coulometric method are consumable components. The correction factor of the device is not long-term effective. It needs to be periodically calibrated and must be replaced when the loss of the sensor reaches a certain level. At the same time, the amount of nitrogen and oxygen used in the test is also large, so the cost of testing is much higher than the differential pressure method.
3. Method Using the following standard of pharmaceutical packaging containers (materials), we will look at the specific use of the two methods for testing the permeability of the package. Table 1. Test method for gas permeability of pharmaceutical packaging materials Standard No. Standard name YBB00082003* Method Differential pressure method Second method Electricity analysis method YBB00132002 Composite film for pharmaceutical packaging, bag general √ 1×YBB00172002 Polyester/Aluminum/Polyethylene pharmaceutical packaging compound Film, bag √ 1×YBB00182002 polyester/low density polyethylene composite film for pharmaceutical packaging, bag √ 1×YBB00192002 biaxially oriented polypropylene/low density polyethylene composite film for pharmaceutical packaging, bag √ 1×YBB00242002 polyamide/aluminum /Polyvinyl chloride cold stamping forming solid medicinal composite hard sheet √ 1×YBB00342002 multi-layer co-extruded infusion film, bag general √ 1,2 × YBB00182004 aluminum / polyethylene cold-formed solid medicinal composite hard sheet √√ YBB00192004 two-way Composite film for stretching polypropylene/vacuum aluminized cast polypropylene for pharmaceutical packaging, bag √×YBB00202004 cellophane/aluminum/polyethylene composite film for pharmaceutical packaging, bag √×YBB00072005 medicinal low-density polyethylene film, bag √×YBB00102005 Three-layer co-extrusion film (I), bag √ 2×YBB00112005 five-layer co-extrusion film (I), bag √ 2 × YBB00202005 polyvinyl chloride / polyethylene / polyvinylidene chloride solid medicinal composite hard √1×YBB00212 005 polyvinyl chloride solid medicinal hard sheet √ 1×YBB00222005 polyvinyl chloride / polyvinylidene chloride solid medicinal composite hard sheet √ 1×YBB00232005 polyvinyl chloride / low density polyethylene solid medicinal composite hard sheet √ 1×YBB00252005 medicinal polyethylene/aluminum/polyethylene composite ointment tube Note: 1. When the standard was formulated, or the original standard of the revised standard was formulated, YBB00082003 has not been formulated, and the implementation standard GB/T1038- 2000. 2. It is necessary to detect the oxygen permeation amount and nitrogen permeation amount of the material. It can be seen from Table 1 that the drug packaging materials listed in the table all perform the differential pressure method when performing the gas permeability test of the material, and only two materials can perform the gas analysis method when performing the gas permeability test. Therefore, the device using differential pressure method fully meets the requirements for barrier detection of drug packaging materials, and the electricity analysis method (sensor method) currently does not seem to meet the testing requirements of most materials.
4. Summary Although the gas permeability test standard for pharmaceutical packaging materials is based on the national standard detection method, a new test method for the characteristics of the pharmaceutical packaging industry has been proposed. However, it can be seen from the above analysis that the pressure difference method can completely meet the detection requirements of the drug packaging materials, and the application method of the electricity analysis method is very narrow. Therefore, the pressure difference method gas permeability detecting device is selected, and the medicine packaging material can be satisfactorily satisfied. The detection standard effectively avoids the impact of different detection methods, which helps to save the cost of testing and improve productivity.
1. The differential pressure method* method differential pressure method is formulated in accordance with the national standard GB1038-2000. The test principle is to separate the low-pressure chamber and the high-pressure chamber by using a film or a sheet, and the high- and low-pressure chambers respectively have a pressure measuring device, and the high-pressure chamber is filled with a test gas of about 0.1 MPa, and the volume of the low-pressure chamber is known, after the test is sealed. The vacuum pump is used to draw the air in the low pressure chamber to a value close to zero, and the pressure increment Δp of the low pressure chamber is measured by a pressure gauge to determine the amount of gas in the test gas from the high pressure chamber to the low pressure chamber as a function of time. However, the initial stage in which the gas permeation rate changes over time should be excluded. After entering the test phase, when the pressure difference of the low pressure chamber is kept constant at the same time interval, the stable penetration of the gas is achieved, and the gas permeation amount and gas permeability coefficient can be calculated according to the formula given in the standard, and the unit thereof It is: cm3/m2·24h·0.1MPa. It is important to note that at the beginning of the test, the entire venting chamber needs to be evacuated to below 27 kPa and degassed continuously. The differential pressure method can simultaneously detect the gas permeability coefficient of the material, the diffusion coefficient of the detection gas in the material, and the solubility coefficient of the material to the gas, and can be used for detecting various common inorganic gases such as oxygen, nitrogen, carbon dioxide and air. In the drafting instructions of YBB00082003, it is pointed out that the formulation of the *method pressure difference method is based on GB/T1038-2000 "Test method for the penetration of plastic film and sheet gas - differential pressure method", and compares the method descriptions of the two standards. It can be seen that the content requirements are basically the same, and GB/T1038-2000 is more complete than YBB00082003, so it can be considered that the implementation of GB/T1038-2000 can fully meet the requirements of the YBB00082003* law. Of course, it should be noted that compared with the international standard for measuring the gas permeability of the differential pressure method, ASTM D1434, ISO15105-1, ISO2556:2001, etc., although the description of the operating rules of GB/T1038-2000 is not perfect, but The requirements for testing and various indicators during the test are fully consistent with international standards. For example, for the vacuum side of the test chamber, ASTM D1434-82 (2003) requires less than 26Pa, and ISO2556:2001 and GB/T1038-2000 require no more than 27Pa.
2. The electricity analysis method YYB00082003 has established a power analysis method based on the preservation of the differential pressure method in the establishment of the standard method, which is the second method in the standard. The coulometric method, which is the sensor method, is one of the methods of isostatic testing. The test principle is to use a medicinal film or sheet to separate the permeate chamber into two separate airflow systems, one for the active test gas (which can be pure oxygen or a mixture of oxygen) and the other for active drying. Nitrogen, the pressure on both sides of the sample is equal, but the partial pressure of oxygen is different. Under the effect of the difference in oxygen concentration, oxygen is transmitted through the membrane and sent to the oxygen sensor by the nitrogen gas. The oxygen sensor accurately measures the amount of oxygen carried in the nitrogen stream. To calculate the oxygen transmission rate of the material. The commonly used unit of oxygen permeation measured directly by coulometry is cm3/m2·d. This type of equipment needs to be calibrated using a standard membrane prior to testing and to determine the calibration factor of the equipment. The test principle of the differential pressure method and the electric quantity analysis method are different. The test conditions are different, and the unit of the test result is different. Therefore, the uncorrected raw data obtained by the two methods is theoretically not comparable, but by using The comparable performance of the test results after standard film calibration is improved. In addition, the data of the coulometric method can be traced to the differential pressure method, which is clearly stated in the ASTM D3985-05 standard: "Limited statistical data on correlations with Test Method D1434 method. Among them, ASTMD1434 is the differential pressure test standard. The sensors used in the coulometric method are consumable components. The correction factor of the device is not long-term effective. It needs to be periodically calibrated and must be replaced when the loss of the sensor reaches a certain level. At the same time, the amount of nitrogen and oxygen used in the test is also large, so the cost of testing is much higher than the differential pressure method.
3. Method Using the following standard of pharmaceutical packaging containers (materials), we will look at the specific use of the two methods for testing the permeability of the package. Table 1. Test method for gas permeability of pharmaceutical packaging materials Standard No. Standard name YBB00082003* Method Differential pressure method Second method Electricity analysis method YBB00132002 Composite film for pharmaceutical packaging, bag general √ 1×YBB00172002 Polyester/Aluminum/Polyethylene pharmaceutical packaging compound Film, bag √ 1×YBB00182002 polyester/low density polyethylene composite film for pharmaceutical packaging, bag √ 1×YBB00192002 biaxially oriented polypropylene/low density polyethylene composite film for pharmaceutical packaging, bag √ 1×YBB00242002 polyamide/aluminum /Polyvinyl chloride cold stamping forming solid medicinal composite hard sheet √ 1×YBB00342002 multi-layer co-extruded infusion film, bag general √ 1,2 × YBB00182004 aluminum / polyethylene cold-formed solid medicinal composite hard sheet √√ YBB00192004 two-way Composite film for stretching polypropylene/vacuum aluminized cast polypropylene for pharmaceutical packaging, bag √×YBB00202004 cellophane/aluminum/polyethylene composite film for pharmaceutical packaging, bag √×YBB00072005 medicinal low-density polyethylene film, bag √×YBB00102005 Three-layer co-extrusion film (I), bag √ 2×YBB00112005 five-layer co-extrusion film (I), bag √ 2 × YBB00202005 polyvinyl chloride / polyethylene / polyvinylidene chloride solid medicinal composite hard √1×YBB00212 005 polyvinyl chloride solid medicinal hard sheet √ 1×YBB00222005 polyvinyl chloride / polyvinylidene chloride solid medicinal composite hard sheet √ 1×YBB00232005 polyvinyl chloride / low density polyethylene solid medicinal composite hard sheet √ 1×YBB00252005 medicinal polyethylene/aluminum/polyethylene composite ointment tube Note: 1. When the standard was formulated, or the original standard of the revised standard was formulated, YBB00082003 has not been formulated, and the implementation standard GB/T1038- 2000. 2. It is necessary to detect the oxygen permeation amount and nitrogen permeation amount of the material. It can be seen from Table 1 that the drug packaging materials listed in the table all perform the differential pressure method when performing the gas permeability test of the material, and only two materials can perform the gas analysis method when performing the gas permeability test. Therefore, the device using differential pressure method fully meets the requirements for barrier detection of drug packaging materials, and the electricity analysis method (sensor method) currently does not seem to meet the testing requirements of most materials.
4. Summary Although the gas permeability test standard for pharmaceutical packaging materials is based on the national standard detection method, a new test method for the characteristics of the pharmaceutical packaging industry has been proposed. However, it can be seen from the above analysis that the pressure difference method can completely meet the detection requirements of the drug packaging materials, and the application method of the electricity analysis method is very narrow. Therefore, the pressure difference method gas permeability detecting device is selected, and the medicine packaging material can be satisfactorily satisfied. The detection standard effectively avoids the impact of different detection methods, which helps to save the cost of testing and improve productivity.
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