The use of packaging materials with good barrier properties can effectively extend the shelf life of products, broaden the preservation environment, and provide more convenience for storage and transportation. Therefore, barrier materials have been rapidly applied and promoted in recent years. The material permeability test method can be divided into differential pressure method and isobaric method. Different test methods can not completely eliminate the impact on the test data. Due to less knowledge of the material's barrier detection methods, current drug companies are less concerned about the choice of test methods when choosing barrier devices. In order to unify the method used for permeability testing of pharmaceutical packaging materials in China, and to enhance the comparability of test data, China Food and Drug Administration established the YBB00082003 Gas Permeability Assay to standardize the testing methods for drug packaging materials in 2003 and become a drug package. Field selection guide for air permeability testing equipment. YBB00082003 "Gas Permeability Measurement Method" provides two kinds of test methods: the first method of differential pressure method and the second method of coulometry. The following will be introduced separately.
1. Differential pressure method
The first method of differential pressure complies with the national standard GB 1038-2000. The test principle is to use the film or sheet used to separate the low pressure chamber from the high pressure chamber. The high and low pressure chambers respectively have a pressure measuring device. The high pressure chamber is filled with a test gas of 0.1 MPa. The volume of the low pressure chamber is known, after the test is sealed. The air in the low pressure room is pumped to near zero by a vacuum pump, and the pressure increase Δp in the low pressure room is measured by a pressure gauge to determine the amount of time the gas passes through the sample from the high pressure chamber to the low pressure chamber. However, the initial phase of the gas transmission rate change over time should be excluded. After entering the test phase, when the pressure difference in the low pressure chamber remains constant during the same time interval, a stable gas permeation is achieved. The gas permeation and gas permeation coefficients can be calculated according to the formula given in the standard. The unit is : cm3/m2·24h·0.1MPa. It is important to note that at the beginning of the test, the entire evacuated chamber needs to be evacuated until it is less than 27 kPa, and degassing continues. The differential pressure method can simultaneously detect the permeability coefficient of gas to the material, the diffusion coefficient of the detected gas in the material, and the solubility coefficient of the material to the gas. It can also be used for the detection of various common inorganic gases such as oxygen, nitrogen, carbon dioxide, and air. In the drafting instructions of YBB00082003, it was pointed out that the formulation of the differential pressure method of the first method was developed with reference to GB/T 1038-2000 "Plastic Film and Sheet Gas Permeation Test Method - Differential Pressure Method" to compare the two standards. The method description shows that the content requirements are basically the same, and GB/T 1038-2000 is more complete than YBB00082003. Therefore, it can be considered that implementing GB/T 1038-2000 can fully meet the requirements of the first method of YBB00082003. Of course, it should be noted that compared with the existing international standards for pressure difference membrane gas permeability test ASTM D1434, ISO 15105-1, ISO 2556:2001, although GB/T 1038-2000 is not described in the operating rules It is perfect, but the requirements of the indicators in the testing and testing process are completely consistent with international standards. For example, for the test chamber vacuum requirements on the low pressure side, ASTM D 1434-82 (2003) requirements below 26Pa, ISO 2556:2001 and GB/T 1038-2000 requirements are not more than 27 Pa.
2. Coulometric analysis
YYB00082003 establishes a standard method, which is based on the pressure difference method, which is the second method in the standard. The coulometric method, that is, the sensor method, is one of the equal pressure test methods. The test principle is to use a medicinal film or sheet to separate the permeation chamber into two independent gas flow systems. One side is a flowing test gas (which may be pure oxygen or a mixed gas containing oxygen), and the other side is a dry flow. Nitrogen, the pressure on both sides of the sample is equal, but the oxygen partial pressure is different. Under the effect of oxygen concentration difference, oxygen is transmitted through the membrane and sent to the oxygen sensor by the nitrogen flow. The oxygen sensor accurately measures the amount of oxygen carried in the nitrogen flow. To calculate the oxygen transmission rate of the material. The oxygen permeability measured directly by the coulometric method and not corrected, the common unit is: cm3/m2·d. This type of equipment needs to be calibrated using a standard membrane before testing and the calibration factor of the equipment is determined. The differential pressure method and the coulometric method have different test principles. The test conditions are different, and the units of the test results are not the same. Therefore, the uncorrected raw data obtained by these two methods are theoretically not comparable, but they are not comparable. The comparable performance of the test results after standard film calibration is improved. In addition, the coulometric data can be traced back to the differential pressure method. This is clearly stated in the ASTM D3985-05 standard: “Limited data on correlations with Test Method D1434 methods. “Observe; however, the oxygen transmission rate of a standard reference material as determined manometrically by NIST, is in good agreement with the values ​​obtained in the coulometric interlaboratory test using material from the same manufacturing lot.â€. Among them, ASTM D 1434 is the differential pressure test standard. The sensor used in the coulometric method is a consumable component. The correction factor of the device is not valid for a long period of time and needs to be periodically calibrated. When the loss of the sensor reaches a certain level, it must be replaced. At the same time, the use of nitrogen and oxygen is also large during the test, so the cost of the test is much higher than that of the differential pressure method.
3. Method usage
Here we combine specific implementation of the drug packaging containers (materials) standard, look at the specific use of these two drug packaging material permeability testing methods. Table 1. Test Methods for Gas Permeability of Drug Packages Standard Number Standard Name YBB00082003 Method No. 1 Method of Differential Pressure Second Method Coulometric Analysis YBB00132002 Composite Films for Pharmaceutical Packaging, General Requirements for Bags 1 × YBB00172002 Polyester/Aluminum/Polyethylene Drugs Packaging Composite film, bag √ 1 × YBB00182002 Polyester / low-density polyethylene drug packaging film, bag √ 1 × YBB00192002 Biaxially oriented polypropylene / LDPE drug film, bag √ 1 × YBB00242002 Polyamide / Aluminum/polyvinyl chloride cold stamping forming solid pharmaceutical composite hard sheet √ 1 × YBB00342002 Multilayer co-extruded film, general rule √ 1,2 × YBB00182004 Aluminum/polyethylene cold formed solid pharmaceutical composite hard sheet √ YBB00192004 Biaxially Extruded Polypropylene/Vacuum Aluminized Casting Compound Films for Polypropylene Pharmaceutical Packaging, Bags × YBB00202004 Cellophane/Aluminum/Polyethylene Pharmaceutical Compounding Films, Bags × YBB00072005 Pharmaceutical Low Density Polyethylene Films, Bags × YBB00102005 Films for three-layer co-extrusion infusion (I), Bags 2 × YBB00112005 Films for five-layer co-extrusion infusion (I), Bags 2 × YBB00202005 Polyvinyl chloride/polyethylene/Polydichlorodichloromethane Ethylene solid pharmaceutical composite hard tablets 1 × YBB00212005 Polyvinyl chloride solid medicinal rigid tablets 1 × YBB00222005 Polyvinyl chloride / polyvinylidene chloride solid pharmaceutical composite hard tablets 1 × YBB00232005 PVC / low Density polyethylene solid pharmaceutical composite hard tablets 1 × YBB00252005 Pharmaceutical polyethylene/aluminum/polyethylene composite ointments √ Note: 1. When the standard is formulated, or when the original standard of the revised standard is being formulated YBB00082003 Has not yet been formulated, the implementation of the standard GB/T 1038-2000. 2. Need to check the oxygen permeability and nitrogen permeability of the material. It can be seen from Table 1 that all of the drug packaging materials listed in the table perform the pressure difference method when performing the gas permeability test of the materials, and only two materials can perform the electricity quantity analysis method when performing the gas permeability test. Therefore, the use of differential pressure equipment fully meets the requirements for the barrier properties of drug packaging materials, while the coulometric method (sensor method) currently does not seem to meet the testing requirements for most materials.
4. to sum up
Although the gas permeability test standard for drug packaging materials is based on the national standard detection method, a new test method for the characteristics of the pharmaceutical packaging industry has also been proposed. However, it can be seen from the above analysis that the pressure difference method can fully meet the inspection requirements of the drug packaging material, and the application of the coulometric analysis method is very narrow. Therefore, the differential pressure method permeability testing equipment can best meet the requirements of drug packaging materials. The testing standards can effectively avoid the possible impact due to the different detection methods, help to save testing costs and increase production capacity.
1. Differential pressure method
The first method of differential pressure complies with the national standard GB 1038-2000. The test principle is to use the film or sheet used to separate the low pressure chamber from the high pressure chamber. The high and low pressure chambers respectively have a pressure measuring device. The high pressure chamber is filled with a test gas of 0.1 MPa. The volume of the low pressure chamber is known, after the test is sealed. The air in the low pressure room is pumped to near zero by a vacuum pump, and the pressure increase Δp in the low pressure room is measured by a pressure gauge to determine the amount of time the gas passes through the sample from the high pressure chamber to the low pressure chamber. However, the initial phase of the gas transmission rate change over time should be excluded. After entering the test phase, when the pressure difference in the low pressure chamber remains constant during the same time interval, a stable gas permeation is achieved. The gas permeation and gas permeation coefficients can be calculated according to the formula given in the standard. The unit is : cm3/m2·24h·0.1MPa. It is important to note that at the beginning of the test, the entire evacuated chamber needs to be evacuated until it is less than 27 kPa, and degassing continues. The differential pressure method can simultaneously detect the permeability coefficient of gas to the material, the diffusion coefficient of the detected gas in the material, and the solubility coefficient of the material to the gas. It can also be used for the detection of various common inorganic gases such as oxygen, nitrogen, carbon dioxide, and air. In the drafting instructions of YBB00082003, it was pointed out that the formulation of the differential pressure method of the first method was developed with reference to GB/T 1038-2000 "Plastic Film and Sheet Gas Permeation Test Method - Differential Pressure Method" to compare the two standards. The method description shows that the content requirements are basically the same, and GB/T 1038-2000 is more complete than YBB00082003. Therefore, it can be considered that implementing GB/T 1038-2000 can fully meet the requirements of the first method of YBB00082003. Of course, it should be noted that compared with the existing international standards for pressure difference membrane gas permeability test ASTM D1434, ISO 15105-1, ISO 2556:2001, although GB/T 1038-2000 is not described in the operating rules It is perfect, but the requirements of the indicators in the testing and testing process are completely consistent with international standards. For example, for the test chamber vacuum requirements on the low pressure side, ASTM D 1434-82 (2003) requirements below 26Pa, ISO 2556:2001 and GB/T 1038-2000 requirements are not more than 27 Pa.
2. Coulometric analysis
YYB00082003 establishes a standard method, which is based on the pressure difference method, which is the second method in the standard. The coulometric method, that is, the sensor method, is one of the equal pressure test methods. The test principle is to use a medicinal film or sheet to separate the permeation chamber into two independent gas flow systems. One side is a flowing test gas (which may be pure oxygen or a mixed gas containing oxygen), and the other side is a dry flow. Nitrogen, the pressure on both sides of the sample is equal, but the oxygen partial pressure is different. Under the effect of oxygen concentration difference, oxygen is transmitted through the membrane and sent to the oxygen sensor by the nitrogen flow. The oxygen sensor accurately measures the amount of oxygen carried in the nitrogen flow. To calculate the oxygen transmission rate of the material. The oxygen permeability measured directly by the coulometric method and not corrected, the common unit is: cm3/m2·d. This type of equipment needs to be calibrated using a standard membrane before testing and the calibration factor of the equipment is determined. The differential pressure method and the coulometric method have different test principles. The test conditions are different, and the units of the test results are not the same. Therefore, the uncorrected raw data obtained by these two methods are theoretically not comparable, but they are not comparable. The comparable performance of the test results after standard film calibration is improved. In addition, the coulometric data can be traced back to the differential pressure method. This is clearly stated in the ASTM D3985-05 standard: “Limited data on correlations with Test Method D1434 methods. “Observe; however, the oxygen transmission rate of a standard reference material as determined manometrically by NIST, is in good agreement with the values ​​obtained in the coulometric interlaboratory test using material from the same manufacturing lot.â€. Among them, ASTM D 1434 is the differential pressure test standard. The sensor used in the coulometric method is a consumable component. The correction factor of the device is not valid for a long period of time and needs to be periodically calibrated. When the loss of the sensor reaches a certain level, it must be replaced. At the same time, the use of nitrogen and oxygen is also large during the test, so the cost of the test is much higher than that of the differential pressure method.
3. Method usage
Here we combine specific implementation of the drug packaging containers (materials) standard, look at the specific use of these two drug packaging material permeability testing methods. Table 1. Test Methods for Gas Permeability of Drug Packages Standard Number Standard Name YBB00082003 Method No. 1 Method of Differential Pressure Second Method Coulometric Analysis YBB00132002 Composite Films for Pharmaceutical Packaging, General Requirements for Bags 1 × YBB00172002 Polyester/Aluminum/Polyethylene Drugs Packaging Composite film, bag √ 1 × YBB00182002 Polyester / low-density polyethylene drug packaging film, bag √ 1 × YBB00192002 Biaxially oriented polypropylene / LDPE drug film, bag √ 1 × YBB00242002 Polyamide / Aluminum/polyvinyl chloride cold stamping forming solid pharmaceutical composite hard sheet √ 1 × YBB00342002 Multilayer co-extruded film, general rule √ 1,2 × YBB00182004 Aluminum/polyethylene cold formed solid pharmaceutical composite hard sheet √ YBB00192004 Biaxially Extruded Polypropylene/Vacuum Aluminized Casting Compound Films for Polypropylene Pharmaceutical Packaging, Bags × YBB00202004 Cellophane/Aluminum/Polyethylene Pharmaceutical Compounding Films, Bags × YBB00072005 Pharmaceutical Low Density Polyethylene Films, Bags × YBB00102005 Films for three-layer co-extrusion infusion (I), Bags 2 × YBB00112005 Films for five-layer co-extrusion infusion (I), Bags 2 × YBB00202005 Polyvinyl chloride/polyethylene/Polydichlorodichloromethane Ethylene solid pharmaceutical composite hard tablets 1 × YBB00212005 Polyvinyl chloride solid medicinal rigid tablets 1 × YBB00222005 Polyvinyl chloride / polyvinylidene chloride solid pharmaceutical composite hard tablets 1 × YBB00232005 PVC / low Density polyethylene solid pharmaceutical composite hard tablets 1 × YBB00252005 Pharmaceutical polyethylene/aluminum/polyethylene composite ointments √ Note: 1. When the standard is formulated, or when the original standard of the revised standard is being formulated YBB00082003 Has not yet been formulated, the implementation of the standard GB/T 1038-2000. 2. Need to check the oxygen permeability and nitrogen permeability of the material. It can be seen from Table 1 that all of the drug packaging materials listed in the table perform the pressure difference method when performing the gas permeability test of the materials, and only two materials can perform the electricity quantity analysis method when performing the gas permeability test. Therefore, the use of differential pressure equipment fully meets the requirements for the barrier properties of drug packaging materials, while the coulometric method (sensor method) currently does not seem to meet the testing requirements for most materials.
4. to sum up
Although the gas permeability test standard for drug packaging materials is based on the national standard detection method, a new test method for the characteristics of the pharmaceutical packaging industry has also been proposed. However, it can be seen from the above analysis that the pressure difference method can fully meet the inspection requirements of the drug packaging material, and the application of the coulometric analysis method is very narrow. Therefore, the differential pressure method permeability testing equipment can best meet the requirements of drug packaging materials. The testing standards can effectively avoid the possible impact due to the different detection methods, help to save testing costs and increase production capacity.
Red Jasper is stone of stamina and strength. It is used to stabilize the root chakra. Use this egg to:
- Balance emotions
- Increase your connection with the earth
- Enhance memory
- Stimulate creative and sexual activity
- For Energy, Strength, Stamina, Spiritual Grounding
Red Jasper Stone carries a strong spiritual grounding vibration, and resonates within the lower three chakras.
It creates a strong connection to the earth and this is very helpful for emotional equilibrium and spiritual grounding.
It gives deep insight into personal difficulties and gives you a strong sense of stability.
Red Jasper stone increases life force or pranic energy, and will stabilize the aura as it creates a better energy flow within your energy field. It has many strong healing attributes, within the sacral or navel chakra.
It aids healing within the liver, and may assist you to detoxify, as well as healing blockages in the bile ducts.
To enhance your ability to recall your dreams, keep one of these red stones under your pillow at night.
It is also quite beneficial to activate and enhance your creativity. It may improve your endurance, and is very helpful for healing any dysfunctions within the procreative area of the body.
Red Jasper Bracelet, Fine Jewelry, Couples Red Jasper Bracelet, Red Jasper Jewelry
JOYA GIFT CO.,LIMITED , http://www.joyagifts.com