The hottest weighing method is the preferred metho

2022-10-15
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Weighing method is the preferred method for the moisture permeability test of drug packaging materials

Abstract: This paper introduces the moisture permeability test method of drug packaging materials in detail in combination with YBB standard. The data relationship between various test methods, the relationship between weight gain method and weight loss method, and the future development direction are explained

key words: weighing method, drug packaging material detection, moisture permeability test, the first method, detection instrument

this paper is provided by Jinan Languang Electromechanical Technology Co., Ltd., that is, useful elasticity; Measure the percentage of the ratio of the energy lost during the elongation and shortening of the sample to the work consumed during the elongation and shortening. Please indicate the source for reprint! Welcome to call and consult relevant drug packaging materials testing technology and instruments.

moisture permeability is an important index for evaluating barrier materials, which is as important as air permeability. Moisture permeability test methods can be divided into weighing method and sensor method. Weighing method is the basic method (also known as cup method). The test data of sensor method need to be calibrated by weighing method data, including infrared verification method, dynamic relative humidity measurement method and electrolytic analysis method. Due to the unified weighing method data system, the data comparability between various methods is very good. The State Food and Drug Administration formulated YBB "water vapor transmission measurement method" in 2003, including the first method cup method, the second method electrolytic analysis method and the third method gravimetric method. Among them, the first method and the second method are applicable to pharmaceutical films, thin sheets and pharmaceutical aluminum foil, and the third method gravimetric method is applicable to pharmaceutical containers

1. Cup method

cup method (5. According to the description of the shape and fracture characteristics of the experiment, i.e. weighing method) can be divided into two test methods: the weight gain method of penetrating into the moisture permeable cup and the weight loss method of penetrating out of the moisture permeable cup. The desiccant is placed in the moisture permeable cup of the weight gain method (this method is used in YBB), so it can be considered that the interior of the moisture permeable cup is 0% RH, and the test environment is 38 ℃ and 90% RH; The moisture permeable cup of weight reduction method contains distilled water or saturated salt solution. If it contains distilled water, it can be considered that the interior of the moisture permeable cup is 100% RH, and the test environment is 38 ℃ and 10% RH. The measurement essence of the two methods is the same, that is, fix the sample on the moisture permeable cup, and then calculate the water vapor transmission of medicinal film, sheet and medicinal aluminum foil by measuring the weight change of the moisture permeable cup. Therefore, the test data of weight increase method and weight reduction method are the same, which is clearly stated in ASTM E 96

the rise of weight loss method is later than that of weight increase method, but its own advantages are very prominent. It can maintain 100% RH of the internal environment of the moisture permeable cup for a long time (the interior is filled with distilled water). The air flow above the sample takes away the water vapor permeating out, which is convenient for the realization of automatic detection

increase C. inter laboratory comparison; Due to the upper absorption limit of desiccant, the gravimetric method cannot realize full-automatic detection, while the weight reduction method has a strong advantage in the humidity control of the test environment, which is only allowed to be used in the fusion system. At present, the automated test has been realized, and the development potential is huge. The detection environment of weight reduction method is consistent with several sensor methods (electrolytic analysis method, infrared verification method, etc.), that is, distilled water or saturated salt solution is used to provide stable humidity on one side of the sample, while the other side (test chamber environment) is kept dry by external control means, and this drying control can be carried out stably without destroying the test process, so the stability of test data is better, It is the development trend of weighing method

2. Electrolytic analysis method

electrolytic analysis method uses the electrolytic chamber as the humidity sensor, and the permeation chamber is divided into a dry chamber and a humidity controllable wet chamber by the film or sheet. After the water vapor penetrates through the sample from the wet chamber, it will be carried into the electrolytic chamber by the carrier gas flow. The humidity of the carrier gas is measured by the electrolytic chamber and the electrical signal is output, and then the water vapor transmission of the sample can be calculated. It should be noted that several sensor methods, including electrolytic analysis method, need to be calibrated with the data of weighing method, so the measured data is in good consistency with the data of weighing method

international standards of electrolytic method include ISO and din, of which ISO is more detailed and has a wider range of actual use. Therefore, if electrolytic analysis method is needed for detection, it is recommended to implement ISO

3. The third method formulated in weight method

ybb contains three specific test methods, which are specially formulated for the particularity of drug packaging containers. Its testing principle comes from the first cup method. The specific test process is relatively simple, but the test time is much longer than film detection

4. Methods use

because all container detection methods implement the third method gravimetric method, here we will only analyze the specific use of the two detection methods of film and sheet in combination with the specific implementation of the drug packaging container (material) standard

table 1 Test method for moisture permeability of drug packaging materials

it can be seen from table 1 that most of the moisture permeability test methods of drug packaging materials listed in the table implement weighing method, and only two materials need to implement electrolytic analysis method. It can be seen that weighing method is the preferred test method for the moisture permeability test of flexible packaging materials for drug packaging

5. Summary

at present, the corresponding moisture permeability test method in the national standard is only gb/t (weighing method), and there is no sensor method standard. Therefore, the moisture permeability test standard of drug packaging materials puts forward that electrolytic analysis method is a useful supplement to the test method based on the national standard. Therefore, the moisture permeability test equipment based on weighing method can best meet the test standard of drug packaging materials

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