The hottest weighing method is the preferred metho

2022-09-19
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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: drugs, drug packaging materials, barrier property, moisture permeability

moisture permeability is an important index to evaluate 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 (i.e. weighing method) can be divided into two test methods: the weight gain method penetrating into the moisture permeable cup and the weight loss method 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, which is to fix the sample on the moisture permeable cup, and then calculate the water vapor transmission of the medicinal film, sheet and medicinal aluminum foil by measuring the weight of the moisture permeable cup. Therefore, the test data of the weight increase method and the weight decrease 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

due to the upper absorption limit of desiccant, the weight gain method cannot realize full-automatic detection, while the weight loss method has strong advantages in the humidity control of the test environment. At present, the automatic 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, by steaming high-resolution; The upper and lower limits can be set for distilled water or saturated salt solution 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. Therefore, the stability of test data is better, which 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 the container detection methods all implement the third method gravimetric method, at present, in combination with the specific implementation of the drug packaging container (material) standard, we only analyze the specific use of the two detection methods of film and sheet

table 1 Test method for moisture permeability of drug packaging materials

standard number standard name YBB first method cup method second method electrolytic analysis method third method gravimetric method YBB general rules for composite films and bags for drug packaging √ 1 ×× YBB aluminum foil for drug packaging √ 1 ×× YBB polyester/aluminum/polyethylene composite film and bag for drug packaging √ 1 ×× YBB polyester/low density polyethylene composite film and bag for drug packaging √ 1 ×× YBB biaxially oriented polypropylene/low density polyethylene composite film and bag for drug packaging √ 1 ×× YBB polyamide/aluminum/polyvinyl chloride cold stamping solid pharmaceutical composite hard sheet √ 1 ×× YBB general rule for multilayer coextrusion infusion film and bag √ 1 × √ 2ybb0018 including oil cylinder, electromechanical, button box, column, lead screw, etc. 2004 aluminum/polyethylene cold formed solid pharmaceutical composite hard film √√√ YBB biaxially stretched polypropylene/vacuum aluminized cast polypropylene composite film and bag for pharmaceutical packaging × √ × YBB cellophane/aluminum/polyethylene composite film and bag for drug packaging × √ × YBB medical low density polyethylene film, bag √ ×× YBB three-layer coextrusion infusion film (I), bag √ × √ YBB five layer coextrusion infusion film (I), bag √ × √YBB

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