YBB00082003 "Gas Permeability Measurement Method" and YBB00092003 "Water Vapor Permeation Measurement Method" are the indicators for the detection of water vapor permeation and gas permeation of pharmaceutical packaging containers (materials) by the State Food and Drug Administration. The test method is formulated to provide a chapter for the testing of pharmaceutical packaging materials, packaging materials, and pharmaceutical companies. First, the gas permeability The gas permeation test is in accordance with the provisions of YBB0082003, and two measurement methods are specified: * method (pressure difference method) and second method (electricity analysis method). Most of the drug packaging product standards are stipulated by the * method (pressure difference method), and a few (about 2 kinds of materials) can be used in both methods. In order to facilitate the development of the testing work, the gas permeability detecting methods specified in the corresponding product testing standards are summarized as follows for reference. Table 1. Method for testing the permeability of pharmaceutical packaging materials Product standards standard name Inspection method YBB00082003 Remarks *law (pressure difference method) Second method (electricity analysis method) YBB00132002 Composite film and bag general rule for pharmaceutical packaging √1 × Determined according to the * method (pressure difference method) YBB00172002 Polyester/aluminum/polyethylene composite film and bag for pharmaceutical packaging √1 × Determined according to the * method (pressure difference method) YBB00182002 Polyester/low density polyethylene pharmaceutical packaging composite film, bag √1 × Determined according to the * method (pressure difference method) YBB00192002 Biaxially oriented polypropylene/low density polyethylene composite film and bag for pharmaceutical packaging √1 × Determined according to the * method (pressure difference method) YBB00242002 Polyamide/aluminum/polyvinyl chloride cold stamping solid pharmaceutical composite hard film √1 × Determined according to the * method (pressure difference method) YBB00342002 Multilayer coextrusion infusion film, bag general rule √ 1, 2 × Determined according to the * method (pressure difference method) To test oxygen permeation and nitrogen permeation YBB00182004 Aluminum/polyethylene cold formed solid medicinal composite hard sheet √ √ Unspecified method, differential pressure method and electricity analysis method can be used YBB00192004 Biaxially oriented polypropylene/vacuum aluminized cast polypropylene composite film and bag for pharmaceutical packaging √ × Determined according to the * method (pressure difference method) YBB00202004 Composite film and bag for cellophane/aluminum/polyethylene pharmaceutical packaging √ × Determined according to the * method (pressure difference method) YBB00072005 Medicinal low density polyethylene film, bag √ × Determined according to the * method (pressure difference method) YBB00102005 Three-layer co-extrusion film (I), bag √2 × Determine according to the * method (pressure difference method) and test oxygen and nitrogen. YBB00112005 Five-layer co-extruded film (I), bag √2 × Determine according to the * method (pressure difference method), and test oxygen and nitrogen. YBB00202005 Polyvinyl chloride/polyethylene/polyvinylidene chloride solid medicinal composite hard film √1 × Determined according to the * method (pressure difference method) YBB00212005 Polyvinyl chloride solid medicinal hard film √1 × Determined according to the * method (pressure difference method) YBB00222005 Polyvinyl chloride/polyvinylidene chloride solid medicinal composite hard film √1 × Determined according to the * method (pressure difference method) YBB00232005 Polyvinyl chloride / low density polyethylene solid medicinal composite hard film √1 × Determination by the method of * (pressure difference method GB1038-2000) YBB00252005 Medicinal polyethylene/aluminum/polyethylene composite ointment tube √ √ Unspecified method, differential pressure method and electricity analysis method can be used Note: 1) In the table, √1 refers to the implementation of the *method pressure difference method, and the implementation of GB/T 1038-2000 uses the differential pressure method. 2) √2 in the table refers to the oxygen permeation amount and nitrogen permeation amount of the material to be tested by the method of differential pressure method. 3) * method refers to differential pressure method, and second method refers to electricity analysis method 4) In the original product standard of the 2002 edition: YBB00202002 was replaced by YBB00202005, YBB00212002 was replaced by YBB002122005, YBB00222002 was replaced by YBB00222005, YBB002302002 was replaced by YBB00232005, and YBB00252002 was replaced by YBB00252005. Second, water vapor transmission YBB00092003 "Water vapor transmission measurement method" introduced three methods, wherein the * method is the cup method, the second method is the third method of electrolytic analysis method is the weight method. The inspection system for the inspection of pharmaceutical packaging materials needs to be tested according to the methods specified in the standards for the implementation of different products. At present, there are many methods for detecting the amount of water vapor transmission in the world. However, in the detection of drug packaging materials, there are only cup method (weighing method) and electrolytic analysis method. Therefore, when choosing, we must pay attention to whether the test principle of the instrument meets the requirements of the product standard. The following table summarizes the requirements for the test method for water vapor transmission rate of related drug packaging products by the State Food and Drug Administration: Table 2. Method for testing water vapor permeability of pharmaceutical packaging materials Product standards standard name Inspection method YBB00092003 Remarks *law (cup method) Second method (electrolysis analysis method) YBB00072005 Medicinal low density polyethylene film, bag √ × Unless otherwise specified, according to the * method cup method YBB00102005 Three-layer co-extrusion film (I), bag √ × According to the method of the cup method. YBB00112005 Three-layer co-extrusion film (I), bag √ × It is measured by the water vapor transmission amount method* method. YBB00252005 Medicinal polyethylene/aluminum/polyethylene composite ointment tube √ √ Both the cup method and the electrolytic analysis method are available. YBB00132002 Composite film and bag general rule for pharmaceutical packaging √ × Photo method Row YBB00152002 Aluminum foil for pharmaceutical packaging √ × Photo method Row YBB0000172002 Polyester/aluminum/polyethylene composite film and bag for pharmaceutical packaging √ × Photo method Row YBB00182002 Polyester/low density polyethylene composite film and bag for pharmaceutical packaging √ × Photo method Row YBB00192002 Biaxially oriented polypropylene/low-density ethylene-based pharmaceutical packaging film, bag √ × Photo method Row YBB00202005 Polyethylene solid medicinal composite tablet √ × Photo method Row YBB00222005 Polyvinyl chloride/polyvinylidene chloride solid medicinal composite hard film √ × Photo method Row YBB00232005 Polyvinyl chloride / low density polyethylene solid medicinal composite hard film √ × Photo method Row YBB00242002 Medicinal polyethylene/aluminum/polyethylene composite ointment tube √ × Photo method Row YBB00252002 Polyethylene/aluminum/polyethylene composite medicinal ointment tube √ × Photo method Row YBB00182004 Aluminum/polyethylene cold formed solid medicinal composite hard sheet √ √ Both the cup method and the electrolytic analysis method are available. YBB00192004 Biaxially oriented polypropylene/vacuum aluminized cast polypropylene composite film and bag for pharmaceutical packaging × √ According to the second method of electrolytic analysis YBB00202004 Composite film and bag for cellophane/aluminum/polyethylene pharmaceutical packaging × √ According to the second method of electrolytic analysis Note: 方法 The method X identified as used is not used. Labthink, an excellent provider of inspection instruments and inspection services, continues to provide outstanding products to customers in the pharmaceutical, food, daily chemical, packaging, printing, adhesives, automotive, petrochemical, environmental, biological, new energy, construction, aerospace and electronics industries. ,zui comprehensive quality control solutions. Labthink has a complete brand system. Outside the corporate brand Labthink, the two major product brands Perme and Param share the same international market. Labthink is committed to sharing the highest quality inspection control technology with customers around the world, and is known for covering global testing standards. Labthink is involved in the drafting of several important standards in the food, pharmaceutical and packaging industries and is an excellent partner of national certification bodies. Creating satisfactory value and professional service for customers is the goal of Labthink. Together with many well-known distributors such as IGT, Rycobel, Metrotec, Chilton, Moroka, etc., we provide thoughtful and timely technical services to customers in more than 40 countries and regions around the world. Languang, single-minded only for you! For more information, please call Zhang Jianbo (), headquarter of Jinan Languang Electromechanical Technology Co., Ltd.
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