Pharmaceutical packaging materials testing solutions

In recent years, with the improvement of people's living standards, the reform of medical security system and the expansion of urban residents' medical insurance, the Chinese pharmaceutical industry has played a huge role in promoting As an important part of the development of pharmaceutical industrialization, pharmaceutical packaging has been paid more and more attention by the national quality inspection system and many pharmaceutical manufacturers Labthink, Jinan ）As an international well-known manufacturer specializing in the manufacture and supply of testing instruments for drug packaging materials, we have professional testing experience and solutions for drug packaging materials In order to facilitate you to have a more detailed understanding of the quality control indicators of "drug packaging materials, containers" and relevant information of instruments, we hereby present this information to you in order to make a little contribution to your quality control in production 1、 For drugs, oxidation and hydrolysis are the important factors of drug decomposition failure, which will cause the instability of drugs Many drugs are easy to be oxidized, causing discoloration, odor, deterioration and failure, and some will produce toxicity Water is the medium of chemical reaction, which can cause caking, deliquescence, dilution, mildew, hydrolysis, oxidation and other changes after hygroscopic absorption of drugs, making it difficult for some drugs to prepare or master the exact dosage, even reducing the efficacy of some drugs or producing irritation and toxicity, so the requirements of drug packaging for barrier are very high For this reason, the national food and Drug Administration issued the compilation of standards for packaging materials and containers in direct contact with drugs, which stipulates the measurement methods of gas transmission and water vapor transmission Each test item has two test methods (please refer to table 2 in the appendix for the selected method) The specified methods are as follows: 1 Gas transmission measurement method: * method differential pressure method, the second method isobaric method 2 Water vapor transmission measurement method: * method cup method (weighing method), the second method electrolytic method Product name and model brief introduction gas transmission measurement instrument vac-vbs differential pressure method - * method for the measurement of oxygen, nitrogen and other gas transmission of plastic film, sheet, composite film and other materials Vac-v1 vac-v2 vac-v3 toy-c1 isobaric method (electricity method) - the second method is the determination of oxygen permeability of plastic film and packaging bag Toy-c2 toy-c3 water vapor transmission measuring instrument tsy-t1 series cup method (gravimetric method) - * method is used for measuring the water vapor transmission of thin film, sheet and composite film tsy-t3 tsy-w3 electrolytic method the second method is used for measuring the water vapor transmission of thin film, sheet, composite film and packaging bag tsy-w3 / 3 the second method is used for testing the heat sealing strength of drug packaging In order to achieve the purpose of packaging, the sealing of drug packaging must have a certain strength to be able to bear the effect of internal and external pressure, so as to ensure that it will not crack or damage in the process of circulation To solve this problem, we need to use "heat sealing tester" and "intelligent electronic tensile tester" to test Product name and model brief introduction heat seal tester hst-h3 film heat seal strength test sample preparation Pressure, temperature and time can be controlled by rtd-r2 gradiometer Third, the tensile strength of drug packaging materials is the value of Zui stress that the materials bear before breaking Through testing, it can effectively solve the packaging damage and fracture caused by external force because the mechanical strength of the selected packaging materials is not enough Intelligent electronic tensile testing machine shall be used for testing Product name and model introduction intelligent electronic tensile testing machine XLW (PC) is specialized in the detection of tensile strength, peel strength, thermal strength and tear performance of film and composite film XLW (m) IV the sealing performance of the finished product of drug packaging is also an important index of drug packaging inspection The sealing test of drug packaging is to test the barrier bacteria layer of the whole package, such as the leakage test and sealing test of other drug packaging such as blister packaging or blister capsule for the finished product Poor sealing is the main cause of future leakage Generally, sealing performance test instruments are used for testing Product name and model brief introduction sealing tester mfy-01 uses the principle of negative pressure method, fast packaging sealing reliability test leakage and sealing strength tester lssd-01 uses the principle of positive pressure to detect and analyze the sealing performance and leakage of packaging v thickness detection of infusion bag membrane Whether the thickness of the coating material is uniform or not is the basis of testing the properties of the film The uneven thickness of the film will not only affect the tensile strength and barrier of the film, but also affect the subsequent processing of the film Product name and model brief introduction thickness gauge chy-c2 0.1um high precision film thickness measurement, LCD display, micro printing, statistics, communication Chy-ca 0.1um high precision, multi-point automatic continuous measurement, LCD display, micro printing, statistics, communication The above test indexes of infusion bag and its membrane material are very important to adjust production process and improve product quality in actual production Through the corresponding test instruments, the quality can be monitored to ensure the quality of products