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目的:考察不同的测试仪器、方法及试验条件下测定药品包装用复合膜水蒸气透过量的可比性,为相关检验人员提供参考和建议。方法:比较国内外测试水蒸气透过量的3种方法标准包括国家标准(GB)、国际标准(ISO)和国际标准(ASTM),分析其原理、测试参数、条件及适用范围,采用3种基于不同原理的仪器进行试验。结果:不同的温度、湿度条件对同一台仪器测得的结果影响较大;在相同的温度、湿度条件下,不同试验原理的仪器对试验结果影响较小。结论:检验人员需定期使用标准膜来校准传感器法的仪器,试验严格控制温湿度,应从测量精度、人员操作、经济损耗多方面考虑,根据自身需要来选择合适的方法。
OBJECTIVE: To investigate the comparability of water vapor transmission rate of the composite film for pharmaceutical packaging under different testing instruments, methods and test conditions, and to provide references and suggestions for the relevant inspectors. Methods: The three methods to compare water vapor transmission rate at home and abroad are GB, ISO and ASTM. The principle, test parameters, conditions and application range are analyzed. Different principles of the instrument test. Results: Different temperature and humidity conditions have a great influence on the results measured by the same instrument. Under the same temperature and humidity conditions, the instruments with different experimental principles have less influence on the test results. Conclusion: The inspectors need to regularly calibrate the sensor method with standard membrane. The temperature and humidity should be strictly controlled in the test. From the aspects of measurement accuracy, personnel operation and economic loss, the appropriate method should be selected according to their needs.