药品包装用复合膜水蒸气透过量检测方法研究与测试

Research and Testing of Water Vapor Transmission of Laminated Films for Pharmaceutical Packaging

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 research the comparability of water vapor transmission of laminated films for pharmaceutical packaging determined by different instruments, methods and experimental conditions to provide reference and advice for the related inspection personnel. Methods： The principle, test parameters, conditions and scope of application for the testing methods for water vapor transmission in the national standard （GB） and international standards （ ISO, ASTM） were compared by using three kinds of instruments based on different testing principles. Results： Different temperature and humidity conditions had great influence on the results of the same instrument. Under the same temperature and humidity, the instrument with different principles had little influence on the test results. Conclusion ： Testing personnel should regularly use the standard membrane to calibrate the instrument of the sensor method. The temperature and humidity should be strictly controlled during the test. They should take measurement accuracy, personnel operation and economic loss into consideration to select the suitable method.