基于真空测试技术的药用玻璃瓶微孔孔径测量技术研究

Research on the Measurement Technology of Micropore Diameter for Medical Glass Bottles Based on Vacuum Measurement Technology

药用玻璃瓶的密封完整性直接影响到药品的安全性和有效性,药用玻璃瓶微孔孔径是评价密封完整性的重要指标。提出一种基于真空测试技术的药用玻璃瓶微孔孔径测量新方法,应用经典真空技术理论公式推导稀薄气体在漏孔中流动时气体流量与漏孔孔径、气压以及温度的函数关系,并基于以上函数关系研制一种基于真空测试技术的药用玻璃瓶微孔孔径测量装置。通过测量气体流量、上游压力、下游压力与环境温度,可实现对药用玻璃瓶的漏孔孔径的间接测量。结果表明:在实验室温湿度正常控制范围内,所提方法可实现药用玻璃瓶微孔孔径测量,测试结果与参考标准值的示值误差小于0.1μm,满足药用玻璃瓶密封完整性评价的要求。

The sealing integrity of medical glass bottles directly affects the safety and effectiveness of drugs,the micropore diameter of pharmaceutical glass bottle is an important index to evaluate the sealing integrity.A new method for measuring the micropore diameter of pharmaceutical glass bottles based on vacuum testing technology is proposed,the classical vacuum technology theoretical formula is used to deduce the functional relationship between the gas flow rate and the hole diameter,air pressure and temperature of the leak when the thin gas flows in the leak,and based on the above functional relationship,a device for measuring the micropore diameter of medicinal glass bottles based on vacuum testing technology is developed.By measuring the device,the gas flow,upstream pressure,downstream pressure and ambient temperature,the indirect measurement of the leakage aperture of the medical glass bottle can be realized.The results show that within the range of temperature and humidity in the laboratory,by using the method,the micropore diameter of medical glass bottles can be measured,and the indication error between the test result and the reference standard value is less than 0.1μm,which meets the requirements of sealing integrity evaluation of medical glass bottles.