目的: 研究示踪气体法在管制玻璃注射剂瓶包装系统密封完整性考察上的运用。方法: 以氦气作为示踪气体,采用真空模式,用10-6、10-7、10-9 Pa·m3·s-1标准漏孔测试系统适应性后,激光钻孔制备阳性样品,对阳性对照样品、阴性对照样品及测试样品分别进行充氦处理和氦气泄漏率检测,考察管制玻璃注射剂瓶包装系统的密封完整性。结果: 建立了氦质谱(真空模式)对管制注射剂瓶与胶塞的包装系统密封性的考察方法,并经过验证,对3批管制玻璃注射剂瓶包装密封完整性检测结果均小于6.0×10-7 Pa·m3·s-1。结论: 采用氦质谱(真空模式)灵敏度较高,满足注射剂药品质量控制要求,能够作为管制玻璃注射剂瓶包装系统的密封完整性的有效考察手段,操作简单,结果真实可靠。
Objective: To study the application of the tracer gas method in the inspection of the integrity of the tubular glass injection vial packaging system. Methods: Using helium as the tracer gas, in vacuum mode, testing the suitability of the system with 10-6 Pa·m3·s-1, 10-7 Pa·m3·s-1, 10-9 Pa·m3·s-1 leak standard, positive controls were prepared by laser drilling. Positive controls, negative controls and test samples were filled with helium. And then helium leak rate was tested, and the container closure integrity of the glass injection vial packaging system was investigated. Results: The testing method of the helium mass spectrometry (vacuum mode) for the integrity of the glass injection vial packaging system was established and verified. The test results of three batches of samples were all less than 6.0×10-7 Pa·m3·s-1. Conclusion: Helium mass spectrometry (vacuum mode) has high sensitivity and can meet the quality control requirements of injection drugs. It can be used as an effective means of inspecting the integrity of the tubular glass injection vial packaging system. The operation is simple and the results are true and reliable.
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