摘要
目的探讨并寻找不同熔封燃气对安瓿瓶熔封导致灭菌注射用水检测过程中亚硝酸盐不合格的解决方案。方法在灭菌注射用水的生产过程中,分别在各工序取样检测,并将用氧气-煤气、氧气-氢气燃烧对灌装灭菌注射用水的安瓿瓶进行熔封,考察不同熔封燃气对灭菌注射用水的影响,根据《中国药典》(2015年版)二部的规定对灭菌注射用水亚硝酸盐和电导率进行检测。结果氧气-煤气火焰与氧气-氢气火焰两种熔封装置对安瓿瓶熔封前后,各取样位置所取灭菌注射用水样检测电导率值都合格,均不大于限度值25μS/cm;氧气-煤气熔封装置对安瓿瓶熔封后灭菌前的灭菌注射用水的亚硝酸盐检测结果不合格,氧气-氢气熔封装置对安瓿瓶熔封后的亚硝酸盐检测结果合格,且两次检测结果一致。结论氧气-氢气燃烧可对安瓿瓶进行熔封,并且制备的灭菌注射用水质量可靠,能够最终达到成品检定标准。
Objective To explore and find out different sealing gas for ampoule sealing to nitrite faild solution of sterile wa- ter for injection detection process.Methods In the process of sterile water for injection in the production, each working procedure were collected and tested respectively, and would be used for sealing by oxygen - natural gas, oxygen - hydrogen combustion ampoule filling on sterile water for injection, the effect of different sealing gas for sterile water for injection were detected, according to second section of China pharmacopoeia （2015 Edition） , nitrite and electrical conductivity in sterile water for injection were detected.Results Before and after oxygen-gas flame and oxygen hydrogen flame two sealing device for ampoule sealing, each sampling position taken by sterile water samples were qualified with conductivity value, which didn＇t exceed the limit value of 25 i^S/cm;Oxygen-gas sealing device for ampoule sterilization after nitrite mehing before sterile water for injection failed the test results, test results of the oxygen-hydrogen gas sealing device for nitrite ampoule af- ter the bottle melting were qualified, and the two test results were consistent. Conclusion The oxygen-hydrogen combus- tion can be sealed for ampoule, and preparation for the reliable quality of sterile water for injection, and finally reach the finished product test standard..
出处
《中国卫生工程学》
CAS
2017年第5期592-594,共3页
Chinese Journal of Public Health Engineering
