生物制药注射用水工艺的质量控制趋势分析

Trend analysis of quality control for water for injection used in pharmaceutical and biological products

目的分析2014—2015年度制药注射用水系统4个重要质量指标的趋势,为制水系统日常运行及生产过程中的质量控制提供依据。方法对注射用水p H、电导率、总有机碳（Total organic carbon,TOC）、微生物限度4项质量指标进行趋势分析。结果 104周注射用水的质量检测结果显示p H均在5.0~7.0之间,25℃电导率均≤1.3μS/cm,TOC远低于药典标准0.50 mg/L,微生物限度检查未检出细菌、霉菌和酵母菌,各项指标均符合《中华人民共和国药典》2010版（二部）标准,且连续2年趋势稳定。结论制水系统运行正常,可以持续有效地生产出符合制药工艺要求的注射用水,为生物制药提供了安全保证。

Objective The statistical investigation was performed in analysis of four key quality indicators in system of water for injection used in pharmaceutical and biological products from 2014 to 2015,so as to provide scintific basis in conventional operation and quality control of preparation water for injection system. Methods The four quality indicators were carried out a trend analysis including p H,conductivity,total organic carbon（ TOC） and microbial limit in water for injection. Results p H was in a range from 5.0 to 7.0,conductivity was≤1.3 us / cm（ at 25 ℃）,TOC had a far below value from the pharmacopoeia criterion of 0.50 mg / L,no bacterium,mycete and yeast were detected by the microbial limit test in a survey for 104 weeks. All indexes were in conformity with the standard of《Pharmacopoeia of People＇s Republic of China》VolumeⅡ（ 2010 verson）,which were maintained in a stable trend for 2 years. Conclusion The water for injection system was managed in a normal condition,by which the water for injecion could be stably prepared. It provided a guarantee in preparation of pharmaceutical and biological products.