某口服液制剂消毒工艺改进及其消毒效果评价
Improvement of disinfection progress and evaluation of disinfection effect for an oral liquid preparation
李侯 1尹鹏 1罗来龙 1唐志坤 1王文静 1卜梅彦 1杨曜榕1
作者信息
- 1. 云南白药集团股份有限公司,云南昆明 650500
- 折叠
摘要
目的 在关键质量属性符合要求的基础上选择适合某口服液的消毒工艺,并观察其消毒效果.方法 观察增加制剂成品消毒工艺对关键质量属性的影响,并制订改进措施;采用微生物定量检测方法,对某口服液制剂过程中消毒工艺及其消毒效果进行评价.结果 通过车间洁净技术、湿热消毒工艺和工作人员手消毒措施等综合消毒工艺,某口服液产品微生物限度检测全部合格,跟踪统计消毒工艺改进后的产品微生物检测结果全部合格.结论 消毒工艺能显著降低微生物污染风险,确保产品微生物限度检测合格.
Abstract
Objective To select the appropriate disinfection process based on the key quality met the requirement of an oral liquid,and to evaluate the disinfect effect.Methods The impact of adding the disinfection process on key quality attributes of the oral liquid was observed,and improvment measures were formulated.Using microbial quantitative method,the disinfection process and disinfection effect of the oral liquid were assessed.Results Through workshop cleaning,wet heat disinfection,and staff hand disinfection measures,the microbial limit test of the oral liquid was qualified,and the microbial test results showed that the improved disinfection process had been tracked and all test were qualified.Conclusion The disinfection process can significantly decrease the risk of microbial contamination, which ensure the microbial limit test of the product to be qualified.
关键词
口服液/制剂过程/消毒工艺/微生物限度Key words
oral liquid/preparation process/disinfection process/microbial limit引用本文复制引用
出版年
2024
NETL
NSTL
万方数据