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摘要：清洁验证对于无菌药品生产而言是至关重要的，即要求将污染物的控制摆在首要位置。其目的是确认清洁方法和程序是安全有效的，即残留物浓度在可控范围内。首先采用多标准分析方法对上海新亚药业有限公司冻干车间同一生产线上已经过清洁的四种产品打分得出注射用兰索拉唑的得分为16即为参照物，若其清洁程序有效则证明其他清洁程序同样安全有效，故对注射用兰索拉唑清洁后的化学残留进行取样确认。通过系统适应性确认、线性回归确认、回收率确认等测试证明本次验证使用的检验方法为高效液相色谱法是科学合理的，而取样分析结果也表明已清洗的设备还存在残留污染物但浓度小于1.2×10-5g/ml在安全可控范围内。即兰索拉唑的清洁程序安全有效，但仍需通过对日常监控数据的回顾，来确定是否需要再验证或确定再验证的周期。5869
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关键词: 清洁程序; 清洁验证; 无菌药品生产
Cleaning validation of aseptic pharmaceutical production
ABSTRACT：Cleaning Validation for aseptic pharmaceutical production is crucial,that is to say they put pollutants control in a primary position. Its purpose is to confirm the cleaning method and procedure are safe and effective and the residue concentration is in the controllable range. Firstly, a multi-criteria analysis method is adopted to the four kinds of products cleaned on the same production line of Shanghai new Asia pharmaceutical company , and the injection lansoprazole score of 16 is the reference, if its cleaning procedure is effective,that is to say, other cleaning procedures are also safe and effective. so it needs to confirm the injection of lansoprazole after cleaning chemical residue sampling .Through the system adaptability confirmation, linear regression confirmation, recovery confirmation test prove the validation method used for high performance liquid chromatography method is scientific and reasonable, and the results of sample analysis also shows that the equipment still has residual contaminants ,but its concentration less than 1.2×10-5g/ml is in the safety control scope. The lansoprazole cleaning procedure is safe and effective, but still need through the review of the daily monitoring data, to determine whether it needs to verify or confirm the periodic revalidation.
Key Words: cleaning procedures; cleaning validation; Aseptic pharmaceutical production
目 录
1绪论 1
1.1 清洁验证的现状 1
1.2 清洁验证的目的及意义 1
1.3清洁验证的范围及作用 2
2清洁验证前期准备 3
2.1拟定清洁方式 3
2.1.1 污染物分类 3
2.1.2设备设计 3
2.1.3 选定清洁方式 3
2.1.4 选择清洁溶剂 4
2.2制定清洁规程 5
2.2.1 制定SOP 5
2.2.2 清洁规程要点 5
2.2.3 设备清洗规程需要说明 6
2.3 多标准分析方法介绍 6
3 验证清洗规程草案 8
3.1 制定验证方案 8
3.1.1 验证产品的选择及确定（找最差条件） 8
3.1.2取样方法的选择 9
3.2 清洁分析方法的验证 11
3.2.1取样方法验证 11
3.2.2检验方法验证 12
3.3清洁方法的监控与再验证 13
3.3.1日常监控 13
3.3.2变更管理 14
4实验 15
4.1实验内容及结果 15