乳化机设备清洁及清洁验证方法的探讨  

A new way for cleaning emusifying machines

作　　者：徐兴亚 丁苏苏 周泉 

机构地区：[1]江苏省扬州市疾病预防控制中心,扬州225009 [2]江苏省扬州食品药品检验检测中心,扬州225009 [3]扬州大学附属医院,扬州225008

出　　处：《天津药学》2017年第5期12-14,23,共4页Tianjin Pharmacy

摘　　要：目的:制定乳化机清洁方法,对方法进行验证。方法:目测乳化机清洗后的状态,测定淋洗水的物理常数及乳化机内表面微生物限度,同时用HPLC法测定残留物主要成分含量。结果:所有检测结果均在清洁合格标准之内。结论:该清洁方法可靠易行,符合清洁要求。Objective: to develop a method for cleaning the cleaning of emulsifyng machine. Methods: A new method was applied in the field of cleaning emusifying machine and clearance of the machine was visually inspected. Physical constants of washing water and the limits of microbes on the interior surface of the machine were determnined. The amount of the main residuals were also determined by HPLC method. Results: The cleaning effects was satisfactory and conformed to relevant critera. Conclusion: the cleaning method is easily perfored and the clearance degree is reliable. All the parameters and limits of residual substances are in compliance with the requirements.

关 键 词：乳化机 清洁方法 清洁验证 

分 类 号：R955[医药卫生—药学]