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.
出处
《天津药学》
2017年第5期12-14,23,共4页
Tianjin Pharmacy
关键词
乳化机
清洁方法
清洁验证
emulsifying machine
cleaning methods
cleaning validation