中药饮片产设备清洁验证方案.doc

清洁验证文件 中药饮片生产设备清洁验证方案 验证文件名称 验证文件编码 中药饮片生产设备清洁验证方案 TS5-901-A 目 录 验证方案审批…………………………………………………… 4 验证方案及报告………………………………………………… 5 引言..…………………………………………………5 取样方法和工具………………………………………5 验证标准………………………………………………5 取样计划及方法 ……………………………………5 验证结果记录 …………………………………6 结果评价与结论……………………………………7 再验证………………………………………………7 验证合格证书………………………………………………………8 一、验证目的：从目检和样品水浊度试验证明直接接触药品的设备按规定的清洗程序清洗后，设备上残留的污染物是否符合规定的限度标准，证明这些设备的清洁规程是可靠的，从而消除了换品种设备清洗不彻底造成残留物对下一个产品污染的发生，有效地保证药品质量。为了增强此次验证的可靠性，清洁验证需进行三批。 二、验证范围：CYZ700B型滚筒式炒药机、DY-300型煅药机、电热蒸药系统(DLD24-0.4-1电加热蒸汽锅炉、ZYG-700可倾式蒸煮锅)(DLD24-0.4-1电加热蒸汽锅炉、ZYG-700可倾式蒸煮锅)(DLD24-0.4-1电加热蒸汽锅炉、ZYG-700可倾式蒸煮锅)(DLD24-0.4-1电加热蒸汽锅炉、ZYG-700可倾式蒸煮锅)(DLD24-0.4-1电加热蒸汽锅炉、ZYG-700可倾式蒸煮锅) family 7 being killed there. Zhu Xi forces, hundreds of people were killed and 19 captured fighters of their respective Corps Youth pioneers, opening of a temple by the Japanese military in ocean a thick wire through the Palm of each hand, pulled a long, red with the blood of the Earth. The face of the enemys power, captured 19 young men and women, none have ever been intimidated, no yield. Escort of the Japanese captain, kept shouting vicious Zhu Xi forces, an enemy of the Imperial Army, big bad! Japan helps you build a new order in East Asia, you see, as long as you repent and regret, in favour of Japan-China goodwill, is overkill. Enemy of 18 year old twin sisters are hypocritically surnamed Yao said: our youth, a lot of things are waiting for you, how can you quickly leave the world. In the face of enemy threats, seduce, 19 soldiers die, shouting: down with Japan imperialism! long live the nation! Ictus of times, fell to the enemy under the butchers knife. 　　He (she) for the liberation of the Chinese nation, the beauty of youth to the liberation cause of the Chinese nation, motherland cavity blood sprinkled on the ground. Zhong Jia DUN bloody battle, belongs to a group of Zhu Xi forces, two missions, Chen Qi, Zhu Jiemin Brigade Brigade suffered heavy casualties. Chinese Communist Party Membe