反应釜验证方案.pdf

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1、合成反应釜验证方案修 订 号 00 01 02起 草 人：年月日审阅会签：批 准 人：年月日实施日期：年月日编码：VP-B-019-00 合成反应釜验证方案第 2 页 共 11 页目录1.引言1.1 概述1.2 验证小组成员1.3 验证方案起草1.4 验证方案审核1.5 验证方案批准1.6 验证方案实施日期2.验证目的3.验证内容3.1 预确认（DQ）3.1.1 供应商的资格和服务3.1.2 设备使用材质和结构3.1.3 需要的性能参数，能达到要求压力、温度3.2 回顾性安装确认（IQ）3.2.1 随机技术资料3.2.2 电源的连接情况3.2.3 材质确认3.2.4 公用配套工程3.2.5 结

2、构情况和安装情况：3.2.6 润滑剂确认3.2.7 仪器仪器仪表校验确认3.3 运行和性能确认3.3.1 操作方法3.3.2 按以下步骤进行确认3.3.3 将以上确认结果填入运行确认记录表中。3.4 性能确认3.4.1 确认内容与方法：3.4.2 将测定结果填入性能确认相应记录表中。4.验证结果及分析评价5.批准6.再验证周期7.附件文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5

3、Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7

4、H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5

5、Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7

6、H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5

7、Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7

8、H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7编码：VP-B-019-

9、00 合成反应釜验证方案第 3 页 共 11 页1.引言1.1 概述本公司合成使用的两台反应釜根据工艺要求和使用的物料性质选择200L 和300L搪瓷反应釜，其生产厂家为，安装于一车间精制间及一车间防爆车间合成岗位，设备编号分别为：。该设备耐腐蚀，耐有机溶剂，结构简单，操作方便，专用于 原料的合成反应。经过对本设备及附属设施使用、维护记录的审阅，表明设备在经过近1 年的使用，使用一直正常，设备状态良好；仪表的校验仍在合格期限之内。1.2 验证小组成员组长小 组 成 员1.3 验证方案起草：1.4 验证方案审核：1.5 验证方案批准：傅雪琦总经理1.6 验证方案实施日期：本方案计划于 2009

10、年月日到 2009 年月日实施。2.验证目的按照 GMP 的要求，需要对该设备进行安装确认、运行和性能确认，通过该设备的验证，检查设备的规格、型号是否符合设计要求，设备的安装质量是否符合该设备正常运行的基本条件，辅助设施的布置是否合理、可靠、安全等，设备的生产能力是否既能满足生产需要，又能符合工艺要求。3.验证内容3.1 预确认（DQ）3.1.1 供应商的资格和服务供应商名称地址江苏省联系电话联系人确认项目确认结果生产此类设备的经验、水平D1、D2级低中压压力容器制造生产商信誉文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW

11、6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M

12、7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW

13、6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M

14、7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW

15、6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M

16、7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW

17、6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7编码：VP-B-019-00 合成反应釜验证方案第 4 页 共 11 页能否保证在安装、培训和试车方面给予全面支持技术培训水平技术文件（技术图样、设计资格证明）等是否完整，符合国家标准评价与结论：相关人员签名：3.1.2 设备使用材质和结构确 认 项 目符合情况备注材质要求不与物料或清洗消毒剂反应材质中无组分排出或吸收组分不脱落材料颗粒材质内外表面均为不锈钢结构不锈钢表面光滑、无棱角和凹槽，不粘、不积，易清洁便于操作，物料能全部排出便于拆卸、维护设备零件、计量仪表有较高的通

18、用性和标准化程度润滑密封装置合理、安全，不会对药物造成污染检查人日期年月日复核人日期年月日3.1.3 需要的性能参数，能达到要求压力、温度该设备安装于本公司一车间合成岗位，结构简单，操作方便，物料能全部排文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3

19、M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 H

20、W6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3

21、M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 H

22、W6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3

23、M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 H

24、W6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7编码：VP-B-019-00 合成反应釜验证方案第 5 页 共 11 页出，运行过程中噪声不会使人感到不适，且与采用的厂房、设施匹配。型号容积设计压力实际使

25、用压力设计温度实际使用温度符合情况：检查人日期年月日复核人日期年月日3.2 回顾性安装确认（IQ）3.2.1 随机技术资料文件名称数 量存 放 地 点产品质量证明书（反应釜）产品质量证明书（换热器）设备图纸备注：检查人日期年月日复核人日期年月日3.2.2 电源的连接情况：项目设计标准实际使用结论电机4Kw防爆电机电压380V 频率50Hz 接地保护安全可靠文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文

26、档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F

27、5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文

28、档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F

29、5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文

30、档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F

31、5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7编

32、码：VP-B-019-00 合成反应釜验证方案第 6 页 共 11 页检查人日期年月日复核人日期年月日3.2.3 材质确认：要求：反应釜内外表面均为不锈钢材质.连接部位使用的垫片材料应采用聚四氟乙烯。检查情况：检查人日期年月日复核人日期年月日3.2.4 公用配套工程名称技术指标实测结论管径和连接方式材质冷凝器总电源蒸汽安全阀疏水阀检查人日期年月日复核人日期年月日3.2.5 结构情况和安装情况：检查项目符合与否备 注外观无明显缺陷主要焊缝平整无明显缺陷或裂缝机器安装水平，偏差不超过设定标准设备的高度、体积与使用厂房、设施匹配状况合理文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7

33、H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5

34、Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7

35、H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5

36、Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7

37、H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5

38、Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7

39、H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7编码：VP-B-019-00 合成反应釜验证方案第 7 页 共 11 页设备安装位置及方位便于操作或清洗连接的管道与阀门材质符合工艺要求检查人日期年月日复核人日期年月日3.2.6 润滑剂确认使用部位类别制造厂检查结果备注检查人日期年月日复核人日期年月日3.2.7 仪器仪器仪表校验确认名称规格数量校正情况压力表温度计检查人日期年月日复核人日期年月日3.3 运行和性能确认：3.3.1 操作方法（1）启动前的检查及准备a)操作

40、人员在启动前应先检查反应釜锅体是否清洁，有无搪瓷脱落。b)检查安全防护、防爆装置，各零部件是否齐全、完好，有无松动现象。c)检查减速机油位是否正常，机械密封是否完好，有无泄漏。d)检查机械密封冷却水是否开启，检查各阀门转动是否灵活。e)用手试车运转，检查温度计套管与搅拌轴有无碰撞。f)用手点动按钮，检查电机转向是否正确，听各转动部位有无异常响文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3

41、N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6

42、 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3

43、N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6

44、 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3

45、N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6

46、 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7编码：VP-B-

47、019-00 合成反应釜验证方案第 8 页 共 11 页声，如有异常，须停机检查。g)准备好生产中所需的工具、容器具。（2）运行a)经检查无异常后，打开进料阀门，将物料加入反应釜，开启搅拌。b)打开蒸汽阀，加热升温。c)打开底阀，出料。d)将反应锅内物料放完，关闭电源，停车。3.3.2 按以下步骤进行确认a)按 3.3.1 操作方法试车；b)减速机油位情况和搅拌桨减速机的声响；c)搅拌桨的摆动情况和运转方向；d)空运转后轴承、机械密封的运转情况；e)加料运转后搅拌桨的摆动情况。3.3.3将以上确认结果填入运行确认记录表中。反应釜运行确认记录表设备号：位置：用途：序号检查项目检查结果1 减速机油

48、位情况2 手动阻力是否大3 搅拌桨减速机的声响是否大4 运转方向是否正确5 搅拌桨的摆动6 轴承、机械密封的运转情况7 转数控制是否符合工艺要求8 加料运转搅拌桨的摆动情况检查人日期年月日文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:C

49、W3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9

50、M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:CW3N9T5Q7S4 HW6F5I2H9M6 ZP7H2N7G3M7文档编码:C