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3、纯化水储罐、输送管道清洁、消毒操作规程SOP-GWO015-04

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promotion of employment, form a reasonable and orderly pattern of income distribution, build a more fair and sustainable social security systems, medical and health system reform. The plenary, innovation of social governance, must focus on the maintenance of fundamental interests of the overwhelming majority of the people, maximize factors, enhance social development, improving social governance, the interests of national security, ensure that the people live and work, social stability and order. o improve social governance, stimulating social organization, innovative and effective system of preventing and resolving social conflicts, improving the public security system, set up the National Security Council, national security systems and national security strategy to ensure national security. Plenary session, the construction of ecological civilization, you must establish systems of ecological system, using the system to protect the ecological environment. o improve natural resources asset property right system and use control, red lineof delimitation of ecological protection, resources paid use system and ecological compensation system in ecological environmnt protection management system reform. Plenary session, centering on building a listening party command, can win and having a fine style of the people's army, a strong army under the new situation of the party Goals, restricting the development of national defense and army building is solved outstanding contradictions and problems, innovation and development of military theory, enhance military strategic guidance, improve the military strategy in the new period, building a modern military force system with Chinese characteristics. o deepen the adjustment of personnel system reform in the army, military policy and system reform, promote the development of military and civilian integration depth. Plenary session stressed that comprehensive reform must be to strengthen and improve the party's leadership, give full play to the core role of the party commands the overall situation and coordinating all parties, improving the party's leading water ... Margin. Challenged the leadership of the Communist Party of China, Marxism-Leninism and Mao Zedong thought by Deng Xiao-ping's flag, replaced by three representatives and the harmonic society. The former Communist Party spirit and social cohesion point of almost all political makeover. Characteristics of socialism public ownership is shifting to private ownership, planned regulation and market regulation, the proletarian regime controlled by the elite. Of universal equality, fairness and basic principles of distribution system is socialist society, however after economic monopolized by powerful, vested interests grow, employers do not have the same status, hardly seems fair social distribution. State key protection of capital interests rather than the interests of citizens, had been hits the bottom of the proletariat题 目 制 定 人 制定日期 批 准 人 颁发部门 纯化水储罐、输送管道清洁、消毒操作规程 QA中心 审 核 人 审核日期 批准日期 分发部门 QA审核人 审核日期 生效日期 变更历史 1 目的:为规范纯化水储罐(水箱)、管道的清洁、消毒,制定本规程。

2 适用范围:预处理水箱、中间水箱、纯化水储罐、输送管道。

3 责任者:动力车间主任、纯水冷冻班长、生产各车间、纯水站操作人员。 4 内容:

4.1 每月中旬的第一个周日,对预处理水箱、中间水箱、纯化水储罐、输送管道清洗、消毒。

4.2 清洁剂、消毒剂的配制:

1% 的洗洁精溶液 100ml的洗洁精加纯化水配至10000ml混匀 75% 的乙醇溶液 7895ml的95%乙醇加纯化水配至10000ml混匀 4.3 预处理水箱的清洁、消毒

4.3.1 配制清洁剂和消毒剂,准备清洗工具。

4.3.2 进入水箱清洁者将手、胶鞋和人梯用清洁剂清洗干净。

4.3.3排空预处理水箱中的余水,一人从人孔进入水箱内,一人在入口处帮助递送清洁抹布和清水。

4.3.4 用1%的洗洁精溶液浸润清洁抹布,拧干清洁抹布后(不滴液)擦洗内壁两遍,罐盖朝内侧和难擦洗的地方应擦洗四遍,最后用清水浸润清洁抹布擦洗内壁及灌盖内侧两遍。

4.3.5用75%的乙醇溶液浸润清洁抹布,拧干清洁抹布后(不滴液)擦洗内壁、罐盖内侧,全部消毒一遍,最后制预处理水冲洗30分钟。

4.3.6 预处理水箱经清洁消毒后,以目视方法检测合格,处于待运行准备状态。 4.4 中间水箱的清洁、消毒

4.4.1 进入水箱清洁者将手、胶鞋和人梯用清洁剂清洗干净。

4.4.2排空预处理水箱中的余水,一人从人孔进入水箱内,一人在入口处帮助递送清洁抹布和清水。

bviously, face China's Socialist system, the Communist Party is not the party. In that case, political chaos has been very tight. Is remodeling or reconstruction, is a correction or a stove. Whether to turn right or left, is back to the source or put forward new political ideas. This is to determine the road problems in China, is also the key out of the deep water of the reform of the economic system. After 18, the new Central collective leadership attaches great importance to political orientation. First, the \s\starting from the Central Government's self-restraint, which preaches and pro-image, brought fresh feeling to the community. Secondly, before reform and opening up and reform and opening two periods after non-negative, untying the tangle of the society a long time on this issue. Third, a new generation of party leaders on various occasions to Mao Ze-Dong and Mao Ze-Dong's thought of evaluation has room for manoeuvre, through to the ruling ideology of Mao Zedong thought, is thecall of the soul to the Socialist Revolution and construction. Empty talks jeopardize national interests and try again, is an affirmation of Deng Xiao-ping's reform ideas. These strong political signal showing a new generation of political leaders is still keeping to the Socialist road. Four is revisiting the \o Ze-Dong's historical cycle of\ofile anti-corruption and the importance of the Constitution, reorganization is bad style of officialdom, was to civilize people obey the law, while improving the color change of the regime of vigilance. Five is to reform into deeper waters and stressed that top-level design, this is a review on the reform and opening up in the past, is also looking for a way out. Six foreign and Russia closer, the flexible attitude on the issue of the Korean peninsula, Sino-Japanese fishing hardline China on the island out of the \tient\ow profile shadow began to gradually plan development. Signs show that the new leadership began to make a left turn in politics. However, as of right nownot only ideological confusion in the community, the new leadership's thinking is messy. New leaders both stressed the need to implement the Constitution, stressed the need to turn off the power in a cage. Also stresses that Mao Zedong thought cannot be lost, 30 years after the reform and opening up 30 years ago can not deny each other. Both advocate democracy and release \does not speak of\constraints. Neither deny the history of the CPC Central Committee on several issues ... Comrades: today brings together members, mainly in order to provide a platform to Exchange and learn from each other in order to facilitate our work. Just now, we focus on taxation, planning and stability, safety, project construction, typical topics such as private facts presentation and interaction, and towns currently exist in the in-depth analysis of the problems to be solved, to explore new methods to solve the problem. It can be said that summing up the achievement, no grandstanding; analysis promotion of employment, form a reasonable and orderly pattern of income distribution, build a more fair and sustainable social security systems, medical and health system reform. The plenary, innovation of social governance, must focus on the maintenance of fundamental interests of the overwhelming majority of the people, maximize factors, enhance social development, improving social governance, the interests of national security, ensure that the people live and work, social stability and order. o improve social governance, stimulating social organization, innovative and effective system of preventing and resolving social conflicts, improving the public security system, set up the National Security Council, national security systems and national security strategy to ensure national security. Plenary session, the construction of ecological civilization, you must establish systems of ecological system, using the system to protect the ecological environment. o improve natural resources asset property right system and use control, red lineof delimitation of ecological protection, resources paid use system and ecological compensation system in ecological environmnt protection management system reform. Plenary session, centering on building a listening party command, can win and having a fine style of the people's army, a strong army under the new situation of the party Goals, restricting the development of national defense and army building is solved outstanding contradictions and problems, innovation and development of military theory, enhance military strategic guidance, improve the military strategy in the new period, building a modern military force system with Chinese characteristics. o deepen the adjustment of personnel system reform in the army, military policy and system reform, promote the development of military and civilian integration depth. Plenary session stressed that comprehensive reform must be to strengthen and improve the party's leadership, give full play to the core role of the party commands the overall situation and coordinating all parties, improving the party's leading water ... Margin. Challenged the leadership of the Communist Party of China, Marxism-Leninism and Mao Zedong thought by Deng Xiao-ping's flag, replaced by three representatives and the harmonic society. The former Communist Party spirit and social cohesion point of almost all political makeover. Characteristics of socialism public ownership is shifting to private ownership, planned regulation and market regulation, the proletarian regime controlled by the elite. Of universal equality, fairness and basic principles of distribution system is socialist society, however after economic monopolized by powerful, vested interests grow, employers do not have the same status, hardly seems fair social distribution. State key protection of capital interests rather than the interests of citizens, had been hits the bottom of the proletariat4.4.3 用1%的洗洁精溶液浸润清洁抹布,拧干清洁抹布后(不滴液)擦洗内壁两遍,罐盖朝内侧和难擦洗的地方应擦洗四遍,最后用清水浸润清洁抹布擦洗内壁及灌盖内侧两遍。

4.3.4 用75%的乙醇溶液浸润清洁抹布,拧干清洁抹布后(不滴液),擦洗内壁、罐盖内侧,全部消毒一遍,最后用离子交换后的水冲洗30分钟。

4.3.5 中间水箱经清洁消毒后,以目视方法检测合格,处于待运行准备状态。 4.5 纯水储罐和输送管道的清洁、消毒

4.5.1 打开喷淋球管道阀门,用纯水输送泵循环清洗纯化水储罐20分钟后排空储罐。 4.5.2制纯化水至纯化水储罐高液位,停止制水后,启动水处理臭氧发生器和不锈钢气液混合泵运行40分钟,臭氧水制备完成。

4.5.3 先将输送至口服液车间的管道阀门打开,用纯水输送泵将储罐内臭氧水送至口服液车间管道,循环回制水站纯化水储罐,循环30分钟后,再启动水处理臭氧发生器和不锈钢气液混合泵运行20分钟,然后,开启输送至固体、提取、制剂二车间的管道阀门,用纯水输送泵将纯水站储罐内的臭氧水输送至各车间的纯化水中间站,各车间清洗、消毒完成后,从各自车间的排空口排空臭氧水。

4.5.4 纯化水站制备新纯化水至纯化水储罐高液位,供本站和各制剂车间清洁、消毒后的冲洗。

4.5.5 开启从纯水站至口服液车间的纯水管道阀门,用纯水输送泵将纯水站储罐内的纯化水送至口服液管道,循环回纯水站回水口排净,循环30分钟后,开启固体、提取、制剂二车间管道阀门,用纯水输送泵将纯水站储罐的纯化水送至固体 、提取、制剂二车间纯水中间站,待各车间对其纯水储罐和管道系统清洗完毕后,各车间自行将清洗后的纯化水排净。

4.5.6 纯化水储罐、输送管道的清洁消毒后的检测方法是:从储罐的取样口和回水取样口取样检测,其酸碱度符合规定,5≤PH≤7,电导率≤2μS/cm。

4.5.7除口服液车间外,其余车间的管道清洁、消毒按各车间纯化水清洁、消毒SOP进行。

4.5.8 臭氧水制备、使用由动力车间统一协调完成。

4.5.9 纯化水储罐、输送管道的清洁消毒周期为每月进行一次。

4.5.10 纯水装置清洁后的最长保存时间为一个月,重新生产前需进行再清洁、消毒。

bviously, face China's Socialist system, the Communist Party is not the party. In that case, political chaos has been very tight. Is remodeling or reconstruction, is a correction or a stove. Whether to turn right or left, is back to the source or put forward new political ideas. This is to determine the road problems in China, is also the key out of the deep water of the reform of the economic system. After 18, the new Central collective leadership attaches great importance to political orientation. First, the \s\starting from the Central Government's self-restraint, which preaches and pro-image, brought fresh feeling to the community. Secondly, before reform and opening up and reform and opening two periods after non-negative, untying the tangle of the society a long time on this issue. Third, a new generation of party leaders on various occasions to Mao Ze-Dong and Mao Ze-Dong's thought of evaluation has room for manoeuvre, through to the ruling ideology of Mao Zedong thought, is thecall of the soul to the Socialist Revolution and construction. Empty talks jeopardize national interests and try again, is an affirmation of Deng Xiao-ping's reform ideas. These strong political signal showing a new generation of political leaders is still keeping to the Socialist road. Four is revisiting the \o Ze-Dong's historical cycle of\ofile anti-corruption and the importance of the Constitution, reorganization is bad style of officialdom, was to civilize people obey the law, while improving the color change of the regime of vigilance. Five is to reform into deeper waters and stressed that top-level design, this is a review on the reform and opening up in the past, is also looking for a way out. Six foreign and Russia closer, the flexible attitude on the issue of the Korean peninsula, Sino-Japanese fishing hardline China on the island out of the \tient\ow profile shadow began to gradually plan development. Signs show that the new leadership began to make a left turn in politics. However, as of right nownot only ideological confusion in the community, the new leadership's thinking is messy. New leaders both stressed the need to implement the Constitution, stressed the need to turn off the power in a cage. Also stresses that Mao Zedong thought cannot be lost, 30 years after the reform and opening up 30 years ago can not deny each other. Both advocate democracy and release \does not speak of\constraints. Neither deny the history of the CPC Central Committee on several issues ...Comrades: today brings together members, mainly in order to provide a platform to Exchange and learn from each other in order to facilitate our work. Just now, we focus on taxation, planning and stability, safety, project construction, typical topics such as private facts presentation and interaction, and towns currently exist in the in-depth analysis of the problems to be solved, to explore new methods to solve the problem. It can be said that summing up the achievement, no grandstanding; analysispromotion of employment, form a reasonable and orderly pattern of income distribution, build a more fair and sustainable social security systems, medical and health system reform. The plenary, innovation of social governance, must focus on the maintenance of fundamental interests of the overwhelming majority of the people, maximize factors, enhance social development, improving social governance, the interests of national security, ensure that the people live and work, social stability and order. o improve social governance, stimulating social organization, innovative and effective system of preventing and resolving social conflicts, improving the public security system, set up the National Security Council, national security systems and national security strategy to ensure national security. Plenary session, the construction of ecological civilization, you must establish systems of ecological system, using the system to protect the ecological environment. o improve natural resources asset property right system and use control, red line of delimitation of ecological protection, resources paid use system and ecological compensation system in ecological environment protection management system reform. Plenary session, centering on building a listening party command, can win and having a fine style of the people's army, a strong army under the new situation of the party Goals, restricting the development of national defense and army building is solved outstanding contradictions and problems, innovation and development of military theory, enhance military strategic guidance, improve the military strategy in the new period, building a modern military force system with Chinese characteristics. o deepen the adjustment of personnel system reform in the army, military policy and system reform, promote the development of military and civilian integration depth. Plenary session stressed that comprehensive reform must be to strengthen and improve the party's leadership, give full play to the core role of the party commands the overall situation and coordinating all parties, improving the party's leading water ... Margin. Challenged the leadership of the Communist Party of China, Marxism-Leninism and Mao Zedong thought by Deng Xiao-ping's flag, replaced by three representatives and the harmonic society. The former Communist Party spirit and social cohesion point of almost all political makeover. Characteristics of socialism publiownership is shifting to private ownership, planned regulation and market regulation, the proletarian regime controlled by the elite. Of universal equality, fairness and basic principles of distribution system is socialist society, however after economimonopolized by powerful, vested interests grow, employers do not have the same status, hardly seems fair social distribution. State key protection of capital interests rather than the interests of citizens, had been hits the bottom of the proletariat汇仁药业

编码:SOP-QJO015-04

4.5.11 纯水装置使用前检查设备清洁状态的方法:打开原水进口阀,正洗机械过滤器5分钟,用洁净试管在机滤出水口取样,用肉眼观察其水质澄清,然后关机滤下排阀。开活性炭过滤器进水阀并正洗5分钟,用洁净试管在正洗出口取样,用肉眼观察其水质澄清时,打开精密过滤器下进阀和上排阀,正洗精密过滤器5分钟,用洁净试管在正洗出口取样,用肉眼观察其水质澄清时,表明纯水过滤装置清洁合格。

4.5.12 动力车间纯水站按动力车间5S管理规定执行,外人不得入内,清洁后的罐盖处常闭状态。 5 相关记录

5.1 消毒剂配制记录 SOP-QJO015-04R1 5. 1 纯化水储罐、管道清洁、消毒记录 SOP-QJO015-04R2 5. 2 纯化水预处理水箱、中间水箱清洁、消毒记录 SOP-QJO015-04R3

bviously, face China's Socialist system, the Communist Party is not the party. In that case, political chaos has been very tight. Is remodeling or reconstruction, is a correction or a stove. Whether to turn right or left, is back to the source or put forward new political ideas. This is to determine the road problems in China, is also the key out of the deep water of the reform of the economic system. After 18, the new Central collective leadership attaches great importance to political orientation. First, the \es\point, starting from the Central Government's self-restraint, which preaches and pro-image, brought fresh feeling to the community. Secondly, before reform and opening up and reform and opening two periods after non-negative, untying the tangle of the society a long time on this issue. Third, a new generation of party leaders on various occasions to Mao Ze-Dong and Mao Ze-Dong's thought of evaluation has room for manoeuvre, through to the ruling ideology of Mao Zedong thought, ithe call of the soul to the Socialist Revolution and construction. Empty talks jeopardize national interests and try again, is an affirmation of Deng Xiao-ping's reform ideas. These strong political signal showing a new generation of political leaders is still keeping to the Socialist road. Four is revisiting the \o Mao Ze-Dong's historical cycle of\ofile anti-corruption and the importance of the Constitution, reorganization is bad style of officialdom, was to civilize people obey the law, while improving the color change of the regime of vigilance. Five is to reform into deeper waters and stressed that top-level design, this is a review on the reform and opening up in the past, is also looking for a way out. Six foreign and Russia closer, the flexible attitude on the issue of the Korean peninsula, Sino-Japanese fishing hardline China on the island out of the \ow profile shadow began to gradually plan development. Signs show that the new leadership began to make a left turn in politics. However, as of right now, not only ideological confusion in the community, the new leadership's thinking is messy. New leaders both stressed the need to implement the Constitution, stressed the need to turn off the power in a cage. Also stresses that Mao Zedong thought cannot be lost, 30 years after the reform and opening up 30 years ago can not deny each other. Both advocate democracy and release \n does not speak of\cal constraints. Neither deny the history of the CPC Central Committee on several issues ...Comrades: today brings together members, mainly in order to provide a platform to Exchange and learn from each other in order to facilitate our work. Just now, we focus on taxation, planning and stability, safety, project construction, typical topics such as private facts presentation and interaction, and towns currently exist in the in-depth analysis of the problems to be solved, to explore new methods to solve the problem. It can be said that summing up the achievement, no grandstanding; analysis

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