卫生管道清洗钝化技术规范.doc

Shanghai Ideal Sanitary System Engineering Co Ltd Sanitary System Solution for Pharmaceutical Enterprises Technical Specification of Cleaning and Passivation of Sanitary Piping Page1of11 Technical Specification of Cleaning and Passivation of Sanitary Piping 卫生管道清洗钝化技术规范卫生管道清洗钝化技术规范 编写编写 Prepared by 公司 部门 Company Dept 签字 Signature 日期 Date 审核审核 Checked by 公司 部门 Company Dept 签字 Signature 日期 Date 批准批准 Approved by 公司 部门 Company Dept 签字 Signature 日期 Date Shanghai Ideal Sanitary System Engineering Co Ltd Sanitary System Solution for Pharmaceutical Enterprises Technical Specification of Cleaning and Passivation of Sanitary Piping Page2of11 CONTENT 目录目录 1 范围 RANGE 3 2 概述 SUMMARY 3 3 方法 METHODS 4 4 准备工作 PREPARATIONS 4 5 操作过程 OPERATION PROCESS 6 6 注意点 ATTENTION 10 7 防护要点 SAFETY 10 8 资料 DOCUMENT 11 Shanghai Ideal Sanitary System Engineering Co Ltd Sanitary System Solution for Pharmaceutical Enterprises Technical Specification of Cleaning and Passivation of Sanitary Piping Page3of11 1 范围范围 RANGE 本文件属于上海意迪尔洁净系统工程有限公司内部文件 仅用于指导意迪尔公司所承担的 洁净系统工程的管道焊接 包括 但不局限以下项目 制药用水贮存和分配系统 配料系 统 This document is the internal document for Shanghai Ideal Sanitary Engineering Co Ltd and is applicable for the project validation Ideal has undertaken including but not only including the following Manufacturing storage and distribution system of water for pharmaceutical use product manufacturing system 文件描述文件描述 Description of Document 本技术规范是对成都苑东药业有限公司工厂设施中 PW 和 WFI 系统以及混料罐系统的技 术要求进行明确 The technical specification specifies the requirements regarding storage tanks and distribution loops in the PW and WFI System and Mixing Tank System in the Baxter Healthcare Co Ltd Facility at Guangzhou China 文件版本文件版本 Version Handling VersionDateStatusChange A018 08 2008Quotation design 2 概述概述 SUMMARY 1 目的 通过该程序和灭菌程序 使洁净管道能够达到符合输送纯水 注射用水 纯蒸汽 及其它物料的要求 Intents Through this procedure and sterilization procedure the sanitary pipes can conform to the requirements of transporting PW WFI pure steam and other materials A 碱洗 清洗管道内壁的油污 杂物及其它有机物 Alkali cleaning remove the grease mess and other organism from the inner piping wall B 酸洗 将管道内壁焊缝处的焊瘤 毛刺等洗除 Pickling remove the burr and welding bulge from the welding seam of the inner piping wall C 钝化 将管道内壁的凸出 尖出洗平或洗钝 Passivation level or passivate the bulge and spine on the inner piping wall 2 要求 经过酸洗 钝化的洁净管道 在管路灭菌后对所输送的介质不产生新的污染 Shanghai Ideal Sanitary System Engineering Co Ltd Sanitary System Solution for Pharmaceutical Enterprises Technical Specification of Cleaning and Passivation of Sanitary Piping Page4of11 Requirement the passivated and pickled sanitary pipes don t make recontamination to the transporting media after sterilization 3 方法方法 METHODS 1 原理 通过强酸 一般为 HNO3 对金属的强氧化性 强腐蚀性对管路进行酸洗 钝化 Principle pickle and passivate the pipes through strong oxidation and corrosion of strong acid generally HNO3 to metal 2 配制 详见附表 Compounding method for details see the attached form A 碱洗 10 的 NaOH 浓度为 98 和 90 的纯水的碱溶液对管路循环冲洗 Alkali cleaning circularly flush the loop with alkali solution of 10 NaOH concentration 98 and 90 PW B 酸洗 50 的酸 其中 HNO3 浓度为 65 68 占 75 HF 浓度为 40 占 25 和 50 的纯水的酸溶液对管路循环冲洗 Pickling circularly flush the loop with acid solution of 50 acid among it 75 is HNO3 concentration between 65 68 and 25 is HF concentration 40 and 50 PW C 钝化 20 的 HNO3 浓度为 65 68 和 80 的纯水的酸溶液对管路循环冲 洗 Passivation circularly flush the loop with acid solution of 20 HNO3 concentration 65 68 and 80 PW 4 准备工作准备工作 PREPARATIONS 1 材料准备 事先应先按管路的长度和容器的容积计算出所需酸碱的容积 然后根据配制 比例 准备好所需的酸碱量 Material preparation calculate in advance the acid and alkali needed according to the piping length and container capacity Prepare certain needed quantities of acid and alkali according to the compounding proportion 若无处理排放酸的设施 最好应增加用于中和酸的 NaOH Use NaOH to neutralize the acid if no facilities are available for disposing of and discharging the acid 酸最好是桶装酸 纯度为工业用纯度就可 Acid in bucket is preferred Industry purity is enough 碱可用袋装片碱 纯度为工业用纯度就可 Alkali tablets in bag are acceptable Industry purity is enough 2 计量 检查工具的准备 酸洗 钝化的容器最好为带有刻度的容器 便于计量溶液的体 积 重量 Preparation of dosing and inspecting tools vessels with scales are preferred for pickling and passivation because it s convenient to measure the solution volume weight Shanghai Ideal Sanitary System Engineering Co Ltd Sanitary System Solution for Pharmaceutical Enterprises Technical Specification of Cleaning and Passivation of Sanitary Piping Page5of11 固体碱称量可用杆秤 弹簧秤称量 Steelyard and spring balance can be used to weigh the solid alkali 温度表 压力表 试纸等 Thermometer pressure gauge test paper etc 3 防护用品的准备 安全帽 防酸手套 防酸面罩 耐酸围裙及其它劳保用品 Preparation of safety apparatus safety helmet antacid gloves antacid veil antacid apron and other labor protection apparatus 为防止酸 碱溅到人体 皮肤上 最好应准备部分醋酸和小苏打 NaHCO3 溶液和干 纱布 同时还应准备创口贴 白药 脱脂纱布 胶布等常用药品 Prepare some acetic acid saleratus NaHCO3 solution and dry gauze to prevent acid and alkali spattering to human body and skins Prepare some common drugs as well such as wound protector Baiyao degreased gauze rubberized cloth etc 4 设备的准备 耐酸碱循环泵 阀门 耐酸碱的橡胶软管 喉箍 铅丝 盲板 垫片 卡 箍 卡箍长接头 以及用于封堵拆除仪表后的接口堵头 Equipment preparation acid and alkali resistant pump valve acid and alkali resistant rubber hose lead thread blind plate gasket clamp clamp liner long and joint block for sealing after the gauges are removed 氩弧焊机 电源线 氩气以及防护面罩 焊丝等 Argon Arc Weld Machine power supply line argon safety veil and welding rod etc 5 其它工具的准备 扳手 手虎钳 螺丝刀 电笔 手电筒 耐酸的搅拌棒 水桶等 Other tool preparation spanner pliers screwdriver electroprobe electric torch acid resistant muddler bucket etc 若检查部位较多 如多层建筑 或制水间离用水点距离较远 应配备对讲机 以便即时 通知 更好的协调工作 If the locations needing check are too many like multi layer building or the water generation room is too far away from points of using interphones should be used for timely notification and better communications 以上所有材料 设备 工具均应完好 可直接投入使用 All the above materials equipments and tools are perfect and can be put into use directly Shanghai Ideal Sanitary System Engineering Co Ltd Sanitary System Solution for Pharmaceutical Enterprises Technical Specification of Cleaning and Passivation of Sanitary Piping Page6of11 5 操作过程操作过程 OPERATION PROCESS 1 水冲洗 Water flushing 用纯水经循环泵对管路进行循环冲洗 边冲洗 边排放 时间不得低于 20 分钟 Purified water circularly flushes the loop through circulating pump Drain the water at the same time it is flushing Duration should be no less than 20 minutes 2 碱洗准备 Preparation for alkali cleaning 先将装碱液的容器与循环泵及管路系统连接起来 在末端接上软管至碱液容器 并保证 连接和容器严密不漏 确认后先向容器中放入已计算好用量的纯水 再慢慢放入已计算 好用量的固体碱 并用搅拌棒充分搅拌均匀 接通水泵电源 断开控制开关 准备碱洗 Firstly connect the alkali solution vessel with circulating pump and piping system by a hose between the vessel and pipe end After confirming the vessel and connection are tight and have no leaks infuse stated quantities of PW into the vessel Then slowly put in stated quantities of solid alkali and mix them equally with a mix rod Connect power supply for the pump turn off the switch and get ready for alkali washing 搅拌人员应戴好防酸碱面罩 防止对人员造成伤害 Mixing person shall wear acid and alkali resistant veil in order not to bring damages to personnel 装碱的容器应完好 无任何渗漏 与管道接口处连接良好 The alkali solution vessel shall be in good conditions and have no leakages The joint should be well connected 3 碱洗 Alkali cleaning 合上控制开关 用循环泵抽碱溶液进管路系统 对管路循环冲洗 时间大约为 30 分钟 在碱洗过程中 应有专人检查 检查方法 用试纸与焊点处接触 若无变色则说明无泄 露 每一焊点 发现漏点 应立即通知看泵人员停泵 并在漏点附近的用水点放空碱液 并对漏点进行补焊等相关处理 处理后方可继续进行碱洗 对流到地面 吊顶上的碱液 应用干布擦拭干净 Switch on the controller and flush the piping loop with alkali solution through circulating pump for about 30 minutes During this period there shall be person specially in charge of checking method contact the welding point with test paper No discoloration means no leak each welding point If any leaking point is found notify the pump monitoring person to stop the pump immediately drain the alkali solution at the using points nearby the leaking point and process certain treatment like rewelding to the leaking point Until after treatment can alkali cleaning continue wipe off the alkali solution water flowed on the floor or suspended ceiling with dry cloth 4 水冲洗 Water flushing Shanghai Ideal Sanitary System Engineering Co Ltd Sanitary System Solution for Pharmaceutical Enterprises Technical Specification of Cleaning and Passivation of Sanitary Piping Page7of11 用纯水经循环泵对管路进行循环冲洗 边冲洗 边排放 直至排放的水为中性为止 Purified water circularly flushes the loop through circulating pump Drain the water at the same time it is flushing until the draining water is neutral 对循环后的碱溶液 应用另外的容器暂存 以用于与酸中和排放 Use a vessel in addition to store the circulated alkali solution so that it can be drained after neutralization with acid 5 酸洗准备 Preparation for pickling 先将装酸的容器与循环泵及管路系统连接起来 在末端接上软管至酸溶液容器 并保证 连接和容器严密不漏 确认后先向容器中放入已计算好用量的纯水 再慢慢放入已计算 好用量的酸 并用搅拌棒充分搅拌均匀 接通水泵电源 断开控制开关 准备试压 First connect the acid solution vessel with circulating pump and piping system by a hose connecting the vessel and pipe end After confirming the vessel and connection are tight and have no leakages pour stated quantities of PW into the vessel Then slowly put in stated quantities of acid and mix them equally with a mix rod Connect power supply for the pump turn off the switch and get ready for pickling 搅拌人员应戴好防酸碱面罩 防止对人员造成伤害 Mixing person shall wear acid and alkali resistant veil in order not to bring damages to personnel 装酸的容器应完好 无任何渗漏 与管道接口处连接良好 如可能也可将容器放到室外 The acid solution vessel shall be in good conditions and have no leakages The joint shall be well connected Laying the vessel outdoor is acceptable 若容器渗漏时 可用清水对准渗漏点不停的冲洗 直至酸洗完成 If vessel leaks flush the leaking point ceaselessly with clear water until pickling accomplished 6 酸洗 Pickling 合上控制开关 用循环泵抽酸溶液进管路系统 对管路循环冲洗 时间大约为 60 分钟 在酸洗过程中 应有专人检查 检查方法 用试纸与焊点处接触 若无变色则说明无泄 露 每一焊点 发现漏点 应立即通知看泵人员停泵 并在漏点附近的用水点放空酸液 后 用胶带纸缠绕包扎漏点 并在漏点下方放上水桶 以便接住流出的酸液 若无法用 桶接水 应在漏点下方垫上浸过稀碱液的抹布 将循环泵接通纯水对管路进行水冲洗 待管路系统中的酸液全部排放后 方可对漏点进行补焊等相关处理 处理后方可继续进 行酸洗 对流到地面 吊顶上的酸液应用干布擦拭干净 对流到缝隙处的酸 应用稀碱 液进行中和后 在用干布擦净 Switch on the controller and flush the piping loop with acid solution through circulating pump for about 60 minutes During this period there shall be person specially in charge of checking method contact the welding point with test paper No discoloration means no leakage each welding point If any leaking point is found notify the pump monitoring person to stop the pump immediately After draining the acid solution at the using points nearby the leaking point rotate bandage around the leaking point and put a bucket under the leaking point to collect the leaking acid solution if bucket is not available replace it with weak alkali solution soaked Shanghai Ideal Sanitary System Engineering Co Ltd Sanitary System Solution for Pharmaceutical Enterprises Technical Specification of Cleaning and Passivation of Sanitary Piping Page8of11 duster cloth Switch on the circulating pump and flush the loop with PW Process certain treatment like rewelding on the leaking point until all the acid solution is drained from the loop Only after treatment could pickling continue wipe off the acid solution water flowed on the ground or suspended ceiling with dry cloth To the acid flowing to the cracks neutralize them with weak alkali solution before wiping them off 7 水冲洗 Water Flushing 用纯水经循环泵对管路进行循环冲洗 边冲洗 边排放 直至排放的水为中性为止 Purified water circularly flushes the loop through circulating pump Drain the water at the same time it is flushing until the draining water is neutral 8 钝化准备 Preparation for Passivation 先将装酸的容器与循环泵及管路系统连接起来 在末端接上软管至酸溶液容器 并保证 连接和容器严密不漏 确认后先向容器中放入已计算好用量的纯水 再慢慢放入已计算 好用量的酸 并用搅拌棒充分搅拌均匀 接通水泵电源 断开控制开关 准备试压 First connect the acid solution vessel with circulating pump and piping system by a hose connecting the vessel of acid solution and pipe end After confirming the vessel and connection are tight and have no leakages pour stated quantities of PW into the vessel Then slowly put in stated quantities of acid and mix them equally with a mix rod Connect power supply to the pump turn off the switch and get ready for pickling 9 钝化 Passivation 合上控制开关 用循环泵抽酸溶液进管路系统 对管路循环冲洗 时间大约为 120 分钟 在钝化过程中 应有专人检查 检查方法 用试纸与焊点处接触 若无变色则说明无泄 露 每一焊点 发现漏点 应立即通知看泵人员停泵 并在漏点附近的用水点放空酸液 后 用胶带纸缠绕包扎漏点 并在漏点下方放上水桶 以便接住流出的酸液 若无法用 桶接水 应在漏点下方垫上浸过稀碱液的抹布 将循环泵接通纯水对管路进行水冲洗 待管路系统中的酸液全部排放后 方可对漏点进行补焊等相关处理 处理后方可继续进 行钝化 对流到地面 吊顶上的酸液应用干布擦拭干净 对流到缝隙处的酸 应用稀碱 液进行中和后 在用干布擦净 Switch on the controller and flush the piping loop with acid solution through circulating pump for about 120 minutes During this period there shall be person specially in charge of checking method contact the welding point with test paper No discoloration means no leakage each welding point If any leaking point is found notify the pump monitoring person to stop the pump immediately After draining the acid solution at the using points nearby the leaking point rotate bandage around the leaking point and put a bucket under the leaking point to collect the leaking acid solution if bucket is not available replace it with weak alkali solution soaked duster cloth Switch on the circulating pump and flush the loop with PW Process certain treatment like rewelding to the leaking point until all the acid solution is drained from the loop Only after treatment could pickling continue wipe off the acid solution water flowed on the ground or suspended ceiling with dry cloth To the acid flowing to the cracks neutralize them with weak alkali solution before wiping them off 10 水冲洗 Shanghai Ideal Sanitary System Engineering Co Ltd Sanitary System Solution for Pharmaceutical Enterprises Technical Specification of Cleaning and Passivation of Sanitary Piping Page9of11 Water Flushing 用纯水经循环泵对管路进行循环冲洗 边冲洗 边排放 直至排放的水为中性为止 Purified water circularly flushes the loop through circulating pump Drain the water at the same time it is flushing until the draining water is neutral 11 废液排放 Wastewater discharge 将用完后的废酸 废碱应中和至中性或近似中性后方可直接排放 另有处理的除外 Neutralize the waste acid and alkali to neutralization or almost neutralization prior to discharge unless they are treated in other ways Shanghai Ideal Sanitary System Engineering Co Ltd Sanitary System Solution for Pharmaceutical Enterprises Technical Specification of Cleaning and Passivation of Sanitary Piping Page10of11 6 注意点注意点 ATTENTION 1 碱洗 酸洗 钝化时每个检查人员应以高度的责任心仔细检查每一焊点 坚决不放过每 一个可能漏点 When alkali cleaning pickling and passivation are carried out each inspector shall check each welded point with high responsibility and do not let pass each possible leaking point 试压 碱洗 酸洗 钝化时每个检查人员都应带好水桶 抹布和试纸等物 碱洗 酸洗 钝化时还应带好耐酸手套 防酸面罩等防护用品 吊顶内检查人员还应戴好安全帽 带 上照明器材 保证检查时有足够的照度 When operating pressure test alkali cleaning pickling and passivation each inspector shall bring bucket duster cloth and test paper safety apparatus shall be put on such as antacid gloves and antacid veil when operating alkali cleaning pickling and passivation Inspectors on the suspended ceiling shall wear safety helmet and bring lighting facilities to ensure enough light 7 防护要点防护要点 SAFETY 1 人员防护 Personnel Safety A 配制酸碱液人员 检查人员等相关人员均应戴好防酸手套 防酸面罩及防酸工作 服等 Alkali and acid compounding personnel inspector and relative person shall wear antacid gloves antacid veil and antacid uniform B 发生事故时 第一要确保人员的安全 Protect human safety firstly once accident happens C 若碱液溅到皮肤上应立即用干布擦净 然后用醋酸涂于溅落处片刻 最后用清水 冲洗干净 If alkali spatters on skin wipe it off immediately by dry cloth paint acetic acid on the spattered area for a while then clean it by clean water D 若酸液溅到皮肤上应立即用干布擦净 然后用小苏打溶液涂于溅落处片刻 最后 用清水冲洗干净 If acid spatters on skin wipe it off by dry cloth immediately paint saleratus on the spattered area for a while then clean it by clean water E 严禁直接用手或其它裸露皮肤直接接触酸液 碱液 用抹布擦拭酸碱液时必须带 好防酸手套和防酸面罩 Touching the alkali and acid directly with hands or other exposed skin is strictly forbidden Wear the antacid gloves and antacid veil while wiping the acid and alkali solution with duster cloth F 配制酸碱溶液时 应缓慢地将碱 酸沿容器壁流进水中 严禁直接将酸碱溶液倒 入水中 以防溅起酸碱液 特别严禁将碱 或酸 直接倒入酸 或碱 中 Slowly pour the alkali and acid and let it flow to the water along the inner wall while compounding the alkali or acid solution Directly pour the acid or alkali into water is Shanghai Ideal Sanitary System Engineering Co Ltd Sanitary System Solution for Ph