卫生管道清洗钝化技术规范.doc

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1、ShanghaiIdealSanitarySystemEngineeringCo.,Ltd.SanitarySystemSolutionforPharmaceuticalEnterprisesTechnicalSpecificationofCleaningandPassivationofSanitaryPiping卫生管道清洗钝化技术规范编写Preparedby公司/部门Company/Dept签字Signature日期Date审核Checkedby公司/部门Company/Dept签字Signature日期Date批准A

2、pprovedby公司/部门Company/Dept签字Signature日期DateTechnicalSpecificationofCleaningandPassivationofSanitaryPipingPage11of11ShanghaiIdealSanitarySystemEngineeringCo.,Ltd.SanitarySystemSolutionforPharmaceuticalEnterprisesCONTENT目录1.范围RANGE32.概述SUMMARY33.方法METHODS44.准备工作PREP

3、ARATIONS45.操作过程OPERATIONPROCESS66.注意点ATTENTION107.防护要点SAFETY108.资料DOCUMENT111.TechnicalSpecificationofCleaningandPassivationofSanitaryPipingPage11of11ShanghaiIdealSanitarySystemEngineeringCo.,Ltd.SanitarySystemSolutionforPharmaceuticalEnterprises范围RANGE本文件属于上海意迪尔洁

4、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。ThisdocumentistheinternaldocumentforShanghaiIdealSanitaryEngineeringCo.,Ltd,andisapplicablefortheprojectvalidationIdealhasundertaken,includingbutnotonlyincludingthefollowing:Manufacturing,storage

5、anddistributionsystemofwaterforpharmaceuticaluse,productmanufacturingsystem.文件描述DescriptionofDocument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。ThetechnicalspecificationspecifiestherequirementsregardingstoragetanksanddistributionloopsinthePWandWFISystemandMix

6、ingTankSystemintheBaxterHealthcareCo.,LtdFacilityatGuangzhouChina.文件版本VersionHandlingVersionDateStatusChangeA018-08-2008Quotationdesign1.概述SUMMARY1)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:Throughthisprocedureandsterilizationprocedure,thesanitarypipe

7、scanconformtotherequirementsoftransportingPW,WFI,puresteamandothermaterials.A.碱洗：清洗管道内壁的油污、杂物及其它有机物。Alkalicleaning:removethegrease,messandotherorganismfromtheinnerpipingwallB.酸洗：将管道内壁焊缝处的焊瘤、毛刺等洗除。Pickling:removetheburrandweldingbulgefromtheweldingseamoftheinnerpip

8、ingwallC.钝化：将管道内壁的凸出、尖出洗平或洗钝。Passivation:levelorpassivatethebulgeandspineontheinnerpipingwall2)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。TechnicalSpecificati