设备管理_制药行业全面设备管理和gmp相适应的对策培训课件

制药行业全面设备管理与GMP相适应的对策 Total Equipment Management in Pharmaceutical Industry and the Countermeasures Compatible with GMP 2011制药工程国际论坛 2011 International Forum on Pharmaceutical Engineering 2011年06月22日 June 22,2011 中国上海 Shanghai, P.R.China 更多g m p 资料 h t t p :/w w w .c g m p .n e t GMP制度内容制度内容 GMP System Contents GMP 硬件 Hardware 厂房 Building 设备 Equipment 环境 Environment 软件 Software 先进可靠的生产工艺 Advanced and reliable production process 严格的管理制度 Strict management system 质量控制 Quality control 更多g m p 资料 h t t p :/w w w .c g m p .n e t GMP对于对于制药设备制药设备的相关规定的相关规定 GMP regulations for pharmaceutical equipment 设备的设计、选型、安装应符合设备的设计、选型、安装应符合GMP生产要求生产要求 Equipment design, selection and installation should meet the requirements of GMP production 易于清洗、消毒和灭菌易于清洗、消毒和灭菌 Easy for cleaning, disinfection and sterilization 便于生产操作和维修、保养便于生产操作和维修、保养 Easy for production operation, repair and maintenance 能防止差错和减少污染能防止差错和减少污染 To prevent errors and reduce contamination 更多g m p 资料 h t t p :/w w w .c g m p .n e t 全面设备管理举例全面设备管理举例-从设计开始考虑从设计开始考虑 Example of total equipment management start from design 设备工艺设计设备工艺设计 Equipment process design 保证工艺流程畅通 Ensure smooth process procedure 保留合适设备距离 Reserves suitable equipment space 满足土建要求 Meet the requirements of civil construction 满足安全卫生和防震要求 Meet the requirements of safety, health and earthquake-proof 更多g m p 资料 h t t p :/w w w .c g m p .n e t 1. 保证工艺流程保证工艺流程畅Ensure smooth process procedure 通按工艺流程的顺序布置，保证水平方向和垂直方向的连续性，保障生产连续正常运行。 Arrange the equipments according to the sequences of process procedure to ensure the continuity in horizontal and vertical direction, to make sure the continuous production operation . 2. 保留合适设备间距保留合适设备间距Reserves suitable equipment space 设备间距过大，管道拉长，操作管理不方便。 Too large equipment space will elongated tube and cause inconvenience in operation and management; 设备间距过小，给操作安装维修带来困难。 Too small equipment space will cause problem in operation , installation and maintenance. 设备与设备、设备与建筑物之间的安全距离。 Safe space among equipments, between equipments and buildings. 化工车间工人操作设备最小距离。 Minimum equipment space for workers operation in chemical workshop. 其他 Others： a. 设备水平运输通道（进出车间） The horizontal transportation passage of equipment. ( in and out of workshop) b. 设备垂直运输通道（起吊，安装） The vertical transportation passage of equipment. ( lifting and installation) 全面设备管理举例全面设备管理举例-从设计开始考虑从设计开始考虑 Example of total equipment management start from design 500 12001500 800 700 500 700900 更多g m p 资料 h t t p :/w w w .c g m p .n e t 500 700 10001200 b+400 b l+300 900 650 8001000 1000 2000 l 900 全面设备管理举例全面设备管理举例-从设计开始考虑从设计开始考虑 Example of total equipment management start from design 更多g m p 资料 h t t p :/w w w .c g m p .n e t 序号序号No.项目项目Item净安全距离净安全距离 net safe space/m 1泵与泵的距离 space of pumps不小于 not less than 0.7 2泵离墙的距离 space between pump and wall至少 at least 1.2 3泵列与泵列间的距离（双排泵间）space of pump lines 不小于not less than 2.0 4计量罐与计量罐间的距离 space of measuring tanks0.40.6 5贮槽与贮槽间的距离（指车间中一般情况）space of storage slots (normal status in workshop)0.40.6 6换热器与换热器间距离 space of heat exchanger至少at least 1.0 7塔与塔的间距 space of tower1.02.0 8离心机周围通道 passages surrounding centrifuge不小于not less than 1.5 9过滤机周围通道 passages surrounding filter1.01.8 10反应罐盖上传动装置离天花板距离（如搅拌轴拆装有困难时，距离还需加大）space between transmission devices above the reactor and ceiling ( enlarge the space if there is problem in dismantle and installation of mixer shaft 不小于not less than 0.8 11反应罐底部与人行通道距离 space between the bottom of reactor and staff passage不小于not less than 1.82.0 12反应罐卸料口至离心机的距离 space between the reactor discharge port and centrifuge不小于not less than 1.01.5 13起吊物品与设备最高点距离 space between the lifted items and the highest point of equipment不小于not less than 0.4 14 往复运动机械的运动部件离墙距离 space between the acting p arts of reciprocating machinery and walls 不小于not less than 1.5 15回转机械离墙距离 space between the rotating machinery and walls不小于not less than 0.81.0 16回转机相互间距离 space of rotating machineries不小于not less than 0.81.2 17走廊、操作台通行部分的最小净空高度 the minimum net high of corridor and passage of console不小于not less than 2.02.5 18不常通行的地方 seldom pass area净高不小于net high not less than 1.9 19操作台梯子的斜度 slope of console ladder 一般情况 normal condition不大于not more than 45 特殊情况 special condition60 20控制室、开关室与炉子之间距离 space among the control room, switch room and camp stove15 21产生可燃性气体的设备和炉子间距离 space between equipment generating of flammable gas and camp stove不小于not less than 8.0 22工艺设备和通道间距离 space between process equipments and passages不小于not less than 1.0 全面设备管理举例全面设备管理举例- -从设计开始考虑从设计开始考虑 Example of total equipment management start from design 更多g m p 资料 h t t p :/w w w .c g m p .n e t 3. 满足土建要求满足土建要求 Meet the requirements of civil construction 笨重，运转产生振动较大的设备（如离心机、压缩机、鼓风机、真空泵等）应布置在厂房底层，以减 少楼面的荷载和振动。 Heavy and large vibration equipments (such as centrifuges, compressors, blowers, vacuum pumps etc.) should be arranged in the bottom floor of plant to reduce the load and vibration. 有强烈的振动或静载荷很大的设备，其操作台和设备基础等不得与建筑物的柱，墙和基础连在 一起，以免影响厂房的安全。 The console and foundation of equipments with strong vibration or large static load, shall not be connected with the columns, walls and foundations of building, so as not to affect the plants safety. 穿过横面的设备孔、安装孔和吊物孔，一律避开厂房的柱子和主梁，绝不允许穿过主梁。 The equipment holes, mounting holes and hanging objects holes which need cross the horizontal surface of the building, shall not be set on the columns and main beams, forbidden to cross the main beams. 全面设备管理举例全面设备管理举例-从设计开始考虑从设计开始考虑 Example of total equipment management start from design 更多g m p 资料 h t t p :/w w w .c g m p .n e t 4. 满足安全卫生和防震要求满足安全卫生和防震要求 Meet the requirements of safety, health and earthquake-proof 通风：医药生产中有毒物质的散发是不可避免的，故应考虑车间的通风。 Ventilation: The dissemination of toxic substances is unavoidable in pharmaceutical production in, it is very important to consider the ventilation of workshop. 防火防爆区 Fire and explosion proof area a. 易燃易爆的生产部门布置在防火防爆区，区内防火爆，防静电等； The explosive and fire production sector should be set in the fire and explosion proof area, which is fire and explosion proof, anti-static etc.; b. 防爆防火等级高的生产区，宜应独立布置在敞开或半敞开的厂房中，或布置在厂房中单层靠外墙处或多层厂房的 最上层靠外墙处，并采取必要的泄压设施。 The production sector with high glass requirement of fire and explosion proof, should be solely set in the open or semi-open plant, or near the external wall of single layer plant or near the external wall of top layer of multi-layers plant , it is necessary to equip with pressure relief facilities. 防腐：生产腐蚀性气体、液体和固体的车间，应对产生腐蚀性介质的设备周围建筑物进行局部的特殊防腐处理。 Anti-corrosion: in the workshop produce of corrosive gases, liquids and solids, buildings surrounding the equipments produce of corrosive media should partially have special anti-corrosion treatment. 远距离控制生产。 Remote control of the production. 全面设备管理举例全面设备管理举例- -从设计开始考虑从设计开始考虑 Example of total equipment management start from design 更多g m p 资料 h t t p :/w w w .c g m p .n e t 设备布管原则设备布管原则 Equipment, piping principle 在满足工艺要求的前提下，达到安装和检修的方便。 Meet the process requirements, easy to install, inspect and repair. 管道集中敷设布置以便于管理和操作。 Pipe laying centralized for easy management and operation. 对易燃易爆，有毒有腐蚀性的介质要远离人群和生活区，保证安全。 The media of flammable, explosive, toxic and corrosive, should stay away from population and living areas, to ensure safety. 美观和投资最省。 Beautiful out looking and least investment. 全面设备管理举例全面设备管理举例-从设计开始考虑从设计开始考虑 Example of total equipment management start from design 更多g m p 资料 h t t p :/w w w .c g m p .n e t 全面设备管理举例全面设备管理举例-从设计开始考虑从设计开始考虑 Example of total equipment management start from design 设备管道材质设备管道材质 Equipment pipe material 金属金属 Metal 耐温、耐压、有一定耐腐蚀性 resistance to temperature, pressure, a certain corrosion 碳钢 carbon steel 不锈钢 stainless steel 低合金钢 low-alloy steel 非金属非金属Nonmetal 耐腐蚀、不耐温、不耐压 resistance to corrosion, but not temperature and pressure 耐酸陶瓷 acid-resistant ceramic 玻璃钢 fiberglass reinforced plastic 硬聚氯乙烯 PVC 聚四氟乙烯 Polytetrafluoroethylene 设备管道材质设备管道材质 Equipment pipe material 更多g m p 资料 h t t p :/w w w .c g m p .n e t 全面设备管理全面设备管理 Total equipment management 1 设备资产管理设备资产管理 Equipment Asset Management 2 前期管理前期管理 Prophase Management 3 使用与维护管理使用与维护管理 Usage and Maintenance Management 4 润滑管理润滑管理 Lubrication Management 5 故障管理故障管理 Fault Management 更多g m p 资料 h t t p :/w w w .c g m p .n e t 1. 设备资产管理设备资产管理 Equipment Asset Management(EAM) 对企业与设备维护工作相关的各项资源（设备档案、备件、配件、折旧、维修、保养、润滑、报废等）的设备资产全 寿命周期、标准化管理。目前已有诸多企业应用设备资产管理和维护系统对设备资产进行管理。 EAM is standardization management to the whole life cycle of maintenance work-related resources of enterprise (equipment files, spare parts, accessories, depreciation, repairs, maintenance, lubrication and retirement etc.) . At present, many enterprises adopt EAM and Computerized Maintenance Management System(CMMS)to manage their equipment asset. 全面设备管理全面设备管理 Total equipment management 更多g m p 资料 h t t p :/w w w .c g m p .n e t 全面设备管理全面设备管理 Total equipment management 设备资产管理和维护设备资产管理和维护 系统系统 EAM DQ should include URS, design standard and supplier evaluation etc. 安装确认安装确认 Installation Qualification -IQ 整体安装情况评价及按GMP要求，对校准、维护、证明和资料的检查 Evaluation of the overall installation , check of calibration, maintenance, certification and inspection data as per GMP requirements, 运行确认运行确认 Operation Qualification- OQ 动态确认，证明设备能一致地、连续地符合用户要求的功能标准 Dynamic qualification, which proves that the equipment can be consistently and continuously meet the user requirement standard 性能确认性能确认 Performance Qualification- PQ 通过文件证明在其设定的参数下进行生产时能够连续、一致地达到预 设定的标准Through the documents to prove that the equipment can consistently and continuously achieve pre-set parameters. 更多g m p 资料 h t t p :/w w w .c g m p .n e t 验证状态维护 Validation status maintenance 全面设备管理全面设备管理 Total equipment management 再验证 re-validation 回顾性验证 retrospective validation 变更控制 change control 更多g m p 资料 h t t p :/w w w .c g m p .n e t 全面设备管理全面设备管理 Total equipment management 设备验证生命周期 Equipment Validation Life Cycle 更多g m p 资料 h t t p :/w w w .c g m p .n e t 3. 使用与维护管理使用与维护管理 Usage and Maintenance Management 包括设备使用准备、清洁、检查、维护，该环节保证正确操作运行设备、合理进行技术维护、充分发挥设备技术性 能，延长设备使用寿命，确保设备经济效益最佳。 Including equipment operation preparation, cleaning, inspection and maintenance, this is to ensure proper operation of equipment, reasonable technical maintenance, fully exert technical performance of equipment, extend equipment life, ensure the best economic benefits of equipment. 使用管理：推行标准操作规程(SOP)管理，即在药品生产 过程中，规范工作方法和工人 操作、维修方法，以便 于跟踪管理和提高操作、维修技能。 Usage management: performation of standard operating procedures (SOP) management, i.e. during the pharmaceutical production process, standardize methods of work and workers operation, maintenance method to track the management and improved operation and maintenance skills. 维护管理:包括设备日常维护、定期维护、事先维护。 Maintenance management: including equipments routine maintenance, regular maintenance, preventive maintenance. 全面设备管理全面设备管理 Total equipment management 更多g m p 资料 h t t p :/w w w .c g m p .n e t 全面设备管理全面设备管理 Total equipment management 维护管理维护管理 Maintenance Management 日常维护日常维护Routine Maintenance 设备、生产管理人员应要求操作人员按设备维护保养SOP执行并做好点 检检查 。 Manager of equipment and production should require the operator to perform the equipment maintenance SOP and make point inspection check. 定期维护定期维护Regular Maintenance 设备管理部门以计划形式下达执行，由操作、维修人员按设备维护保养 SOP进行定期维护工作。 Equipment management department should issue maintenance plan and schedule, the operator and repair personnel perform regular maintenance according to equipment maintenance SOP. 事先维护事先维护 Preventive Maintenance. 通过一定的技术手段，对设备各部位进行状态监测，提前发现设备故障 的发生趋势，在设备故障还未发生时采取措施，排除故障隐患。 Through certain technical method to monitor the status of all parts of equipment , pre-find the equipment problem trend, take measures to eliminate hidden Fault before it occur. 更多g m p 资料 h t t p :/w w w .c g m p .n e t 4. 润滑管理润滑管理 Lubrication Management 严格执行设备润滑SOP规定，做到“五定” 和“三级过滤” 。 Strictly perform equipment lubrication SOP to achieve “ Five Fix” and “ Three-step Filtering” 全面设备管理全面设备管理 Total equipment management 三级过滤三级过滤 Three-step Filtering 入库过滤入库过滤 Entrance Filtering 油液经运输进入油罐时要过滤 Filtering the oil when put it into the tank after transportation 发放过滤发放过滤 Release Filtering 油液发放注入润滑油容器时要过滤 Filtering the oil when put it into the lubrication container 加油过滤加油过滤 Recharge oil Filtering 油液加入设备润滑和储油部位时要过滤 Filtering the oil when put it into the lubrication and reservation part of equipment 更多g m p 资料 h t t p :/w w w .c g m p .n e t 全面设备管理全面设备管理 Total equipment management 五定五定 Five Fix 定点定点 Fix Part 根据设备的润滑部位、润滑点和润滑装置（油标、油槽、 油泵等）的位置和数量进行加油和换油 Recharge or change oil according to the location and quantity of lubrication parts, points and devices (oil mark, tank and pump, etc.) 定定质质 Fix Material 对不同设备的不同部位，选择说明书所规定牌号的润滑油 For different parts of different devices, select the lubrication oil according to their manual indicated brand and specification. 定量定量 Fix Quantity 在加润滑油的时候，要定量 Recharge oil by the fixed quantity each time 定人定人 Fix Person 设备上各润滑点都由专人负责进行润滑 Fix the person to recharge oil for equipment parts 定时定时 Fix Time 确定加油的周期，并按规定的时间加润滑油Fix the period of lubrication, and perform it accordingly 更多g m p 资料 h t t p :/w w w .c g m p .n e t 5. 故障管理故障管理 Fault Management 设计故障:受设备制造者技术水平和制造质量制约，是设备在设计、选材、制造、装配等方面的不当造成设备固 有缺陷引起的故障，是设备前期管理所带来的故障。 Design fault: this is caused by the potential defectiveness of equipment due to the improper design, material selection, manufacturing, assembly etc, which comes from the fault of equipment by prophase management. 运行故障: 由于设备安装调试、运行操作、日常保养、维修检修以及自然磨损等因素所造成的故障，是设备在运行管理中所 带来的故障。 Running fault: this is caused by the equipment installation and commissioning, running operation, routine maintenance, repair and natural wear etc., which comes from the running management of equipment. 全面设备管理全面设备管理 Total equipment management 更多g m p 资料 h t t p :/w w w .c g m p .n e t 问题问题1 Problem 1 维保未采用风险意识管理维保未采用风险意识管理 A risk-based approach to maintenance is not used 全面设备管理全面设备管理 制药企业维保部面临的制药企业维保部面临的10大问题大问题 Total equipment management -10 problem facing maintenance departments in pharmaceutical plants 设备四类系统设备四类系统 Four-category system for equipment 直接影响（生产关键设备）直接影响（生产关键设备） Direct Impact (Product Critical Equipment) 间接影响（工艺间接影响（工艺/系统关键设备）系统关键设备） Indirect Impact (Process / System Critical Equipment) 无影响设备无影响设备 No Impact Equipment 安全安全/环境影响系统环境影响系统 Safety/Environmental Impact System 更多g m p 资料 h t t p :/w w w .c g m p .n e t 问题问题2 Problem 2 未利用或未充分利用或未有效利用未利用或未充分利用或未有效利用 计算机化的设备资产管理和维护系统进行管理计算机化的设备资产管理和维护系统进行管理 Computerized Maintenance Management Systems (CMMS) are not utilized, are under utilized or are not validated 计算机化的设备资产管理和维护系统通常执行五个GMP关键任务: A CMMS typically performs five GMP-critical tasks: 每个设备分配有一个单独的识别码 Allocating a Unique Identifying Number (UINs) to each piece of equipment 记录了有效的工厂配置 Describing the validated plant configuration 有维保计划库 Being the repository of maintenance plans 有维保工作记录 Holding records of maintenance activities 计划维保工作 Scheduling maintenance activities 全面设备管理全面设备管理 制药企业维保部面临的制药企业维保部面临的10大问题大问题 Total equipment management -10 problem facing maintenance departments in pharmaceutical plants 更多g m p 资料 h t t p :/w w w .c g m p .n e t 全面设备管理全面设备管理 制药企业维保部面临的制药企业维保部面临的10大问题大问题 Total equipment management -10 problem facing maintenance departments in pharmaceutical plants 问题问题3 Problem 3 新引进的设备维保计划未更新新引进的设备维保计划未更新 Maintenance plans are not updated as part of new equipment introduction 更多g m p 资料 h t t p :/w w w .c g m p .n e t 问题问题4 Problem 4 维保人员或承包商没有经过适当的培训维保人员或承包商没有经过适当的培训 Maintenance staff and contractors are not trained properly 全面设备管理全面设备管理 制药企业维保部面临的制药企业维保部面临的10大问题大问题 Total equipment management -10 problem facing maintenance departments in pharmaceutical plants 更多g m p 资料 h t t p :/w w w .c g m p .n e t 问题问题5 Problem 5 未考虑未考虑GMP润滑影响润滑影响 The GMP impact of lubricants is not considered 全面设备管理全面设备管理 制药企业维保部面临的制药企业维保部面临的10大问题大问题 Total equipment management -10 problem facing maintenance departments in pharmaceutical plants 更多g m p 资料 h t t p :/w w w .c g m p .n e t 问题问题6 Problem 6 部门合作不良导致公用设施维保与供给跟不上部门合作不良导致公用设施维保与供给跟不上 Maintenance of utilities and supplies falls between departmental cracks 全面设备管理全面设备管理 制药企业维保部面临的制药企业维保部面临的10大问题大问题 Total equipment management -10 problem facing maintenance departments in pharmaceutical plants 表现不太好的维保清单 The not-so-glamorous end of the maintenance activity list includes: 化学品Chemicals 电源 Power supplies 消防系统 Fire protection systems 安保系统Security systems 暖通系统HVAC 水和气体供应Water and gas supplies 更多g m p 资料 h t t p :/w w w .c g m p .n e t 问题问题7 Problem 7 无维保文件记录无维保文件记录 Maintenance activities are undocumented 全面设备管理全面设备管理 制药企业维保部面临的制药企业维保部面临的10大问题大问题 Total equipment management -10 problem facing maintenance departments in pharmaceutical plants 无维保文件记录无维保文件记录 Maintenance activities are undocumented 更多g m p 资料 h t t p :/w w w .c g m p .n e t 问题问题8 Problem 8 未运用现代维保管理技术未运用现代维保管理技术 Modern maintenance management techniques are not used 全面设备管理全面设备管理 制药企业维保部面临的制药企业维保部面临的10大问题大问题 Total equipment management -10 problem facing maintenance departments in pharmaceutical plants 更多g m p 资料 h t t p :/w w w .c g m p .n e t 问题问题9 Problem 9 设备文件不易查找设备文件不易查找 Equipment documentation is not readily accessible 全面设备管理全面设备管理 制药企业维保部面临的制药企业维保部面临的10大问题大问题 Total equipment management -10 problem facing maintenance departments in pharmaceutical plants 制造商操作手册 The manufacturers operation manual 制造商安装手册 T