最佳实践的分享和研讨

Sharing Best Practice Workshop 最佳实践的分享和研讨 Design and Operation of cGMP Utilities Facility cGMP公用工程设施的设计和运作 David James Process Engineering Manager 工艺工程经理 S2F Consulting (Shanghai) 诚赋开朋商务咨询（上海）有限公司 Presentation Agenda 演讲议题 Facility Life Cycle 设施的生命周期 Turning Business Needs into a Design 将业务需求融入设计 Good Design for Commissioning and Qualification 充分考虑调试和验证的良好设计 Good Commissioning and Qualification 良好的调试和验证 What Matters in Operations & Maintenance Phase 运行和维护阶段的主要问题 Design Decisions that Last a Life Cycle 设计中的决策贯穿整个生命周期 Design Impacts on Commissioning & Qualification 设计对调试和确认的影响 Design Impacts on Operations & Maintenance 设计对运行和维护的影响 Critical Design Considerations for cGMP Utilities cGMP公用设施的设计要点 Questions & Discussion 问题和讨论 S2F Consulting (Shanghai) S2F咨询（上海） S2F is an established multi-disciplinary Architectural and Engineering consulting firm focused on the delivery of complex buildings where the integration of science & technology, building services and architecture requires a considered response. S2F是一家多专业的建筑和工程咨询公 司，专注于提供科技、设施和建筑的综合 性解决 方案 气瓶 现场处置方案 .pdf气瓶 现场处置方案 .doc见习基地管理方案.doc关于群访事件的化解方案建筑工地扬尘治理专项方案下载 。 S2F Consulting – Our Services and Experience S2F咨询 –我们的设施和经验 Architecture 建筑 Mechanical Engineering 机械工程 Electrical Engineering 电气工程 Process Engineering 工艺工程 Validation 验证 Project Management 项目管理 Master Planning / Front End Studies 总体规划/前端研究 Procurement 采购 Value engineering reviews工程经济评估 Hazard analysis灾害危险性 分析 定性数据统计分析pdf销售业绩分析模板建筑结构震害分析销售进度分析表京东商城竞争战略分析 Life cycle costing 生命周期成本估算 Energy recovery and sustainability 能量回收和可持续性 Cost engineering and scheduling 造价管理和工期计划 Production capacity modeling生产能力模型 cGMP engineering cGMP工程 Commissioning & Qualification 调试和验证 Sterile Parenterals无菌静脉注射剂 Oral solid dose口服固体制剂 Liquids, Creams and ointments 液体、乳霜和软膏 Potent and toxic compounds 强效及含有毒成分药 Antibiotics抗生素 Biologicals生物制剂 Aerosols气雾剂 Radiopharmaceuticals放射性药物 Complimentary medicines替代性药品 Medical devices医疗设施 Dispensing and compounding配料 Filling & compression充装和压片 Packaging and warehousing包装和仓储 R&D and QA laboratories研发和质检实验室 Containment systems密闭系统 Pilot plants中试装置 Waste treatment facilities废水处理设施 Utilities infrastructure公用工程设施 Facility Life Cycle 设施生命周期 Business Need 业务需求 Design 设计 Construction 施工 Commissioning & Qualification 调试和确认 Validation 验证 Operation & Maintenance 运行和维护 Demolition 拆除 Major Refurbishment 主要的更新 Changes 变更 $ $$ $ $ $$ The V – Model V模型 The V – Model V模型 V – Model Approach – Relies on getting the first stage right V模型方法 取决于能否使第一阶段正确 – Tends to minimise what is captured in URS 倾向于将URS中捕捉到的特性数最小化 User Req Specs (URS) 用户需求说明 Functional Specs (FS) 功能说明 Performance Qualification 性能验证 Operational Qualification 运行验证 Tendency: Only put in here….….……….………..…..What is tested here 趋向：仅在这里列出 这里需要测试什么 The V – Model V模型 V – Model Approach V模型的方法 Can miss important aspects of the business need and return on investment 可能会忽略业务需求和投资回报的重要方面 Focuses on – Quality Aspects 专注于： 质量方面 – Performance / Capacity – Quality at specified rate 性能/能力 –质量达到指定的级别 Ignores – Unit Costs / Operating Costs 忽略： 装置成本 / 运行费用 – Reliability and long term performance 可靠性和长期性能 – Corporate policies – safety, sustainability, etc 公司策略 –安全性，可持续性等 Solution - Project Brief 解决方案 -项目概要 BUSINESS CASE 业务案例 $$ IN $$ OUT DESIGN / SPECIFICATION – PROJECT BRIEF 设计/说明书 –项目概要 > Registered Process 合格的工艺 > Product Quality Attributes 产品质量特性 > Performance / Capacity / Output 性能/生产能力/产量 > Reliability / Maintainability / Availability / Efficiency – OOE or OEE 可靠性/可维护性/可用性/生产效率 –总体运行效率/总体设备效率 > Business Case Assumptions – Unit Costs, Capital Budget 业务案例假设-单位造价，基本预算 > Intended Life / Duration of the Facility 预期寿命/设施的延续时间 > Corporate Policies and Standards – Quality, Safety, Sustainability 公司政策和 标准 excel标准偏差excel标准偏差函数exl标准差函数国标检验抽样标准表免费下载红头文件格式标准下载 –质量、安全、可持续性 > Future flexibility / changes 未来的灵活性/变更 Project Brief in the V-Model V模型中的项目概要 Project Brief 项目概要 DQ The New Lean Approach – e.g. ASTM E2500 新的精益方法 –例如：ASTM E2500 Project Brief 项目概要 URS FS/TS C&Q PVDQ Business Case Good Design Practice for 充分考虑调试和验证 Commissioning & Qualification 的良好设计实践 To assist with Commissioning and Qualification, the Design must : 为了给调试和验证阶段提供充分的支持，设计应确保以下方面: > Define a documentation structure – e.g. V–Model, Lean approach 定义文档体系结构 –例如，V模型，精益方法等 > Establish process systems structure and define system boundaries 建立工艺系统结构并定义系统边界 > Assess each system and define Critical Quality Attributes (CQAs) 评估每个系统，并定义关键质量指标(CQA) > Focus on what defines the product quality and how these attributes are measured and controlled 关注于用什么来定义产品质量，以及这些指标如何被测量和被控制 > Assessment tools – e.g. FMEA, HACCP, HAZOP, etc 评估工具 –例如潜在失效模式及后果分析FMEA，危害分析和灾害控制点 HACCP，危险和可操作性分析HAZOP Good Design Practice for 充分考虑调试和验证 Commissioning & Qualification 的良好设计实践 > Assess each system and define Critical Quality Attributes (CQAs) 评估每个系统并定义关键质量指标CQA > GMP Impact Assessment – e.g. SIA & CIA (ISPE), FLIA (Lean) GMP影响性评估 –例如：SIA和CIA (ISPE)，以及FLIA (精益方法) > Document the results 将结果文档化 > This is the basis for focused commissioning and qualification 这是我们所关注的调试和确认过程的基础 > Establish operating and acceptance ranges for each CQA 为每个CQA建立运行和验收范围 > These are Acceptance Criteria for Commissioning and Qualification 作为调试和确认过程的验收标准 > Determine what is Good Engineering Practice (GEP) and what is GMP 确定哪些是良好工程实践GEP，哪些是药品质量管理规范GMP Impact (Risk) Assessment Results 影响性评估结果 Good Engineering Practice (GEP) & Good Manufacturing Practice (GMP) 良好工程实践GEP和药品质量管理规范GMP From the Critical Quality Attribute Assessments: 来自关键质量指标评估： GEP – Contractual, Business Impact & Plant Performance Risks GEP –受制于 合同 劳动合同范本免费下载装修合同范本免费下载租赁合同免费下载房屋买卖合同下载劳务合同范本下载 约束，对业主的业务产生影响，存在设备运行风险 > Results go into Functional & Technical Specifications 结果进入功能说明和技术说明 > Test / Prove during FAT, Commissioning & SAT FAT、调试和SAT过程中的测试和证明 GMP – Product Quality & End User Risks GMP –产品质量和最终用户风险 > Results go into Qualification and Validation Plans & Protocols 结果进入到确认和验证计划和 协议 离婚协议模板下载合伙人协议 下载渠道分销协议免费下载敬业协议下载授课协议下载 > Test / Prove during Qualification / Validation 确认和验证期间的测试和证明 Efficient Commissioning & Qualification 有效的调试和确认 Good Engineering Practice Good Manufacturing Practice 良好工程实践 药品质量管理规范 Installation Checks Installation Qualification 安装检查 安装确认 Operational Checks Operation Qualification 运行检查 运行确认 Site Acceptance Tests 现场验收测试 Performance Qualification 性能确认 > Reliability 可靠性 > Product Quality 产品质量 > Business Case 业务案例 > Consistency 一致性 Well planned and documented Commissioning means Qualification can focus on confirming the Commissioning documentation and close-out of defects 经过良好计划和文档化的调试意味着确认过程能专注于调试文档的确认以及缺陷的关 闭。 Qualification documentation is carried through to Operations and Maintenance phase to support on-going re-validation and periodic performance reviews. 确认文档用于运行和维护阶段，以支持进行中的再验证和阶段性的性能评估。 Examples of Design Impacts on 设计对确认和验证 Commissioning & Qualification 阶段的影响 –举例 Definition of Critical Quality Attributes – Measurable and Responsive 关键质量指标的定义 –可测试并且可响应 > Conductivity of water – cheap and easy to do in-line, rapid response 水的电导率 可廉价并且简单地在线测得，反馈非常快 > TOC in Water – expensive, slow response if not on-line 水的总有机碳含量 如果不是在线测得，较昂贵，反馈较慢 > Hydrocarbons in air – expensive to measure, slow turn-around 空气中的碳氢化合物 测试代价较昂贵，周期缓慢 – eliminate by using oil-free compressors 通过选用无油空压机来消除 > Contaminants in N2 – expensive to measure, slow turn-around 氮气中含杂质量 测试较昂贵，周期缓慢 – eliminate by using bulk liquid Nitrogen system 通过选用散装液氮系统来消除 Examples of Design Impacts on 设计对确认和确认 Commissioning & Qualification 阶段的影响 Specify Contractor to provide construction records for direct impact systems 明确要求承包商为GMP直接影响系统提供施工安装记录。 > Materials of construction 施工材料 > Fabrication / welding records 制作/焊接记录 Specification of instrument ranges – Operating range vs Instrument range 仪器量程说明 –运行范围和仪器范围的比较 Provision of sample points in GMP utilities – at each point of use, to suit all tests 为GMP相关设施提供取样点 –位于每个用户点附近，以适应所有的测试 Access to components for inspection / calibration / adjustment 使用检测/校验/调节的组件 Consideration of local conditions in specification of equipment 考虑设备规格的本地条件 > Impact of quality fluctuations in Town Water on Pre-Treatment 在前处理考虑城市生活水的水质波动。 Operation & Maintenance Phase 运行和维护阶段 What does an Operations Manager care about? 生产经理最关心什么？ Product Out the Door 把产品送出门去 > Throughput 产能 – Manufacture to “the plan”生产满足原计划 > Unit Cost 单位成本 – Use only the materials and labour in the manufacturing resource plan, minimum waste, rejects and re-work 仅使用生产资源规划中需要的原料和人工，将废 物、尾料和返工最小化 > Quality 质量 – Follow the validated process, pass the quality control tests, complete the batch records, keep the equipment and facility validated 按验证过的过程生产，通过质检测试，完善批次 记录，确保设备和设施已做过验证 > Safety 安全 Operation & Maintenance Phase 运行和维护阶段 Enhancing Manufacturing Output 提高产量 : Machine Reliability – select equipment that does not need to run at maximum speed 设备可靠性 –选择设备时考虑一定的裕量，使其不必在最大能力下运行 Documented machine set up procedures and training programs based on C&Q 基于调试确认阶段的机器启动程序和培训程序 Periodic Re-Validation & Validation of Changes 定期的重验证及变更后的验证 – Takes time away from manufacturing 削减了用于生产的时间 – Focused, well organised qualification documents reduce the burden and time required for re-validation 目标专注且组织良好的验证文件可减少重验证带来的负担和时间 On-going Testing – Focus on CQAs专注于各项CQA 测试过程中 – Use qualification results to justify testing regimes 使用验证结果来调整测试方法 Examples of Design Impacts on 设计对运行和维护 Operations and Maintenance 阶段的影响举例 Capacity of Water Production and Storage 水制备和储存能力 – Manufacturing time lost ‘waiting for water’ 生产时间上忘记加上“等待用水”的时间 – Production make-up rate versus Tank capacity versus Holding time 水制备流量，水罐容量和维持时间的对应 Temperature of WFI – Cold WFI is convenient but requires sanitisation WFI温度 冷WFI更方便，但需要灭菌处理 – Sanitisation takes up to 24 hours of production time 灭菌处理占用生产时间最多达24小时 Sampling of WFI for TOC – Off Line – Convenient, but slow, high operating cost WFI取样作TOC分析 离线方式 –方便但缓慢，操作成本较高 – On Line – High capital cost, fast response, automated 在线方式 –高成本，快速取得结果，自动操作 Redundancy – Adds to capital cost but eliminates unplanned down-time 冗余备份 增加了费用支出，但消除了未预测的停产时间 Examples of Design Impacts on 设计对运行和维护 Operations and Maintenance 阶段的影响举例 Quality of Equipment – Adds to capital cost but reduces unplanned down-time 设备质量 –增加了总成本支出但减少了未预测的停产时间 Space allowed to remove RO membranes or distillation columns 留出足够空间以便移动RO膜或蒸馏柱 Energy & Water Efficiency – reduces operating costs, increases capital cost 提供能量和水的利用率 –降低操作成本，增加总成本 Level of Automation – Reduces labour cost, improves consistency, reduces 自控的级别 errors but increases training effort, maintenance costs, capital cost, down time 降低人力成本，增加一致性，减少错误率，增加培训和维 护成本，总体成本和停产时间 – cGMP Critical control systems - Part 11 compliance cGMP关键控制系统 –第11部分符合性条款 cGMP UTILITIES cGMP公用工程 What defines a utility as cGMP? DIRECT IMPACT on Product Quality 是什么将某种公用工程定义为cGMP？ 对产品质量的直接影响性 System Impact Assessment (ISPE) 系统影响性评估(ISPE) > Does the system have direct product contact? 该系统是否直接接触产品？ > Does the system provide an ingredient, excipient or solvent used in the product? 该系统是否被用作为产品的某种成分，辅料或溶剂？ > Is the system used in cleaning or sterilizing? 该系统是否被用于清洗和灭菌？ > Does the system produce data used to accept or reject product? 该系统是否形成决定产品是否可被接受的数据？ > Is the system a control system that may affect product quality but has no independent verification? 该系统是否被作为一种控制系统，从而影响到生产质量，但未被单独鉴定？ cGMP UTILITIES cGMP公用工程 Direct Impact cGMP Utilities cGMP公用工程的直接影响性 – Water – used in product or cleaning – Water for Injection or Purified Water 水 用于产品或清洗 注射用水或纯化水 Steam – used in product contact – Clean or Pure Steam 蒸汽 用于直接产品接触 洁净蒸汽或纯蒸汽 Air – used in product contact – Process or Sterile Air 空气 用于直接产品接触 工艺或无菌压缩空气 Gases – used in product contact – Nitrogen, Oxygen – Sterile filtered 气体 用于直接产品接触 氮气和氧气 –经无菌过滤 Process Water – Critical Design Considerations 工艺用水 –设计要点 Production Rate - versus - Storage Volume - versus - Holding (turnover) Time 生产率 –存储容量 –事故停顿时间 Balance of factors - Cost of production capacity 各因素的综合平衡 生产能力的成本 - Convenience of holding large volume of water 维持大容量的水是否方便 - Potential Contamination from “old “ water “老”水中潜在的污染 WFI Cons (L) 4460 Prep Phosphate Buffer WFI flush of Solution Prep tan 100 Sunday 24.00 CIP/SIP 2 x Phosphate Buffer 700 Monday 1.00 WFI to Solution Prep vessel 1000 Monday 2.00 CIP Solution Prep vessel 850 Monday 3.00 Wash sundry items 100 Monday 4.00 Monday 5.00 Conc test Wash sundry items 100 Monday 6.00 Monday 7.00 Mix Phosphate buffer WFI flush SATA Reaction Ves 100 Monday 8.00 Monday 9.00 Mix DMSO & SATA Prepare 30% W/V NaOH 50 Monday 10.00 Wash sundry items 100 Monday 11.00 Monday 12.00 UF SATA Wash UF skid and pump 200 Monday 13.00 Wash sundry items 100 Monday 14.00 Monday 16.00 Filtration of SATA CIP/SIP Conjugation Reaction 350 Monday 17.00 CIP SATA Reaction Vessel ve 350 Monday 18.00 Wash sundry items 100 Monday 19.00 Monday 20.00 Preparation of Hydroxylamine /Wash sundry items 100 Monday 21.00 Add WFI to mix 40 Monday 22.00 Monday 23.00 Preparation of Thiomersal Wash sundry items 100 Monday 24.00 WFI CONSUMPTION ESTIMATES DOW TIME WFI Tank Level 0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000 1 .0 0 7 .0 0 1 3. 00 1 9. 00 1 .0 0 7 .0 0 1 3. 00 1 9. 00 1 .0 0 7 . 0 0 1 3. 00 1 9. 00 1 . 0 0 7 .0 0 1 3. 00 1 9. 00 1 .0 0 7 .0 0 1 3. 00 1 9. 00 1 .0 0 7 .0 0 1 3. 00 1 9. 00 1 .0 0 7 .0 0 1 3. 00 1 9. 00 Time - Monday to Sunday L i t r e s Tank Lev Process Water – Critical Design Considerations 工艺用水 –设计要点 Model the water consumption – when used, how much 水消耗的模型 –何时使用，多少量 Plan manufacturing to smooth consumption 适当的生产计划使水消耗的变化比较平滑 Accepted Practice - Use water within 24 hours of production? 可接受的实践 采用满足24小时生产的水量 - Validate actual operation 查验实际的操作 WFI Cons (L) 4460 Prep Phosphate Buffer WFI flush of Solution Prep tan 100 Sunday 24.00 CIP/SIP 2 x Phosphate Buffer 700 Monday 1.00 WFI to Solution Prep vessel 1000 Monday 2.00 CIP Solution Prep vessel 850 Monday 3.00 Wash sundry items 100 Monday 4.00 Monday 5.00 Conc test Wash sundry items 100 Monday 6.00 Monday 7.00 Mix Phosphate buffer WFI flush SATA Reaction Ves 100 Monday 8.00 Monday 9.00 Mix DMSO & SATA Prepare 30% W/V NaOH 50 Monday 10.00 Wash sundry items 100 Monday 11.00 Monday 12.00 UF SATA Wash UF skid and pump 200 Monday 13.00 Wash sundry items 100 Monday 14.00 Monday 16.00 Filtration of SATA CIP/SIP Conjugation Reaction 350 Monday 17.00 CIP SATA Reaction Vessel ve 350 Monday 18.00 Wash sundry items 100 Monday 19.00 Monday 20.00 Preparation of Hydroxylamine /Wash sundry items 100 Monday 21.00 Add WFI to mix 40 Monday 22.00 Monday 23.00 Preparation of Thiomersal Wash sundry items 100 Monday 24.00 WFI CONSUMPTION ESTIMATES DOW TIME WFI Tank Level 0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000 1 .0 0 7 .0 0 1 3. 00 1 9. 00 1 .0 0 7 .0 0 1 3. 00 1 9. 00 1 .0 0 7 . 0 0 1 3. 00 1 9. 00 1 . 0 0 7 .0 0 1 3. 00 1 9. 00 1 .0 0 7 .0 0 1 3. 00 1 9. 00 1 .0 0 7 .0 0 1 3. 00 1 9. 00 1 .0 0 7 .0 0 1 3. 00 1 9. 00 Time - Monday to Sunday L i t r e s Tank Lev Process Water – Critical Design Considerations 工艺用水 –设计要点 WFI System Temperature – WFI is used hot (cleaning) and cold (formulation) WFI系统温度 WFI使用高温(清洗用)和低温(制剂) – Industry practice is <15°C or >75°C 工业实践中为<15°C 或 >75°C – Chinese GMP requires <4°C or >80°C 中国GMP要求<4°C 或 >80°C – All WFI systems require sanitization 所有WFI系统都要求灭菌 – Sanitization takes time – usually up to 24 hrs 灭菌时间 –通常达到24小时 – Heating & Cooling takes time and energy 加热和冷却消耗时间和能量 Sanitization Options – High temperature or Ozone? 灭菌选项 高温法还是臭氧法？ – High temperature is industry norm 高温法是行业标准 – High temp is easy, no extra parts, but takes time 高温法简单易行，没有增加物质，但费时 – Ozone sanitization is usually faster 臭氧法通常更快速 – Ozone is not considered an ‘added substance’ 臭氧法并未被认为是“增加物质” – Many design considerations for ozone 臭氧法有许多设计要点 > Materials, maintenance costs, safety, etc 材料，维护成本，安全性等 – Calibration of ozone sensors 臭氧传感器的校准 Process Water – Critical Design Considerations 工艺用水 –设计要点 Clean Steam – Critical Design Considerations 洁净蒸汽 –设计要点 GMP Requirements – No US FDA or USP requirements GMP要求 没有美国FDA或USP要求 – No mention in ChP or SFDA cGMP 在ChP或中国SFDA cGMP中提及 – EU - EN285 or HTM 2031 欧盟EN285或HTM 2031 > Dryness 干燥度大于 ≥ 0.9 or ≥ 0.95 > Non Condensable Gas (NCG) 不凝性气体含量≤ 3.5% > Superheat 强热 ≤ 25°C Industry Practice – Condensate meets WFI specifications 来自行业实践 冷凝水符合WFI规范 – Limits on additives, pH, superheat, Dryness, NCG 增加物、pH值、过热、干燥度、不凝性气体的限度 – Endotoxins and pyrogens to WFI standard WFI标准中的内毒素和热原 Clean Steam – Critical Design Considerations 洁净蒸汽 –设计要点 Capacity Testing – Facility to run CS Generator at full capacity 生产能力测试 满负荷运行洁净空气发生装置的设施 Steam Sampling – At CS Generator and Points of Use 蒸汽取样 在洁净蒸汽发生装置及用户点处 – Condenser for conductivity, TOC and micro sampling 用于电导率、TOC和微生物测试取样的冷凝器 – End of distribution line condenser - Conductivity 分布管线末端冷凝器 –电导率 – EN285 test points – next slide EN285测试点见下页 “Point of Use” – Supply to machine or “product contact”? 用户点 仅提供给机器，或者直接接触产品？ Clean Steam Sampling – EN285:2006 洁净蒸汽取样– EN285:2006 Refer to EN285:2006 for details and procedures 细节及程序请参EN285:2006 Dryness 干燥性 Non Condensable Gases (NCG) 不凝性气体 Superheat 强热 Clean Steam Quality Sampling 洁净蒸汽质检取样 EN285 Sample Point EN285中的取样点 Micro & Chemical Sample Point 微生物和化学取样点 Steam Condenser 蒸汽冷凝器 Conductivity Sensor 电导率探头 Temp Sensor 温度传感器 Sample Storage 样品存放 Sample Valve 取样阀 Drain Valve 排放阀 Orifice 孔板 Compressed Air – Critical Design Considerations 压缩空气 –设计要点 GMP Requirements – “dry” and “cleaned to meet requirements” (SFDA) GMP要求 – “干燥”及“洁净程度符合要求” (中国FDA) – “free from oil and water vapor” (US FDA) –无油，无水汽 (美国FDA) – Micro and particulate levels to match environment –微生物和粉尘含量应符合所处环境的要求 “Dry” 干燥的 – Measure Dewpoint – In-line sensor at source –露点测试 –在源头使用在线传感器 – Dryness to suit application – Hydrophobic filters –干燥度符合应用需要 –带疏水的过滤器 – Refrigerated Dryers to 0°C, Desiccant Dryers -70°C –冷冻干燥机至0°C，吸附式干燥机至-70°C “Cleaned” 已清洗 – Particulate filtering – to suit application –粉尘过滤 –满足应用的需要 – 0.45 micron for product contact, 0.2 micron for sterile – 0.45μ用于产品接触， 0.2μ用于无菌生产 Compressed Air – Critical Design Considerations 压缩空气 –设计要点 “Oil free” 无油 – No clear, agreed definition of “oil free” –没有非常清楚的公认的“无油”定义 – Industry norm is <0.1 to <1.0 mg/m3 –工业标准是<0.1 到 <1.0 mg/m3 – Hydrocarbon levels measured by sampling –通过取样测量碳氢化合物等级 – New on-line meters available down to 0.001 mg/m3 –新的在线测量仪可测得低至0.001 mg/m3 – Desiccant dryers will trap oil but at what cost? –吸附式干燥器可以捕集油，但其代价如何考虑？ – Oil in the piping? How to clean it? –管道中含油吗？如何清洗？ – Oil-free compressors strongly recommended –强烈推荐无油空压机 Refer to ISO 8573 for specific contaminant levels and tests (杂质等级和测试规定参考ISO8573)Basil V R Greatex oil sensor Nitrogen – Critical Design Considerations 氮气 –设计要点 Bulk Liquid Storage or Nitrogen Generator 散装液氮储存或者氮气发生器 General Design Considerations 一般设计要点 :- > Rate of Consumption 消耗程度 > Cost per kilogram 每公斤损耗 > Quality – What purity is required? Are you sure? 质量 –究竟需要多少纯度？是否确信？ > Quality Testing – Who will do this? 品质测试 –谁能做这些？ Nitrogen – Critical Design Considerations 氮气 –设计要点 Considerations for Bulk Liquid N2 :- 散装液氮的考虑： > Availability of bulk liquid 桶装液体的可获得性 > Security of Supply 供应可靠性 > Size of storage tank – Frequency of refill 储罐的大小 -重新充满的频率 > Ability to change Suppliers 更换供应商的能力 > Ownership of Storage tank 储罐的拥有权 Considerations for N2 Generator :- 氮气发生器的考虑： > Ownership of equipment 设备的拥有权 > Who wi