BCD/PRESENTATION Biotech and Sterile Skid Design ...
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BCD/PRESENTATION Biotech and Sterile Skid Design, Manufacture and Testing 生物无菌制药技术模块的设计、制备和测试 Mar. 27th 2015 《制药业》
Transcript of BCD/PRESENTATION Biotech and Sterile Skid Design ...
BCD/PRESENTATION Biotech and Sterile Skid Design, Manufacture and Testing 生物无菌制药技术模块的设计、制备和测试 Mar. 27th 2015
《制药业》
AGENDA议程
• BCD Overview, history and key metrics BCD概述、历史及关键指标
• Project Implementation Approach 项目实施流程
• Selected project examples 精选项目案例
• Q&A 问答环节
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BCD COMPANY HISTORY 历史
2013
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BCD TEAM 团队
ENGINEERING 工程 PROCUREMENT 采购 OPERATIONS MANAGEMENT 运营管理 ADMINISTRATIVE 行政 FITTERS / WELDERS 钳工/焊工 QUALITY & COMPLIANCE 质量与合规 SAFETY 安全
40
6
4
5
141
4
5
TOTAL 205 EMPLOYEES 总计205名员工
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BCD CAMPUS OVERVIEW BCD园区总览
IRELAND CHARLEVILLE
FACILITIES设施介绍 1. ENGINEERING OFFICE 工程办公室 2. MODULE WORKSHOP A 模块车间A 3. VESSELS WORKSHOP 容器车间 4. MODULE WORKSHOP B 模块车间B 5. SERVICE & MAINTENANCE 维修售后
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PRODUCTS & SERVICES 产品与服务 Preliminary Design 初步设计 BoD (Basis of Design) Packs 生物需氧量（基础设计）包括： Process 工艺流程 Mechanical 机械 Electrical 电气 Automation 自动化 Constructability / Project Execution
Plans 施工/项目执行计划 Budget and detailed cost estimates 预算和详细的成本估算
Process Vessels 工艺罐 Product formulation, Media / Buffer Prep / Hold, Reactors, CIP, WFI, etc. 工艺配料，培养基/缓冲液制备/存储，反应 器，CIP，WFI，等。 Detailed Design 详细设计 ASME VIII, BPE, CODAP, AD Merkblätter，GB etc.
压力容器标准 PED, ATEX认证 Fabrication 制造 Vessels (up to 300,000L) 罐（最大可达300000L） Skid Modules 模块 High Alloy (AL6XN, C22, SMO, Duplex, Super
Duplex) 高合金（AL6XN，C22，SMO，双相，超级双相）
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PRODUCTS & SERVICES产品与服务 Modular Process Systems 模块化系统 Product Formulation, Sterile Filtration, CIP, SIP, Bioprocess Modules: Media
Prep, Buffer Prep, Harvest Skids, Effluent and Bio-effluent Treatment Systems 配料系统，无菌过滤，CIP，SIP，生物模块：培养基制备，缓冲液制备，收获模
块，污水与生物污水处理系统 Utility Skids – Heating & Cooling, Dosing etc. 设备模块–加热和冷却，加药等。 Detailed Design 详细设计
ASME BPE, 31.3, GAMP, etc. Inventor 3D, Electrical & Automation PED, ATEX
Fabrication 制造
Skid Modules, Superskids 标准模块，大模块。
High Alloy (AL6XN, C22, SMO, Duplex, Super Duplex) 高合金（AL6XN，C22，SMO，双相，超级双相）
Integrated Testing 集成测试 Mechanical and electrical verification 机械和电气的验证 Riboflavin sprayball coverage 核黄素喷淋覆盖 SIP / Thermal mapping SIP /热分布 Integrated functional testing 集成功能测试 IV / OV / ASTM E2500
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PRODUCTS & SERVICES产品与服务 Site services 现场服务
Installation of vessels and skids 罐子及模块的安装 Degreasing, De-rouging & Passivation 脱脂、除锈及钝化 Soft parts replacement 垫片等更换 Commissioning Plans and execution 调试方案及执行 Validation of process systems 工艺验证 Scheduled Maintenance Planning and execution 定期维修计划及执行 Traceable recording of maintenance activities 可追溯的维护活动记录
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PROJECT EXECUTION PROCESS 项目执行过程
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• Certified quality management system to I.S. EN ISO 9001:2008 (National Standards Authority of Ireland, NSAI 19.1719).
EN ISO 9001:2008质量认证管理体系（爱尔兰国家标准局， NSAI 19.1719） • The scope of certification is认证范围:
The design, manufacture and installation of process vessels, modular process units and piping systems. The provision of de-greasing, passivation, de-rouging and sanitisation services. 工艺罐、模块单元及管路系统的设计制造和安装。并且提供相应的脱脂、钝化、除锈及灭菌服务。
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NDT Supplier Process
NDT Execution Management
NDT Report Validation
NDT Report
Welding & Welder Qualification Management
Welding Validation
Databook NDT
DatabookWPS & PQR
Databook Welder
CertificationWPS & PQR
Database
Procurement Process
Weld Log
Production Material
ManagementSupplier Process
Material Certification
Material Incoming InspectionProcess
Material Certification Validation
Databook Material
Certification
Databook Test Certification
Estimation Process
Production Planning & Scheduling
Fabrication Process
NoBo Design Approval Process
Test Certification and PED
Documentation
CE Certificate
REALISATION (OP110)STORES (OP120)PROCUREMENT (OP120) VALIDATION (OP100) CLIENT ACCEPTANCE (OP100)MECHANICAL ENGINEERING (OP90)
Pricing Information & Delivery
Norms
Proposal & Quotation
Material / Equipment
Transfer Process
Welder Qualification
Database
In Process Inspection &
Pre-FATStatic FAT
Design Library
Project Management
Processes
User Requirements Specification
DEFINITION (OP60)
Schedule Definition
Scope Definition
Cost Definition(incl. Cash Flow)
Quality Definition
Risk Register
Schedule(incl. WBS)
Cost Report & Invoicing
Project / Quality Plan
Risk Assessment
Action Log & Meeting
Schedule
Cost Management
Schedule Management
Quality Management
Risk Management
Communication & Coordination
Scope Management
Variation/Change Control
Log
PROCESS ENGINEERING (OP80)
Feedback
Process Design
P&ID
Line List
Process Calculations
Project Engineering
Equipment & Component List
Equipment Datasheets
Risk Assessments(PED, MD, ATEX)
Mechanical Design
Model / GA Drawings
Detail / Isometric Drawings
MTO(incl. Material Log)
Risk Assessment
(HAZOP)
Test Protocols(FAT, SAT, Pressure
Test etc.)
Welding Requirements Specification
NDT Requirements Specification
EquipmentPRF & RFD
CE Certification(incl. IOM)
Mechanical Calculations
Procurement Status Report
Purchase Order Equipment Certification
NoBo Construction Verification
Equipment Inspection(Engineering)
Process Engineering
Documentation
Project Quality Plan
Databook Equipment Certification
Project Engineering
Documentation
Mechanical Engineering
Documentation
Electrical Engineering
HFS / HDS
Electrical Drawings
I/O List
Parts List
Subcontract Scope of Works
Automation Engineering
FDS / DDS / SMDS
Subcontract Scope of Works
Process Steps / PFS / PFD
Configuration
Panel Build
Electrical Installation
Test Protocols(SFAT, SMTS)
Test Protocols(HFAT)
Electrical Panel pre-FAT
Electrical Panel FAT
Electrical Installation
pre-FAT
Electrical Installation
FAT
Electrical Engineering
Documentation
Automationpre-FAT
AutomationFAT
Automation Documentation
Statutory Requirements
(PED, ATEX, MD etc.)
Code Requirements(EN, ASME etc.)
PROJECT ENGINEERING (OP80)
SUPPLIER
DEFINITION (OP60)
ELECTRICAL ENGINEERING (OP85) AUTOMATION ENGINEERING (OP85)
MECHANICAL ENGINEERING (OP90)PROJECT ENGINEERING (OP80)
Electrical Contractor Process
Automation Contractor Process
Preliminary Engineering /
Design
Project Execution Strategy
Functional FAT
Client Feedback
Document Validation Process
Document Management
Process
Document Register
Definition Phase 定义阶段
Planning Phase 计划阶段
Design Phase 设计阶段
Procurement Phase 采购阶段
Fabrication Phase 制备阶段
Validation / Verification
Phase 验证或确认阶段
• Product Realisation Process is fully documented in the Quality Management System (QMS). 产品实现过程完全记录在质量管理系统中（QMS）。
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• Quality Plan describes how the requirements of the contract will be met throughout the project lifecycle.
质量计划描述了怎样通过项目周期来满足合同要求。 • Schedule Development in MS Project Ms Project格式的进度计划 • Project Meetings (Internal & Client). 项目会议（与内部或与客户） • Action Log. 操作记录 • Constraint & Risk Review. 约束条件与风险回顾 • Change Management 变更管理 • Project Reporting. 项目报告
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• Procedures are in place to define the design process
定义设计过程的程序已落实 • Where in BCD scope, HAZOP’s are
executed. 在BCD范围内，已经执行HAZOP分析。 • Design risk assessments are completed
for pressure equipment, machinery and ATEX risks, where applicable.
设计风险评估在压力设备、机器以及适用的防爆风险中已经是完善的。 • Design is subject to peer review. 设计是经过内部审核的 • Internal & client design review meetings
and model reviews are conducted. 会进行内部及客户设计审查会议和模块审查。
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• Supplier & Subcontractor assessment and management processes.
评估和管理供应商及分包商。 • Material & Equipment Inspection is in accordance with
OP120-004 and to ASME BPE. 根据标准OP120-004 和ASME BPE检查材料。 • Visual and Physical Inspection. 外观和物理检查 • Calibrated inspection equipment includes:
Micrometers, Profilometers, Ferrite scope, Digital Protractors, Positive Material Identification (PMI).
校准检测设备包括:千分尺、表面粗造度检测仪,铁素体检测仪,数显角度仪, 材料光谱分析仪(PMI)。 • The material traceability and certification lifecycles are
in accordance with OP100-18 Material Certification Review.
材料的可追溯性和认证周期符合OP100-18材料认证审核。
《制药业》
Fabrication Phase制造阶段 BCD has a comprehensive welding and welder qualification system:
BCD有完善的焊接和焊工资格审核系统
• Library of Procedure Qualification Records (PQR’s).
工艺评定记录的程序库
• Library of Welding Procedure Specifications (WPS’s).
焊接工艺评定的程序库
• Notified Body Approved.
公告机构批准
• Dual Qualified (EN/ASME).
双标准（EN/ASME）
• Stainless Steel, Higher Alloys, Titanium, Carbon.
不锈钢、高合金、钛、碳
• Manual & Semi-Automatic Welding.
手动焊及半自动焊
• Low Ferrite Welding.
低铁素体焊接
• Range of Processes.
广阔的工艺范围
《制药业》
Welding Implementation焊接实施 Welding Equipment Includes焊接设备: • Calibrated Orbital Welders标准轨道自动焊机 • Calibrated Purge Monitors标准吹扫检测仪
• Magnahelic Gauges 气压表 • High Purity Purge Gas高纯度气体
Welding Documentation Includes焊接文件: • Weld Maps焊接图 • Weld Logs焊接日志 • Weld Coupon Logs焊样日志
Welding Inspection To Approved Procedures By焊接检
验批准程序: • Qualified BCD Personnel BCD相关资格人员 • Independent Third-Party NDT Contractors
独立第三方无损检测承包商
Cleaning, Pickling, Passivation Cert
(F110-004-A)
PRELIMINARIES
Job Pack(OP70-018)
Materials & Equipment
(OP120-003)
PRODUCTIONPRE-CUTTING CHECKS In-Process
Inspection Sheet(F70-018-B)
Welding Qualification Management(OP110-003)
Calibration Management(OP10-010)
Project Schedule(OP70-004)
Pressure/Leak Test Certificate(F100-002/3-A)
Notified Body Witness As Required
Welding Procedure
Specification(OP110-003)
Design Documentation
(OP70-007)
PRODUCTIONFABRICATION CHECKS
PRE-HYDROTEST
Weld Log(OP70-018)
HYDROTEST
Drainability Certificate
(F100-005-A)
Surface Finish Certificate
(F-WI-100-003A)
Attachment Leak Test Certificate
(F100-21-A)
Material Record Sheet
(F120-001-A)
Dye Pen Certificate
(F100-024-A)
• Check Head Dimensions/Surface Finish
• Check Nozzle Layout• Check Shell Dimensions
• Check Head/Shell Orientation
• Check Nozzles Straight• Check Surface Finish Per
Drawing
Check Dye Pen of All Polished Welds
(OP100-024)
In-Process Inspection Sheet
(F70-018-B)
Certification Required?
• Check Critical Dimensions
• Welding Visual Inspection (OP100-022)
• Verify Material Records Up-to-Date and Correct
Verify Drainability(OP100-005)
Verify Surface Finish(WI100-003)
PS and QE Approval for Hydrotest
As Required, Leak Test of Reinforcement Pads
(OP100-021)
Pressure/Leak Test(OP100-002/3)
• Verify Barrier Paint Coverage
• Verify Insulation Thickness
• Verify Legs Are Straight• Verify Critical External
Dimensions• Verify Cowl Fabrication &
Polishing• Welding Visual
Inspection (OP100-022)• Verify Material Record
Sheet Up-to-Date and Correct
• Verify attachments fitted
Verify Surface Finish(WI100-003)
Verify Dip Tubes and Spray Lances
(OP110-011)
Verify NDT Complete(OP100-001)
Cleaning & Pickling(OP110-004)
Spool Weld Log(F110-011-A)
As Required, Verify Ferrite Levels
(OP100-008)
Ferrite Report(F100-008-A)
Verify NDT Complete(OP100-001)
NDT Reports and Films
QE/PS Release for Electropolish
Preparation for Electropolish(OP110-007)
ELECTROPOLISH
Third-Party Electropolish
QE Electropolish Approval
Third-Party Electropolish
Certificate
PRODUCTIONFABRICATION CHECKSPOST-HYDROTEST
PS and QE Approval for Pre-FAT
Final Visual and Dimensional Checks
Sprayball Test Certificate
(F100-004-A)
Sprayball Test(OP100-004)
Verify Drainability(OP100-005)
QE/PEPRE-FAT
Agitator Run Test(OP100-007)
Agitator Run Test Certificate
(F100-007-A)
Electrical Installation& Pre-FAT
E&I SCOPE
PM and QE Approval for FAT
FAT
Release Note(OP100-009)
Executed FAT Protocol
Release Note(F100-009-A)
Vessel Packing(WI-111-024)
Final Inspection Pre-Packing(F70-018-B)
Passivation (QMS Series 130)Post-Passivation Cleanliness
Test (OP100-023)
Passivation Certificate
PMPOST-FAT
Production Supervisor Verification of Peer Review
Complete
As Required, Lift Lug Load Testing
(WI100-004)
《制药业》
In-Process inspection is conducted in accordance with defined procedures按既定程序的过程检查. Subsidiary procedures define specific test requirements including辅助程序定义具体测试要求: • Visual Examination of Welds焊缝目测检查
• NDT无损探伤
• Surface Finish表面抛光度
• Drainability排水能力
• Piping Slope Tests管道坡度测试
Pre-FAT & FAT are executed in accordance with pre-approved protocols. 符合预先批准协议的预FAT及FAT。
SAT, Commissioning & Qualification services are provided. 提供SAT、调试及认证服务。
《制药业》
Test Facilities Include: 测试设施包括： RO Water
RO水 Plant Steam
工厂蒸汽 Clean Steam
洁净蒸汽 Clean Dry Air
清洁干燥空气 Vessel Test Bay
容器试验台 Sprayball testing
喷淋测试 Calibrated inspection equipment includes: Micrometers,
Profilometers, Ferritescope, Digital Protractors, Positive Material Identification (PMI).
校准检测设备包括：千分尺，表面粗糙度仪，铁离子检测仪，数显角度仪，材料检测仪（PMI）。
《制药业》
Experienced in delivering large scale projects throughout the globe. 有交付全球大规模项目的丰富经
验。
All aspects of logistics. 全方位物流
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Project Sample项目案例
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COMPOUNDING SKID P&ID组装模块PID图
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COMPOUNDING SKID PLAN组装模块方案
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COMPOUNDING SKID ELEVATIONS 组装模块立面图
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COMPOUNDING SKID 3D MODEL 组装模块3D模型
《制药业》
COMPOUNDING SKID 3D MODEL 组装模块3D模型
《制药业》
COMPOUNDING SKID 3D MODEL 组装模块3D模型
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COMPOUNDING SKID PHOTO组装模块照片
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BCD SELECTED REFERENCE PROJECTS BCD精选项目案例
《制药业》
MEDIA / BUFFER HOLD SUPERSKID 培养基/缓冲液保存 大型设备模块
2012 WAVRE BELGIUM
VALUE € 7,000,000
OVERVIEW概述 BASIS OF DESIGN基础设计 DETAILED DESIGN详细设计 MANUFACTURING HOURS: 24,000 制造耗时24000H ENGINEERING HOURS: 16,000 工程耗时16000H AUTOMATION SYSTEM自动系统: INTEGRATED FAT完整FAT SITE INSTALLATION现场安装 COMMISSIONING IV/OV ASTM E2500 调试IV/OV ASTM E2500
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MEDIA / BUFFER HOLD SUPERSKID 培养基/缓冲液保存 大型设备模块
《制药业》
2008 CORK, IRELAND
VALUE € 5,100,000
MEDIA PREP & HARVEST HOLD 培养基制备和收获存储
OVERVIEW概述 DETAILED DESIGN 详细设计 MANUFACTURING HOURS: 19,000 制造耗时19000H ENGINEERING HOURS: 12,000 工程耗时12000H AUTOMATION SYSTEM自动化系统: INTEGRATED FAT 完整FAT SITE INSTALLATION 现场安装 COMMISSIONING 调试
《制药业》
2009
DENMARK
VALUE € 4,500,000
OVERVIEW概述 DETAILED DESIGN 详细设计 MANUFACTURING HOURS: 15,000 HRS 制造耗时15000H ENGINEERING HOURS: 10,000 HRS 工程耗时12000H AUTOMATION SYSTEM: DELTAV, 570 I/O 自动化系统： DELTAV, 570 I/O CIP SUPERSKIDS (2 X 5 SKID UNITS) CIP大型模块（2×5 模块单元） CIP RINSE SKIDS (2 SKIDS) CIP冲洗模块（2模块） CHROMATOGRAPHY BLEND SKIDS (3 MODULES) 层析模块（3个模块） BIOWASTE INACTIVATION SKID 生物废料失活模块
CIP, CHROMATOGRAPHY & BIOWASTE CIP、层析及生物废料
《制药业》
2008
VALUE € 4,200,000
OVERVIEW DETAILED DESIGN详细设计 6 VACCINE SKIDS 6个疫苗模块 MANUFACTURING HOURS: 12,600 HRS 制造耗时12600H ENGINEERING HOURS: 5000 HRS 工程耗时5000H INTEGRATED TESTING集成测试 AUTOMATION SYSTEM自动化系统: DELTAV, COMMISSIONING调试 SITE INTEGRATION现场集成
VACCINE ADJUVANT SKIDS 疫苗助剂模块
BELGIUM, us, CANADA, 比利时，美国，加拿大， FRANCE, GERMANY, JAPAN 法国，德国，日本
《制药业》
VACCINE ADJUVANT SKIDS 疫苗辅料模块
《制药业》
2007 SWEDEN
VALUE € 2,950,000
OVERVIEW DETAILIED DESIGN详细设计 11 VESSELS 11罐 MANUFACTURING HOURS: 10,900 HRS 制造耗时10900H ENGINEERING HOURS: 6000 HRS 工程耗时6000H INTEGRATED TESTING集成测试 AUTOMATION SYSTEM自动化系统: DELTAV, COMMISSIONING 调试
FLAMMABLE MEDIA / BUFFER & CIP 易燃培养基或缓冲液&CIP
《制药业》
DSP & BUFFER HOLD DSP及缓冲液保存
CURRENT SINGAPORE
VALUE € 10,800,000
OVERVIEW概述 DETAILED DESIGN详细设计 19 VESSELS 19罐 SUPERSKIDS 大型模块 TCM’S INTEGRATED TESTING集成测试 THERMAL MAPPING热辐射 COMMISIOING调试
《制药业》
2011
GENZYME BELGIUM
VALUE € 5,200,000
NANOFILTRATION - FORMULATION - BUFFER HOLD 纳滤-配料-缓冲液储存
OVERVIEW概述 DETAILED DESIGN详细设计 30 VESSELS 30罐 2 SKIDS 2个模块 MANUFACTURING HOURS: 29,000制造耗时29000H ENGINEERING HOURS: 19,000工程耗时19000H AUTOMATION SYSTEM自动化系统: INTEGRATED FAT完整FAT SITE INSTALLATION现场安装 COMMISSIONING调试
《制药业》
Qualifications认证
SAP Code Name Class M03240010 Carbon and Stainless Steel Silos (supply only) 碳及不锈钢料仓（仅供应） M03245012 Pressure Vessels, Columns - Stainless Steel 压力容器、圆柱状不锈钢
Fully ISO Compliant 完全符合ISO
Compliance with Best Practice American Society of Mechanical Engineers 满足BPE ASME
The ATEX directive compliant for working and designing in environments with an explosive atmosphere. 易爆环境下的工作和设计的ATEX标准
Licensed for Manufacturing Specialised Equipment in China 在中国制造专业设备的许可
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Pharmaceutical With 16 of the worlds top 20 pharmaceutical companies[1] as clients, BCD has gained experience in many areas of this industry including: 世界20大制药公司中前16家是BCD用户，并且BCD有该行业许多领域的经验，包括： - Fine Chemicals 精细化工 - API 原料药 - Sterile Fill/Finish 无菌灌装/完成 - Formulation 配料系统 - CIP System CIP系统 - Clean Utilities 洁净公用工程
Biotech/Biologics With our niche in High Purity Systems, BCD have been working closely leading companies in these cutting edge sciences. 鉴于在高要求生物系统中的优势，BCD已经与在如下领域领先的公司密切合作： Biotechnology 生物技术 - Vaccine Production 疫苗产品 - Biological Research Laboratories 生物研究实验室
Clients & Industries客户及行业:
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QUESTIONS & ANSWERS BCD Ireland, Railway Road, Charleville, Co. Cork总部地址 Tel: +353 (0)63 30200 Email: [email protected] BCD China Distributor中国分销商 Winatech Shanghai Mobile:18601780888 Email：[email protected]
《制药业》
