christian bachofen 克里斯蒂安巴霍芬 · 2015-09-07 · seite 5 j&j / cilag ag,...

Christian Bachofen | Phone +41 79 215 24 14 | [email protected] CB Consultancy AG | Plazza Pintgia, CH-7416 Almens | www.cbconsultancy.ch

NAME 姓名: Christian Bachofen

YEAR OF BIRTH 出生年: 1965

NATIONALITY 国籍: Switzerland 瑞士

LANGUAGES 语言: German, English 德语，英语

EDUCATION: Engineer for HVAC, Pharma Water System and Clean Room System

教育背景：暖通工程师，制药用水系统和洁净室系统

MOBILE 移动电话: +41 79 215 24 14

E-MAIL 电子邮箱: [email protected]

CHRISTIAN BACHOFEN 克里斯蒂安巴霍芬 CURRICULUM VITAE 简历

SPECIAL FIELDS 专业领域

Project Management, cGMP specialist for Clean Room and HVAC Design, Pharma Water

Systems Design, Quality Management, Layout for Pharmaceutical Facilities, Vaccine

Production Facilities, Fill Finish Facilities

项目管理，cGMP 洁净室和 HVAC 系统设计专家，制药用水系统设计，质量管理系统，制药厂房设施平

面图，疫苗生产厂房设计，灌封厂房设计

REFERENCES 项目参考

Hualan Bacterin, Xinxiang, China, 2013 – 2014 华兰生物，中国新乡 2013-2014 年

Monoclonal Antibody production facility including pilot plant, bulk and fill finisch facility,

Consultant for mechanical and HVAC system as well as process equipment, complete

facility design, CD, BoD and design review

单抗生产厂房包括中试车间，原液和灌封车间。设备和 HVAC 系统方面咨询师包括工艺设备，全套的厂

房设计-概念设计，基础设计和详细设计审核

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Hualan Bacterin, Xinxiang, China, 2012 华兰生物，中国新乡， 2012 年

Egg based virus Production, BSL2+, Lyophilized bacterial vaccine production, Consultant

for mechanical and HVAC system as well as process equipment, complete facility design,

preparation of WHO PQ product summary file CD until start up and Qualification, QMS

training

蛋基病毒疫苗生产，生物安全 2 级加强，冻干疫苗生产，设备和 HVAC 系统方面咨询师包括工艺设备，

全套的厂房设计，帮助客户准备 WHO 预认证产品主文件（PSF），概念设计直至试运行和确认，以及质

量管理体系（QMS）培训

BCHT Changchun, China, 2012 – 2014 百克生物，中国长春， 2012-2014 年

Egg based virus Production, BSL2+, bacterial vaccine production, Consultant for

mechanical and HVAC system as well as process equipment, complete facility design, CD,

BoD and design review

蛋基病毒疫苗生产，生物安全 2 级加强，疫苗生产，设备和 HVAC 系统方面咨询师包括工艺设备，全套

的厂房设计：概念设计，基础设计和详细设计审核

Baxter Vienna, Austria, 2012 – 2013 巴斯德维也纳，澳大利亚，2012-2013 年

New fill- finish facility including lyophilization, Consultant for process equipment as well as

layout development and all cGMP issues, CD and BoD

新的灌封厂房包括冻干，工艺设备方面咨询师，同时也制定平面图以及 cGMP 方面的事宜，概念设计和

基础设计。

Novartis Pharma, Stein Switzerland, 2011 – 2015 诺华制药，瑞士斯坦因，2011-2015

New Solid Launch Facility for highly active solids and inhaler products, Consultant for

mechanical and HVAC system as well as layout development and all cGMP issues, CD until

start up and Qualification

新的固体制剂启动厂房，用于生产高活性固体制剂和吸入式产品，设备和 HVAC 系统方面咨询师，同时

也制定平面图以及 cGMP 方面的事宜，从概念设计直至厂房试运行和确认。

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Panacea Biotec, India, 2009 帕纳西生物，印度，2009 年

Lalru, India, egg based virus Production, BSL2+, Consultant for mechanical and HVAC

system as well as process equipment, CD until start up and Qualification, QMS training

印度拉鲁，蛋基病毒疫苗生产，生物安全 2 级加强，设备和 HVAC 系统方面咨询师包括工艺设备，从概

念设计直至厂房试运行和确认，以及质量管理体系（QMS）培训

GPO, Bangkok, Thailand, 2010 – 2012 GPO 生物，泰国曼谷，2010-2012 年

Egg based virus Production, BSL2+, Consultant for mechanical and HVAC system as well

as process equipment, CD until start up and Qualification, QMS training

蛋基病毒疫苗生产，生物安全 2 级加强，设备和 HVAC 系统方面咨询师包括工艺设备，从概念设计直至

厂房试运行和确认，以及质量管理体系（QMS）培训

ADImmune, Taiwan, 2006 – 2009 国光生物，台湾， 2006-2009 年

Taichung Taiwan, egg based virus Production, BSL2+ and 3, Seed Virus Lab Consultant for

mechanical and HVAC system as well as process equipment, from conceptual design until

start up and Qualification

台湾台中，蛋基病毒疫苗生产，生物安全 2 级加强和 3 级，毒种实验室，设备和 HVAC 系统方面咨询师

包括工艺设备，从概念设计直至厂房试运行和确认

BioFarma, Indonesia, Bacterial / Viral Vaccine production, 2008 – 2014

生物制药，印度尼西亚，菌苗和毒苗生产，2008-2014 年

Bandung Indonesia, Bacterial bulk P, TT, DT, Hib Production, Viral bulk sIPV, IIV

Production, fill- finish and lyophilizing, total 5 lines, Animal QC, Consultant for mechanical

and HVAC system as well as process equipment and production process, conceptual design

and detail design, QMS training

印尼万隆，菌苗原液 P，TT，DT，HiB 生产，病毒原液 sIPV, IIV 生产，灌封和冻干，共 5 条线。动物

QC，设备和 HVAC 系统方面咨询师包括工艺设备，以及生产工艺，概念设计和详细设计，以及质量管理

体系（QMS）培训

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Egyvac, Egypt, 2010 – 2012 埃及生物，埃及，2010-2012 年

Cairo, Egypt, egg based Virus Production, Consultant for mechanical and HVAC system as

well as process equipment, from conceptual design until start up and Qualification

埃及开罗，蛋基病毒疫苗生产，设备和 HVAC 系统方面咨询师包括工艺设备，从概念设计直至厂房试运

行和确认

Vigoo, Beijing China, 2011 微谷，中国北京，2011 年

Beijing, China, Multi-Purpose Vaccine Production Clinical Phase III, Consultant for

mechanical and HVAC system as well as process equipment, design review

中国北京，三期临床多用途疫苗生产，设备和 HVAC 系统方面咨询师包括工艺设备，详细设计审核

J&J / Cilag AG, Switzerland 2013 – 2014 强生，瑞士，2013-1014 年

Schaffhausen, Switzerland, Vials filling line for MAb’s, leader of the design team

瑞士沙夫豪森，单抗-西林瓶分装线，设计团队负责人

J&J / Cilag AG, Switzerland 2003 – 2006 强生，瑞士，2003-2006 年

Schaffhausen, Switzerland, Lyophilization Antibiotics, Production Facility, two Vials Filling

Lines including Compounding and six Lyophilizer, leader of the design team

瑞士沙夫豪森，冻干抗体，生产厂房，2 条西林瓶分装线包括混合和 6 台冻干机，设计团队负责人

J&J / Cilag AG, Switzerland, 2001 – 2006 强生, 瑞士，2001-2006 年

Schaffhausen, Switzerland, Lyophilization Proteins, Production Facility, two Vials Filling

Lines including Compounding and six Lyophilizer, leader of the design team

瑞士沙夫豪森，冻干蛋白，生产厂房，2 条西林瓶分装线包括混合和 6 台冻干机，设计团队负责人

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J&J / Cilag AG, Switzerland, 2005 – 2009 强生，瑞士，2005-2009 年

Schaffhausen, Switzerland, Fill Finish Pilot Plant, Production Facility Clinical Phase 3, Vials

and Syringe Filling Lines including Compounding and two Lyophilizer, leader of the design

team

瑞士沙夫豪森，灌封中试车间，3 期临床生产厂房，西林瓶和注射器分装线包括混合和 2 台冻干机，设计

团队负责人

J&J / Cilag AG, Switzerland, 2006 – 2010 强生，瑞士，2006-2010 年

Schaffhausen, Switzerland, High Speed Syringe Filling Line and Bulk Syringe Filling Line,

leader of the design team

瑞士沙夫豪森，高速注射器分装线和原液注射器分装线，设计团队负责人

Roche, Switzerland, 2001 – 2005 罗氏，瑞士，2001-2005

Basel, Switzerland, R&D lab Building 92, overall project coordinator for HVAC and

mechanical systems

瑞士巴塞尔，研发用实验楼 92，HVAC 和机械设备系统方面的总体项目工程协调人

Novartis Pharma AG, Switzerland, 2003 – 2014 诺华制药，瑞士，2003-2014 年

Basel, Switzerland – R&D Campus – Office and Lab buildings for Research and

Development, incl. Kat III and Kat. IV – Strategy and QA – Project Idea until move in –

Independent Quality Assurance; QA Coordinator

瑞士巴塞尔—研发园区—办公大楼和用于研发的实验室大楼，包括生物安全 3 级和 4 级—项目策划和

QA—从项目意向到搬进去—独立的质量保证；QA 协调人

Scope of Services – Training and Know-How Transfer

服务范围-咨询，设计和规划

Topic 名称

Key Items covered by CB Consultancy

CB咨询公司服务项目

General Regulatory

Requirements

总体法规要求

. Design of risk based quality management systems according

to relevant GMP guidelines(WHO,EU, USA, China)

设计基于风险评估的质量管理体系，依据相关 GMP条例

（WHO， USA，中国）.Evaluation and optimization of existing quality management

systems

评估和优化现有质量管理体系.Assistance for the setup of GMP documentation systems

辅助建立 GMP文件系统.Assistance for the compilation of high level GMP or

regulatory documents(e.g. site master files, etc)

辅助制定高水平的符合 GMP或者相关法规的文件（如现

场主文件等）

.Training and know-how transfer for overall quality

management procedures as e.g. deviation handing, change

control, out-of-specification results, corrective/preventive

action, raw material handling, supplier qualification, etc.

培训和转移整个质量管理程序的知识，如偏差处理，变更

控制，OOS结果，CAPA，原辅料处理以及供应商确认及管

理等

WHO Prequalification of

Vaccines

疫苗项目WHO 预认证

.Training and assistance for the elaboration of product

summary files(PSF)

培训并帮助制定产品主文件（PSF）.Review of PSF documents

审核产品主文件（PSF）. Preparation for the site inspection conducted by the WHO

帮助客户做WHO现场审计的准备工作

Equipment and Facility

Qualification

设备和厂房确认

.Risk based qualification procedure from the URS to the PQ

and the qualification summary report

基于风险的从 URS到 PQ的确认程序以及确认总结报告.Equipment categorization based on the inherent risks

基于风险对设备进行分类.Definition of the basic qualification approach for equipment,

according to the assigned equipment category

依据设备类型来定义基础的设备确认方法， .Integration of Computer System Validation(CSV) into the

general qualification procedure

将计算机系统验证（CSV）整合到总确认程序里.Risk assessments for complex equipment to optimize the

qualification efforts

对复杂设备进行风险评估以优化确认工作人力物力消耗. Utility quality validation for e.g. purified water or water for

injection during the PQ

公用工程质量验证，针对如 PQ过程中的纯化水，注射用

水

Cleaning, Disinfection and

Decontamination

Validation

清洁，消毒和除污染验

证

.Validation of cleaning procedures for process

equipment(lead substance assessments, sampling point

assessment, definition of acceptance criteria, case studies

during the training)

验证工艺设备的清洁程序（在培训过程中学习关键物质评

估，取样点评估，验收标准的定义，并进行案例分析）

.Validation of cleaning/disinfection procedures for clean room

facilities

洁净室厂房的清洁/消毒程序验证.Validation of fumigation processes (risk assessments on

critical spots, cycle development, study design and execution)

熏蒸工艺验证（对关键点进行风险评估，确定周期，方案

设计和执行）

.Guidance on all aspects of environmental monitoring in clean

room facilities

对洁净厂房环境监测的所有方面进行指导Validation of Sterilization

Processes

灭菌工艺验证

. Validation of moist heat processes(worst case definition for

minimum and maximum loads, use of biological indicators,

study design and execution)

验证湿热灭菌工艺（最坏情况如最小和最大装量，使用生

物指示剂，方案设计和执行）

.Validation of equipment SIP(sterilization-in-place) processes

设备 SIP（在位灭菌）工艺验证.Validation of dry heat processes(worst case definition for

minimum and maximum loads, use of endo-toxin indicators,

study design and execution)

干热灭菌工艺验证（最坏情况如最小和最大装量，使用内

毒素指示剂，方案设计和执行）

.Validation of filtration processes

验证过滤工艺Validation Aseptic Filling

Processes(Media Fills)

无菌分装工艺验证

.Definition of critical interventions during filling

定义分装过程中的关键性干预.Compilation of a risk based simulation program for the whole

compounding/formulation and filling process

制定基于分析的模拟混合/配液以及分装工艺方案

.Case studies during the training workshop

在车间内进行案例分析

Validation of Analytical

Methods

分析方法验证

.Categorization of methods, differences between compendia

methods and methods developed by the company itself

方法分类，法规方法和公司自定方法的不同之处.Design of validation studies according to the international

guideline ICH Q2(R1)

依据国际法规 ICH Q2（R1）设计验证方案.Elaboration of sample analysis plans, definition of acceptance

criteria and statistical evaluation of the analytical results

制定样品分析方案，定义验收标准和统计评估分析结果.Case studies for e.g. HPLC methods, UC spectroscopy.etc.

案例研究，如 HPLC 方法，UC 光谱学等

Manufacturing Process

Validation

生产工艺验证

.Identification of critical process parameters using root-cause-

diagrams and HACCP risk assessments

采用 root-cause图和 HACCP风险评估工具确定关键工艺

参数

.Assessment of the variation of critical process

parameters(error propagation calculation of all influencing

factors)

评估关键参数的变化（所有影响因素的的错误累加计算）.Correlation between the critical process parameters and the

product specifications

关键工艺参数和产品质量标准之间的相互关系.Information required from process development and

characterization studies

工艺研发和定性研究所要求的信息.Study design, execution and data evaluation

研究方案设计，执行和数据评估

Scope of Services – Consulting,Design and Planning 服务范围-咨询，设计和规划

Project Phase or Topic

项目阶段或项目

Key Activities covered by CB Consultancy

CB咨询公司参与的主要工作

Facility URS

厂房 URS

. Definition of the project requirements and key data together

with our clients

与客户一起定义项目要求和关键数据. Description and visualization of the project requirements in a

facility URS document

在厂房 URS里对项目要求进行描述并将要求项目要求反映

到图纸上

. Calculation of required installations in the facility and the

building

厂房内级建筑大楼的安装计算Conceptual Design and

Basis of Design

概念设计和基础设计

. Assistance for the design of facility buildings

辅助设计厂房大楼.Design of clean room facilities, layout development

洁净室厂房设计，平面图制定. Illustration and evaluation of manufacturing processes,

assessment of the impact on the facility design(e.g. related to

the personnel, material and product flow)

展示和评估生产工艺，评估厂房设计影响（如，相关于人

员，物料和产品流）

.Heating, Ventilation and Air Conditioning(HVAC) design

暖通空调系统（HVAC）设计.Definition of building automation and facility monitoring

systems

定义楼宇自动化和厂房监测系统.Design of technical areas

设计技术区域.Elaboration of biosafety concepts, hazardous goods concepts

and ATEX concepts(for handling of flammable/explosive

substances)

整合生物安全概念，危险品概念和防爆概念（针对易燃/易

爆物质）

.Description and definition of required decontamination

systems

描述和定义所要求的防污染消毒系统.Definition of required equipment in the facility

定义厂房所要求的设备

.Definition of required process utilities(purified water,etc.) and

building utilities(waste water, power supply, ect.),including

elaboration of consumption lists

定义所要求的工艺公用工程（纯化水，等）和大楼公用工程

（废水，供电，等），包括制定消耗清单.Definition of detailed technical solutions for all topics to be

implemented during the detail design

定义详细的技术方案解决详细设计中的所有问题

.Evaluation of energy saving and energy efficiency

measures(“green” building and facilities)

评估节能和有效能耗（“绿色”环保生产大楼和厂房）

Detail Design Review

详细设计审核

. Review of the locally elaborated(or otherwise outsourced)

detail design for clean room facilities

审核有关洁净室厂房的所有由当地设计方或者委托第三方

做的详细设计方案。

. Value engineering(project optimization to achieve a good cost

benefit-ratio)

工程评估（项目优化已达到一个号的投资收益比例）.Project quality assurance

项目工程质量保证Construction Quality

Assurance

施工质量保证

. Training for local construction companies

培训当地施工公司.Inspection of the construction work at site

在现场检查施工工作.Elaboration of deficiency lists and reports

制定缺陷列表和报告Process Equipment

工艺设备

.Elaboration of process equipment concepts based on the

manufacturing process(for e.g. complex, facility-integrated

equipment)

以生产工艺为基础制定工艺设备概念（针对，如复杂的，

综合性的设备）

.Project quality assurance (review of supplier documents as

functional specifications, P&l diagrams, technical documents,

FAT/SAT reports, etc.; supervision of FATs and SATs)

项目工程质量保证（审核供应商文件，如功能规范，P&ID

图，技术文件， FAT/SAT报告，等；监督 FAT和 SAT）

Qualification and Validation

确认和验证

.Qualification and validation master planning

确认和验证主文件.Formulation of user requirements for individual

systems(elaboration of URS documents)

制定单个设备系统的 URS（制定 URS文件）.Detailed qualification planning for individual

systems(elaboration of System Qualification Plans or detailed

tests plans including the acceptance criteria)

制定单个系统的详细确认方案（制定系统确认方案或者详

细测试方案包括验收标准）

.Review of supplier or customer qualification documents(e.g IQ,

OQ or PQ plan/reports)

审核供应商或者客户的确认文件（如，IQ，OQ或者 PQ方

案/报告）.Qualification traceability and tracking(to verify that all

requirements from URS documents have been implemented)

确认追踪和记录（验证所 URS文件里的要求是否都满足了）

.Assistance for deviation handling and change control

辅助进行偏差处理和变更控制. Training and know-how transfer(please see the separate scope

of service document for this topic)

培训并做知识转移（请参考本服务范围有关培训的内容）

Christian Bachofen | Phone +41 79 215 24 14 | [email protected]

CB Consultancy AG | Plazza Pintgia, CH-7416 Almens | www.cbconsultancy.ch | January 2014

Company Reference

项目参考

Sinovac Biotech Co. Ltd.

科兴生物科技有限公司

Project: Training and design review

项目：培训和设计审核

Manufactured products 产品:

- Pneumococcal and EV71 Vaccine

肺炎疫苗和 EV71 疫苗

Work description 工作描述:

- Design review EV71 detail design

EV71 疫苗厂房详细设计审核

- Design review Pneumococcal CD 肺炎疫苗厂房概念设计审核

- cGMP training Q and V 现行 GMP 确认和验证培训

Our services 我们的服务:

- design review sessions including reports 设计审核包括报告

- training qualification, cleaning validation, computer system validation, process validation, bilingual Chinese – English 确认，清洁验证，计算机系统验证，工艺验证等培训，中英文双语。

Special project features 项目特色:

- Compliance with EU GMP 符合欧盟 GMP

- Compliance with SFDA 符合 SFDA 要求



Company Reference 项目参考

Novartis Pharma AG 诺华制药

Project: New Solid Launch Facility in Switzerland

项目：瑞士总部固体制剂新厂房


- OSD and Inhaler, highly active products up to category 4

OSD 和气雾剂，高活性产品可达生物安全 4 级

Project description 项目描述:

- 16 OSD production modules incl. Dispensing, Granulation, Capsule Filling, Tabletting, Coating, Blistering, Packaging

16 个 OSD 生产模块，包括分配，颗粒化，胶囊填充，压片，包衣，泡罩，包装

- 16 Inhaler production modules 16 个气雾剂产品模块

- OSD pilot scale production OSD 中试生产厂房

- Washing areas, washing isolator, QC lab 清洗区域，清洗隔离器，质控实验室

Our services 服务内容:

- Representing the client in regards to HVAC and clean rooms as well as containment strategy, starting with conceptual design and ending with OQ 给客户 HVAC 系统和洁净室系统以及安全防护策略，启动概念设计和完

成运行确认

- Qualification planning IQ and OQ 安装确认和运行确认规划


- Multi product facility 多产品厂房设施

- New containment concept for highly active products 针对高活性产品的新安全防护概念

- Launch facility for worldwide market 面向国际市场的启动厂房

- Certified planned for EU GMP US FDA 按照欧盟 GMP 和美国 FDA 要求进行规划

- Operational planned 2016

计划 2016 年投入使用



Company Reference 项目参考

Hualan Bio Xinxiang, China 中国新乡，华兰生物

Project: MAB 项目：单抗


- Generic monoclonal antibodies 基因单克隆抗体


- Pilot plant and MAB production facilities 中试车间和单抗生产厂房

- Formulation, filling and lyophilization for bio products 生物制品的配液，分装和冻干

- Logistic 物流

Services 服务内容:

- Conceptual design including building master planning 概念设计，包括厂区总体规划

- Basis of design 基础设计

- Detail design review 详细设计审核

- Qualification and validation planning 确认和验证规划


- Fast track project 快速项目

- Multi product production units 多产品生产厂房

- Easy extendable 易于扩展

- Operational in 2016 计划 2016 年投入使用



Personal Reference 项目参考

Hualan Bacterin, Xinxiang, China 中国新乡，华兰生物

Project: WHO PQ for Influenza Vaccine

项目：流感疫苗 WHO 预认证


- Seasonal and pandemic influenza vaccine 季节性流感和大流感疫苗


- Readiness for WHO PQ WHP 预认证准备


- cGMP training 现行 GMP 培训

- Review and commenting of qualification and validation documents 审核及评价确认和验证文件

- Review and commenting of GEP documents 审核和评价 GEP 文件

- Guidance in issuing the product summary file (PSF) and review 指导华兰制定和审核 PSF 文件


- PQ expected by 2014 可在 2014 年通过 PQ

- Bilingual Chinese – English project documentation 中英文双语项目文件



Personal References 项目参考

Cilag AG, an organization of Johnson & Johnson

Cilag 公司，隶属于强生

Project: Lyophilized Production Facility in Switzerland

项目：位于瑞士的冻干生产厂房


- Lyophilized bio products, MAB (e.g. Remicade) 单抗，冻干生物制品（如，英利息单抗）



- Vials filling line, Isolation technology 西林瓶分装线，隔离技术

- Formulation in C-grade area, filling rooms C-grade C 级区域配液，C 级分装间


- Conceptual design 概念设计


- Detail design 详细设计

- Construction management 施工管理

- Qualification planning DQ, IQ and OQ 设计确认，安装确认和运行确认规划


- Two multi flexible formulation units 2 个多产品灵活配液单元

- Two vials filling lines with total 6 lyophilizer 2 个西林瓶分装线，带 6 台冻干机


- Certified by EU GMP US FDA

按照欧盟 GMP 和美国 FDA 要求进行规划

- Operational since 2007

从 2007 年开始投入使用




Cilag AG, an organization of Johnson & Johnson

Cilag 公司，隶属于强生

Project: cGMP Fill Finish Pilot Plant in Switzerland

项目：现行 GMP 灌封中试车间，位于瑞士


- Bio products, MAB, small molecules, highly active products up to category 3

生物制品，单抗，小分子，高活性产品，可达生物安全 3 级


- Aseptic formulation, filling and lyophilization for bio products 生物制品的无菌配液，分装和冻干

- Syringe and vials filling line, RABS technology 注射器和西林瓶分装线，RABS 技术

- Formulation in C-grade area C 级区域配液






- Qualification planning DQ, IQ and OQ 设计确认，安装确认和运行确认规划


- Fully automated VHP fumigation for the B and A-grade areas B 级和 A 级区域的全自动 VHP 熏蒸

- ISPE facility of the year 2009

2009 年的 ISPE 标准的厂房设施









Roche Pharma

罗氏制药

Project: New mAb Facility in Switzerland

项目：位于瑞士的新单抗（mAb）生产厂房


- Lyophilized and liquid bio products, MAB (e.g. Avastin) 单抗，冻干和液体生物制品（如，贝伐单抗）


- mAb production in a multiproduct facility 在多产品厂房内进行单抗生产


- Vials filling line, Isolation technology 西林瓶分装线，隔离技术

- Formulation in C-grade area, filling rooms D-grade C 级区域配液，D 级分装间






- Qualification planning IQ and OQ 安装确认和运行确认规划


- Multi product mAb production 多产品单抗（mAb）生产

- multi flexible formulation units 多产品灵活配液单元

- three vials filling lines with total 2 lyophilizer 3 条西林瓶分装线，带 2 台冻干机








Personal Reference 项目参考

Changchun BCHT Biotechnology Co., China

百克生物，中国长春

Project: Influenza and DTP Vaccine Production

项目：流感和百白破疫苗生产厂房设施


- Seasonal and pandemic influenza vaccine 季节性流感和大流感疫苗

- Diphtheria, Tetanus and Pertussis vaccine 白喉，破伤风和百日咳疫苗


- 4 bulk workshops 4 个原液车间

- Formulation and Vials filling lines with lyophilizer, RABS technology

带冻干机的配液和西林瓶分装线，RABS 技术

- Formulation and syringe filling lines, RABS technology 配液和注射器分装线，RABS 技术

- Storage and packaging building including QC 储存和包装区域包括 QC

- Animal QC 动物 QC 实验室




- Detail design review 详细设计


- Bulk workshops with automated VHP disinfection 配备自动化 VHP 消毒的原液车间

- Complete segregation of the workshops for Bio positive area 生物阳性区域车间完全隔离

- Operational planned in 2015 until 2017

计划于 2015 年至 2017 年间启用

christian bachofen 克里斯蒂安 巴霍芬 · 2015-09-07 · seite 5 j&j / cilag ag,...

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christian bachofen 克里斯蒂安巴霍芬 · 2015-09-07 · seite 5 j&j / cilag ag,...