Austin--ExperienceontheMDJ摘要.pptxVIP

On Mudanjiang OncoGenerix, Ltd. Co 在牡丹江基纳瑞克斯有限公司所获的项目经验和总结;Summary概述;Location 位置;Background 背景介绍;Background 背景介绍;Site Layout现场布局;Process / Facility Design Requirements: 工艺/厂房设计要求： Aseptic Manufacture Using Advanced Aseptic Process Technology (e.g., Isolator Based) 采用先进无菌工艺技术的无菌生产（例如，基于过滤器的技术） Multi Product Facility 多产品共线车间 Liquid Lyophilized Product Capability 可生产液体冻干产品 Integrate All Activities To produce A Finished Product (Component Prep, Formulation, Filling, Packaging Distribution) 将成品生产的所有工作集成至一体（制备、配液、灌装、包装和经销） Use Current Guidelines / Thinking In Risk Based Implementation Process Automation Technology 在基于风险的实施工艺自控技术中采用现行指南/理念 Use Disposable Technology To Eliminate The potential Of Cross Contamination Between Products 采用一次性技术来消除产品间发生交叉污染的可能 Use Proven Technologies 采用已经证实的技术 A Facility Sized Specifically To The Process Need Where Construction Costs And Operating Costs Are Optimize 根据工艺需求专门设计的厂房大小，保证建造费用和运行费用实现优化 Facility / Process Must Have The Flexibility To Adapt To Changes In Technology 厂房/工艺必须具有适应技术变更的灵活性 Future Capability For Terminal Sterilization 将来适应最终灭菌工艺的能力 ;Process / Facility Design Objectives工艺/厂房设计目的: Personnel Safety人员安全 Environmental Safety环境安全 Process Safety 工艺安全 Efficient Material And People Flows 有效的物流和人流 Easy To Construct / Implement 易于建造/实施 Safe To Operate 运营安全 Easy To Operate 易于运营 Easy To Clean 易于清洁 Easy To Maintain 易于维护 Easy To Validate 易于验证 Implement Equipment Systems That Are Reliable 采用可靠的设备/系统 Redundancy Strategy To Protect Process / Product Quality 采用冗余测量来保护工艺/产品质量 Energy Saving节能 ;The Manufacturing Process Is Designed To Allow The Following Options生产工艺设计使我们具有如下选项: Process Option A: Vials Solutions 工艺选项A：西林瓶溶液产品 Process Option B: Vial Filling / Lyo Loading / Lyophilization 工艺选项B：西林瓶灌装/冻干机上料/冻干 Process Option C: Vial Lyophilization / Lyo Unloading / Vial Capping 工艺选项C：西林瓶冻干/冻干卸料/西林瓶轧盖 ;Facility Capabilities 车间能力;Facility Capabilities车间能力;Facility Capabilities车间能力;OncoGenerix Capabilities基纳瑞克斯的能力;Process Building 1st Floor La