概述:描述了用于抗体制造的细胞pH臂中空纤维生物反应器的组装、标准化和灭菌方法。包括毛细管内空间（ICS）流道组件、标准化生物反应器、设置pH上限和下限、用WFP启动生物反应器、标准化温度探针、标准化进料速率、标准化再循环速率、准备辅助管道、对生物反应器进行高压灭菌、设置生物反应器、系统启动和冲洗、预接种系统检查、，系统接种、细胞接种和关闭/拆除/再生。 包括的章节:目的、范围、责任、参考和适用文件、材料和设备、健康和安全注意事项、文件要求和程序包括的附件/附录:Cell Pharm生物反应器设置和标准化记录关于本文件:这不是通用模板，这是一个14页的程序，实际上是在FDA监管机构的生物加工操作中创建和使用的。公司特定信息（名称、地址、一些图片、专有产品信息等）。 )已被修订，但内容和格式基本保留。购买理由:将其作为你自己文档项目的起点，将你文档的质量与你所在行业的同行进行比较，了解你所在行业的其他公司在做什么，哪些公司会从中受益:生物制造人员流程开发人员方法开发人员

Summary:Describes a method of assembly, standardization and sterilization of the Cell pH arm Hollow Fiber Bioreactor for use in antibody manufacturing. Covers intra-capillary space (ICS) flowpath assembly, standardizing bioreactor, setting pH high and low limits, priming the bioreactor with WFP, standardizing the temperature probe, standardizing the feed rate, standardizing the recirculation rate, preparing accessory tubing, autoclaving the bioreactor, setting up the bioreactor, system startup and flush, pre-inoculation system check, system inoculation, cell inoculation, and shut down/tear down/regeneration.Included Sections:Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and ProceduresIncluded Attachments/Appendices:Cell-Pharm Bioreactor Set-Up and Standardization RecordAbout This Document:This is not a generic template, it's a 14-page procedure that was actually created and used in the Bioprocessing operations of a FDA-regulated establishment. The company-specific information (names, addresses, some images, proprietary product information, etc.) has been redacted but the content and format have been largely preserved.Reasons to Buy:Use it as a starting point for your own documentation projectCompare the quality of your documents against your industry peersLearn what other companies in your industry are actually doingWho Will Benefit:Biologic Manufacturing PersonnelProcess Development PersonnelMethod Development Personnel