概述:描述了细胞培养生产过程中“无菌技术”的程序指南。提供细胞培养生产过程中的“无菌处理”程序，以及细胞培养生产过程中使用的工作表面和用品的清洁程序。适用于需要在日常工作中进行细胞培养的制造人员。包括的章节:目的、范围、责任、参考和适用文件、材料和设备、健康和安全考虑、文件要求和程序包括的附件/附录:无关于本文件:这不是一个通用模板，它是一个4页的程序，实际上是在FDA的生物加工操作中创建和使用的- 受监管的机构。公司特定信息（名称、地址、一些图片、专有产品信息等）已被编辑，但内容和格式已基本保留。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 the procedural guidelines for "Aseptic Technique" during cell culture Manufacturing. Provides procedures for "Sterile Handling" during cell culture Manufacturing and for the cleaning of work surfaces and supplies used during cell culture Manufacturing. Applies to manufacturing personnel required to perform Cell Culture during their daily duties.Included Sections:Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and ProceduresIncluded Attachments/Appendices:NoneAbout This Document:This is not a generic template, it's a 4-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