概述:描述了使用微孔无菌检测系统对溶液和设备进行膜过滤无菌检测的程序。用于原材料和成品的无菌检测。包括一般设置和装载程序、预湿膜、制备设备和容器、测试设备和容器、冲洗、向罐中添加介质、批量无菌测试和结果解释。包括符合USP 23-NF 18和21 CFR第610.12部分的规定。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:无菌测试膜过滤无菌测试报告关于本文件:这不是通用模板，这是一个长达7页的程序，实际上是在FDA的质量控制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，谁会从中受益:质量保证经理制造经理质量控制人员

Summary:Describes a procedure for using the Millipore Steritest System for membrane filtration sterility testing of solutions and devices. Intended to be used for sterility testing raw materials and finished products. Covers general setup and loading procedures, prewetting the membranes, preparation devices and containers, testing devices and containers, rinsing, adding media to canisters, bulk sterility testing, and interpretation of results. Includes provisions for compliance with USP 23-NF 18 and 21 CFR Part 610.12.Included Sections:Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and ProceduresIncluded Attachments/Appendices:Steritest Membrane Filtration Sterility Test ReportAbout This Document:This is not a generic template, it's a 7-page procedure that was actually created and used in the Quality Control 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:Quality Assurance ManagersManufacturing ManagersQuality Control Personnel