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现行 DOXPUB 09-0033-SOP
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Inoculation of Radiation Exposed and Steam Exposed Biological Indicators 辐射暴露和蒸汽暴露生物指示剂的接种
发布日期: 2007-08-01
小结:提供转移到培养基和培养短小芽孢杆菌和嗜热脂肪芽孢杆菌生物指示孢子条的程序。适用于通过电子束和Co60(伽马)辐射进行最终灭菌的产品,并含有作为灭菌生物指示剂的短小芽孢杆菌孢子条。也适用于所有通过蒸汽(高压灭菌器)灭菌并含有嗜热脂肪芽孢杆菌孢子条作为灭菌生物指示剂的实验室器皿、小瓶和器具。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:生物指示剂测试报告格式关于本文件:这不是通用模板,这是一个长达4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:Provides the procedure for transferring into media and incubating Bacillus pumilus and Bacillus stearothermophilus biological indicator spore strips. Applies to products that are terminally sterilized by E-Beam and Co60 (gamma) radiation and contain a Bacillus pumilis spore strip as a biological indicator of sterilization. Also applies to all lab ware, vials and implements that are sterilized by steam (autoclave) and contain a Bacillus stearothermophilus spore strip as a biological indicator of sterilization.Included Sections:Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and ProceduresIncluded Attachments/Appendices:Biological Indicator Test Report FormAbout This Document:This is not a generic template, it's a 4-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
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