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Cleaning and Sanitization of the Cleanrooms 洁净室的清洁和消毒
发布日期: 2007-08-01
概述:提供清洁和消毒洁净室的程序,以控制微生物污染。适用于制造洁净室和支撑区域。包括安排、获取消毒溶液、每月清洁和消毒、每日清洁和消毒以及清洁和消毒活动顺序的规定。包括的章节:目的、范围、责任、参考文件和适用文件、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:区域清洁和消毒记录表、洁净室和支撑区域布局图示例本文件:这不是通用模板,这是一个9页的程序,实际上是在FDA的GMP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:制造经理物料控制人员质量控制人员
Summary:Provides the procedure for cleaning and sanitizing cleanrooms to control microbial contamination. Applicable to manufacturing cleanrooms and support areas. Includes provisions for scheduling, obtaining sanitizing solutions, monthly cleanings and sanitization, daily cleanings and sanitization, and sequence of clean and sanitization activities.Included Sections:Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and ProceduresIncluded Attachments/Appendices:Area Cleaning and Sanitization Logsheet, Example Layout Diagram of Cleanroom and Support AreasAbout This Document:This is not a generic template, it's a 9-page procedure that was actually created and used in the GMP 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:Manufacturing ManagersMaterial Control PersonnelQuality Control Personnel
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