概述:描述了使用M&O Perry自动灌装和加塞机（AFSM）进行无菌灌装操作期间的环境监测程序。涵盖无菌灌装室和AFSM在使用前、使用中和使用后的清洁度，证明其日常符合预先确定的清洁度标准（警报/行动水平），并识别和调查超过标准的情况、空气小瓶、表面取样、非活性颗粒、样品处理、微生物特性和超限调查。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，包括附件/附录:监测检查表、报告表-表面可行现场、报告表-表面可移动件（非Afsm）、报告表-人员监测、报告表- 空气瓶-Rcs取样器，报告表-空气瓶-沉降板，报告表-颗粒计数（基线/设置），报告表-颗粒计数（100级操作期间）关于本文件:这不是一个通用模板，它是一个17页的程序，实际上是在FDA监管机构的质量控制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 program for environmental monitoring during aseptic filling operations with the M & O Perry Automated Filling and Stoppering Machine (AFSM). Covers cleanliness of the aseptic filling room and AFSM before, during and after use, demonstrating routine compliance with pre-determined cleanliness criteria (alert/action levels), and identify and investigate instances when levels are exceeded, air viables, surface sampling, non-viable particulates, sample handling, microorganism characterization, and exceeded limit investigations.Included Sections:Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and ProceduresIncluded Attachments/Appendices:Monitoring Checklist, Report Form - Surface Viable Sites, Report Form - Surface Viables (Non-Afsm), Report Form - Personnel Monitoring, Report Form - Air Viables - Rcs Samplers, Report Form - Air Viables - Settling Plates, Report Form - Particle Counts (Baseline/Setup), Report Form - Particle Counts (During Class 100 Operations)About This Document:This is not a generic template, it's a 17-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