standard published 08/01/2007 by Doxpub, Inc.
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 Procedures
Included 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.
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