DOXPUB 09-0247-SOP

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.

Reasons to Buy:

• Use it as a starting point for your own documentation project
• Compare the quality of your documents against your industry peers
• Learn what other companies in your industry are actually doing

Who Will Benefit:

• Quality Assurance Managers
• Manufacturing Managers
• Quality Control Personnel