Description
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
Product Details
- Edition:
- 1.0
- Published:
- 08/01/2007
- Number of Pages:
- 17
- File Size:
- 1 file , 1.2 MB
