Summary:

Describes procedures for environmental monitoring during aseptic filling operations. Intended to provide the environmental and personnel monitoring alert and action level specifications for aseptic filling events and contamination investigation procedures when these levels are exceeded. Applies to the Aseptic Fill Room during aseptic filling operations. Covers environmental monitoring, personnel monitoring, sample handling, record, storage, characterization of microorganisms, and investigation procedures.

Included Sections:

Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures

Included Attachments/Appendices:

Environmental Monitoring Checklist for Clinical Antibody Media Fills, Checklist for Surface Viable Counts - RODAC Sampling, Form for Viable Count - Personnel Monitoring, Viable Count - RCS Air Sampling, Viable Count - Air Settling Plates Class 100 Zone, Non-Viable Particle Baseline and Start-up, Particle Counts-During Operations in Class 100 Zone, Particle Counting Data Sheet

About This Document:

This is not a generic template, it's a 16-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