Full Description

This document describes a method for environmental monitoring during aseptic filling operations, and specifies the environmental and personnel monitoring alert and action level specifications for aseptic filling events and contamination investigation procedures when these levels are exceeded. Attachments include Aseptic Fill Environmental Monitoring Checklist, Aseptic Fill Environmental Monitoring Test Report, 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, and Aseptic Filling Area Monitoring Site Map.

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Edition: 1 Published: 11/01/2004 Number of Pages: 15