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This Supplement PDA Aseptic Processing Task Force .
Table of Contents
Table of Contents:
Topic A: Airflow Velocity Topic B: Airflow Patterns Topic C: Grade A Environment Over Cappers Topic D: Differential Pressure Topic E: Testing of HEPA Filters Topic F: HEPA Filter Patching II. Environmental
Monitoring Topic A: Setting Alert and Action Levels Topic B: Environmental Monitoring Alert & Action Levels Topic C: Environmental Monitoring - Relationship to Batch Release Topic D: Continuous vs Intermittent Environmental Monitoring Topic E: Investigation/Documentation of Environmental Monitoring Excursions
Topic F: Location and Frequency of Non-Viable Air Monitoring Topic G: Location and Frequency of Viable Air Monitoring Topic H: Surface Monitoring for Viables Topic I: Identification of Environmental Isolates Topic J: Growth Promotion Testing of Environmental Media Topic K: Incubation Temperatures for Environmental Monitoring Samples
III. Validation (Process Simulation) Topic A: Acceptance Criteria Topic B: Duration of Process Simulations vs Production Topic C: Incubation Temperatures Topic D: Incubation of Normally Excluded Units Topic E: Incubate All Filled Vials - Non-Integral Units Topic F: Process Simulation Reconciliation Topic G: Invert Units at the Half Way Point During Incubation Topic H: Growth Promotion Topic I: Aerobic vs Anaerobic Topic J: When does Process Simulation Start? Topic K: Fill Volume Topic L: Interventions - Type and Number Topic M: Video Recording - Raw Data Topic N: Invalidation of Process Simulation Topic O: Number of Process Simulation Runs Required Topic P: Infrequently Used Lines IV. Personnel Topic A: Glove Monitoring Topic B: Aseptic Personnel Qualification Program Topic C: Aseptic Processing Area Access Control Topic D: Performance of Environmental Monitoring Topic E: Supervision in the Aseptic Processing Area Topic F: Personnel Monitoring Frequency Topic G: Sterile Gown Usage Topic H: Occupancy in the Aseptic Processing Area Topic I: Use of Respirators in Aseptic Processing Areas V.
Material Transfer Topic : Entry of Equipment and Material into the Aseptic Processing Area
VI. Cleaning and Disinfection Topic A: Disinfection Program Topic B: Sterilization of Disinfectants and Cleaning Agents Topic C: Decontamination of Cleaning Equipment, Mechanic's Tools, and
Ancillary Supplies Glossary of Terms
