This Supplement was prepared by PDA Aseptic Processing Task Force.
The document represents over 18
months of dedicated work by the Task Force members. It presents the issues
framed as problem statements with both a recommendation and a rationale for the
recommendation provided.
Table of Contents:
I. Physical
Environment
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