Points to Consider for Aseptic Processing - PDA Journal of Pharmaceutical Science and Technology: 2003 Supplement Volume 57 Issue 2

Mar 2003
PDA Item Number
Softcover: 03004 | Digital: 42148

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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

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