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Aseptic Processing & Sterile Manufacturing Checklist

Esta lista de verificación está en inglés.

Verifies environmental, personnel, and process controls for aseptic manufacturing of sterile drug products. Use for cleanroom readiness, batch review, and self-inspection.

FDA Aseptic Processing Guidance (2004)EU GMP Annex 121 CFR 211USP <797>

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Facility and Cleanroom Classification

  • Are cleanroom areas classified (ISO 5 / Grade A critical zone within Grade B) and qualified? *
  • Is unidirectional airflow (HEPA) maintained over the critical aseptic work zone? *
  • Are room pressure differentials monitored and within limits? *
  • Record the current Grade A/B differential pressure reading (Pa).

Personnel and Gowning

  • Are aseptic operators qualified through gowning qualification and periodic requalification? *
  • Is aseptic technique training documented for all personnel entering the critical area? *
  • Is personnel monitoring (gloves/gown) performed and trended? *

Environmental Monitoring

  • Is viable and non-viable particulate monitoring performed at defined locations and frequencies? *
  • Are alert and action limits established, trended, and investigated on excursion? *
  • Is the critical zone monitored during each production shift/operation? *

Sterilization and Depyrogenation

  • Are sterilization processes (steam, filtration, dry heat) validated for the load configurations used? *
  • Is sterilizing-grade filtration integrity tested pre- and post-use? *
  • Is depyrogenation of containers/closures validated to achieve the required endotoxin reduction? *

Media Fill / Process Simulation

  • Are aseptic process simulations (media fills) performed at the required frequency per line and operator? *
  • Record the number of units filled in the most recent media fill.
  • Were media fill results within the acceptance criteria (target zero positives)? *

Contamination Control Strategy

  • Is a documented contamination control strategy (CCS) in place and current? *
  • Are interventions during aseptic processing defined, minimized, and documented? *

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