Sterilization Process Advisor V3
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Ph. Eur. 5.1.1 Reference Cycle
Overkill cycle F₀ ≥12 min
F₀ > 8 min (Non-bioburden characterized)
F₀ > 8 min (Bioburden characterized)
F₀ < 8 min (Post-aseptic processing)
Process Hold Temperature (°C):
Process Parameters:
Process Type:
Bioburden Level:
Bioburden Characterized:
Temperature Requirement:
Required Information for Quality Dossier:
Note on Bioburden Characterization: