Fbiological Calculator for Moist Heat Sterilization
Calculate biological lethality (Fbio in minutes at 121°C) for overkill (heat-stable products) or product-specific (heat-sensitive) approaches. Based on SAL ≤10^-6.
For heat-stable products. Assumes worst-case bioburden (10^6 spores, D121=1 min). Targets ≥12-log reduction of BI (e.g., Geobacillus stearothermophilus, 10^6 CFU, D121 ≥1.5 min). Minimum Fbio ≥18 min. Validation: Half-cycle (6-log BI kill), full cycle doubles for 12-log.
Range: 1.0–2.5
Enter D between 1.0 and 2.5 minutes.
Minimum: 12
Enter LR ≥ 12.
Explanation
Formula: Fbio = DT × LR
Validation notes: Half-cycle validation demonstrates ≥6-log BI kill; doubling exposure time for the full cycle achieves ≥12-log reduction.
USP <1229.2>Ph.Eur. 5.1.1EMA GuidelinePDA TR1