The process is divided into four stages: pre-humidification → drug addition and sterilization → maintaining exposure → residue removal. The industry standard duration is provided directly, and it is differentiated between small and large transfer windows.
1. General standard time (Pharmaceutical GMP standard)
a) Small VHP transfer window (cavity size around 600×600×600)
Pre-humidification: 5–10 minutes
Drug addition + maintaining sterilization exposure: 20–30 minutes (core sterilization time)
Residue removal (ventilation and decomposition): 20–40 minutes
Total cycle: 45–80 minutes
b) Large VHP transfer window (cavity > 800mm, or double-door interlocked large volume)
Sterilization exposure time: 30–45 minutes
Residue removal longer: 30–60 minutes
Total cycle: 70–115 minutes
Key point: The exposure maintenance time is the actual sterilization time. Generally, maintaining for ≥ 30 minutes can stably achieve 6log spore kill and meet the aseptic level.
2. What determines the sterilization time?
Cavity volume: The larger the volume, the longer the time
VHP generator power: Higher power, faster drug addition, can shorten the time
Humidity: 50%–65% humidity has the best effect, and meeting the standard can shorten the sterilization time
Verification requirements: GMP projects must verify the final time using biological indicators (BI), not a fixed value
All negative results of Bacillus subtilis var. niger ATCC 9372: The time is qualified
3. Industry commonly used experience parameters (directly applicable)
Daily routine sterilization: Exposure 30 minutes
High-risk aseptic areas (Class A/B, vaccines, cell rooms): Exposure 40–45 minutes
Residue removal must be achieved: Hydrogen peroxide residue < 0.5 ppm before opening the door
4. Quick memory
Small standard: Sterilization 30 minutes, total duration approximately 1 hour
High-risk large: Sterilization 40–45 minutes, total duration about 1.5 hours