1. The vaporized hydrogen peroxide sterilization method is a standard in the pharmacopoeias of various countries GMP、 The recommended methods for disinfection and sterilization technology specifications have good repeatability in the sterilization process and can be validated using biological indicators.
2. High safety: The sterilization process of this method operates at room temperature and atmospheric pressure, and the drying oven and cold hydrazine of the freeze-drying machine do not need to be designed as Class D pressure vessels.
3. Low operating costs: This method consumes very little hydrogen peroxide per sterilization cycle. Taking a 15m freeze-drying machine as an example, the operating cost per batch for vaporized hydrogen peroxide is 10% of that for pure steam.
4. Low supporting costs: The initial installation cost of freeze-drying machines using vaporized hydrogen peroxide sterilization is lower than that of steam sterilization freeze-drying machines. If a movable VHP generator is used to sterilize multiple lyophilizers, the equipment cost will be doubled. No need for long-term configuration of pure steam system, no need for long-term supply of pure steam.
5. Short sterilization cycle: If the pure steam disinfection cycle is 8-10 hours and the epoxy ethylene sterilization cycle is 12-18 hours, then the gasification hydrogen peroxide disinfection cycle is only 5-8 hours.
6. Harmless and pollution-free: As the final residue of gasification hydrogen peroxide sterilization is water and oxygen, there is no toxicity or carcinogenic effect of epoxyformaldehyde, so it is harmless to the environment and operators.
7. No damage to equipment: Steam sterilization causes significant pressure changes within the sterilization chamber, often resulting in a vacuum state under pressure. Wet and hot gases can easily damage the passivation film on the surface of the stainless steel inside the freeze-drying chamber, shortening the lifespan of the equipment. Vaporized hydrogen peroxide sterilization extends the operating life and maintenance cycle of freeze-drying machines due to the improvement of pressure and temperature conditions.
8. The sterilization of vaporized hydrogen peroxide requires that all sterilization surfaces must be dry and the temperature in each area must be balanced. Otherwise, there will be significant differences in the sterilization effect of small water droplets or ice residue inside the chamber.