2.相关法规

2.1EU GMP附录一（2022） Manufacture of Sterile Medicinal Products
Premises第4.36条规定: Where fumigation or vapour disinfection (e.g.Vapour-phase Hydrogen Peroxide) of cleanrooms and associated surfaces are used, the effectiveness of any fumigation agent and dispersion system should be understood and validated.
2.2PDA TR70 第9章 Cleaning And Disinfection 第9.2条 Application Methods 下Fogging or Gassing 规定：This method can produce excellent results but does require longer periods of time to ensure adequate distribution of the agent and sufficient surface contact time. Chemical agents that have commonly been used with this method of application are peracetic acid, hydrogen peroxide, phenol, bleach, quaternary ammonia, paraformaldehyde, and chlorine dioxide.
2.3PDA TR51 第8.0部分
Any indicator system that relies on living organisms is liable to variation. The organisms themselves are inherently variable (genotypic factors) and are affected by external factors which lead to phenotypic variation.
2.4cGMP 附录一 无菌药品 第九章 消毒 第四十五条 必要时，可采用熏蒸的方法降低洁净区内卫生死角的微生物污染，应当验证熏蒸剂的残留水平。
2.5USP-NF2021 <1229.11> VAPOR PHASE STERILIZATION
Vapor sterilization processes require appropriate sterilant concentration, temperature, and relative humidity, all of which may be variable during the exposure period.
2.6Chp 2020 <1421>灭菌法
汽相灭菌法（新增）
微生物挑战试验用来确认灭菌效果，生物指示剂的放置位置应包括灭菌剂最难到达的位置。
日常使用中，汽相灭菌前灭菌物品应进行清洁。灭菌时应最大限度地暴露表面，确保灭菌效果。灭菌后应将灭菌剂残留充分去除或灭活。

3.STERIS 干法VHP®技术

Is it a Liquid or  a Gas? Wet or Dry?

• 气态H2O2可操控性更强，气体浓度更容易被监测、控制，并能快速均匀分布。

• 气态H2O2对材料更温和，冷凝的H2O2比过氧化氢溶液本身浓度要高，腐蚀风险升级。

• 气态H2O2一旦出现任何形式的冷凝，液体会吸收任何形式的气体，使得H2O2气体浓度不再大幅增长。

4.VHP VS Fogging

雾/干雾、气溶胶与气体的表现特征不同：

• 更稠密且更容易附着在表面并结合（冷凝/腐蚀）

• 更容易与表面发生非弹性碰撞

• 更大粒径微生物杀灭效率低（杀灭效率）