Apart from the fumigation with VHP, disinfection with sporicidal agent, whether Ozone disinfection is acceptable in sterile area.
I’ve been reviewed US FDA, WHO EU GMP (Annex-1), ISPE Guideline but didn’t find anything. In chinese validation books, it is mentioned that ozone is an effective and safe way of disinfection for sterile area.
Could you please suggest me in this regards with reference.
Thanks