A: VHP Passbox sterilizes at very low temperatures making use of vaporized hydrogen peroxide, contrary to traditional steam sterilization that requires high heat. For most units marketed as sterile, a premarket submission should include information sufficient to show the sterilization process is efficient and consistent with internationally approved consensus https://tailinscitech.wordpress.com/2026/04/24/pes-membrane-applications-in-modern-pharmaceutical-processes/