A. Vaporized Hydrogen Peroxide Bio Decontamination Sterilization System

Q&A FDA-15-223-SOL-1152366 Sterilization System Q-1. What is the total cubic area of the room that needs to be decontaminated? A-1. We are not requesting decontamination services for rooms or space. Instead, we require a stand-alone enclosed system, such as an autoclave sterilizer. Q-2. What sort of HVAC system serves this room? A-2. We have 20-40 micron HVAC system-based biological hoods, but not in the room. Q-3. Is there a budget in place for this project? A-3. No Q-4. Will there be a need to provide aeration equipment to remove the H2O2? How much time would be considered reasonable to completely remove the H2O2 at the completion of the decontamination A-4. We are not requesting decontamination services for rooms or space. Instead, we require a stand-alone enclosed system, such as an autoclave sterilizer. Q-5. Does this enclosure have any ports to supply and return the H2O2? A-5. The enclosure of the sterilizer shall have a port(s) for a cup or bottle from which hydrogen peroxide is directly dispensed into the chamber. During all cycles any hydrogen peroxide outflow from the chamber should be converted to water and oxygen to minimize the operator's exposure to vaporized hydrogen peroxide. If technically feasible and operationally safe, vaporized hydrogen peroxide should be recovered as long as the system controls the hydrogen peroxide concentration below the dew point throughout the sterilization process as described in Part II: Technical Requirements in the solicitation.