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Air Changes, Exhaust Requirements, and Ventilation Requirements for ETO Sterilization Equipment Room
The ETO sterilization equipment room must have a minimum number of air changes per hour as per Table 4-A and must maintain a negative air balance. All air from the ETO sterilizer equipment room must be exhausted to the outside using a dedicated system or another approved method. The exhaust fan for the dedicated system must be located at the discharge point of the system and identified as the ETO Equipment Room Exhaust. The discharge point must be at least 25 feet (7620 mm) away from any outside intake, operable window, or personnel passage.
Aeration units must be ventilated through a non-recirculating dedicated ventilation exhaust system. When the drain is not located in the ETO sterilizer equipment room, ventilation is required by a capture box. Exhaust during cylinder change is required by installing a hood that is part of a dedicated ventilation exhaust system, positioned no more than 1 foot (305 mm) above or behind the point where the change of cylinders takes place.
The ventilation of the sterilizer relief valve is required through a pipe connected to the outlet of the relief valve exhausted directly to the outdoors at a point high enough to be away from passersby, and not near any windows that open, nor near any air-conditioning or ventilation air intakes. The system must be designed to capture the ETO when the door is opened following the completion of the sterilization process. A hood or canopy closed on each end should be installed over the sterilization door, connected to a dedicated exhaust ventilation system.
Installation of gas line hand valves at the connection to the supply cylinders is required to minimize leakage during cylinder change. An audible and visual alarm system must be installed to alert sterilizer operating personnel if the air flow falls below the design cubic feet per minute (L/s).

Design Requirements For Ethylene Oxide (ETO) Sterilization Areas

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The ETO sterilization equipment room must have a minimum number of air changes per hour as per Table 4-A and must maintain a negative air balance. All air from the ETO sterilizer equipment room must be exhausted to the outside using a dedicated system or another approved method.

Design Requirements For Ethylene Oxide (ETO) Sterilization Areas

Publish Time：2024-06-19