§ 63.361 Definitions.

Terms and nomenclature used in this subpart are defined in the Clean Air Act (the Act) as amended in 1990, §§ 63.2 and 63.3, or in this section. For the purposes of this subpart, if the same term is defined in subpart A of this part and in this section, it shall have the meaning given in this section.

Acid-water scrubber means an add-on air pollution control device that uses an aqueous or alkaline scrubbing liquor to absorb and neutralize acid gases.

Aeration means, for the purposes of this rule, exposing sterilized material at elevated temperatures to drive EtO out of the material.

Aeration room means any vessel or room that is used to facilitate off-gassing of EtO at a sterilization facility. If a facility uses only combination sterilization units, for the purposes of this rule, there are no aeration rooms at the facility.

Aeration room vent (ARV) means the point(s) through which the evacuation of EtO-laden air from an aeration room occurs. For combination sterilization units, there is no ARV.

Catalytic oxidizer means a combustion device that uses a solid-phase catalyst to lower the temperature required to promote the oxidization and achieve adequate reduction of volatile organic compounds, as well as volatile hazardous air pollutants.

Chamber exhaust vent (CEV) means the point(s) through which EtO-laden air is removed from the sterilization chamber during chamber unloading following the completion of sterilization and associated air washes. This may also be referred to as a “backvent” (or “back vent”). For combination sterilization units, there is no CEV.

Combination sterilization unit means any enclosed vessel in which both sterilization and aeration of the same product occur within the same vessel, i.e., the vessel is filled with ethylene oxide gas or an ethylene oxide/inert gas mixture for the purpose of sterilizing and is followed by aeration of ethylene oxide.

Combined emission stream means when the emissions from more than one emission source are routed together using common ductwork prior to the control system.

Continuous monitoring system (CMS) means, for the purposes of this rule, the equipment necessary to continuously samples the regulated parameter specified in § 63.364 or § 63.365 of this subpart without interruption, evaluates the detector response at least once every 15 seconds, and computes and records the average value at least every 60 seconds, except during allowable periods of calibration and except as defined otherwise by the continuous emission monitoring system (CEMS) performance specifications (PS) in appendix B to part 60 of this chapter.