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40 C.F.R. § 63.365

Test methods and procedures.

§ 63.365 Test methods and procedures.

(a) Performance testing. The owner or operator of a source subject to the emissions standards in § 63.362 shall comply with the performance testing requirements in § 63.7 of subpart A of this part, according to the applicability in Table 1 of § 63.360, and in this section.

(b) Efficiency at the sterilization chamber vent. California Air Resources Board (CARB) Method 431 or the following procedures shall be used to determine the efficiency of all types of control devices used to comply with § 63.362(c), sterilization chamber vent standard.

(1) First evacuation of the sterilization chamber. These procedures shall be performed on an empty sterilization chamber, charged with a typical amount of ethylene oxide, for the duration of the first evacuation under normal operating conditions (i.e., sterilization pressure and temperature).

(i) The amount of ethylene oxide loaded into the sterilizer (Wc) shall be determined by either:

(A) Weighing the ethylene oxide gas cylinder(s) used to charge the sterilizer before and after charging. Record these weights to the nearest 45 g (0.1 lb). Multiply the total mass of gas charged by the weight percent ethylene oxide present in the gas.

(B) Installing calibrated rotameters at the sterilizer inlet and measuring flow rate and duration of sterilizer charge. Use the following equation to convert flow rate to weight of ethylene oxide:

er06de94.024.gif

where:

Wc = weight of ethylene oxide charged, g (lb) Fv = volumetric flow rate, liters per minute (L/min) corrected to 20 °C and 101.325 kilopascals (kPa) (scf per minute (scfm) corrected to 68 °F and 1 atmosphere of pressure (atm)); the flowrate must be constant during time (t) t = time, min %EOV = volume fraction ethylene oxide SV = standard volume, 24.05 liters per mole (L/mole) = 22.414 L/mole ideal gas law constant corrected to 20 °C and 101.325 kPa (385.32 scf per mole (scf/mole) = 359 scf/mole ideal gas law constant corrected to 68 °F and 1 atm). MW = molecular weight of ethylene oxide, 44.05 grams per gram-mole (g/g-mole) (44.05 pounds per pound-mole (lb/lb-mole)), or
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