Illinois Administrative Code
Title 35 - ENVIRONMENTAL PROTECTION
Part 215 - ORGANIC MATERIAL EMISSION STANDARDS AND LIMITATIONS
Subpart T - PHARMACEUTICAL MANUFACTURING
Section 215.480 - Applicability of Subpart T

Universal Citation: 35 IL Admin Code ยง 215.480

Current through Register Vol. 48, No. 38, September 20, 2024

a) The rules of this Subpart, except for Sections 215.483 through 215.485, apply to all emission sources of volatile organic material, including but not limited to reactors, distillation units, dryers, storage tanks for volatile organic liquids, equipment for the transfer of volatile organic liquids, filters, crystallizers, washers, laboratory hoods, pharmaceutical coating operations, mixing operations and centrifuges used in manufacturing, including packaging, of pharmaceuticals, and emitting more than 6.8 kg/day (15 lbs/day) of volatile organic material and more than 2268 kg/year (2.5 tons/year) of volatile organic material. If an emission source emits less than 2,268 kg/year (2.5 tons/year) of volatile organic material, the requirements of this Subpart, except for Sections 215.483 through 215.485, still apply to the emission source if volatile organic material emissions from the emission source exceed 45.4 kg/day (100 lbs/day).

b) Notwithstanding subsection (a), the air suspension coater/dryer, fluid bed dryers, tunnel dryers and Accelacotas located in Libertyville Township, Lake County, Illinois shall be exempt from the rules of this Subpart, except for Sections 215.483 through 215.485, if emissions of volatile organic material not vented to air pollution control equipment do not exceed the following levels: for the air suspension coater/dryer: 2268 kg/year (2.5 tons per year); for each fluid bed dryer: 4535 kg per year (5.0 tons per year); and for each tunnel driver: 6803 kg per year (7.5 tons per year); and for each Accelacota: 6803 kg per year (7.5 tons per year).

c) Sections 215.483 through 215.485 apply to a plant having one or more emission sources that:

1) are used to manufacture pharmaceuticals; and

2) emit more than 6.8 kg/day (15 lbs/day) of volatile organic material and more than 2268 kg/year (2.5 tons/year) of volatile organic material, or, if less than 2.5 tons/year, these sections still apply if emissions from one or more emission sources exceed 45.4 kg/day (100 lbs/day).

d) No person shall violate any condition in a permit when the condition results in exclusion of an emission source from this Subpart.

e) Emissions subject to this Subpart shall be controlled at all times, consistent with the requirements set forth in this Subpart.

f) Control devices required pursuant to Section 215.483 shall be operated at all times.

g) If a pharmaceutical manufacturing emission source becomes subject to the provisions of Section 215.481, 215.482 or 215.486 on or after the compliance date specified in Section 215.490(a), the requirements of such section shall continue to apply to the emission source even if there is a reduction in emissions as to be below the applicability criteria of this Section.

h) Determinations of daily and/or annual emissions

1) Determinations of daily and/or annual emissions for purposes of this Section shall be made using:
(A) data on the hourly emission rate or the emission per unit of throughput, and

(B) appropriate daily and annual data from records of emission source operation or material throughput, or material consumption.

2) In the absence of representative test data pursuant to Section 215.487 for the hourly emission rate or emission rate per unit of throughput, such items shall be determined using engineering calculations, including the methods described in Appendix B of "Control of Volatile Organic Emissions from Manufacture of Synthesized Pharmaceutical Products", incorporated by reference at Section 215.105.

3) This subsection shall not affect the Agency's authority to require emissions tests to be performed pursuant to Section 215.487.

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