Current through Register Vol. 39, No. 6, September 16, 2024
(a) For the purpose of this Rule, the
following definitions shall apply:
(1)
"Production equipment exhaust system" means a device for collecting and
directing out of the work area fugitive emissions of volatile organic compounds
from reactor openings, centrifuge openings, and other vessel openings for the
purpose of protecting workers from excessive exposure to volatile organic
compounds.
(2) "Synthesized
pharmaceutical products manufacturing" means manufacture of pharmaceutical
products by chemical synthesis.
(b) This Rule applies to synthesized
pharmaceutical products manufacturing facilities.
(c) The owner or operator of a synthesized
pharmaceutical products manufacturing facility shall control the emissions of
volatile organic compounds from:
(1)
reactors, distillation operations, crystallizers, centrifuges, and vacuum
dryers that have the potential to emit 15 pounds per day or more of volatile
organic compounds with surface condensers that meet the requirements of
Paragraph (e) of this Rule or equivalent controls;
(2) air dryers and production equipment
exhaust system by reducing emissions of volatile organic compounds:
(A) by 90 percent if they are 330 pounds per
day or more; or
(B) to 33 pounds
per day if they are less than 330 pounds per day;
(3) storage tanks by:
(A) providing a vapor balance system or
equivalent control that is at least 90 percent effective in reducing emissions
from truck or railcar deliveries to storage tanks with capacities greater than
2,000 gallons storing volatile organic compounds with a vapor pressure greater
than 4.1 pounds per square inch at 68° F; and
(B) installing pressure/vacuum conservation
vents, which shall be set at plus or minus 0.8 inches of water unless a more
effective control system is used, on all storage tanks that store volatile
organic compounds with a vapor pressure greater than 1.5 pounds per square inch
at 68°F;
(4)
centrifuges containing volatile organic compounds, rotary vacuum filters
processing liquid containing volatile organic compounds, and other filters
having an exposed liquid surface where the liquid contains volatile organic
compounds by enclosing those centrifuges and filters that contain or process
volatile organic compounds with a vapor pressure of 0.5 pounds per square inch
or more at 68°F; and
(5)
in-process tanks by installing covers, which shall remain closed except when
production, sampling, maintenance, or inspection procedures require operator
access.
(d) The owner or
operator of a synthesized pharmaceutical products manufacturing facility shall
repair as expeditiously as possible all leaks from which liquid volatile
organic compounds can be seen running or dripping. This repair shall take place
at least within 15 days after which said leak is discovered, unless the leaking
component cannot be repaired before the process is shutdown, in which case the
leaking component must be repaired before the process is restarted.
(e) If surface condensers are used to comply
with Subparagraph (c)(1) of this Rule, the condenser outlet temperature shall
not exceed:
(1) -13°F when condensing
volatile organic compounds of vapor pressure greater than 5.8 pounds per square
inch at 68°F;
(2) 5°F when
condensing volatile organic compounds of vapor pressure greater than 2.9 pounds
per square inch at 68°F;
(3)
32°F when condensing volatile organic compounds of vapor pressure greater
than 1.5 pounds per square inch at 68°F;
(4) 50°F when condensing volatile organic
compounds of vapor pressure greater than 1.0 pounds per square inch at
68°F; or
(5) 77°F when
condensing volatile organic compounds of vapor pressure greater than 0.5 pounds
per square inch at 68°F.
Authority
G.S.
143-215.3(a)(1);
143-215.107(a)(5);
Eff. July 1, 1994;
Readopted Eff. November 1,
2020.
