Current through Register Vol. 50, No. 9, September 20, 2024
A. Reactors, Distillation Operations,
Crystallizers, Centrifuges, and Vacuum Dryers. The owner or operator of a
synthesized pharmaceutical manufacturing facility subject to this regulation
shall control the volatile organic compound emissions from all reactors,
distillation operations, crystallizers, centrifuges and vacuum dryers that have
the potential to emit prior to control 15 pounds per day (6.8 kg/day) or more
of VOC. Surface condensers or equivalent controls shall be used, provided that:
1. if surface condensers are used, the
condenser outlet gas temperature must not exceed:
a. -13°F (-25°C) when condensing VOC of vapor
pressure greater than 5.8 psia (40.0 KPA);
b. 5°F (-15°C) when condensing VOC of vapor
pressure greater than 2.9 psia (20.0 KPA);
c. 32°F (0°C) when condensing VOC of vapor
pressure greater than 1.5 psia (10.0 KPA);
d. 50°F (10°C) when condensing organic
compounds of vapor pressure greater than 1.0 psia (7.0 KPA); or
e. 77°F (25°C) when condensing organic
compounds of vapor pressure greater than 0.5 psia (3.50 KPA);
2. if equivalent controls are
used, the VOC emissions must be reduced by at least as much as they would be by
using a surface condenser that meets the requirements of Paragraph A.1 of this
Section.
B. Air Dryers
and Production Equipment Exhaust Systems. The owner or operator of a
synthesized pharmaceutical manufacturing facility subject to this regulation
shall reduce the VOC emissions from all air dryers and production equipment
exhaust systems:
1. by at least 90 percent if
emissions are 330 lb/day (150 kg/day) or more of VOC; or
2. to 33 lb/day (15.0 kg/day) or less if
emissions are less than 330 lb/day (150 kg/day) of VOC.
C. Storage and Loading Controls. The owner or
operator of a synthesized pharmaceutical manufacturing facility subject to this
regulation shall:
1. provide 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 that store VOC with vapor pressures greater than 4.1
psia (28.0 KPA) at 20°C; and
2.
install pressure/vacuum conservation vents set at plus or minus 0.03 psi gauge
(plus or minus 0.2 KPA) on all storage tanks that store VOC with vapor
pressures greater than 1.5 psia (10.3 KPA) at 20°C, unless a more effective
control system is used.
D. Centrifuges, Filters, and In-process Tank
Requirements. The owner or operator of a synthesized pharmaceutical facility
subject to this regulation shall:
1. enclose
all centrifuges, rotary vacuum filters, and other filters which have exposed
liquid surfaces, where the liquid contains volatile organic compounds and
exerts a total volatile organic compound vapor pressure of 0.5 psia (3.50 KPA)
or more at 20°C;
2. install covers
on all in-process tanks containing a volatile organic compound at any time.
These covers must remain closed, unless production, sampling, maintenance, or
inspection procedures require operator access.
E. Volatile Organic Compound Leaks. The owner
or operator of a synthesized pharmaceutical manufacturing facility subject to
this regulation shall repair all leaks from which a liquid containing VOC can
be observed running or dripping. The repair shall be completed the first time
the equipment is off line for a period of time long enough to complete the
repair but in no event later than 15 days after observation.
F. Compliance. The owner/operator of any
facility subject to LAC 33:III.2145 shall install and maintain monitors to
accurately measure and record operational parameters of all required control
devices as necessary to ensure the proper functioning of those devices in
accordance with the design specifications. Compliance with this Section shall
be determined by applying the following test methods as applicable:
1. ASTM Test Method D328-82 for determining
Reid vapor pressure;
2. Test
Methods 1-4 ( 40 CFR Part 60, Appendix A, as incorporated by reference at LAC
33:III.3003) for determining flow rates;
3. Test Method 18 ( 40 CFR Part 60, Appendix
A, as incorporated by reference at LAC 33:III.3003) for determining gaseous
organic compound emissions by gas chromatography;
4. Test Method 25 40 CFR Part 60, Appendix A,
(as incorporated by reference at LAC 33:III.3003) for determining total gaseous
nonmethane organic emissions as carbon.
G. Recordkeeping. The owner or operator of a
pharmaceutical manufacturing facility shall maintain the following records at
the facility for at least two years:
1. the
results of all tests conducted in accordance with Subsection F of this
Section;
2. records of surface
condenser outlet gas temperatures;
3. records of operational parameters of other
control devices;
4. the dates and
reasons for any control device malfunction and estimate of resultant VOC
emissions.
AUTHORITY NOTE:
Promulgated in accordance with
R.S.
30:2054.
