La. Admin. Code tit. 33 § III-2145

Current through Register Vol. 50, No. 6, June 20, 2024

Section III-2145 - Pharmaceutical Manufacturing Facilities

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.

La. Admin. Code tit. 33, § III-2145

Promulgated by the Department of Environmental Quality, Office of Air Quality and Nuclear Energy, Air Quality Division, LR 13:741 (December 1987), amended by the Office of Air Quality and Radiation Protection, Air Quality Division, LR 16:964 (November 1990), LR 22:1212 (December 1996), LR 24:25 (January 1998), amended by the Office of the Secretary, Legal Affairs Division, LR 34:70 (January 2008), LR 34:1892 (September 2008).

AUTHORITY NOTE: Promulgated in accordance with R.S. 30:2054.