Ala. Admin. Code r. 335-3-6-.39
Current through Register Vol. 42, No. 8, May 31, 2024
Section 335-3-6-.39 - Manufacture Of Synthesized Pharmaceutical Products(1) For the purpose of this Rule, the following definitions apply: (a) "Condenser" means a device which cools a gas stream to a temperature which removes specific organic compounds by condensation.(b) "Control System" means any number of control devices, including condensers, which are designed and operated to reduce the quantity of VOCs emitted to the atmosphere.(c) "Reactor" means a vat or vessel, which may be jacketed to permit temperature control, designed to contain chemical reactions.(d) "Separation Operation" means a process that separates a mixture of compounds and solvents into two or more components. Specific mechanisms include extraction, centrifugation, filtration, and crystallization.(e) "Synthesized Pharmaceutical Manufacturing" means manufacture of pharmaceutical products by chemical synthesis.(f) "Production Equipment Exhaust System" means a device for collecting and directing out of the work area VOC fugitive emissions from reactor openings, centrifuge fugitive emissions from reactor openings, centrifuge openings, and other vessel openings for the purpose of protecting workers from excessive VOC exposure.(2) This Rule shall apply to all synthesized pharmaceutical manufacturing facilities.(3) This Rule shall apply to all sources of VOCs, including reactors, distillation units, dryers, storage of VOCs, transfer of VOCs, extraction equipment, filters, crystallizers and centrifuges that have the potential to emit 6.8 kilograms per day (15 pounds per day) or more.(4) The owner or operator of a synthesized pharmaceutical manufacturing facility subject to this Rule shall control the VOC emissions from all reactors, distillation operations, crystallizers, centrifuges and vacuum dryers that have the potential to emit 6.80 kilograms per day (15 pounds per day) or more of VOCs. Surface condensers or equivalent controls shall be used, provided that: (a) If surface condensers are used, the condenser outlet gas temperature must not exceed: 1. -25° C (-13° F) when condensing a VOC of a vapor pressure greater than 40.0 kPa (5.8 psia)*;2. -15° C (5° F) when condensing a VOC of a vapor pressure greater than 20.0 kPa (2.9 psia)*;3. O° C (32° F) when condensing a VOC of a vapor pressure greater than 10.0 kPa (1.5 psia)*;4. 10° C (50° F) when condensing a VOC of a vapor pressure greater than 7.0 kPa (1.0 psia)*; or5. 25° C (77° F) when condensing a VOC of a vapor pressure greater than 3.50 kPa (0.5 psia)*.(b) If equivalent controls are used, the VOC emissions shall be reduced by at least as much as they would be by using a surface condenser which meets the requirements of subparagraph (a) of this paragraph.(5) The owner or operator of a synthesized pharmaceutical manufacturing facility subject to this Rule shall reduce the VOC emissions from all air dryers and production equipment exhaust systems: (a) by at least ninety percent (90%) if emissions are 150 kilograms per day (330 pounds per day) or more of VOC; or(b) to 15.0 kilograms per day (33 pounds per day) or less if emissions are less than 150 kilograms per day (330 pounds per day) of VOC.(6) The owner or operator of a synthesized pharmaceutical manufacturing facility subject to this Rule shall: (a) provide a vapor balance system or equivalent control that is at least ninety percent (90%) effective in reducing emissions from truck or railcar deliveries to storage tanks with capacities greater than 7,571 liters (2,000 gallons) that store VOC with vapor pressures greater than 28.0 kPa (4.1 psia) at 20° C (68° F); and(b) install pressure/vacuum conservation vents set at + 0.2 kPa on all storage tanks that store VOC with vapor pressures greater than 10.0 kPa (1.5 psia) at 20° C (68° F), unless a more effective control system is used.(7) The owner or operator of a synthesized pharmaceutical facility subject to this Rule shall enclose all centrifuges, rotary vacuum filters, and other filters which process liquids containing VOC with vapor pressures of 3.50 kPa (0.5 psia) or more at 20° C (68° F).(8) The owner or operator of a synthesized pharmaceutical facility subject to this Rule shall install covers on all in-process tanks containing a VOC at any time. These covers must remain closed, unless production, sampling, maintenance, or inspection procedures require operator access.(9) The owner or operator of a synthesized pharmaceutical manufacturing facility subject to this Rule 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. Author:
Ala. Admin. Code r. 335-3-6-.39
Effective Date: June 9, 1987. Amended: Effective Date: July 31, 1991. Amended: Filed October 17, 1996; effective November 21, 1996.Statutory Authority:Code of Ala. 1975, §§ 22-28-14, 22-22A-5, 22-22A-6, 22-22A-8.