Section 421.03. Chemical manufacture.

 

(1)   Pharmaceutical manufacture.

(a) Applicability. This subsection applies, subject to the provisions of s. NR 425.03 , to all operations at pharmaceutical manufacturing facilities involved in the manufacture of pharmaceutical products by chemical synthesis, with the exception of any reactor, distillation unit, dryer, filter, crystallizer, centrifuge, or other individual operation that has an actual emission rate of less than 6.8 kilograms per day (15 pounds per day) with all emission control equipment inoperative.

(b) Emission control requirements. Except as provided under par. (a) , the owner or operator of a synthesized pharmaceutical manufacturing facility shall:

1. Equip each vent from reactors, distillation operations, crystallizers, centrifuges, or vacuum dryers with surface condensers or an equally effective control device as approved by the department. If a surface condenser is used, the condenser outlet gas temperature may not exceed:

a. -25 ° C (-13 ° F) for VOCs with vapor pressure greater than 40 kPa (5.8 psia) as measured at 20 ° C (68 ° F).

b. - 15 ° C (5 ° F) for VOCs with vapor pressure between 20 kPa (2.9 psia) and 40 kPa (5.8 psia) as measured at 20 ° C (68 ° F).

c. 0 ° C (32 ° F) for VOCs with vapor pressure between 10 kPa (1.5 psia) and 20 kPa (2.9 psia) as measured at 20 ° C (68 ° F).

d. 10 ° C (50 ° F) for VOCs with vapor pressure between 7 kPa (1.0 psia) and 10 kPa (1.5 psia) as measured at 20 ° C (68 ° F).

e. 25 ° C (77 ° F) for VOCs with vapor pressure between 3.5 kPa (0.5 psia) and 7 kPa (1.0 psia) as measured at 20 ° C (68 ° F).

2. Limit the VOC emissions from air dryer exhaust systems and production equipment exhaust systems to 15.0 kilograms per day (33 pounds per day) or to 10% of the uncontrolled emission rate of the system, whichever is less stringent.

3. Enclose all centrifuges, rotary vacuum filters, and any other filters having an exposed liquid surface, where the liquid contains VOCs and exerts a total VOC vapor pressure of 3.5 kPa (0.5 psia) or more at 20 ° C (68 ° F).

4. Install covers on all in-process tanks that contain a VOC at any time. Covers are to be closed except for necessary operator access during production, sampling, maintenance or inspection.

5. Repair all visually detectable leaks of liquid VOCs the first time the equipment is off-line for a period long enough to complete the repair.

(2)   Transfer of VOCs at pharmaceutical manufacturing facilities.

(a) Applicability. Subject to the provisions of s. NR 425.03 , this subsection applies to all storage vessels for VOCs of more than 7,751 liter (2,000 gallon) capacity at a synthetic pharmaceutical manufacturing facility.

(b) Emission reduction requirements. No owner or operator of a synthetic pharmaceutical manufacturing facility may permit the delivery of VOCs with vapor pressure in excess of 28.0 kPa (4.1 psia) at 20 ° C from a truck or railcar to the storage vessel unless a vapor balance or equivalent control system is provided. The system must be at least 90% effective in reducing emissions from transfer operations.

(3)   Storage of VOCs at pharmaceutical manufacturing facilities.

(a) Applicability. This subsection applies, subject to the provisions of s. NR 425.03 , to all storage vessels for VOCs of more than 3,785 liters (1,000 gallon) capacity at synthetic pharmaceutical manufacturing facilities.

(b) Storage requirements. The owner or operator of any storage vessel shall install pressure-vacuum conservation vents set at ± 0.2 kPa, or an equally effective control device approved by the department, on all storage vessels that store VOCs with vapor pressures in excess of 10.5 kPa (1.52 psia) at 21 ° C (70 ° F).

History: Renum. from NR 154.13 (2) (b), (3) (e) and (9) and am., Register, September, 1986, No. 369 , eff. 10-1-86; am. (1) (b) 1. and (2) (b), Register, February, 1990, No. 410 , eff. 3-1-90; am. (1) (a), Register, December, 1993, No. 456 , eff. 1-1-94.