Wisconsin Administrative Code
Department of Natural Resources
NR 400-499 - Environmental Protection - Air Pollution Control
Chapter NR 421 - Control Of Organic Compound Emissions From Chemical, Coatings And Rubber Products Manufacturing
Section NR 421.03 - Chemical manufacture
Universal Citation: WI Admin Code ยง NR 421.03
Current through August 26, 2024
(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 betwee n 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).
Disclaimer: These regulations may not be the most recent version. Wisconsin may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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