(a)
Process equipment requirements.
The owner or operator of a pharmaceutical or cosmetic
manufacturing process subject to this Part must control the volatile organic
compound emissions from reactors, extractors, distillation operations,
crystallizers, centrifuges, and vacuum dryers which have an emission rate
potential of more than 15 pounds per day as follows:
(1) When surface condensers are used, the
condenser outlet gas temperature must not exceed the allowable temperature
limit described for each associated vapor pressure in the Table 1.
Table 1
VOC vapor pressure at 20° C
(psi) |
Allowable condenser outlet gas
temperature (° C) |
> 5.8 |
- 25 |
> 2.9 |
- 15 |
> 1.5 |
0 |
> 1.0 |
10 |
> 0.5 |
25 |
(2) If the operation of a condenser at the
exit temperature specified above results in freezing and consequent plugging of
the condenser, the allowable exit temperature may be raised to a maximum of
2°C above the freezing point of the volatile organic compound.
(3) In cases where the condenser outlet gas
temperature is not readily measurable due to negligible gas flow rate, the
temperature of the condenser coolant may be used in lieu of condenser outlet
gas temperature as long as the temperature of the condenser coolant does not
exceed the allowable condenser outlet gas temperature shown in Table
1.
(b)
Air dryer
and production equipment exhaust system requirements.
Except as provided under subdivision (a) of this section,
the owner or operator of a pharmaceutical or cosmetic manufacturing process
subject to this Part must not operate, cause, allow or permit the operation of
any air dryer or production exhaust system which conducts fugitive volatile
organic compounds from a work area unless the emissions to the outdoor
atmosphere are controlled as follows:
(1) for air dryers and production equipment
exhaust systems with an emission rate potential of volatile organic compounds
of 330 pounds per day or more, 90 percent control is required;
(2) for air dryers and production equipment
exhaust systems with an emission rate potential of volatile organic compounds
of less than 330 pounds per day, an emission reduction to 33 pounds per day is
required.
(c)
VOC
transfer requirements.
For the transfer of volatile organic compounds with vapor
pressures greater than 4.1 psi at 20°C from trucks or railcars to storage
tanks with capacities greater than 2,000 gallons, other than tanks with
floating roofs, vapor recovery or equivalent controls, a vapor balance system
or equivalent control that provides at least 90.0 percent control of the
volatile organic compound emissions is required.
(d)
Storage tank requirements.
For all storage tanks that store volatile organic compounds
with vapor pressures greater than 1.5 psi at 20°C, pressure/vacuum
conservation vents set at 0.03 psi must be installed, unless more effective
control equipment is used.
(e)
Centrifuge and filter
requirements.
All centrifuges containing volatile organic compounds,
rotary vacuum filters processing volatile organic compounds and any other
filters having an exposes liquid surface where the liquid contains volatile
organic compounds and exerts a total vapor pressure of 0.5 psi or more at
20°C must be enclosed unless production, sampling, maintenance, or
inspection procedures require operator access.
(f)
In-process tank
requirements.
For in-process tanks containing a volatile organic
compound, covers must be installed on openings to these tanks. Tank openings
must remain covered unless production, sampling, maintenance, or inspection
procedures require operator access.
(g)
Leak requirements.
All leaks from which a liquid containing volatile organic
compounds can be observed running or dripping must be repaired the first time
the equipment is off-line for a period of time long enough to complete the
repair, but not later than 15 days after the leak is discovered. If the leaking
component cannot be repaired until the process is shut down, and a shut down
cannot be done within the 15 days after the leak is detected, the leaking
component must then be repaired before the process is restarted.
(h)
(1) The commissioner may allow processes
subject to this Part to operate with a lesser degree of control than what is
required per subdivisions (a)-(g) of this section provided that a process
specific reasonably available control technology (RACT) demonstration has been
made to the satisfaction of the commissioner. Process specific RACT
demonstrations must be submitted with the application for a permit to
construct, a certificate to operate, or renewal of a certificate to operate for
an existing source under the provisions of Part 201 of this Title. Such process
specific RACT demonstrations must be submitted to the United States
Environmental Protection Agency as a revision to the State Implementation Plan
and must address the technical and economic feasibility of:
(i) utilizing demonstrated and proven
emission control technologies which would achieve the degree of control
required in subdivision (a)-(g) of this section;
(ii) utilizing demonstrated and proven
emission control technologies which would not achieve the degree of control
required in subdivision (a)-(g) of this section;
(iii) utilizing demonstrated and proven
production modification methods which would result in real, documented, and
enforceable reductions in the volatile organic compound emissions from the
process.
(2) Facilities
with processes subject to this Part with an annual potential to emit less than
five tons of volatile organic compounds will only be required to comply with
subparagraphs (1)(i) and (1)(iii) of this subdivision in order to demonstrate
that a lesser degree of control is RACT for these processes.
(3) The commissioner may allow sources which
use natural gas fired afterburners as control devices for processes subject to
this Part, to shut down these natural gas fired afterburners from November 1st
through March 31st for the purposes of natural gas conservation, provided that
the commissioner has determined that this action will not jeopardize air
quality. Such evidence must be submitted with the application for a permit to
construct, a certificate, or renewal of a certificate to operate for an
existing source under the provisions of Part 201 of this Title.