(a) This section applies to synthesized
pharmaceutical manufacturing facilities.
(b) The owner or operator of a synthesized
pharmaceutical manufacturing facility subject to this section shall control the
VOC emissions from reactors, distillation operations, crystallizers,
centrifuges and vacuum dryers that emit 15 pounds per day or more of VOC.
Surface condensers or equivalent controls shall be used if:
(1) Surface condensers are used, the
condenser outlet gas temperature may not exceed:
(i) -25°C when condensing VOC of vapor
pressure greater than 5.8 psi (40 kilopascals) when measured at
68°F.
(ii) -15°C when
condensing VOC of vapor pressure greater than 2.9 psi (20 kilopascals) when
measured at 68°F.
(iii) 0°C
when condensing VOC of vapor pressure greater than 1.5 psi (10 kilopascals)
when measured at 68°F.
(iv)
10°C when condensing VOC of vapor pressure greater than 1 psi (7
kilopascals) when measured at 68°F.
(v) 25°C when condensing VOC of vapor
pressure greater than .5 psi (3.5 kilopascals) when measured at
68°F.
(2) Equivalent
controls are used, the VOC emissions shall be reduced by an equivalent or
greater amount than would be required in paragraph (1).
(c) The owner or operator of a synthetic
pharmaceutical manufacturing facility subject to this section shall reduce the
VOC emissions from air dryers and production equipment exhaust systems:
(1) By at least 90% if emissions are 220
pounds per day (100 kilograms per day) or more of VOC.
(2) To 33 pounds per day or less if emissions
are less than 220 pounds per day of VOC.
(d) The owner or operator of a synthesized
pharmaceutical manufacturing facility subject to this section shall enclose
centrifuges, rotary vacuum filters and other filters having an exposed liquid
surface, where the liquid contains VOC and exerts a total VOC vapor pressure of
.5 psi (3.5 kilopascals) or more at 20°C.
(e) The owner or operator of a synthesized
pharmaceutical facility subject to this section shall install covers on
in-process tanks containing a VOC at any time. These covers shall remain
closed, unless production, sampling, maintenance or inspection procedures
require operator access.
(f) The
owner or operator of a synthesized pharmaceutical manufacturing facility
subject to this section shall repair 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.
Notes
The
provisions of this § 129.68 adopted June 19, 1981, effective
6/20/1981, 11 Pa.B. 2118;
amended August 2, 1991, effective 8/3/1991, 21 Pa.B.
3406.
The provisions of this § 129.68 issued under the
Air Pollution Control Act (35 P.S. §§
4001-4015).
This section cited in 25 Pa. Code §
129.51 (relating to general); 25
Pa. Code §
129.54 (relating to seasonal
operation of auxiliary incineration equipment); 25 Pa. Code §
129.66 (relating to compliance
schedules and final compliance dates); 25 Pa. Code §
129.91 (relating to control of
major sources of NOx and VOCs); 25 Pa. Code §
129.96 (relating to
applicability); and 25 Pa. Code §
129.111 (relating to
applicability).
