Section 326IAC8-5-3. Synthesized pharmaceutical manufacturing operations

   (a) This section applies to the manufacture of pharmaceutical products by chemical synthesis. This section applies to all facilities emitting volatile organic compounds, including reactors, distillation units, dryers, storage of volatile organic compounds, transfer of volatile organic compounds, extraction equipment, filters, crystallizers, and centrifuges that have the potential to emit six and eight-tenths (6.8) kilograms per day (fifteen (15) pounds per day) or more.

  (b) Control requirements are as follows:

(1) Volatile organic compound emissions from all reactors, distillation operations, crystallizers, centrifuges, and vacuum dryers shall be controlled by surface condensers or equivalent controls.

(A) If surface condensers are used, the condenser outlet gas temperature must not exceed:

(i) minus twenty-five degrees Celsius (-25°C) when condensing VOC of vapor pressure greater than forty (40) kilo Pascals (five and eight-tenths (5.8) pounds per square inch);

(ii) minus fifteen degrees Celsius (-15°C) when condensing VOC of vapor pressure greater than twenty (20) kilo Pascals (two and nine-tenths (2.9) pounds per square inch);

(iii) zero degrees Celsius (0°C) when condensing VOC of vapor pressure greater than ten (10) kiloPascals (one and five-tenths (1.5) pounds per square inch);

(iv) ten degrees Celsius (10°C) when condensing VOC of vapor pressure greater than seven (7) kiloPascals (one (1) pound per square inch); or

(v) twenty-five degrees Celsius (25°C) when condensing VOC of vapor pressure greater than three and five-tenths (3.5) kilo Pascals (five-tenths (0.5) pound per square inch).

(B) The vapor pressures listed above shall be measured at twenty degrees Celsius (20°C).

(C) If equivalent controls are used, the VOC emissions must be reduced by at least as much as they would be by using a surface condenser which meets the requirements of clause (A).

(2) VOC emissions from all air dryers and production equipment exhaust systems at sources existing as of July 1, 1990, in Clark, Elkhart, Floyd, Lake, Marion, Porter, and St. Joseph Counties and at new sources located in any county construction of which commences after July 1, 1990, shall be reduced:

(A) by at least eighty-five percent (85%) until July 1, 1991, and by at least ninety percent (90%) commencing July 1, 1991, if emissions are one hundred fifty (150) kilograms per day (three hundred thirty (330) pounds per day) or more of VOC; or

(B) to fifteen (15) kilograms per day (thirty-three (33) pounds per day) or less if emissions are less than one hundred fifty (150) kilograms per day (three hundred thirty (330) pounds per day) of VOC.

This requirement may be waived by the commissioner if the owner or operator can show to the satisfaction of the commissioner that such control is not practical at a reasonable cost because of dilution of the exhaust gas with large quantities of air. Any such waiver shall be submitted to the U.S. EPA as a SIP revision.

(3) The owner or operator of a synthesized pharmaceutical manufacturing facility subject to this section 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 seven thousand five hundred (7,500) liters (two thousand (2,000) gallons) that store VOC with vapor pressures greater than twenty-eight (28) kiloPascals (four and one-tenth (4.1) pounds per square inch) at twenty degrees Celsius (20°C); and

(B) install pressure/vacuum conservation vents set at plus or minus two-tenths (+ 0.2) kilo Pascals on all storage tanks that store VOC with vapor pressures greater than ten (10) kilo Pascals (one and five-tenths (1.5) pounds per square inch at twenty degrees Celsius (20°C)), unless a more effective control system is used.

(4) The owner or operator of a synthesized pharmaceutical facility subject to this section shall enclose all 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 three and five-tenths (3.5) kiloPascals (five-tenths (0.5) pounds per square inch) or more at twenty degrees Celsius (20°C).

(5) The owner or operator of a synthesized pharmaceutical facility subject to this rule shall install covers on all inprocess tanks containing a volatile organic compound at any time. These covers must remain closed, unless production, sampling, maintenance, or inspection procedures require operator access.

(6) The owner or operator of a synthesized pharmaceutical manufacturing facility subject to this section 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.

(Air Pollution Control Division; 326 IAC 8-5-3; filed Mar 10, 1988, 1:20 p.m.: 11 IR 2544; filed Apr 18, 1990, 4:55 p.m.: 13 IR 1683; readopted filed Jan 10, 2001, 3:20 p.m.: 24 IR 1477)