Section 218.489  Recordkeeping for Air Pollution Control Equipment

a)         The owner or operator of a pharmaceutical manufacturing source shall maintain the following records:

1)         Parameters listed in Section 218.488(a) of this Part shall be recorded.

2)         For emission units subject to Section 218.481 of this Part, the vapor pressure of VOM being controlled shall be recorded for every process.

b)         For any leak subject to Section 218.485 of this Part which cannot be readily repaired within one hour after detection, the following records shall be kept:

1)         The name of the leaking equipment,

2)         The date and time the leak is detected,

3)         The action taken to repair the leak, and

4)         The date and time the leak is repaired.

c)         The following records shall be kept for emission units subject to Section 218.484 of this Part which contain VOL:

1)         For maintenance and inspection:

A)        The date and time each cover is opened,

B)        The length of time the cover remains open, and

C)        The reason why the cover is opened.

2)         For production and sampling, detailed written procedures or manufacturing directions specifying the circumstances under which covers may be opened and the procedures for opening covers.

d)         For each emission unit used in the manufacture of pharmaceuticals for which the owner or operator of a pharmaceutical manufacturing source claims emission standards are not applicable, because the emissions are below the applicability cutoffs in Section 218.480(a) or 218.480(b) of this Part, the owner or operator shall:

1)         Maintain a demonstration including detailed engineering calculations of the maximum daily and annual emissions for each such emission unit showing that the emissions are below the applicability cutoffs in Section 218.480(a) or 218.480(b) of this Part, as appropriate, for the current and prior calendar years;

2)         Maintain appropriate operating records for each such emission source to identify whether the applicability cutoffs in Section 218.480(a) or 218.480(b) of this Part, as appropriate, are ever exceeded; and

3)         Provide written notification to the Agency and the USEPA within 30 days of a determination that such an emission unit has exceeded the applicability cutoffs in Section 218.480(a) or 218.480(b) of this Part, as appropriate.

e)         Records required under subsection (a) of this Section shall be maintained by the owner or operator for a minimum of two years after the date on which they are made.

f)         Copies of the records shall be made available to the Agency or the USEPA upon verbal or written request.

(Source:  Amended at 17 Ill. Reg. 16636, effective September 27, 1993)