Recordkeeping (Renumbered)

Section 215 Section 215.489  Recordkeeping (Renumbered) a)         The owner or operator of a pharmaceutical manufacturing plant shall maintain the following records: 1)         The parameters listed in Section 215.488 shall be recorded. 2)         For sources subject to Section 215.482, the vapor pressure of the volatile organic material being controlled shall be recorded for every process. b)         For any leak subject to Section 215.485 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. 4)         The date and time the leak is repaired. c)         The following records shall be kept for emission sources subject to Section 215.484 which contain volatile organic liquid: 1)         For maintenance and inspection: A)        The date and time each cover is opened. B)        The length of time the cover remains open. C)        The reason why the cover is opened. 2)         For production and sampling, written procedures or manufacturing directions specifying the circumstances under which covers may be opened and the procedures for opening covers. d)         For each emission source used in manufacture of pharmaceuticals for which the owner or operator of a pharmaceutical manufacturing plant claims emission standards are not applicable because the emissions are below the applicability cutoff in Section 215.480(a) or (b), the owner or operator shall: 1)         Maintain a demonstration, including detailed engineering calculations, of the maximum daily and annual emissions for each such emission source showing that the emissions are below the applicability cutoffs in Section 215.480(a) or (b), as appropriate, for the current and prior calendar years; 2)         Maintain operating records for each emission source to identify whether the cutoffs in Section 215.480(a) or (b), as appropriate, are ever exceeded; and 3)         Provide written notification to the Agency within 30 days of a determination that such an emissions source has exceeded the applicability cutoff of Section 215.480(a) or (b), as appropriate. e)         Records required under 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 upon verbal or written request.