(13a) Emission Profiler©2005 Calculation and Reporting Software Targets New Jersey Department of Environmental Protection Pilot Plant, R&D General Permit Compliance

Emission Profiler©2005 SPRI Calculation and Reporting Software Targets NJDEP Pilot Plant, R&D General Permit Compliance Elizabeth A. Dirnfeld and Frederick R. Kohler Schering-Plough Research Institute, 1011 Morris Avenue, Union, NJ 07083 John F. Takacs HighPoint Software Services, Inc., P.O. Box 874, Westminster, MA 01473

ABSTRACT Emission Profiler (EP) was designed for pharmaceutical batch processing applications. Emission Profiler incorporates an innovative and customized approach to air quality and permit compliance management. EP provides a platform that facilitates rapid modeling of sequential unit operations enabling a faster turn-around time for environmental approval of new / modified research and development processes. Emission Profiler was developed to address the requirements of both the Pilot Plant Permit and the new General Permit for Research & Development issued by the New Jersey Department of Environmental Protection (NJDEP). Emission Profiler is a Windows-based system that calculates, tracks and reports emissions in the kilo to pilot plant-scale batch production of pharmaceutical products. EP is based on US EPA Office of Quality Planning and Standards (OAQPS) calculation methods. EP maintains all individual unit operations by experiment for each product in the system. Control devices are also tracked in the system to calculate pre- and post-control emissions. To verify the calculations, a detailed step-by-step printout of each unit operation's calculations is available with references in the calculations to the appropriate US EPA equation. The reports in the system are used to meet state, federal and internal reporting requirements. Although primarily an air permit compliance tool, EP has the additional ability to simultaneously track information on wastewaster and hazardous waste production from pharmaceutical processes for use in other regulatory systems. © 2005 Schering-Plough Research Institute