Treatment Works under a Pretreatment Discharge Permit No. BW01-98.  This permit expires on May 3, 1998.

 

(4)                 Effect of the action upon compliance with current emissions requirements.

 

Waste streams resulting from the production of bupropion hydrochloride and WELLBUTRIN (bupropion hydrochloride) Sustained Release tablets well include air emissions, solid waste, flammable waste, and wastewater.  Each waste stream is described below and its impact on current emissions requirements is addressed.

 

Air Emissions

 

Potential air emissions from the production of bupropion hydrochloride will come from chemical manufacturing areas as air toxic constituents and volatile organic compounds (VOC’s).  Control devices installed in the manufacturing areas are packed tower type verturi scrubbers and condensers.  Bupropion hydrochloride production has been in place prior to submission of any recent air permit modifications and thus no permit modifications will be required for this process.  Potential air emissions from the formulation of WELLBUTRIN Sustained Release tablets will be in the form of particulate emissions and VOC’s.  Formulation processes will take place in an area currently permitted for particulate and VOC emissions.  The current capacity for this production area will not require modification of the AQ-22 Permit (No. 575R52) when WELLBUTRIN Sustained Release tablet production is brought on line.  Particulate generated during granulating and drying will be collected in baghouse/HEPA filter device.  The addition of new particulate collection devices is not anticipated.  Compliance with VOC limitations is accomplished through monitoring and recording of organic compounds (solvents) used in the printing process.  Refer to CONFIDENTIAL Appendix B (NOT PROVIDED THROUGH FOI ACT) for VOC constituents used in the tablet printing process.  No impact on the air quality permit is expected.

 

In the event that process changes require air toxic evaluation or additional pollution control devices, a modification to the AQ-22 Permit will be requested.  Modification requests by the North Carolina Department of Environment, Health and Natural Resources are normally processed in ninety days.  The amount of time necessary to prepare a modification up through approval is included with any design scope for new equipment requiring pollution control devices or contributing regulating air emission.  In-house review of the design scopes are handled by the Environmental Services Department which subsequently prepares all permit modifications and requests.

 

Nonhazardous Solid Waste

 

Nonhazardous solid waste is generated from production of bupropion hydrochloride and WELLBUTRIN (bupropion hydrochloride) Sustained Release tablets.  This waste will be treated on site either through use of the

 

 

GCPV/93/0011/03                                  8

 

 

 

 

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