6.                   INTRODUCTION OF SUBSTANCES INTO THE ENVIRONMENT

 

6.a           For the production site – Burroughs Wellcome Co.

 

(1)                 Substances expected to be emitted

 

A list of materials used in the manufacture of bupropion hydrochloride is furnished in CONFIDENTIAL Appendix B (NOT PROVIDED THROUGH FOI ACT) with the Occupational Exposure Limits and a discussion of controls exercised within the process designed to prevent their emission into the environment.  Chemical Abstract Services (CAS) numbers are provided in CONFIDENTIAL Appendix B (NOT PROVIDED THROUGH FOI ACT) to facilitate acquisition of Material Safety Data Sheets for OSHA regulated materials.

 

(2)                 Controls exercised

 

Air Emissions

 

Air emissions from stage 1 of the manufacture of bupropion hydrochloride are controlled by passing through packed tower type venturi scrubbers.  Stage 2 emissions are controlled through condensers.  Any uncontrolled air emissions are monitored, recorded, and maintained in accordance with permit limitations established under Air Permit No. 5754R52.  The permit limitations are covered under State Toxic Air Pollutant Standards and VOC limits.  All control devices are included in the Air Permit.  Particulate synthesis are passed through HEPA filer/dust collector devices.  The dust collection devices are also permitted in the above-referenced air permit.  CONFIDENTIAL Appendix B (NOT PROVIDED THROUGH FOI ACT) contains specific constituents and permit limits.  Standard Operating Procedures are carried out in the manufacturing process to further control air emissions generated through nitrogen sweeping of lines and reactor vessels.

 

During formulation of the drug product, WELLBUTRIN (bupropion hydrochloride), air emissions expected to occur will be in the form of particulates which are controlled by baghouse/HEPA filter equipment on the granulating and drying rooms and VOC’s from tablet printing operations.  The filter control devices are covered in Air Permit No. 5754R52.  This permit also has VOC limitations for the printers to be used.  A Standard Operating Procedure (SOP) entitled “Volatile Organic Compound Emission Reporting for SDFMD Coating” is followed for recording and reporting VOC emissions from tablet printing operations.

 

Wastewater and Solid Waste

 

Wastewater generated from production of drug substance and drug product is discharged to the Burroughs Wellcome Co. Wastewater Pretreatment Facility.  The facility is operated in accordance with Discharge Permit, BW01-98, which permits the discharge of pharmaceutical wastewater to the Greenville Utilities.

 

 

 

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