Commission
(GUC) treatment plant. Limitations of
this permit cover conventional wastewater pollutants, and heavy metals. Procedures for operating the Wastewater
Treatment facilities are covered in an SOP titled “Wastewater Pretreatment
Plant and Wastewater Monitoring Operations, Inspection/Corrective Actions.”
Solid
waste generated from production of drug substance and drug product includes
flammable liquid waste and nonhazardous solid waste. Nonhazardous solid waste is managed on site through incineration
or shredding. The solid waste
incinerator is operated under a permit granted by the N.C. Division of Solid
Waste, Permit No. 74-03-1. Procedures
for operating the solid waste incinerator are covered in an SOP titled
“Operation of the Solid Waste Incinerator.”
Expired, rejected or returned product and packaging material is
physically destroyed in the solid waste incinerator or by an on-site Milpac
shredder. All shredded packaging
material, glass and product are washed with water. Wastewater from the wash operation is discharged to an on-site
biological pretreatment facility and then discharged to the Greenville
Utilities Publicly Owned Treatment Works under Pretreatment Permit
BW01-98. Shredded packaging material,
glass, and plastic is incinerated on site or may be disposed off site at the
Bertie Regional Landfill. Shredder
operations are covered in SOP’s titled “Labeling, Disposition, and On Site
Destruction of Product-Related Waste,” and “Waste Destruction Area Daily
Inspection.”
Flammable Liquid Waste
Flammable
liquid waste is managed through special waste lines to the on-site liquid waste
incinerators. The incinerators are
operated under a site permit granted by EPA and the State of North Carolina,
Permit ID NCD047373766. Procedures for
operating the incinerators and waste transfer lines are covered in SOP’s titled
“Flammable Waste Incinerator Inspection” and “Flammable Waste Tank and Piping
Operating Procedures.”
(3) Citation of and statement of compliance with applicable emission requirements.
Burroughs
Wellcome Co. states that it is in compliance with, or on an enforceable
schedule to be in compliance with, all emission requirements set forth in
permits, consent decrees and administrative orders applicable to the production
of bupropion hydrochloride and WELLBUTRIN (bupropion hydrochloride) Sustained
Release Tablets (drug product) at its facilities in the United States, as well
as emission requirements set forth in federal, state, and local statutes and
regulations applicable to the production of bupropion hydrochloride and
WELLBUTRIN Sustained Release Tablets at its facilities in the United States.
All
the following applicable emissions requirements are complied with on a daily
basis for the production of WELLBUTRIN at Burroughs Wellcome Co.’s Greenville,
North Carolina, facility:
GCPV/93/0011/03 6
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