crusher facility or the solid waste incinerator [see 4.c(3)].  The amount of rejected product from tablet formulation processes is expected to be kept to a minimum acceptable reject standard, and would therefore not impact the ability of the waste treatment systems to handle the waste.  Treatment of all rejected product through the crusher facility would consume less than 0.14 percent per year of the unit’s waste handling capacity.  Alternatively, treatment of the rejected product in the solid waste incinerator would consume less than 0.017% per year of the permitted capacity of the unit.  Permits applicable to these waste treatment systems are the local Pretreatment Discharge Permit No. BW01-98 for the crusher facility, and N.C. Department of Environment, Health and Natural Resources Air Quality Permit No. 5754R52 and N.C. Division of Solid Waste Permit No. 74-03-1 for the solid waste incinerator.

 

Waste solids generated from production of bupropion hydrochloride incinerated on site.  Specific permit limitations controlling incineration of these waste streams are VOC limits in Air Quality Permit No. 5754R52.  Waste solids generated from production of WELLBUTRIN Sustained Release tablets will not contain any compound restricted by these site permits.  No impact is expected on the current emissions requirements for solid waste management.

 

Any permit modifications would require similar preparation as described above, under Air Emissions.

 

Flammable Waste (Liquid)

 

Flammable waste is treated on site by liquid incinerators operated under EPA permit No. NCD047373766 granted by the state of North Carolina.  Incineration of flammable waste generated from the bupropion hydrochloride manufacturing process is projected to consume approximately 40% of current excess capacity by 1999.  Incineration of bupropion hydrochloride production waste streams will not impact current permit limitations.

 

In event incinerator capacity is exceeded, Burroughs Wellcome Co. will evaluate design and construction of additional treatment facilities and submit necessary permit applications.  Burroughs Wellcome Co. is also in the final stages of design of a toluene recovery facility.  Operation of the recovery facility will free up additional incinerator capacity for waste solvents generated during manufacture of bupropion hydrochloride.

 

Wastewater

 

Wastewater will be generated from production processes through equipment cleanup, product washing and from waste disposal processes using the crusher facility’s shredding and rinsing procedure [see 6.a(2)].  The only potential area of impact on emissions limitations is the local Pretreatment Discharge Permit No. BW01-98, specifically flow limitations.  However, because the equipment to be used for production and disposal processes is currently in place, no increase in flow is anticipated, therefore no impact on the permit is expected.

 

 

 

GCPV/93/0011/03                                  9

 

 

 

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