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October29, 2003
RECEJIVED
CLERK’S
OFFICE
OCT
30
~OO3
Charles E. Matoesian
STATE OF IWNOIS
Division ofLegal Counsel
Pollution
Control Board
Illinois Environmental Protection Agency
1021 North Grand Avenue East
POBox
19276
Springfield,
Illinois 62794
Re: Wallace v. IEPA, PCB 02-207 (Air Variance)
Dear Mr. Matoesian,
As per condition 3.h. ofthe Order granting a variance in the
above referenced matter,
MedPointe Healthcare, Inc. is submitting this letter as a progress report for the period
from April
1, 2003 through
September 30, 2003.
As noted previously, the Wallace
Pharmaceuticals’ name has been changed to MedPointe Pharmaceuticals.
According to the Order, MedPointe is required to report on the progress ofthe
development of a suitable alternative to the
usage ofethanol in the affected processes.
During the above referenced period, we were installing new air handling equipment in the
tablet production area, and the tabletproduction area was idle from March through early
June.
As a result, we outsourced the development and production oftwo new tablet
products that were recently introduced to the market.
In the event that manufacture of
these products is transferred back to Decatur in the future, we are pleased to report that
their direct-compression manufacturing processes do not involve the use ofethanol.
These research efforts should satisfy both conditions 3.a.
and 3.b. ofthe Order, in that the
bench-top, pilot, and
commercial scale processes were successful for these products, and
do not utilize VOM solvents.
As we reported last April, a dry granulation process which uses no ethanol is in use for
Tussi
12-D Tablets, a new product launched by MedPointe in 2002.
We expect to
continue further evaluation ofthe dry granulation processes and substitute, where
possible, for the ethanol-based wet granulation process.
We continue our research efforts with emphasis being placed on non-VOM products and
processes for our future product development. These efforts should not only minimize
our VOM emissions but quite possibly keep them well within our pre-variance levels.
In
light ofthe items mentioned above, it is
likely that add-on control technology may not be
necessary to achieve compliance with our pre-variance limits of 12.5 tons per year.
434 North Morgan Street, Decatur, IL 62523-1125
217-424-8400
www.medpointepharma.corn
-2-
At this writing, we expect our VOM emissions to be
well below the allowable variance
limit of 25 tons per year.
I trust this briefletter report satisfies the Order requirement for a progress report. Ifany
additional information is required please advise.
Sincerely,
William J.
araszewski, Ph.D.
Director, Pharmaceutical Production
cc:
Dorothy Gunn, Clerk
Illinois Pollution Control Board
State ofIllinois
Center
100 West Randolph St., Suite 11-500
Chicago, IL
60601