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RECEIVED
CLERK’S OFFICE
April 26, 2004
APR
302004
STATE
OF ILLINOIS
Charles E. Matoesian
Pollution Control
Board
Division ofLegal Counsel
Illinois Environmental Protection Agency
1021
North Grand Avenue East
P0 Box
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 October
1, 2003 through March 31, 2004.
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 of
the development ofa suitable alternative to the usage ofethanol in the
affected processes.
We are pleased to report that research and development
of direct-compression manufacturing processes has been successful,
and do
not involve the use ofethanol.
These research efforts should satisf~’
conditions 3.a., 3.b., and 3.c. of the Order, in that the bench-top, pilot, and
commercial scale processes were successful for these products, and do not
utilize VOM solvents.
As was previously reported, a dry granulation process which uses no ethanol
is in use for Tussi
12-D Tablets, our largest volume coughlcold tablet
product.
We expect to continue further evaluation ofthe dry granulation
processes and substitute, where possible,
for the ethanol-based wet
granulation process.
434 North Morgan Street, Decatur, IL 62523-1125
217-424-8400
www.medpointepharma.com
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 also presumably keep
them well within our pre-variance levels.
In light ofthe items mentioned
above, it is likely that add-on control technology will not be necessary to
achieve compliance with our pre-variance limits of 12.5 tons per year.
At this writing, we expect our VOM emissions to be well below the
allowable variance limit of 25
tons per year.
Our VOM emissions for 2003,
which are being reported separately, were well below that level.
I trust this briefletter report satisfies the Order requirement for a progress
report. If any additional information is required please advise.
Sincerely,
William J. Taraszews
1,
.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