Attachment IV - Page 1 
SCHEMING CORPORATION 
n f 
60 ORANCE STREET ! ' B LOOM F I E LD. N. ]. 07003 
TELEPHONE: (2011429-4000 
CABLES: SCHERING BLOOMFIELD. N.J. 
February 2, 1984 
Dr. Elizabeth Milewski 
Executive Secretary, 
Large Scale Review Working Group 
N I A ID 
Building 31, Room 3B10 
Bethesda, MD 20205 
Dear Dr. Milewski : 
In response to the Large Scale Review Working Group's request for 
technical information on containment systems for fermenters (49 FR 696), 
Schering Corporation offers the attached description of the systems in use at 
our facilities in Bloomfield and Union, NJ. Included also are our facility 
operating practices and an outline of our equipment validation and 
inactivation assurance programs. 
During the design phase of large scale facilities an IBC subcommittee 
works closely with the principal investigator and our engineering staff to 
review facility design and containment features. Upon completion of the 
design, it is presented for approval to the full IBC. Prior to conducting 
large scale fermentations involving recombinant organisms, the IBC meets to 
review containment equipment and process validation data. 
We appreciate the opportunity to share data on our containment systems 
and are willing to discuss this in greater detail with the committee. We 
believe we can all benefit by continued communication with the Large Scale 
Review Working Group which has provided and hopefully will continue to provide 
a forum for discussion regarding large-scale uses of recombinant DNA 
technology. 
Sincerely, 
/ 1 b 
Att. 
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