SCHER I NG CORPORATION 
Attachment IV - 
1 . 
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'I 
FACILITY DESIGN AND SAFEGUARDS 
All of Schering Corporation's facilities in which recombinant organisms 
| are used have been built or modified to exceed the physical containment 
! requirements in the NIH Guidelines for laboratory (Appendix G) and Large Scale 
Uses of Organisms Containing Recombinant DNA Molecules (Appendix K). 
I 
1 1. Facility Design 
a. Laboratory Facilities : Laboratory facilities used for rDNA research 
have been designed at a minimum to meet the P2 level of physical containment, 
I with the facilities at Bloomfield having the capability of being upgraded to 
meet P3 containment conditions. 
b. Large Scale Facilities : Schering has facilities designed for large 
scale uses of recombinant organisms at Bloomfield and Union, NJ. Each is a 
dedicated facility and although used for recombinant organisms requiring Pl-LS 
physical containment, each contains many of the features required for P2-LS 
physical containment. The Bloomfield facilities have the capability of being 
upgraded to P3-LS should the need ever arise. 
c. Fermenters : All vessels used for fermentation are stainless steel, 
steam steri 1 izable, capable of being pressurized and equipped with either top 
or bottom driven agitators. Each fermenter is jacketed to provide cooling or 
heating. All connections between the fermenters, pumps, and associated tanks 
that may come in contact with viable organisms are hard piped and steam 
sterilizable in place. Other containment features include: 
o The agitator shaft seals for each fermenter are double mechanical 
rotating seals between the fermenter and agitator shaft. Each is 
designed to prevent escape of viable organisms in the event of seal 
failure. 
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