Attachment IV - Page 3 
2 . 
o Fermenter covers and penetrations for probes used for monitoring pH, 
dissolved oxygen, and other parameters are protected by 0 ring seals. 
In the case of the Bloomfield fermenter (capable of P3 containment) 
an additional 0-ring and steam tracing have been added. 
o All incoming and exhaust air is filtered. Exhaust air passes through 
a 0.22 micron absolute filter prior to being released to the 
atmosphere. A back up system either in the form of a second absolute 
filter or thermal oxidizer is provided in the event of primary system 
failure. Each filter can be steam sterilized in place. Absolute 
rather than HEPA filters, as recommended in the Guidelines, are used 
because of their higher filtration efficiency. 
o Each fermenter is operated at a positive pressure of up to 15 psig. 
A pressure controlling system limits the maximum air pressure to the 
fermenter to prevent over pressurization of the vessel. 
o Each vessel used for growth and all piping that could potentially 
come in contact with viable organisms is capable of being steam 
sterilized. All condensate collected from the transfer lines, sample 
valves, filters and steam seals is piped to a dedicated condensate 
tank. The contents are decontaminated prior to disposal. 
o Both the inoculation and sampling systems are designed to maintain 
containment during transfer of live culture to a seed or production 
fermenter and during sampling of live culture for analysis during 
fermentation. 
o Included in each plant are a series of instruments, controls and 
alarms to continuously monitor equipment operation and process 
parameters and warn of an impending failure. Deviation from 
established settings will alert the operator to the problem and its 
source so that corrective action can be taken. 
o Culture is transferred from the production fermenter for further 
processing only after the recombinant organisms have been inactivated. 
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