Attachment IV - Page 6 
5 . 
o Filter integrity at plants where performed is checked periodically 
and each time the filter is changed. 
o Cell inactivation is verified in duplicate prior to breaking 
containment. 
o Inactivation temperature and time is recorded for each fermenter 
following transfer of inactivated culture. 
o Autoclave sterlization temperature is certified using temperature 
sensitive indicator tape and biological indicator strips. 
o Temperature, pressure and other recording devices on the fermenters 
are calibrated. 
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