17 
recognize a system consisting of fermentor , centrifuge, homogenizer , and 
holding tank as a primary system. Er. McKinney said that if the system is 
totally contained and the culture is not exposed to the environment, the system 
is a primary system. He said that if the system is open at any point, e.g., 
if aerosols are generated during centrifugation, the system is not closed and 
does not provide primary containment. 
Drs. Be ms and McKinney suggested that the language of Sections VII-B-1, 
VII-C-1, and VII-D-1 is adequate; Dr. Be ms pointed out that two examples of 
equipment vdiich might be considered part of the primary containment system are 
provided in the language of these sections. 
Er. Be ms adjourned the meeting at 11:10 a.m. Tuesday, October 26, 1982. 
[54] 
