7 
"... so that the space above the culture level will be maintained 
at a pressure level appropriate for the equipment design to main- 
tain the required containment." 
Dr. West felt the motion was a good one, but wondered whether the word "required" 
might be vague. Er. Levin agreed. Dr. iblin suggested the phrase "not to 
exceed" might be appropriately added. Dr. Be ms said the addition of numbers 
would render the language too specific and would be disadvantageous. 
Dr. Levin questioned whether the motion as proposed would require the operator 
to show that the integrity of the system would be maintained. Dr. Berns felt 
that concern was addressed by Section VII-D-9: Section VII-D-9 requires that 
the system's integrity be tested and that containment be demonstrated. 
Dr. Levin noted that Section VII-D-9 does not require that data be evaluated, 
only that "records of tests and results shall be maintained on file." 
Dr. West offered an amendment bo Er. Tolin's motion. Dr. Tolin accepted the 
language which would read in part: 
"... so that the space above the culture level will be main- 
tained at a pressure as low as possible consistent with the 
production needs, but in all circumstances not greater than 
the system design, to assure that the integrity of the closed 
system is maintained." 
Dr. McKinney suggested the proposed language be modified since containment is 
not maintained by pressure, rather the pressure is limited so that containment 
is not compromised or jeopardized. 
T441 
