Dr. Donald S. Fredrickson 
Page 4 
November 29, 1979 
VII-C-l-o — The concept of validation of 
procedures should be adequate for demonstration 
of the inactivation of the organisms as in our 
suggestion for VII-B-1-1. 
p. 9 — viI-C-2-a — As in our suggestion for VII-B-2-b, 
HEPA filters should not be designated. "Filters 
capable of sterilization" should be inserted and 
incineration can be considered as an alternative. 
Vii-C-2-b — Insert the word "viable" immediately 
ahead of organisms in the first sentence. 
p. 10 — VII-C-2-b-(2) — As we suggested for VII-B-2-b-(2), 
"sensing or monitoring system or device "should 
be substituted for the term "observation". 
VII-C-2-b-(4) — "disassembly" should be deleted 
as recommended for VII-B-2-b-(4). 
VII-C-2-b-(6) — The equipment design may include 
processing the recombinant organism through 
killing; beyond this point the organisms would 
not be viable and design considerations would be 
exempt from the Guidelines. 
p. 11 — VII-C-3-b — The surfaces required are not 
necessarily consistent with a production facility. 
The design of equipment for complete containment 
should eliminate the .necessity for such a feature. 
VII-C-3-c — This type of sealed facility is only 
required for P4 laboratories. It is inconsistent 
to require it for P3-LS. 
VII-C-3-g — The phrase "shall be provided within" 
should be deleted and "shall be available to" 
substituted. 
VII-C-3-h — Our comments on "curbs" in section 
VII-B-3-b are applicable here as well. The 
requirement for "curb or similar architectural 
feature" again clearly fails to recognize the 
construction and capability of large-scale fermen- 
tation vessels. In our experience of over 35 
years of use of equipment of this type, such a 
vessel has never ruptured. These stainless steel 
vessels provide for in-place sterilization. This 
procedure plus pumpirig contents into a harvest 
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