Or. Donald S. Fredrickson 
Page 3 
November 29, 1979 
p. 5 — VII-B-2-b-(2) — Use of the term "observation" is 
inappropriate. A statement recognizing the 
validity of "sensing or monitoring device or 
system" should be inserted. In addition, there 
should be recognition of pre- and post- use 
validation [as for example, on line dioctyl 
phthalate (OOP) testing] rather than observation 
or continuous monitoring "during" operation. 
VII-B-2-b-(4) — The use of the term "disassembly" 
fails to recognize the construction of large-scale 
fermentation vessels. Standard production 
facilities include the CIP concept for cleaning 
in-place without disassembling. "Disassembly" 
should be deleted. 
p. 6 — VII-B-3-a — The phrase "in the same building... 
molecules" should be deleted. It is adequate 
that an autoclave is available for batch 
treatment. The transfer of materials is 
frequently an on-line operation utilizing piping 
and could involve transfer between buildings. 
VII-B-3-b — The requirement for a "curb or 
similar architectural feature" again clearly 
fails to recognize the construction and capability 
of large-scale fermentation 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 rapid 
in-place chemical sterilization. This procedure 
plus pumping contents into a harvest vessel for 
inactivation is far superior in terms of safety 
to the concept of allowing the contents to flow 
into a curbed area followed by chemical 
inactivation. 
VII-C-1-b — This section should be modified to 
read "Persons entering the production area shall 
exchange or cover their personal clothing with 
work garments such as jump suits, laboratory 
coats, pants and shirts, head cover and shoes or 
shoe covers". 
p. 8 — VII-C-1-k — The phrase "except as necessary for 
access" should be inserted following the word 
"closed". 
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