Page ll-VII-C-3-c : This requirement for complete sealing of the 
production area is a P4 specification and is unnecessarily 
stringent. The viable cells are totally contained in the 
fermentor. Rather, attention should be directed to a safe 
closed sampling system. We recommend this entire 
requirement be deleted. 
Page ll-VII-C-3-g: The phrases "shall be provided within the production 
area" should be replaced by "shall be available to the 
production area." 
Page ll-VII-C-3-h : The requirement for curbs or similar features to 
contain the total tank contents as also stated for the 
proposed LS-P2 proposal is excessive, adds little to lower 
risk and operationally is highly impractical. Please see 
our comments for Page 6-VII-B-3-b to only contain 500 
liters or less of broth by curbing or similar feature. 
Page 12-VII-C-3-k : Only production equipment which produces aerosols 
containing viable recombinant organisms should be treated 
by passage through filters capable of sterilizing. 
Therefore, the first sentence should be replaced as 
follows: "The exhaust air from biological safety cabinets 
and other containment units, as well as exhaust gas 
containing viable recombinant organisms from aerosol 
generating equipment shall be treated by passage through a 
filter(s) capable of sterilizing or equivalent procedure." 
The requirement for a separate air treatment device to have 
a separate individual exhaust blower would require the roof 
of the production area to sprout many individual blowers, 
an expensive and inefficient mode of operation. We 
recommend that the last word, "area", be followed by the 
phrase, "or designed as an integral part of the air 
handling system." This would permit some manifolding of 
the system. 
- 6 - 
[ 286 ] 
