Page 4 of Attachment C 
The fermentation process is monitored and terminated when optimum 
cell growth is attained. Termination may be by chemical or physical 
means depending on the product or process. Harvest of the cells is 
accomplished by centrifugation followed by physical lysis of the 
cells. The crude product undergoes purification and extraction pro- 
cesses such as chromatography. The extraction, cell lysing, and pro- 
duct purification processes were not observed during this survey. 
These processes should be observed and evaluated for potential haz- 
ards when the company has developed them to the state of continuous 
production. 
DESCRIPTION OF INDUSTRIAL HYGIENE, 
SAFETY AND MEDICAL PROGRAMS 
Industrial Hygiene 
This company has no industrial hygienist on staff. Environmental mon- 
itoring has been limited to open agar plate sampling for settling 
aerosol particles and air sampling by impaction on agar plate tech- 
niques. The air impaction technique was used for containment certifi- 
cation of the fermentation system for submission to NIH and is not 
a routine measurement. Results of the open agar plates have been re- 
corded on the fermentation batch records since October 1979. The open 
agar plates are placed next to the agitator seal of the 600-liter 
fermentor during each batch. This seal would appear to be the most 
likely source of leakage, should it occur during the fermentation 
run. Potential fpr leakage, or aerosol production, may also exist due 
to the methods and equipment used for inoculation and sampling of the 
fermentors. No viable organisms have been recovered by this method 
at the time of the survey. 
Safety and Health 
A formal safety program- is being development by the Director of Human 
Resources. The company has a safety committee and specific guidelines 
for work practices, housekeeping, safe laboratory practices, and 
emergency procedures are being drafted. 
An Institutional Bio-Safety Committee (IBC) has been formed in com- 
pliance with the NIH guidelines. The Bio-Safety officer is a member 
of the company safety committee. A local physician and a consulting 
environmental engineer are also members of the IBC. 
Employees are supplied laboratory coats as protective clothing. These 
coats are laundered outside the company by a contract laundry. Em- 
ployees are required to wear the coats in accordance with the NIH 
guidelines. Showers and change rooms are available for emergency use. 
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