Biomedical Engineering Reference
In-Depth Information
TABLE 14.9
Physical Containment Requirements for Large-scale Fermentations Using Organisms
Containing Recombinant DNA Molecules
Item no. Description
BL1-LS
BL2-LS
BL3-LS
1
Closed vessel
2
Inactivation of cultures by validated procedure before removing from
the closed system
3
Sample collection and addition of material in a closed system
4
Exhaust gases sterilized by filters before leaving the closed system
5
Sterilization by validated procedures before opening for maintenance
or other purposes
6
Emergency plans and procedures for handling large losses
7
No leakage of viable organisms from rotating seals and other
mechanical devices
8
Integrity evaluation procedure: monitors and sensors
9
Containment evaluation with the host organism before introduction of
viable organisms
10
Permanent identification of closed system (fermentor) and
identification to be used in all records
11
Posting of universal biohazard sign on each closed system and
containment equipment when working with a viable organism
12
Posting of universal biohazard sign on entry doors when work is in
progress
13
Operations to be in a controlled area:
Separate specified entry
Double doors, air locks
Walls, ceiling, and floors to permit ready cleaning and
decontamination
Utilities and services (process piping and wiring) to be protected
against contamination
Handwashing facilities and shower facilities in close proximity
Area designed to preclude release of culture fluids outside the
controlled area in the event of an accident
Ventilation: movement of air, filtration of air
With permission, from R. J. Giorgiou and J. J. Wu,
Trends in Biotechnology
4:198 (1986).
present some operating issues, since the inactivation of the host cell must be done in such
a way as not to harm what are often fragile products. Emergency plans and devices must
be on hand to handle any accidental spill or loss of fluid in the fermentation area. These extra
precautions increase manufacturing costs.
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