Biomedical Engineering Reference
In-Depth Information
Appendix K-V-M. Emergency plans required by Sections IV-B-2-b-(6),
Institutional Biosafety Committee
, and IV-B-3-c-(3),
Biological Safety Officer,
, shall
include methods and procedures for handling large losses of culture on an
emergency basis.
Appendix K-V-N. Closed systems and other primary containment equip-
ment used in handling cultures of viable organisms containing recombinant
DNA molecules shall be located within a controlled area that meets the fol-
lowing requirements:
Appendix K-V-N-1. The controlled area shall have a separate entry area. The
entry area shall be a double-doored space such as an air lock, anteroom, or
change room that separates the controlled area from the balance of the facility.
Appendix K-V-N-2. The surfaces of walls, ceilings, and floors in the con-
trolled area shall be such as to permit ready cleaning and decontamination.
Appendix K-V-N-3. Penetrations into the controlled area shall be sealed to
permit liquid or vapor phase space decontamination.
Appendix K-V-N-4. All utilities and service or process piping and wiring
entering the controlled area shall be protected against contamination.
Appendix K-V-N-5. Hand-washing facilities equipped with foot, elbow, or
automatically operated valves shall be located at each major work area and
near each primary exit.
Appendix K-V-N-6. A shower facility shall be provided. This facility shall
be located in close proximity to the controlled area.
Appendix K-V-N-7. The controlled area shall be designed to preclude
release of culture fluids outside the controlled area in the event of an acci-
dental spill or release from the closed systems or other primary contain-
ment equipment.
Appendix K-V-N-8. The controlled area shall have a ventilation system that
is capable of controlling air movement. The movement of air shall be from
areas of lower contamination potential to areas of higher contamination
potential. If the ventilation system provides positive pressure supply air, the
system shall operate in a manner that prevents the reversal of the direction
of air movement or shall be equipped with an alarm that would be actuated
in the event that reversal in the direction of air movement were to occur. The
exhaust air from the controlled area shall not be recirculated to other areas of
the facility. The exhaust air from the controlled area may not be discharged
to the outdoors without being high efficiency particulate air/HEPA filtered,
subjected to thermal oxidation, or otherwise treated to prevent the release of
viable organisms.
Appendix K-V-O. The following personnel and operational practices shall
be required:
Appendix K-V-O-1. Personnel entry into the controlled area shall be
through the entry area specified in Appendix K-V-N-1.
Appendix K-V-O-2. Persons entering the controlled area shall exchange or
cover their personal clothing with work garments such as jumpsuits, labora-
tory coats, pants and shirts, head cover, and shoes or shoe covers. On exit
