Biomedical Engineering Reference
In-Depth Information
to viable organisms containing recombinant DNA molecules at a level that
does not adversely affect the health and safety of employees.
Appendix K-II-G. The facility's emergency response plan shall include
provisions for handling spills.
Appendix K-III: Biosafety Level 1 (BL1)—Large Scale
Appendix K-III-A. Spills and accidents that result in overt exposures to organ-
isms containing recombinant DNA molecules are immediately reported to
the Laboratory Director. Medical evaluation, surveillance, and treatment are
provided as appropriate, and written records are maintained.
Appendix K-III-B. Cultures of viable organisms containing recombinant
DNA molecules shall be handled in a closed system (e.g., closed vessel used
for the propagation and growth of cultures) or other primary containment
equipment (e.g., biological safety cabinet containing a centrifuge used to
process culture fluids), which is designed to reduce the potential for escape
of viable organisms. Volumes less than 10 liters may be handled outside
of a closed system or other primary containment equipment provided all
physical containment requirements specified in Appendix G-II-A,
Physical
Containment Levels—Biosafety Level 1
, are met.
Appendix K-III-C. Culture fluids (except as allowed in Appendix K-III-D)
shall not be removed from a closed system or other primary containment
equipment unless the viable organisms containing recombinant DNA
molecules have been inactivated by a validated inactivation procedure. A
validated inactivation procedure is one that has been demonstrated to be
effective using the organism that will serve as the host for propagating the
recombinant DNA molecules. Culture fluids that contain viable organisms
or viral vectors intended as the final product may be removed from the pri-
mary containment equipment by way of closed systems for sample analysis,
further processing, or final fill.
Appendix K-III-D. Sample collection from a closed system, the addition
of materials to a closed system, and the transfer of culture fluids from one
closed system to another shall be conducted in a manner that minimizes the
release of aerosols or contamination of exposed surfaces.
Appendix K-III-E. Exhaust gases removed from a closed system or other
primary containment equipment shall be treated by filters which have effi-
ciencies equivalent to high efficiency particulate air/HEPA filters or by other
equivalent procedures (e.g., incineration) to minimize the release of viable
organisms containing recombinant DNA molecules to the environment.
Appendix K-III-F. A closed system or other primary containment equip-
ment that has contained viable organisms containing recombinant DNA
molecules shall not be opened for maintenance or other purposes unless it
