Biomedical Engineering Reference
In-Depth Information
has been sterilized by a validated sterilization procedure except when the
culture fluids contain viable organisms or vectors intended as the final prod-
uct as described in Appendix K-III-C above. A validated sterilization proce-
dure is one that has been demonstrated to be effective using the organism
that will serve as the host for propagating the recombinant DNA molecules.
Appendix K-III-G. 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-IV: Biosafety Level 2 (BL2)—Large Scale
Appendix K-IV-A. Spills and accidents that result in overt exposures to organ-
isms containing recombinant DNA molecules are immediately reported
to the Biological Safety Officer, Institutional Biosafety Committee, NIH/
OBA, and other appropriate authorities (if applicable). Reports to NIH/OBA
shall be sent to the Office of Biotechnology Activities, National Institutes of
Health, 6705 Rockledge Drive, Suite 750, MSC 7985, Bethesda, MD 20892-7985
(20817 for non-USPS mail), 301-496-9838, 301-496-9839 (fax). Medical evalua-
tion, surveillance, and treatment are provided as appropriate, and written
records are maintained.
Appendix K-IV-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., Class III biological safety cabinet containing a centrifuge
used to process culture fluids), which is designed to prevent the 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-B,
Physical
Containment Levels--Biosafety Level 2
, are met.
Appendix K-IV-C. Culture fluids (except as allowed in Appendix K-IV-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-IV-D. Sample collection from a closed system, the addition
of materials to a closed system, and the transfer of cultures fluids from one
