Biomedical Engineering Reference
In-Depth Information
closed system to another shall be conducted in a manner that prevents the
release of aerosols or contamination of exposed surfaces.
Appendix K-IV-E. Exhaust gases removed from a closed system or other
primary containment equipment shall be treated by filters that have efficien-
cies equivalent to high efficiency particulate air/HEPA filters or by other
equivalent procedures (e.g., incineration) to prevent the release of viable
organisms containing recombinant DNA molecules to the environment.
Appendix K-IV-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
has been sterilized by a validated sterilization procedure except when the
culture fluids contain viable organisms or vectors intended as final product
as described in Appendix K-IV-C above. A validated sterilization procedure
is one that has been demonstrated to be effective using the organisms that
will serve as the host for propagating the recombinant DNA molecules.
Appendix K-IV-G. Rotating seals and other mechanical devices directly
associated with a closed system used for the propagation and growth of
viable organisms containing recombinant DNA molecules shall be designed
to prevent leakage or shall be fully enclosed in ventilated housings that are
exhausted through filters that have efficiencies equivalent to high efficiency
particulate air/HEPA filters or through other equivalent treatment devices.
Appendix K-IV-H. A closed system used for the propagation and growth
of viable organisms containing recombinant DNA molecules and other pri-
mary containment equipment used to contain operations involving viable
organisms containing sensing devices that monitor the integrity of contain-
ment during operations.
Appendix K-IV-I. A closed system used for the propagation and growth of
viable organisms containing the recombinant DNA molecules shall be tested
for integrity of the containment features using the organism that will serve
as the host for propagating recombinant DNA molecules. Testing shall be
accomplished prior to the introduction of viable organisms containing recom-
binant DNA molecules and following modification or replacement of essen-
tial containment features. Procedures and methods used in the testing shall
be appropriate for the equipment design and for recovery and demonstration
of the test organism. Records of tests and results shall be maintained on file.
Appendix K-IV-J. A closed system used for the propagation and growth
of viable organisms containing recombinant DNA molecules shall be per-
manently identified. This identification shall be used in all records reflect-
ing testing, operation, and maintenance and in all documentation relating to
use of this equipment for research or production activities involving viable
organisms containing recombinant DNA molecules.
Appendix K-IV-K. The universal biosafety sign shall be posted on each
closed system and primary containment equipment when used to contain
viable organisms containing recombinant DNA molecules.
