Biomedical Engineering Reference
In-Depth Information
equivalent procedures (e.g., incineration) to prevent the release of viable
organisms containing recombinant DNA molecules to the environment.
Appendix K-V-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 the final prod-
uct as described in Appendix K-V-C above. A validated sterilization proce-
dure 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-V-G. A closed system used for the propagation and growth of
viable organisms containing recombinant DNA molecules shall be operated
so that the space above the culture level will be maintained at a pressure as
low as possible, consistent with equipment design, in order to maintain the
integrity of containment features.
Appendix K-V-H. Rotating seals and other mechanical devices directly
associated with a closed system used to contain 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-V-I. A closed system used for the propagation and growth of
viable organisms containing recombinant DNA molecules and other primary
containment equipment used to contain operations involving viable organ-
isms containing recombinant DNA molecules shall include monitoring or
sensing devices that monitor the integrity of containment during operations.
Appendix K-V-J. A closed system used for the propagation and growth
of viable organisms containing recombinant DNA molecules shall be tested
for integrity of the containment features using the organisms that will serve
as the host for propagating the recombinant DNA molecules. Testing shall
be accomplished prior to the introduction of viable organisms containing
recombinant DNA molecules and following modification or replacement of
essential containment features. Procedures and methods used in the testing
shall be appropriate for the equipment design and for recovery and demon-
stration of the test organism. Records of tests and results shall be maintained
on file.
Appendix K-V-K. A closed system used for the propagation and growth of
viable organisms containing recombinant DNA molecules shall be perma-
nently identified. This identification shall be used in all records reflecting test-
ing, operation, maintenance, and use of this equipment for research production
activities involving viable organisms containing recombinant DNA molecules.
Appendix K-V-L. 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.
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