Biomedical Engineering Reference
In-Depth Information
TABLE K.1 (Continued)
Comparison of Good Large-Scale Practice (GLSP) and Biosafety Level (BL)—
Larg
e-Scale (LS) Practice
CRITERION [See Appendix
K-VI-B, Footnotes of Appendix K]
GLSP
BL1-LS
BL2-LS
BL3-LS
20.
Access to the workplace.
NR
G-II-A-1-a
G-II-B-
1-a
K-V-N
21.
Requirements for controlled
access area.
NR
NR
NR
K-V-N&O
Note:
NR = not required. The criteria in this grid address only the biological hazards associ-
ated with organisms containing recombinant DNA. Other hazards accompanying the
large-scale cultivation of such organisms (e.g., toxic properties of products; physical,
mechanical, and chemical aspects of downstream processing) are not addressed and
shall be considered separately, albeit in conjunction with this grid.
Appendix K-VI-B. The criteria in this grid address only the biological haz-
ards associated with organisms containing recombinant DNA. Other haz-
ards accompanying the large-scale cultivation of such organisms (e.g., toxic
properties of products; physical, mechanical, and chemical aspects of down-
stream processing) are not addressed and shall be considered separately,
albeit in conjunction with this grid.
Appendix K-VII: Definitions to Accompany
Containment Grid and Appendix K
Appendix K-VII-A. Accidental Release. An accidental release is the uninten-
tional discharge of a microbiological agent (i.e., microorganism or virus) or
eukaryotic cell due to a failure in the containment system.
Appendix K-VII-B. Biological Barrier. A biological barrier is an impedi-
ment (naturally occurring or introduced) to the infectivity and/or survival
of a microbiological agent or eukaryotic cell once it has been released into
the environment.
Appendix K-VII-C. Closed System. A closed system is one in which by its
design and proper operation, prevents release of a microbiological agent or
eukaryotic cell contained therein.
Appendix K-VII-D. Containment. Containment is the confinement of
a microbiological agent or eukaryotic cell that is being cultured, stored,
manipulated, transported, or destroyed in order to prevent or limit its con-
tact with people and/or the environment. Methods used to achieve this
include physical and biological barriers and inactivation using physical or
chemical means.
Appendix K-VII-E. De minimis Release. De minimis release is the release
of: (i) viable microbiological agents or eukaryotic cells that does not result in
