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
10.
Control of aerosols by
engineering or procedural
controls to prevent or
minimize release of
organisms during sampling
from a system, addition of
materials to a system,
transfer of cultivated cells,
and removal of material,
products, and effluent from a
system.
Minimize
Procedure
K-II-F
Minimize
Engineer
K-III-B
K-III-D
Prevent
Engineer
K-IV-B
K-IV-D
Prevent
Engineer
K-V-B
K-V-D
11.
Treatment of exhaust gases
from a closed system to
minimize or prevent release
of viable organisms.
NR
Minimize
K-III-E
Prevent
K-IV-E
Prevent
K-V-E
12.
Closed system that has
contained viable organisms
not to be opened until
sterilized by a validated
procedure.
NR
K-III-F
K-IV-F
K-V-F
13.
Closed system to be
maintained at as low a
pressure as possible to
maintain the integrity of
containment features.
NR
NR
NR
K-V-G
14.
Rotating seals and other
penetrations into closed
system designed to prevent
or minimize leakage.
NR
NR
Prevent
K-IV-G
Prevent
K-V-H
15.
Closed system shall
incorporate monitoring or
sensing devices to monitor
the integrity of containment.
NR
NR
K-IV-H
K-V-I
16.
Validated integrity testing of
closed containment system.
NR
NR
K-IV-I
K-V-J
17.
Closed system to be
permanently identified for
record keeping purposes.
NR
NR
K-IV-J
K-V-K
18.
Universal biosafety sign to be
posted on each closed
system.
NR
NR
K-IV-K
K-V-L
19.
Emergency plans required for
handling large losses of
cultures.
K-II-G
K-III-G
K-IV-L
K-V-M
Continued
