Biomedical Engineering Reference
In-Depth Information
TABLE 13.7 Risk Assessment for Changing Reaction Vessel
Process Step,
Change Control,
Deviation, Failure
Current
Accept
Event, etc.
Failure
SEV
Causes
OCC
Controls
DET RPR
Risk?
Actions
Increase vessel
size
Product
inadequately
mixed; does
not meet
content
uniformity
H
Agitator type
and speed
control;
inadequate
mix time
M
Current procedures
require engineering
study, design
qualification,
development batch,
and process
validation
L
M
N
Perform detailed 3D
engineering/process
simulation as part
of design
qualification before
specifying new
mixing equipment
Increase vessel
size
Product does not
meet release
specs because
of degradation
(localized
overheating)
H
Heat transfer
system on
jacket may
not be as
effective
M
Current procedures
require engineering
study, design
qualification,
development batch,
and process
validation; product
release testing
L
M
N
Perform detailed 3D
engineering/process
simulation studies
as part of design
qualification before
specifying new
mixing equipment
Increase vessel
size
Product is
contaminated
by corrosion
H
Inadequate
MOC
(materials of
construction)
L
Current procedures
require engineering
study, design
qualification,
development batch,
and process
validation
L
L
Y
None required
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