PAT Modules Questions & Answers Verified
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Simulated moving bed chromatography
Simulated moving bed (SMB) chromatography can provide continuous (cyclic) operation for the
separation of binary mixtures, for example, for removal of product variants or oligomers
types of mathematical models in PAT
first principles/mechanistic
empirical
hybrid
first principles/mechanistic
expressed in the form of equations arrhenius equation/lambert beer law
empirical models
data based models, DOE (casual empirical models)
hybrid models
combine theoretical knowledge with empirical data
batch processing
raw material charged into the system at beginning all product collected at end.
continuous processing
material and product continuously charged/discharged throughout duration of system
, types of probes
PH, Temp, DO, Pressure,fill level, Impellar speed,
processes
viable cell density, glucose levels, lactic acid, glycosylation,aggregation
example of continuous process
perfusion bioreactor (online probes for monitoring)
process analysers
probes Ph temp pressure (biological,chemical and physical attributes)
off line
sample removed and analyzed in separate lab away from production
At line
sample is removed and analyzed CLOSE proximity to process stream
In line
sample not removed from process stream
On line
Sample diverted from manufacturing process and may be returned to process stream
Level of quality control
level 1,2,3
100% Correct!
Simulated moving bed chromatography
Simulated moving bed (SMB) chromatography can provide continuous (cyclic) operation for the
separation of binary mixtures, for example, for removal of product variants or oligomers
types of mathematical models in PAT
first principles/mechanistic
empirical
hybrid
first principles/mechanistic
expressed in the form of equations arrhenius equation/lambert beer law
empirical models
data based models, DOE (casual empirical models)
hybrid models
combine theoretical knowledge with empirical data
batch processing
raw material charged into the system at beginning all product collected at end.
continuous processing
material and product continuously charged/discharged throughout duration of system
, types of probes
PH, Temp, DO, Pressure,fill level, Impellar speed,
processes
viable cell density, glucose levels, lactic acid, glycosylation,aggregation
example of continuous process
perfusion bioreactor (online probes for monitoring)
process analysers
probes Ph temp pressure (biological,chemical and physical attributes)
off line
sample removed and analyzed in separate lab away from production
At line
sample is removed and analyzed CLOSE proximity to process stream
In line
sample not removed from process stream
On line
Sample diverted from manufacturing process and may be returned to process stream
Level of quality control
level 1,2,3
