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ICAS-PAT manual for Design of process monitoring and ... - CAPEC

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Cell mass 30 900 kg<br />

Foaming level 0 0.01 m<br />

Stirrer speed 0 10 rps<br />

Cell growth rate 0.1 0.15 hr-1<br />

Homogeneity 0.7 1 fractional<br />

homogeneous<br />

Sterilizer Steam temperature 120 200 oC<br />

Main stream temperature 120 150 oC<br />

Main stream flow rate 300 700 Kg/hr<br />

Steam flow rate 0 1000 Kg/hr<br />

Sterilization duration 0 7 hour<br />

Mixing tank Stirrer speed 0 36000 rps<br />

Step4: Sensitivity analysis<br />

Mixing time 0 3 hour<br />

Homogeneity 0.95 1 Fractional<br />

homogeneous<br />

Critical <strong>process</strong> points<br />

Mixing tank<br />

Sterilizer<br />

Fermentor<br />

Fermentor<br />

Fermentor<br />

Fermentor<br />

Fermentor<br />

Critical <strong>process</strong> variables<br />

Homogeneity<br />

Main stream temperature<br />

DO (Dissolved oxygen)<br />

pH<br />

Dissolved CO2<br />

Temperature<br />

Homogeneity<br />

Step5: Interdependency analysis<br />

Critical <strong>process</strong> points Critical <strong>process</strong> variables Actuators<br />

Mixing tank Homogeneity Mixing time<br />

Sterilizer Main stream temperature Steam flow rate<br />

Fermentor DO (Dissolved oxygen) Air flow rate<br />

Fermentor pH Flow rate <strong>of</strong> NH3<br />

Fermentor Dissolved CO2 Air flow rate<br />

Fermentor Temperature Coolant flow rate<br />

Fermentor Homogeneity Stirrer speed<br />

Step6: Per<strong>for</strong>mance analysis <strong>of</strong> <strong>monitoring</strong> tools<br />

Critical points Critical variables Monitoring Monitoring tools<br />

techniques<br />

Mixing tank Homogeneity NIR EPP 2000 Fiber Optic Spectrometer-<br />

NIR2<br />

Sterilizer Main stream<br />

temperature<br />

Thermistor DO-35 Interchangeable Thermistor --<br />

103JL1A<br />

Fermentor DO (Dissolved<br />

oxygen)<br />

Optical sensor FOXY Sensor System<br />

30

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