K-patents PR-23 for K-Patents Appendix Manual de usuario descargar pdf (Pagina 5)

This Instruction Manual Appendix covers K-Patents Pharma Refractometer PR-23-AC

when used in the production of viral vaccines. The vaccines are either produced by

inoculating viruses into specic pathogen-free eggs or in animal cell culture based process.

The allantoic uid of these processes is harvested and puried by centrifugation and

stabilised with buffer containing sucrose. The centrifugation process typically uses density

gradient continuous ow ultracentrifuge for the purication of the virus particles. The internal

subviral core of the virus is separated and fractionated on the basis of its’ sedimentation

rate, and the buoyant sucrose density. The K-Patents Pharma Refractometer PR-23-AC is

used for accurate measurement of these sucrose densities. The measurement signal is used

for reliable and timely determination of the product peak in the density gradient (0 to 60%

w/w sucrose), and the subsequent collection of the virus rich fraction (Figure 1.1.).

The K-Patents Pharma Refractometer PR-23-AC can be installed in the vaccines

fractionation unit for in-line process control. The output of the transmitter is a 4 to 20mA

DC output signal proportional to sucrose solution density or Brix. Process data can also be

downloaded to a computer via an Ethernet cable.

High Density

Solution

• Inoculation egg

with virus

• Incubation

• Inoculation

preparation

• Cell expansion

• Virus propagation

Low Density

Solution

Low Density High Density

Filling

Fractionation and separation

Chart Recorder

Rotor unloading

Sucrose gradient purication by zonal centrifugation

Inactivation

of virus

Figure 1.1 Ultracentrifugation density gradient purication process steps.

K-Patents Products for Vaccine

Production and Sucrose Gradient

Ultracentrifugation

1 2 3 4 5 6 7 8 9 10 ... 55 56

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K-patents PR-23 for K-Patents Appendix Manual de usuario Pagina 5