K-patents PR-23 for K-Patents Appendix Manual de usuario descargar pdf (Pagina 3)

Contents

Section 1 K-Patents Products for Vaccine Production and

Sucrose Gradient Ultracentrifugation ............................................................................... 5

1.1 DesignQualication ....................................................................................................... 6

Section 2 The Pharma Refractometer PR-23-AC ................................................................................ 7

2.1 System description ........................................................................................................ 7

2.2 System components ...................................................................................................... 8

2.2.1 Checklist of components .................................................................................... 8

2.3 Pharma Refractometer Sensor PR-23-AC-62-HSS-SC ............................................. 10

2.3.1 Sensor Model code .......................................................................................... 10

2.3.2 PharmaMiniowCellModelcode ................................................................... 10

2.4 Indicating Transmitter DTR-GP-SC ............................................................................. 12

2.4.1 Indicating Transmitter Model code................................................................... 12

2.5 Pharma Vaccines Accessories .................................................................................... 13

2.5.1 ComputerCommunicationSoftwareCC-11 .................................................... 13

Section 3 Installation of PR-23 Pharma Refractometer ................................................................... 15

3.1 HardwareandSoftwareRequirements ....................................................................... 15

3.2 MechanicalandElectricalRequirements .................................................................... 15

3.3 Sensor installation for use in Pharmaceutical Batch Manufacturing ........................... 15

3.4 Indicating Transmitter installation for use in table top ................................................. 19

3.5 Wiringtransmitterconnectionstosensor,powercableandcomputer ....................... 20

3.6 RefractometerInstrumentVerication ......................................................................... 21

Section 4 Electronic Data Capture and Storage .............................................................................. 23

4.1 Ethernet connection ..................................................................................................... 23

4.2 ComputerCommunicationSoftwareCC-11 ................................................................ 23

4.2.1 Functionality and Main Menu ........................................................................... 24

4.2.2 TrendViewMenu ............................................................................................. 25

4.2.3 Data Logging Menu.......................................................................................... 26

Section 5 Complying with Documentation and Validation Regulations ....................................... 29

5.1 Documentation ............................................................................................................. 29

5.2 Qualication ................................................................................................................. 29

5.3 Protocol Acceptance by Customer and List of Tests Performed ................................. 29

5.4 Electronic Data Management and Data Storage ......................................................... 30

5.5 Electronic Signatures/Audit Trail .................................................................................. 30

5.6 Record Keeping ........................................................................................................... 30

5.7 Security ........................................................................................................................ 30

5.8 System Validation ........................................................................................................ 30

5.9 K-Patents Refractometer System Adherence to Part 11 ............................................. 31

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

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K-patents PR-23 for K-Patents Appendix Manual de usuario Pagina 3