K-Patents PR-23 for K-Patents Appendix - Manual (Page 3)

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Contents
Section 1 K-Patents Products for Vaccine Production and
Sucrose Gradient Ultracentrifugation ............................................................................... 5
1.1 Design Qualification ....................................................................................................... 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 Miniflow 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 Verification ......................................................................... 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 Qualification ................................................................................................................. 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