K-Patents PR-23 for K-Patents Appendix User Manual
K-Patents Equipment
Table of contents
Document Outline
- 1 K-Patents Products for Vaccine Production and Sucrose Gradient Ultracentrifugation
- 2 The Pharma Refractometer PR-23-AC
- 3 Installation of PR-23 Pharma Refractometer
- 3.1 Hardware and Software Requirements
- 3.2 Mechanical and Electrical Requirements
- 3.3 Sensor installation for use in Pharmaceutical Batch Manufacturing
- 3.4 Indicating Transmitter installation for use in table top
- 3.5 Wiring transmitter connections to sensor, power cable and computer
- 3.6 Refractometer Instrument Verification
- 4 Electronic Data Capture and Storage
- 5 Complying with Documentation and Validation Regulations
- 6 Onsite Qualification Protocols and Records: Installation Qualification
- 6.1 Authorization and responsibilities
- 6.2 System
- 6.3 IQ Protocol
- 6.4 Documentation
- 6.5 Operating environment
- 6.6 Installation
- 6.7 Setting up the system components and devices
- 6.8 Electrical connections and wiring
- 6.9 Ethernet connection
- 6.10 Field communication software FC-11
- 6.11 Initial check and switching the device on
- 6.12 Installation Qualification Summary Report
- 7 Onsite Qualification Protocols and Records: Operational Qualification
- 7.1 Individual module and system components check
- 7.2 Installation Qualification has been performed successfully
- 7.3 Test procedure
- 7.4 Authorized officiator
- 7.5 System qualification
- 7.6 Setting up the system components and devices
- 7.7 Instrument verification with Sample holder and Refractive Index Liquids
- 7.8 Operational Qualification Summary Report
- 8 Routine Operation Phase
- 9 Preventive Maintenance
- 10 Other Documentation