K-Patents PR-23 for K-Patents User Manual
K-Patents Equipment
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Table of contents
Document Outline
- Contents
- 1 K-Patents Products for the Pharmaceutical Industry
- 2 The Pharma Refractometer PR-23-AC with Laboratory Test Cuvette LTC
- 2.1 System description
- 2.2 Use of Laboratory Test Cuvette for validation and sample testing
- 2.3 System components provided by K-Patents
- 2.4 Pharma validation package
- 2.5 Laboratory Test Cuvette LTC
- 2.6 Indicating Transmitter DTR-GP-SC
- 2.7 Ancillary equipment and materials required, but not supplied by K-Patents
- 2.8 Hardware and Software Requirements
- 2.9 Mechanical and Electrical Requirements
- 2.10 Sensor installation and system connections
- 2.11 Indicating Transmitter DTR assembly for use in Laboratory
- 2.12 Wiring connections of transmitter to sensor, power cable and computer
- 3 Use of PR-23 Pharma Refractometer with Laboratory Test Cuvette LTC: Static Sampling
- 4 Verification of Laboratory Test Cuvette LTC: Static sampling
- 5 Use of Laboratory Test Cuvette LTC: Continuous sampling
- 6 Complying with Documentation and Validation Regulations
- 7 Onsite Qualification Protocols and Records: Installation Qualification
- 7.1 Authorization and responsibilities
- 7.2 System
- 7.3 IQ Protocol
- 7.4 Documentation
- 7.5 Operating environment
- 7.6 Installation
- 7.7 Setting up the system components and devices
- 7.8 Electrical connections and wiring
- 7.9 Ethernet connection
- 7.10 Initial check and switching the device on
- 7.11 Installation Qualification Summary Report
- 8 Onsite Qualification Protocols and Records: Operational Qualification
- 8.1 Individual module and system components check
- 8.2 Installation Qualification has been performed successfully
- 8.3 Test procedure
- 8.4 Authorized officiator
- 8.5 System qualification
- 8.6 Setting up the system components and devices
- 8.7 Instrument verification with Sample holder and Refractive Index Liquids
- 8.8 Instrument verification with Laboratory Test Cuvette for Static sampling and Refractive Index Liquids
- 8.9 Operational Qualification Summary Report
- 9 Analytical Method Validation: Establishing product refractive index monitoring validation protocols
- 10 Routine Operation Phase
- 11 Preventive Maintenance
- 12 Other Documentation