Thermo Scientific UltiMate, Протоколы и инструкции по квалификации установки и эксплуатационной квалификации

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OQ/PQ Operating Instructions
M1393R0
Page 5 of 60
Table of Contents
Warnings ................................................................................................. 3
Safety Precautions .................................................................................... 3
CHAPTER 1
Introduction .........................................................................7
1.1 The Purpose of OQ/PQ.................................................................... 7
1.2 Defining the Limits ......................................................................... 7
1.3 General Notes and Recommendations ............................................... 8
1.4 How this Manual is structured ......................................................... 8
1.5 For Additional Information ............................................................... 8
CHAPTER 2
Requirements for a Successful OQ/PQ .....................................9
2.1 Overview ...................................................................................... 9
2.2 Checks and Acceptance Limits....................................................... 10
CHAPTER 3
Process ............................................................................. 13
3.1 Required Materials........................................................................ 13
3.2 Preparations ................................................................................ 15
3.2.1 CHROMELEON® Setup ................................................................ 15
3.2.2 System Setup ............................................................................ 18
3.3 Performing the Checks .................................................................. 21
3.4 Evaluating the Tests ..................................................................... 22
3.4.1 Repeating Tests ......................................................................... 22
CHAPTER 4
Test Procedures.................................................................. 23
4.1 Overview .................................................................................... 23
4.2 Lamp Intensity of the UV Detector ................................................. 24
4.2.1 Performing the Lamp Intensity Test .............................................. 24
4.3 Wavelength Check ....................................................................... 25
4.3.1 Performing the Test.................................................................... 25
4.4 Flow Cell Check ........................................................................... 26
4.4.1 Performing the Intensity Test of the Flow Cell ............................... 26
4.5 UltiMate Fluid Path Test ................................................................ 27
4.5.1 Performing the Test.................................................................... 27
4.6 Baseline Noise and Drift Test of the UV Detector and Oven Test........ 28
4.6.1 Drift and Noise........................................................................... 28
4.6.2 Theory of the Noise and Drift Calculation of CHROMELEON ............ 29
4.6.3 Oven accuracy........................................................................... 29