cytiva Sefia ReadySelect - Default Chapter; Table of Contents

Table of Contents
1 Introduction ........................................................................................................ 4
1.1 Important user information ....................................................................................................................... 5
1.2 About this manual ......................................................................................................................................... 6
1.3 Associated documentation ....................................................................................................................... 7
2 Safety instructions ............................................................................................. 8
3 Application and kit description ......................................................................... 10
3.1 Application overview .................................................................................................................................... 11
3.2 CT‑350.1 kit ...................................................................................................................................................... 13
3.3 Application workflow .................................................................................................................................... 15
3.4 Parameters ....................................................................................................................................................... 19
3.4.1 Parameter values ......................................................................................................................................... 20
3.4.2 Parameter validation .................................................................................................................................. 25
3.5 Application scenarios ................................................................................................................................... 26
3.5.1 Application scenarios overview .............................................................................................................. 27
3.5.2 Scenario 1: ready-to-use formulation only ........................................................................................ 28
3.5.3 Scenario 2: cryopreparation only .......................................................................................................... 29
4 Operation ............................................................................................................ 30
4.1 Prerequisites and required materials .................................................................................................... 31
4.2 Prepare the solutions for the procedure ............................................................................................... 32
4.3 Prepare the Sefia Select system and the ReadySelect application ............................................ 35
4.3.1 Start the system and the ReadySelect application ........................................................................ 36
4.3.2 Verify and prepare the kit .......................................................................................................................... 38
4.3.3 Connect the cryobags to the kit ............................................................................................................. 44
4.3.4 Install the CT
‑ 350.1 kit ............................................................................................................................... 46
4.3.5 Connect the solution and initial bags to the kit ................................................................................ 50
4.3.6 Complete application preparation ........................................................................................................ 51
4.4 Start and monitor the procedure ............................................................................................................. 53
4.5 End the procedure ......................................................................................................................................... 56
4.6 Emergency stop during a procedure ...................................................................................................... 57
5 Troubleshooting ................................................................................................. 58
5.1 Overview ............................................................................................................................................................ 59
5.2 SmartResume ............................................................................................................................................... 62
5.3 Recovery scenarios ....................................................................................................................................... 64
5.3.1 Interruption during preliminary steps phase ................................................................................... 65
5.3.2 Interruption during ready-to-use formulation phase ................................................................... 66
5.3.3 Interruption during cryopreparation phase ...................................................................................... 68
5.3.4 Interruption during cryobag splitting phase ..................................................................................... 72
5.3.5 Restart the interrupted procedure ....................................................................................................... 73
5.4 Manual transfer of bag content ................................................................................................................ 74
5.5 Line identification .......................................................................................................................................... 75
5.6 Warning messages ........................................................................................................................................ 79
6 Reference information ....................................................................................... 88
6.1 Get Help ............................................................................................................................................................. 89
Table of Contents
ReadySelect application Operator Manual 29479384 AE 2