Electronic Test System 4
7.7 Exporting ..................................................................................................... 43
7.7.1 Exporting the Table ...................................................................... 43
7.7.2 Exporting the Control Points ......................................................... 43
7.7.3 Exporting Data Records to Files ................................................... 43
7.7.4 Exporting the Summary ................................................................ 44
7.7.5 Exporting the Software Settings ................................................... 44
7.8 Data Transfer ................................................................................................ 45
7.8.1 Typical Procedure......................................................................... 45
7.8.2 Status of the System before, during and after Data Transfer ....... 46
7.8.3 Test Identification ......................................................................... 46
7.8.4 Trace ability, Authenticity and Data Integrity ................................ 48
8 Data Analysis ..................................................................................................... 49
8.1 Master Overlay (Tab "Master") ...................................................................... 49
8.1.1 Typical Procedure......................................................................... 49
8.1.2 Designating a Data Record as Master Record ............................. 49
8.2 Control Points (Tab "Control Points") ............................................................ 49
8.2.1 Condensed List with Control Points .............................................. 50
8.2.2 Control Points in Table ................................................................. 50
8.2.3 Differences between ETS and Sterilizer ................................ ....... 51
8.2.3.1 Setting a Filter for Control Point Recognition ............... 51
8.3 Table (Tab "Table") ....................................................................................... 51
8.3.1 Add or Remove Columns ............................................................. 51
8.4 EN 285 Leak Rate Test (Tab "Leake Rate") .................................................. 52
8.4.1 Definition of the Test..................................................................... 52
8.4.2 Typical Procedure......................................................................... 52
8.4.3 Leak Rate Test Pass and Fail Critera ........................................... 53
8.4.4 Changing the Leak Rate Test Criteria .......................................... 54
8.4.5 Storing the EN 285 Leak Rate Test .............................................. 54
8.5 Pressure Change Rate (Tab "Pressure Change") ......................................... 55
8.5.1 Definition of the Test..................................................................... 55
8.5.2 Typical Procedure......................................................................... 55
8.6 Dilution ..................................................................................................... 56
8.6.1 Overall Dilution Factor ................................................................ .. 56
8.6.2 Continuous Dilution Factor ........................................................... 57
8.7 Residual Air ..................................................................................................... 57
8.7.1 Residual Air as Single Value ........................................................ 57
8.7.2 Residual Air as Curve or Table ..................................................... 57
8.8 F0 Lethality .................................................................................................... 57
8.8.1 Formula ........................................................................................ 57
8.8.2 Change Temperature for Calculation............................................ 57
8.9 Sterilization (Tab Sterilization) ....................................................................... 58
8.9.1 Sterilization Temperature Band .................................................... 58
8.9.2 Sterilization Parameter Indication ................................................. 58
8.9.3 Evaluation Period ......................................................................... 58
8.9.3.1 Typical Procedure ........................................................ 59
8.9.4 Residual Air at Start of Sterilization .............................................. 60
8.10 Data Scanner ................................................................................................ 60
8.10.1 Selecting a Point of Interest .......................................................... 60
8.10.2 Showing / Hiding Data Scanner Information ................................. 60
8.11 Theoretical Temperature ............................................................................... 61
8.12 Vacuum Pump Efficiency .............................................................................. 61
8.13 Generating a Summary ................................................................................. 62