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  • VSummary Jun-2-2012 - 03-11 PM

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    Ronaldo Janglin
    22 views4 pages
    This document summarizes the results of a validation test of an autoclave using 12 temperature sensors over the course of 1 hour and 52 minutes. It provides the minimum, maximum, and average temperature readings for each sensor during the heating, exposure, and discharge phases of the cycle. The minimum temperature was 25.81°C and the maximum was 123.60°C. No system messages or errors were reported.

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    Resumen

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    This document summarizes the results of a validation test of an autoclave using 12 temperature sensors over the course of 1 hour and 52 minutes. It provides the minimum, maximum, and average temperature readings for each sensor during the heating, exposure, and discharge phases of the cycle. The minimum temperature was 25.81°C and the maximum was 123.60°C. No system messages or errors were reported.

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    © All Rights Reserved
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    22 views4 pages

    VSummary Jun-2-2012 - 03-11 PM

    Uploaded by

    Ronaldo Janglin
    This document summarizes the results of a validation test of an autoclave using 12 temperature sensors over the course of 1 hour and 52 minutes. It provides the minimum, maximum, and average temperature readings for each sensor during the heating, exposure, and discharge phases of the cycle. The minimum temperature was 25.81°C and the maximum was 123.60°C. No system messages or errors were reported.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 4

    Validator - Qualification Summary Report

    Study Name:
    Vessel ID:
    Programmed by:
    Validator SN:

    Autoclave Cargas validacion SIM 1


    Company:
    Autoclaves Tuttnahuer
    SOP/Protocol #:
    01-Jun-2012 11:43:25 Comments:
    abel
    Date:
    0805014
    Firmware Version 03.10.0000

    Gemabiotech SA
    N/A

    Printed on 02-Jun-2012 15:12:20 by abel


    Software Version:3.10
    Run #:0001

    Comments:

    Sensor Input Modules (SIMs)


    Validator SN:0805014 = A
    Slot
    Serial Number
    1
    411057

    Groups included in Report


    Grupo 1A - Include sensor inputs statistical calculations, lethality

    Performed by:_____________________________________________

    Date: ____________

    Reviewed by:_____________________________________________

    Date: ____________

    Page 1 of 4

    Validator - Qualification Summary Report


    Study Name:
    Autoclave Cargas validacion SIM 1
    Sensors included in Report
    Group
    Sensor
    FW
    Sensor
    Type
    S/N
    Version Description
    Grupo 1A - Temperature(C)
    101A-T01
    TC 01 -Termocupla 01
    102A-T02
    TC 02 -Termocupla 02
    103A-T03
    TC 03 -Termocupla 03
    104A-T04
    TC 04 -Termocupla 04
    105A-T05
    TC 05 -Termocupla 05
    106A-T06
    TC 06 -Termocupla 06
    107A-T07
    TC 07 -Termocupla 07
    108A-T08
    TC 08 -Termocupla 08
    109A-T09
    TC 09 -Termocupla 09
    110A-T10
    TC 10 -Termocupla 10
    111A-T11
    TC 11 -Termocupla 11
    112A-T12
    TC 12 -Termocupla 12

    Printed on 02-Jun-2012 15:12:20 by abel


    SOP/Protocol #:

    N/A
    Calculate Battery
    Lethality Life
    Yes
    Yes
    Yes
    Yes
    Yes
    Yes
    Yes
    Yes
    Yes
    Yes
    Yes
    Yes

    Performed by:_____________________________________________

    Date: ____________

    Reviewed by:_____________________________________________

    Date: ____________

    Page 2 of 4

    Printed on 02-Jun-2012 15:12:20 by abel

    Validator - Qualification Summary Report


    Study Name:
    Autoclave Cargas validacion SIM 1

    SOP/Protocol #:

    N/A

    Grupo 1A

    Temperature Data(C)
    Logger S/N

    101A-T01
    102A-T02
    103A-T03
    104A-T04
    105A-T05
    106A-T06
    107A-T07
    108A-T08
    109A-T09
    110A-T10
    111A-T11
    112A-T12

    (C)
    (C)
    (C)
    (C)
    (C)
    (C)
    (C)
    (C)
    (C)
    (C)
    (C)
    (C)

    Exposicion

    Calentamiento
    Min
    27,20
    27,43
    26,56
    28,06
    28,29
    27,51
    27,15
    25,81
    26,28
    28,91
    26,28
    28,77

    Max
    119,43
    119,82
    119,66
    119,69
    119,59
    119,58
    119,50
    119,85
    119,64
    119,50
    119,67
    119,57

    Avg
    78,07
    82,43
    81,27
    82,57
    81,93
    81,89
    82,30
    81,01
    80,98
    82,44
    80,93
    82,39

    Cycle
    ALeth
    2,07
    2,43
    2,34
    2,36
    2,33
    2,33
    2,24
    2,41
    2,33
    2,28
    2,33
    2,29

    Min
    119,45
    119,90
    119,77
    119,82
    119,73
    119,73
    119,52
    119,82
    119,76
    119,64
    119,73
    119,65

    Max
    120,93
    121,10
    120,97
    121,01
    120,94
    120,94
    121,04
    121,08
    120,99
    120,95
    121,01
    120,96

    Avg
    120,46
    120,64
    120,56
    120,59
    120,52
    120,53
    120,57
    120,64
    120,56
    120,52
    120,58
    120,52

    Descarga
    Cycle
    ALeth
    13,04
    13,58
    13,30
    13,41
    13,18
    13,21
    13,38
    13,56
    13,34
    13,21
    13,39
    13,21

    Min
    80,28
    56,74
    56,52
    56,56
    56,00
    55,80
    53,86
    55,77
    55,48
    54,36
    56,06
    54,36

    Max
    120,93
    121,05
    123,11
    123,17
    123,57
    123,31
    122,90
    122,71
    123,18
    123,10
    123,50
    123,60

    Avg
    96,19
    81,44
    80,28
    80,76
    80,18
    79,89
    75,68
    79,67
    80,12
    79,25
    80,45
    79,14

    Cycle
    ALeth
    1,87
    1,19
    1,31
    1,32
    1,36
    1,27
    1,18
    1,26
    1,31
    1,29
    1,30
    1,29

    Totals
    Total
    ALeth
    16,98
    17,20
    16,95
    17,09
    16,87
    16,81
    16,80
    17,23
    16,98
    16,78
    17,02
    16,79

    Temperature Summary Data(C)


    Calentamiento
    Cycle Start
    02-Jun-2012 11:10:30
    Cycle Duration
    0:21:40
    108A-T08
    Min of Min
    25,81
    S/N
    Time
    02-Jun-2012 11:10:30
    108A-T08
    Max of Max
    119,85
    S/N
    Time
    02-Jun-2012 11:31:30
    Max Range
    94,04
    Max Spread/Time
    24,10 Time
    11:17:30
    Min ALeth
    2,07
    S/N
    101A-T01
    102A-T02
    Max ALeth
    2,43
    S/N
    Avg of Avg
    81,52
    Performed by:_____________________________________________
    Reviewed by:_____________________________________________

    Exposicion

    Descarga

    02-Jun-2012 11:47:10
    02-Jun-2012 11:32:10
    0:25:10
    0:15:00
    119,45
    S/N
    101A-T01
    53,86
    S/N
    107A-T07
    02-Jun-2012 12:12:20
    02-Jun-2012 11:32:10
    121,10
    S/N
    102A-T02
    123,60
    S/N
    112A-T12
    02-Jun-2012 11:47:18
    02-Jun-2012 11:47:00
    1,65
    69,74
    0,49 Time
    11:32:50
    26,42 Time
    12:12:20
    13,04
    S/N
    101A-T01
    1,18
    S/N
    107A-T07
    13,58
    S/N
    102A-T02
    1,87
    S/N
    101A-T01
    120,56
    81,09
    Date: ____________
    Date: ____________

    Totals
    Study Start
    02-Jun-2012 11:10:30

    Study End
    02-Jun-2012 12:12:20

    Duration

    1:01:50
    16,78
    S/N
    110A-T10
    Max ALeth
    17,23
    S/N
    108A-T08
    Study Min
    25,81
    S/N
    108A-T08
    Study Max
    123,60
    S/N
    112A-T12
    Min ALeth

    Page 3 of 4

    Validator - Qualification Summary Report


    Study Name:
    Autoclave Cargas validacion SIM 1

    Printed on 02-Jun-2012 15:12:21 by abel


    SOP/Protocol #:

    N/A

    Comments:

    System Messages

    Performed by:_____________________________________________

    Date: ____________

    Reviewed by:_____________________________________________

    Date: ____________

    Page 4 of 4

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