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VSummary Jul-3-2012 - 05-22 PM PDF

This document is a qualification summary report for an autoclave validation study. It provides details of the study such as the vessel ID, sensors included in each sensor group, temperature data for heating, exposure and discharge cycles, and temperature summary statistics. Temperature data is reported for 11 temperature sensors across 3 sensor groups located in different areas of the autoclave. The report documents the temperature profiles achieved during the validation study and ensures sterilization parameters were met.

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Ronaldo Janglin
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48 views6 pages

VSummary Jul-3-2012 - 05-22 PM PDF

This document is a qualification summary report for an autoclave validation study. It provides details of the study such as the vessel ID, sensors included in each sensor group, temperature data for heating, exposure and discharge cycles, and temperature summary statistics. Temperature data is reported for 11 temperature sensors across 3 sensor groups located in different areas of the autoclave. The report documents the temperature profiles achieved during the validation study and ensures sterilization parameters were met.

Uploaded by

Ronaldo Janglin
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 6

Validator - Qualification Summary Report

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

Autoclave Cargas validacion SIM 1


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

Gemabiotech SA
N/A

Printed on 03-Jul-2012 17:22:57 by Hugo Del Rio


Software Version:3.10
Run #:0001

Comments:
User - OQ O-0459 CMARA VACA SIN TC09

The following sensors are excluded from the report


109A-T09-Temperature

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
Grupo 2 (canasto superior)A - Include sensor inputs statistical calculations, lethality
Grupo 3 (canasto inferior)A - Include sensor inputs statistical calculations, lethality

Performed by:_____________________________________________

Date: ____________

Reviewed by:_____________________________________________

Date: ____________

Page 1 of 6

Printed on 03-Jul-2012 17:22:57 by Hugo Del Rio

Validator - Qualification Summary Report


Study Name:
Autoclave Cargas validacion SIM 1

SOP/Protocol #:

N/A

Groups included in Report

Sensors included in Report


Group
Sensor
FW
Type
S/N
Version
Grupo 1A - Temperature(C)
101A-T01
102A-T02
103A-T03
104A-T04
105A-T05
106A-T06
107A-T07
108A-T08
110A-T10
111A-T11
112A-T12
Grupo 2 (canasto superior)A - Temperature(C)
101A-T01
102A-T02
103A-T03
104A-T04
105A-T05
106A-T06
Grupo 3 (canasto inferior)A - Temperature(C)
107A-T07
108A-T08
110A-T10
111A-T11
112A-T12

Sensor
Description

Calculate Battery
Lethality Life

TC 01
TC 02
TC 03
TC 04
TC 05
TC 06
TC 07
TC 08
TC 10
TC 11
TC 12

-Termocupla 01
-Termocupla 02
-Termocupla 03
-Termocupla 04
-Termocupla 05
-Termocupla 06
-Termocupla 07
-Termocupla 08
-Termocupla 10
-Termocupla 11
-Termocupla 12

Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes

TC 01
TC 02
TC 03
TC 04
TC 05
TC 06

-Termocupla 01
-Termocupla 02
-Termocupla 03
-Termocupla 04
-Termocupla 05
-Termocupla 06

Yes
Yes
Yes
Yes
Yes
Yes

TC 07
TC 08
TC 10
TC 11
TC 12

-Termocupla 07
-Termocupla 08
-Termocupla 10
-Termocupla 11
-Termocupla 12

Yes
Yes
Yes
Yes
Yes

Performed by:_____________________________________________

Date: ____________

Reviewed by:_____________________________________________

Date: ____________

Page 2 of 6

Printed on 03-Jul-2012 17:22:57 by Hugo Del Rio

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
110A-T10
111A-T11
112A-T12

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

Calentamiento
Min
22,68
22,27
21,39
21,62
21,69
21,02
18,28
19,39
17,78
18,47
17,44

Max
121,10
121,33
121,01
121,33
121,24
121,23
121,24
121,22
121,29
121,38
121,12

Avg
66,76
67,58
65,95
66,30
66,97
65,69
65,94
64,94
66,26
66,60
65,70

Exposicin
Cycle
ALeth
2,58
2,74
2,52
2,73
2,67
2,39
2,61
2,37
2,73
2,77
2,69

Min
121,02
121,28
121,11
121,31
121,25
121,31
121,29
121,27
121,23
121,38
121,17

Max
121,49
121,63
121,55
121,65
121,58
121,62
121,55
121,54
121,62
121,69
121,47

Avg
121,23
121,45
121,42
121,48
121,42
121,47
121,40
121,40
121,44
121,54
121,32

Descarga
Cycle
ALeth
20,79
21,85
21,71
22,00
21,73
21,98
21,62
21,61
21,80
22,31
21,24

Min
99,92
100,15
100,03
100,06
100,04
100,12
100,00
100,07
100,00
100,13
100,00

Max
121,14
121,20
121,32
121,21
121,16
121,20
121,28
121,17
121,09
121,25
121,05

Avg
107,35
107,51
107,50
107,42
107,42
107,52
107,42
107,49
107,35
107,52
107,36

Cycle
ALeth
1,40
1,44
1,49
1,42
1,41
1,45
1,46
1,45
1,39
1,45
1,39

Totals
Total
ALeth
24,77
26,03
25,72
26,15
25,81
25,82
25,69
25,43
25,92
26,53
25,32

Temperature Summary Data(C)


Calentamiento
Cycle Start
03-Jul-2012 14:36:40
Cycle Duration
0:22:20
112A-T12
Min of Min
17,44
S/N
Time
03-Jul-2012 14:36:40
111A-T11
Max of Max
121,38
S/N
Time
03-Jul-2012 14:58:50
Max Range
103,94
Max Spread/Time
14,56 Time
14:47:20
Min ALeth
2,37
S/N
108A-T08
111A-T11
Max ALeth
2,77
S/N
Avg of Avg
66,24
Performed by:_____________________________________________
Reviewed by:_____________________________________________

Exposicin

Descarga

03-Jul-2012 15:19:10
03-Jul-2012 14:59:00
0:12:22
0:20:10
121,02
S/N
101A-T01
99,92
S/N
101A-T01
03-Jul-2012 15:31:20
03-Jul-2012 15:05:50
121,69
S/N
111A-T11
121,32
S/N
103A-T03
03-Jul-2012 15:19:10
03-Jul-2012 14:59:10
0,67
21,40
0,49 Time
15:13:00
0,49 Time
15:19:30
20,79
S/N
101A-T01
1,39
S/N
110A-T10
22,31
S/N
111A-T11
1,49
S/N
103A-T03
121,42
107,44
Date: ____________
Date: ____________

Totals
Study Start
03-Jul-2012 14:36:40

Study End
03-Jul-2012 15:31:32

Duration

0:54:52
24,77
S/N
101A-T01
Max ALeth
26,53
S/N
111A-T11
Study Min
17,44
S/N
112A-T12
Study Max
121,69
S/N
111A-T11
Min ALeth

Page 3 of 6

Printed on 03-Jul-2012 17:22:58 by Hugo Del Rio

Validator - Qualification Summary Report


Study Name:
Autoclave Cargas validacion SIM 1

Temperature Data(C)
Logger S/N

101A-T01
102A-T02
103A-T03
104A-T04
105A-T05
106A-T06

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

SOP/Protocol #:
Grupo 2 (canasto superior)A

Calentamiento
Min
22,68
22,27
21,39
21,62
21,69
21,02

Max
121,10
121,33
121,01
121,33
121,24
121,23

Avg
66,76
67,58
65,95
66,30
66,97
65,69

N/A

Exposicin
Cycle
ALeth
2,58
2,74
2,52
2,73
2,67
2,39

Min
121,02
121,28
121,11
121,31
121,25
121,31

Max
121,49
121,63
121,55
121,65
121,58
121,62

Avg
121,23
121,45
121,42
121,48
121,42
121,47

Descarga
Cycle
ALeth
20,79
21,85
21,71
22,00
21,73
21,98

Min
99,92
100,15
100,03
100,06
100,04
100,12

Max
121,14
121,20
121,32
121,21
121,16
121,20

Avg
107,35
107,51
107,50
107,42
107,42
107,52

Cycle
ALeth
1,40
1,44
1,49
1,42
1,41
1,45

Totals
Total
ALeth
24,77
26,03
25,72
26,15
25,81
25,82

Temperature Summary Data(C)


Calentamiento
Cycle Start
03-Jul-2012 14:36:40
Cycle Duration
0:22:20
106A-T06
Min of Min
21,02
S/N
Time
03-Jul-2012 14:39:30
102A-T02
Max of Max
121,33
S/N
Time
03-Jul-2012 14:58:50
Max Range
100,31
Max Spread/Time
7,67 Time
14:47:40
Min ALeth
2,39
S/N
106A-T06
102A-T02
Max ALeth
2,74
S/N
Avg of Avg
66,54
Performed by:_____________________________________________
Reviewed by:_____________________________________________

Exposicin

Descarga

03-Jul-2012 15:19:10
03-Jul-2012 14:59:00
0:12:22
0:20:10
121,02
S/N
101A-T01
99,92
S/N
101A-T01
03-Jul-2012 15:31:20
03-Jul-2012 15:05:50
121,65
S/N
104A-T04
121,32
S/N
103A-T03
03-Jul-2012 15:19:10
03-Jul-2012 14:59:10
0,63
21,40
0,42 Time
15:05:50
0,39 Time
15:19:30
20,79
S/N
101A-T01
1,40
S/N
101A-T01
22,00
S/N
104A-T04
1,49
S/N
103A-T03
121,41
107,45
Date: ____________
Date: ____________

Totals
Study Start
03-Jul-2012 14:36:40

Study End
03-Jul-2012 15:31:32

Duration

0:54:52
24,77
S/N
101A-T01
Max ALeth
26,15
S/N
104A-T04
Study Min
21,02
S/N
106A-T06
Study Max
121,65
S/N
104A-T04
Min ALeth

Page 4 of 6

Printed on 03-Jul-2012 17:22:59 by Hugo Del Rio

Validator - Qualification Summary Report


Study Name:
Autoclave Cargas validacion SIM 1

Temperature Data(C)
Logger S/N

107A-T07
108A-T08
110A-T10
111A-T11
112A-T12

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

SOP/Protocol #:
Grupo 3 (canasto inferior)A

Calentamiento
Min
18,28
19,39
17,78
18,47
17,44

Max
121,24
121,22
121,29
121,38
121,12

Avg
65,94
64,94
66,26
66,60
65,70

N/A

Exposicin
Cycle
ALeth
2,61
2,37
2,73
2,77
2,69

Min
121,29
121,27
121,23
121,38
121,17

Max
121,55
121,54
121,62
121,69
121,47

Avg
121,40
121,40
121,44
121,54
121,32

Descarga
Cycle
ALeth
21,62
21,61
21,80
22,31
21,24

Min
100,00
100,07
100,00
100,13
100,00

Max
121,28
121,17
121,09
121,25
121,05

Avg
107,42
107,49
107,35
107,52
107,36

Cycle
ALeth
1,46
1,45
1,39
1,45
1,39

Totals
Total
ALeth
25,69
25,43
25,92
26,53
25,32

Temperature Summary Data(C)


Calentamiento
Cycle Start
03-Jul-2012 14:36:40
Cycle Duration
0:22:20
112A-T12
Min of Min
17,44
S/N
Time
03-Jul-2012 14:36:40
111A-T11
Max of Max
121,38
S/N
Time
03-Jul-2012 14:58:50
Max Range
103,94
Max Spread/Time
14,56 Time
14:47:20
Min ALeth
2,37
S/N
108A-T08
111A-T11
Max ALeth
2,77
S/N
Avg of Avg
65,89
Performed by:_____________________________________________
Reviewed by:_____________________________________________

Exposicin

Descarga

03-Jul-2012 15:19:10
03-Jul-2012 14:59:00
0:12:22
0:20:10
121,17
S/N
112A-T12
100,00
S/N
107A-T07
03-Jul-2012 15:31:20
03-Jul-2012 15:07:50
121,69
S/N
111A-T11
121,28
S/N
107A-T07
03-Jul-2012 15:19:10
03-Jul-2012 14:59:10
0,52
21,28
0,30 Time
15:18:20
0,37 Time
15:19:30
21,24
S/N
112A-T12
1,39
S/N
110A-T10
22,31
S/N
111A-T11
1,46
S/N
107A-T07
121,42
107,43
Date: ____________
Date: ____________

Totals
Study Start
03-Jul-2012 14:36:40

Study End
03-Jul-2012 15:31:32

Duration

0:54:52
25,32
S/N
112A-T12
Max ALeth
26,53
S/N
111A-T11
Study Min
17,44
S/N
112A-T12
Study Max
121,69
S/N
111A-T11
Min ALeth

Page 5 of 6

Validator - Qualification Summary Report


Study Name:
Autoclave Cargas validacion SIM 1

Printed on 03-Jul-2012 17:22:59 by Hugo Del Rio


SOP/Protocol #:

N/A

Comments:

System Messages

Performed by:_____________________________________________

Date: ____________

Reviewed by:_____________________________________________

Date: ____________

Page 6 of 6

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