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Informe de Cualificación

Impreso el 31-Jul-2023 a las 12:38:58


AUTOCLAVE ZIRBUS Realizado por: RODOLFO ARELLANO EMIFARMA S.A de C.V
Número de serie del Validator 2000: 0308038 Ensayo # 1 Versión de Firmware: 02.33 Software versión 2.22

Grupos incluidos en el informe


1. autoclave Incluye entradas de sensores y cálculos de letalidad y estadísticos

Módulos de entrada de los sensores (SIMs)


Ranura Número de Serie
1 0210075
2 ÿÿÿÿÿÿÿÿ

Realizado por: ____________________________________ Fecha: ______________

Revisado por: ____________________________________ Fecha: _______________ Página 1 de 32


Impreso el 31-Jul-2023 a las 12:38:58

Grupo 1 - autoclave - Entradas de sensores


Id. del equipo - EQ-AUT-INY-01 SOP/Número de protocolo - MEV-EQU-AUT-01-029/00/23
Descripción de la carga - BIOBASE 3
Comentario - BIOBASE 3
31-Jul-2023
1-01 1-02 1-03 1-04 1-05 1-06 1-07 1-08 1-09 1-10 1-11 1-12 2-01 2-02 2-03
Ptmp-1 Ptmp-2 Ptmp-3 Ptmp-4 Ptmp-5 Ptmp-6 Ptmp-7 Ptmp-8 Ptmp-9 Ptmp-10 Ptmp-11 Ptmp-12 Ptmp-13 Ptmp-14 Ptmp-15
10:23:10 *** Iniciar cualificación *** Manual RODOLFO ARELLANO
20.12 °C 20.32 °C 20.94 °C 20.98 °C 19.77 °C 21.10 °C 21.39 °C MENOS DE 21.32 °C 20.54 °C 21.00 °C 21.11 °C MENOS DE 20.92 °C 20.06 °C
10:24:00 20.22 °C 20.65 °C 21.73 °C 20.98 °C 19.97 °C 21.15 °C 21.50 °C MENOS DE 21.41 °C 20.65 °C 21.25 °C 21.31 °C MENOS DE 21.03 °C 20.17 °C
10:25:00 20.31 °C 21.02 °C 21.99 °C 21.06 °C 20.28 °C 21.27 °C 21.65 °C MENOS DE 21.57 °C 20.79 °C 21.45 °C 21.48 °C MENOS DE 21.20 °C 20.44 °C
10:26:00 20.46 °C 22.18 °C 22.55 °C 21.27 °C 20.61 °C 21.60 °C 21.96 °C MENOS DE 21.78 °C 20.94 °C 21.65 °C 21.93 °C MENOS DE 21.44 °C 20.83 °C
10:27:00 20.57 °C 22.57 °C 22.98 °C 21.55 °C 21.03 °C 21.98 °C 22.21 °C MENOS DE 22.05 °C 21.13 °C 22.56 °C 22.71 °C MENOS DE 21.82 °C 21.25 °C
10:28:00 20.74 °C 23.17 °C 23.68 °C 21.91 °C 21.48 °C 22.49 °C 22.77 °C MENOS DE 22.41 °C 21.34 °C 23.19 °C 25.09 °C MENOS DE 22.23 °C 21.76 °C
10:29:00 21.32 °C 23.53 °C 24.19 °C 22.17 °C 22.05 °C 23.15 °C 23.45 °C MENOS DE 22.92 °C 21.61 °C 23.65 °C 26.14 °C MENOS DE 22.78 °C 22.29 °C
10:30:00 22.27 °C 23.76 °C 24.28 °C 22.75 °C 22.71 °C 24.17 °C 24.11 °C MENOS DE 23.56 °C 21.98 °C 24.94 °C 28.68 °C MENOS DE 23.57 °C 22.96 °C
10:31:00 22.59 °C 24.61 °C 26.05 °C 23.72 °C 23.50 °C 25.27 °C 25.13 °C MENOS DE 24.22 °C 22.51 °C 25.51 °C 29.47 °C MENOS DE 24.60 °C 23.87 °C
10:32:00 19.90 °C 26.22 °C 28.14 °C 24.82 °C 24.57 °C 26.67 °C 26.12 °C MENOS DE 25.19 °C 23.17 °C 27.39 °C 28.81 °C MENOS DE 25.80 °C 25.04 °C
10:33:00 19.27 °C 28.45 °C 30.45 °C 26.35 °C 26.10 °C 28.50 °C 27.07 °C MENOS DE 26.27 °C 24.12 °C 30.34 °C 29.35 °C MENOS DE 27.47 °C 26.54 °C
10:34:00 22.74 °C 33.88 °C 35.96 °C 27.94 °C 27.53 °C 30.60 °C 28.23 °C MENOS DE 27.42 °C 25.26 °C 32.78 °C 30.80 °C MENOS DE 29.20 °C 28.17 °C
10:35:00 24.31 °C 37.98 °C 39.32 °C 29.73 °C 86.10 °C 32.62 °C 29.79 °C MENOS DE 28.79 °C 26.64 °C 35.07 °C 31.99 °C MENOS DE 31.11 °C 30.08 °C
10:35:16 *** Fallo del sensor ***
24.57 °C 38.16 °C 39.77 °C 30.28 °C ***** 33.15 °C 30.11 °C MENOS DE 29.15 °C 26.99 °C 35.61 °C 32.08 °C MENOS DE 31.67 °C 30.47 °C
10:35:22 *** Fallo del sensor ***
24.66 °C 39.52 °C 41.10 °C 30.54 °C ***** 33.32 °C 30.23 °C MENOS DE 29.24 °C 27.15 °C 35.84 °C 32.28 °C MENOS DE 31.96 °C 30.66 °C
10:35:28 *** Fallo del sensor ***
24.76 °C 39.69 °C 41.52 °C 30.82 °C ***** 33.68 °C 30.42 °C MENOS DE 29.39 °C 27.34 °C 36.39 °C 32.58 °C MENOS DE 32.22 °C 31.03 °C
10:35:32 *** Fallo del sensor ***
24.80 °C 39.09 °C 40.60 °C 31.02 °C ***** 33.78 °C 30.49 °C MENOS DE 29.54 °C 27.46 °C 36.72 °C 32.22 °C MENOS DE 32.31 °C 30.99 °C
10:35:38 *** Fallo del sensor ***
24.93 °C 39.88 °C 41.48 °C 30.99 °C MENOS DE 33.90 °C 30.73 °C MENOS DE 29.65 °C 27.66 °C 37.21 °C 32.28 °C MENOS DE 32.56 °C 31.34 °C
10:36:00 25.40 °C 40.61 °C 42.02 °C 32.07 °C -50.74 °C 34.74 °C 31.33 °C MENOS DE 30.22 °C 28.34 °C 37.00 °C 32.98 °C MENOS DE 33.57 °C 32.30 °C
10:36:08 *** Fallo del sensor ***
25.58 °C 39.46 °C 40.47 °C 32.43 °C ***** 35.26 °C 31.49 °C MENOS DE 30.53 °C 28.58 °C 37.81 °C 33.29 °C MENOS DE 33.89 °C 32.59 °C
10:36:16 *** Fallo del sensor ***
25.78 °C 39.79 °C 41.12 °C 32.52 °C ***** 35.71 °C 31.84 °C MENOS DE 30.78 °C 28.83 °C 38.06 °C 33.79 °C MENOS DE 34.22 °C 32.72 °C
10:36:28 *** Fallo del sensor ***
26.08 °C 40.88 °C 42.80 °C 33.01 °C ***** 35.88 °C 32.15 °C MENOS DE 31.09 °C 29.20 °C 38.80 °C 34.06 °C MENOS DE 34.70 °C 33.45 °C
10:36:58 *** Fallo del sensor ***
26.95 °C 41.13 °C 42.65 °C 34.73 °C ***** 37.43 °C 33.41 °C MENOS DE 32.15 °C 30.29 °C 39.41 °C 35.54 °C MENOS DE 36.13 °C 34.58 °C
10:37:00 26.98 °C 41.29 °C 42.81 °C 34.76 °C ***** 37.28 °C 33.48 °C MENOS DE 32.19 °C 30.36 °C 39.33 °C 35.99 °C MENOS DE 36.17 °C 34.77 °C

Realizado por: ____________________________________ Fecha: ______________

Revisado por: ____________________________________ Fecha: _______________ Página 2 de 32


Impreso el 31-Jul-2023 a las 12:38:58

Grupo 1 - autoclave - Entradas de sensores


Id. del equipo - EQ-AUT-INY-01 SOP/Número de protocolo - MEV-EQU-AUT-01-029/00/23
Descripción de la carga - BIOBASE 3
Comentario - BIOBASE 3
31-Jul-2023
2-04
Ptmp-16
10:23:10 *** Iniciar cualificación *** Manual RODOLFO ARELLANO
21.11 °C
10:24:00 21.18 °C
10:25:00 21.30 °C
10:26:00 21.62 °C
10:27:00 21.94 °C
10:28:00 22.49 °C
10:29:00 23.10 °C
10:30:00 23.91 °C
10:31:00 25.15 °C
10:32:00 26.29 °C
10:33:00 28.20 °C
10:34:00 29.87 °C
10:35:00 31.88 °C
10:35:16 *** Fallo del sensor ***
32.40 °C
10:35:22 *** Fallo del sensor ***
32.68 °C
10:35:28 *** Fallo del sensor ***
33.17 °C
10:35:32 *** Fallo del sensor ***
33.22 °C
10:35:38 *** Fallo del sensor ***
33.45 °C
10:36:00 34.31 °C
10:36:08 *** Fallo del sensor ***
34.62 °C
10:36:16 *** Fallo del sensor ***
35.01 °C
10:36:28 *** Fallo del sensor ***
35.38 °C
10:36:58 *** Fallo del sensor ***
36.78 °C
10:37:00 36.96 °C

Realizado por: ____________________________________ Fecha: ______________

Revisado por: ____________________________________ Fecha: _______________ Página 3 de 32


Impreso el 31-Jul-2023 a las 12:38:58

Grupo 1 - autoclave - Entradas de sensores


Id. del equipo - EQ-AUT-INY-01 SOP/Número de protocolo - MEV-EQU-AUT-01-029/00/23
Descripción de la carga - BIOBASE 3
Comentario - BIOBASE 3
31-Jul-2023
1-01 1-02 1-03 1-04 1-05 1-06 1-07 1-08 1-09 1-10 1-11 1-12 2-01 2-02 2-03
Ptmp-1 Ptmp-2 Ptmp-3 Ptmp-4 Ptmp-5 Ptmp-6 Ptmp-7 Ptmp-8 Ptmp-9 Ptmp-10 Ptmp-11 Ptmp-12 Ptmp-13 Ptmp-14 Ptmp-15
10:37:10 *** Fallo del sensor ***
27.49 °C 42.76 °C 44.60 °C 35.27 °C MENOS DE 38.05 °C 33.98 °C MENOS DE 32.50 °C 30.67 °C 39.44 °C 36.18 °C MENOS DE 36.45 °C 34.82 °C
10:37:48 *** Fallo del sensor ***
28.29 °C 42.00 °C 43.53 °C 37.35 °C MENOS DE 39.87 °C 35.62 °C MENOS DE 33.87 °C 32.10 °C 38.66 °C 39.15 °C MENOS DE 38.26 °C 36.54 °C
10:37:56 *** Fallo del sensor ***
28.50 °C 42.64 °C 44.56 °C 37.88 °C ***** 40.18 °C 35.84 °C MENOS DE 34.23 °C 32.39 °C 38.99 °C 39.27 °C MENOS DE 38.56 °C 36.61 °C
10:38:00 28.61 °C 43.59 °C 45.59 °C 38.05 °C ABIERTO 40.39 °C 35.86 °C MENOS DE 34.29 °C 32.54 °C 39.34 °C 39.88 °C MENOS DE 38.82 °C 36.90 °C
10:38:26 *** Fallo del sensor ***
29.26 °C 43.24 °C 45.20 °C 39.55 °C MENOS DE 41.86 °C 37.00 °C MENOS DE 35.24 °C 33.79 °C 39.86 °C 40.73 °C MENOS DE 40.38 °C 38.59 °C
10:38:38 *** Fallo del sensor ***
29.26 °C 44.30 °C 45.89 °C 40.24 °C ABIERTO 42.17 °C 37.63 °C MENOS DE 35.78 °C 34.44 °C 40.41 °C 42.07 °C MENOS DE 40.94 °C 38.91 °C
10:39:00 30.24 °C 45.11 °C 46.69 °C 41.43 °C ABIERTO 43.74 °C 38.81 °C MENOS DE 36.69 °C 35.46 °C 42.05 °C 42.90 °C MENOS DE 42.17 °C 40.13 °C
10:39:44 *** Fallo del sensor ***
ABIERTO 47.42 °C 49.24 °C 44.32 °C ABIERTO 46.71 °C 40.73 °C MENOS DE 38.77 °C 37.90 °C 46.26 °C 44.47 °C MENOS DE 45.00 °C 42.88 °C
10:39:58 *** Fallo del sensor ***
ABIERTO 48.90 °C 50.55 °C 45.38 °C ABIERTO 47.46 °C 41.75 °C MENOS DE 39.29 °C 38.82 °C 46.88 °C 44.66 °C MENOS DE 45.85 °C 43.46 °C
10:40:00 ABIERTO 48.98 °C 50.65 °C 45.57 °C ABIERTO 47.67 °C 41.99 °C MENOS DE 39.40 °C 38.91 °C 47.36 °C 44.60 °C MENOS DE 46.01 °C 44.05 °C
10:40:10 *** Fallo del sensor ***
ABIERTO 49.98 °C 51.59 °C 46.06 °C ABIERTO 48.22 °C 42.36 °C MENOS DE 40.05 °C 39.59 °C 48.01 °C 44.93 °C MENOS DE 46.68 °C 45.27 °C
10:40:24 *** Fallo del sensor ***
33.21 °C 51.95 °C 53.45 °C 47.05 °C ABIERTO 49.24 °C 42.99 °C MENOS DE 40.68 °C 40.45 °C 49.87 °C 47.01 °C MENOS DE 47.67 °C 45.96 °C
10:40:40 *** Fallo del sensor ***
ABIERTO 53.09 °C 54.57 °C 47.90 °C ABIERTO 49.98 °C 44.59 °C MENOS DE 41.55 °C 41.59 °C 50.00 °C 48.58 °C MENOS DE 48.65 °C 46.31 °C
10:41:00 ABIERTO 52.14 °C 53.66 °C 49.19 °C 46.73 °C 51.61 °C 45.73 °C MENOS DE 42.94 °C 42.84 °C 51.33 °C 49.18 °C MENOS DE 49.98 °C 48.27 °C
10:41:02 *** Fallo del sensor ***
ABIERTO 53.09 °C 54.85 °C 49.28 °C ABIERTO 51.65 °C 45.90 °C MENOS DE 43.05 °C 43.01 °C 51.42 °C 49.55 °C MENOS DE 50.12 °C 48.40 °C
10:41:52 *** Fallo del sensor ***
MENOS DE 55.98 °C 57.45 °C 52.95 °C ABIERTO 54.98 °C 48.52 °C MENOS DE 46.34 °C 46.83 °C 55.39 °C 50.41 °C MENOS DE 53.72 °C 51.56 °C
10:42:00 ABIERTO 57.27 °C 58.51 °C 53.44 °C ABIERTO 55.57 °C 48.92 °C MENOS DE 46.77 °C 47.37 °C 55.97 °C 50.54 °C MENOS DE 54.09 °C 52.02 °C
10:42:52 *** Fallo del sensor ***
MENOS DE 60.88 °C 62.09 °C 56.71 °C ABIERTO 58.94 °C 52.71 °C MENOS DE 50.42 °C 51.28 °C 59.98 °C 54.86 °C MENOS DE 57.61 °C 55.71 °C
10:43:00 32.63 °C 60.93 °C 62.08 °C 57.24 °C ABIERTO 59.11 °C 53.59 °C MENOS DE 51.00 °C 51.96 °C 60.26 °C 54.85 °C MENOS DE 58.09 °C 56.33 °C
10:44:00 49.03 °C 66.41 °C 67.13 °C 61.24 °C ABIERTO 63.37 °C 58.06 °C MENOS DE 55.34 °C 56.50 °C 63.97 °C 61.06 °C -239.36 °C 62.10 °C 60.22 °C
10:44:06 *** Fallo del sensor ***
MENOS DE 65.77 °C 66.55 °C 61.51 °C ABIERTO 63.57 °C 58.20 °C ***** 55.89 °C 57.03 °C 64.23 °C 61.06 °C -200.16 °C 62.56 °C 60.52 °C

Realizado por: ____________________________________ Fecha: ______________

Revisado por: ____________________________________ Fecha: _______________ Página 4 de 32


Impreso el 31-Jul-2023 a las 12:38:58

Grupo 1 - autoclave - Entradas de sensores


Id. del equipo - EQ-AUT-INY-01 SOP/Número de protocolo - MEV-EQU-AUT-01-029/00/23
Descripción de la carga - BIOBASE 3
Comentario - BIOBASE 3
31-Jul-2023
2-04
Ptmp-16
10:37:10 *** Fallo del sensor ***
37.31 °C
10:37:48 *** Fallo del sensor ***
39.03 °C
10:37:56 *** Fallo del sensor ***
39.47 °C
10:38:00 39.75 °C
10:38:26 *** Fallo del sensor ***
41.41 °C
10:38:38 *** Fallo del sensor ***
41.94 °C
10:39:00 43.01 °C
10:39:44 *** Fallo del sensor ***
46.06 °C
10:39:58 *** Fallo del sensor ***
46.69 °C
10:40:00 47.12 °C
10:40:10 *** Fallo del sensor ***
47.65 °C
10:40:24 *** Fallo del sensor ***
48.49 °C
10:40:40 *** Fallo del sensor ***
49.86 °C
10:41:00 50.87 °C
10:41:02 *** Fallo del sensor ***
51.06 °C
10:41:52 *** Fallo del sensor ***
54.63 °C
10:42:00 55.12 °C
10:42:52 *** Fallo del sensor ***
58.09 °C
10:43:00 58.48 °C
10:44:00 62.36 °C
10:44:06 *** Fallo del sensor ***
62.63 °C

Realizado por: ____________________________________ Fecha: ______________

Revisado por: ____________________________________ Fecha: _______________ Página 5 de 32


Impreso el 31-Jul-2023 a las 12:38:58

Grupo 1 - autoclave - Entradas de sensores


Id. del equipo - EQ-AUT-INY-01 SOP/Número de protocolo - MEV-EQU-AUT-01-029/00/23
Descripción de la carga - BIOBASE 3
Comentario - BIOBASE 3
31-Jul-2023
1-01 1-02 1-03 1-04 1-05 1-06 1-07 1-08 1-09 1-10 1-11 1-12 2-01 2-02 2-03
Ptmp-1 Ptmp-2 Ptmp-3 Ptmp-4 Ptmp-5 Ptmp-6 Ptmp-7 Ptmp-8 Ptmp-9 Ptmp-10 Ptmp-11 Ptmp-12 Ptmp-13 Ptmp-14 Ptmp-15
10:44:30 *** Fallo del sensor ***
MENOS DE 67.86 °C 68.69 °C 63.98 °C ABIERTO 65.28 °C 60.67 °C ***** 57.87 °C 58.94 °C 66.70 °C 63.31 °C -100.42 °C 64.16 °C 62.25 °C
10:44:54 *** Fallo del sensor ***
57.36 °C 71.38 °C 72.13 °C 66.74 °C ABIERTO 67.31 °C 64.05 °C ***** 61.04 °C 61.27 °C 70.68 °C 68.56 °C -29.61 °C 66.92 °C 65.14 °C
10:45:00 *** Fallo del sensor ***
58.06 °C 71.69 °C 72.66 °C 66.71 °C ABIERTO 68.33 °C 64.47 °C ***** 61.86 °C 62.04 °C 72.89 °C 68.33 °C -12.93 °C 67.57 °C 65.10 °C
10:45:24 *** Fallo del sensor ***
62.22 °C 74.48 °C 75.44 °C 70.78 °C 349.64 °C 72.18 °C 68.64 °C ***** 65.69 °C 65.75 °C 77.03 °C 73.19 °C 57.87 °C 71.68 °C 69.69 °C
10:45:34 *** Fallo del sensor ***
67.94 °C 77.45 °C 79.05 °C 73.05 °C 349.92 °C 73.64 °C 71.70 °C ***** 69.27 °C 68.58 °C 78.91 °C 79.39 °C 75.91 °C 73.08 °C 71.94 °C
10:45:40 *** Fallo del sensor ***
MENOS DE 79.86 °C 82.03 °C 73.19 °C ABIERTO 75.05 °C 73.69 °C ***** 70.87 °C 73.60 °C 80.51 °C 80.49 °C 93.48 °C 74.64 °C 73.85 °C
10:45:50 *** Fallo del sensor ***
72.87 °C 80.40 °C 81.70 °C 75.21 °C ***** 76.93 °C 75.42 °C ***** 73.20 °C 71.56 °C 81.85 °C 80.75 °C 114.22 °C 76.43 °C 75.94 °C
10:45:56 *** Fallo del sensor ***
75.05 °C 82.14 °C 84.29 °C 76.64 °C ***** 77.70 °C 77.13 °C -226.45 °C 74.72 °C 73.58 °C 82.63 °C 82.28 °C 129.70 °C 77.98 °C 76.84 °C
10:46:00 *** Fallo del sensor ***
74.87 °C 82.77 °C 84.17 °C 77.01 °C ***** 78.65 °C 78.17 °C ***** 76.07 °C 74.64 °C 82.82 °C 83.37 °C 122.89 °C 78.51 °C 77.72 °C
10:46:28 *** Fallo del sensor ***
-185.11 °C 86.65 °C 87.73 °C 81.74 °C ABIERTO 83.42 °C 82.54 °C -94.55 °C 80.41 °C 80.32 °C 83.54 °C 85.90 °C 232.07 °C 83.37 °C 82.57 °C
10:46:42 *** Fallo del sensor ***
MENOS DE 86.79 °C 87.83 °C 83.50 °C ***** 85.19 °C 84.16 °C -82.13 °C 83.04 °C 82.72 °C 83.96 °C 87.24 °C 287.93 °C 85.26 °C 84.75 °C
10:46:54 *** Fallo del sensor ***
83.15 °C 88.06 °C 88.65 °C 85.54 °C ABIERTO 86.77 °C 85.26 °C -90.76 °C 84.59 °C 84.31 °C 84.82 °C 88.09 °C 340.29 °C 86.82 °C 86.14 °C
10:47:00 84.05 °C 88.56 °C 89.37 °C 86.27 °C 85.73 °C 87.19 °C 86.16 °C -65.28 °C 85.64 °C 85.26 °C 85.69 °C 89.18 °C 356.17 °C 87.30 °C 86.63 °C
10:47:06 *** Fallo del sensor ***
84.74 °C 89.08 °C 90.16 °C 86.60 °C ABIERTO 88.00 °C 86.85 °C -13.46 °C 86.28 °C 86.08 °C 86.05 °C 90.10 °C 375.88 °C 87.99 °C 87.59 °C
10:47:14 *** Fallo del sensor ***
85.69 °C 90.34 °C 90.93 °C 87.79 °C ABIERTO 88.71 °C 87.87 °C 45.06 °C 87.23 °C 87.17 °C 87.41 °C 90.37 °C 395.71 °C 88.83 °C 88.45 °C
10:47:18 *** Fallo del sensor ***
86.51 °C 89.92 °C 90.63 °C 88.20 °C ABIERTO 89.17 °C 88.10 °C 39.43 °C 87.67 °C 87.68 °C 88.12 °C 90.43 °C ***** 89.18 °C 88.81 °C
10:47:22 *** Fallo del sensor ***
86.64 °C 89.35 °C 90.24 °C 88.43 °C MENOS DE 89.47 °C 88.17 °C 45.34 °C 87.99 °C 88.03 °C 88.57 °C 90.48 °C ***** 89.50 °C 88.97 °C
10:47:26 *** Fallo del sensor ***
86.66 °C 89.49 °C 90.07 °C 88.70 °C ABIERTO 89.67 °C 88.52 °C 57.72 °C 88.25 °C 88.32 °C 88.76 °C 90.52 °C ***** 89.69 °C 89.07 °C

Realizado por: ____________________________________ Fecha: ______________

Revisado por: ____________________________________ Fecha: _______________ Página 6 de 32


Impreso el 31-Jul-2023 a las 12:38:58

Grupo 1 - autoclave - Entradas de sensores


Id. del equipo - EQ-AUT-INY-01 SOP/Número de protocolo - MEV-EQU-AUT-01-029/00/23
Descripción de la carga - BIOBASE 3
Comentario - BIOBASE 3
31-Jul-2023
2-04
Ptmp-16
10:44:30 *** Fallo del sensor ***
64.22 °C
10:44:54 *** Fallo del sensor ***
66.43 °C
10:45:00 *** Fallo del sensor ***
67.81 °C
10:45:24 *** Fallo del sensor ***
71.74 °C
10:45:34 *** Fallo del sensor ***
73.12 °C
10:45:40 *** Fallo del sensor ***
74.69 °C
10:45:50 *** Fallo del sensor ***
76.66 °C
10:45:56 *** Fallo del sensor ***
77.46 °C
10:46:00 *** Fallo del sensor ***
78.59 °C
10:46:28 *** Fallo del sensor ***
82.98 °C
10:46:42 *** Fallo del sensor ***
84.92 °C
10:46:54 *** Fallo del sensor ***
86.47 °C
10:47:00 86.88 °C
10:47:06 *** Fallo del sensor ***
87.74 °C
10:47:14 *** Fallo del sensor ***
88.45 °C
10:47:18 *** Fallo del sensor ***
88.81 °C
10:47:22 *** Fallo del sensor ***
89.12 °C
10:47:26 *** Fallo del sensor ***
89.33 °C

Realizado por: ____________________________________ Fecha: ______________

Revisado por: ____________________________________ Fecha: _______________ Página 7 de 32


Impreso el 31-Jul-2023 a las 12:38:58

Grupo 1 - autoclave - Entradas de sensores


Id. del equipo - EQ-AUT-INY-01 SOP/Número de protocolo - MEV-EQU-AUT-01-029/00/23
Descripción de la carga - BIOBASE 3
Comentario - BIOBASE 3
31-Jul-2023
1-01 1-02 1-03 1-04 1-05 1-06 1-07 1-08 1-09 1-10 1-11 1-12 2-01 2-02 2-03
Ptmp-1 Ptmp-2 Ptmp-3 Ptmp-4 Ptmp-5 Ptmp-6 Ptmp-7 Ptmp-8 Ptmp-9 Ptmp-10 Ptmp-11 Ptmp-12 Ptmp-13 Ptmp-14 Ptmp-15
10:47:40 *** Fallo del sensor ***
87.58 °C 89.66 °C 90.49 °C 89.28 °C ABIERTO 90.33 °C 89.49 °C 54.53 °C 89.13 °C 89.26 °C 89.12 °C 91.44 °C ***** 90.30 °C 90.00 °C
10:47:56 *** Fallo del sensor ***
89.06 °C 90.99 °C 91.60 °C 90.50 °C ***** 91.11 °C 90.49 °C 76.86 °C 90.12 °C 90.29 °C 89.90 °C 93.14 °C ***** 91.14 °C 90.91 °C
10:48:00 89.39 °C 90.57 °C 91.26 °C 90.48 °C 90.54 °C 91.38 °C 90.74 °C 82.14 °C 90.39 °C 90.59 °C 90.10 °C 93.14 °C ***** 91.32 °C 91.06 °C
10:48:46 *** Fallo del sensor ***
92.21 °C 93.38 °C 94.13 °C 92.78 °C ABIERTO 93.52 °C 93.30 °C 93.68 °C 92.89 °C 93.08 °C 92.24 °C 94.65 °C ***** 93.50 °C 93.37 °C
10:49:00 92.83 °C 93.79 °C 94.34 °C 93.61 °C 93.60 °C 94.13 °C 94.04 °C 116.57 °C 93.58 °C 93.68 °C 92.99 °C 95.51 °C ***** 94.09 °C 94.04 °C
10:49:04 *** Fallo del sensor ***
93.08 °C 94.00 °C 94.67 °C 93.43 °C MENOS DE 94.18 °C 94.30 °C 117.30 °C 93.76 °C 93.87 °C 93.18 °C 95.67 °C ***** 94.24 °C 94.21 °C
10:49:08 *** Fallo del sensor ***
93.29 °C 94.40 °C 94.95 °C 93.49 °C ABIERTO 94.38 °C 94.50 °C 124.81 °C 94.00 °C 94.06 °C 93.37 °C 95.67 °C ***** 94.46 °C 94.41 °C
10:49:12 *** Fallo del sensor ***
93.45 °C 94.29 °C 94.95 °C 94.05 °C ABIERTO 94.58 °C 94.56 °C 120.61 °C 94.27 °C 94.28 °C 93.55 °C 96.02 °C ***** 94.60 °C 94.59 °C
10:49:32 *** Fallo del sensor ***
94.51 °C 95.21 °C 95.67 °C 94.73 °C ***** 95.59 °C 95.37 °C 123.81 °C 95.20 °C 95.16 °C 94.46 °C 96.76 °C ***** 95.51 °C 95.40 °C
10:49:52 *** Fallo del sensor ***
95.46 °C 96.07 °C 96.58 °C 96.08 °C ***** 96.29 °C 96.27 °C 137.69 °C 96.09 °C 96.00 °C 95.36 °C 97.55 °C ***** 96.38 °C 96.27 °C
10:49:58 *** Fallo del sensor ***
95.72 °C 96.36 °C 97.02 °C 96.05 °C ABIERTO 96.57 °C 96.70 °C 148.76 °C 96.33 °C 96.27 °C 95.63 °C 97.88 °C ***** 96.59 °C 96.57 °C
10:50:00 95.79 °C 96.44 °C 96.91 °C 95.94 °C ABIERTO 96.67 °C 96.82 °C 155.33 °C 96.41 °C 96.35 °C 95.71 °C 97.76 °C ***** 96.69 °C 96.66 °C
10:50:16 *** Fallo del sensor ***
96.49 °C 97.58 °C 98.16 °C 96.52 °C ***** 97.43 °C 97.37 °C 152.96 °C 97.14 °C 97.02 °C 96.39 °C 98.43 °C ***** 97.35 °C 97.30 °C
10:50:32 *** Fallo del sensor ***
97.19 °C 98.12 °C 98.65 °C 97.56 °C ABIERTO 97.96 °C 98.08 °C 148.62 °C 97.84 °C 97.71 °C 97.09 °C 98.98 °C ***** 98.04 °C 98.01 °C
10:50:58 *** Fallo del sensor ***
98.24 °C 99.32 °C 99.64 °C 98.41 °C ***** 98.94 °C 99.28 °C 141.91 °C 98.95 °C 98.80 °C 98.19 °C 100.09 °C ***** 99.05 °C 98.99 °C
10:51:00 98.32 °C 99.32 °C 99.68 °C 98.43 °C 401.13 °C 99.02 °C 99.38 °C 142.53 °C 99.03 °C 98.89 °C 98.27 °C 100.11 °C ***** 99.16 °C 99.02 °C
10:51:32 *** Fallo del sensor ***
99.74 °C 100.69 °C 100.97 °C 99.86 °C MENOS DE 100.46 °C 100.41 °C 150.28 °C 100.41 °C 100.27 °C 99.66 °C 101.41 °C ***** 100.47 °C 100.39 °C
10:52:00 *** Fallo del sensor ***
100.92 °C 102.02 °C 102.17 °C 101.11 °C MENOS DE 101.60 °C 101.90 °C 147.28 °C 101.63 °C 101.46 °C 100.90 °C 102.49 °C ***** 101.69 °C 101.53 °C
10:53:00 103.48 °C 104.32 °C 104.52 °C 103.61 °C 104.01 °C 104.01 °C 104.36 °C 102.89 °C 104.17 °C 103.99 °C 103.39 °C 104.96 °C ***** 104.10 °C 104.00 °C
10:54:00 105.90 °C 106.77 °C 106.79 °C 106.17 °C 106.40 °C 106.33 °C 106.70 °C 106.50 °C 106.57 °C 106.37 °C 105.83 °C 107.09 °C ***** 106.46 °C 106.41 °C
10:55:00 108.22 °C 108.88 °C 108.97 °C 108.35 °C 108.03 °C 108.58 °C 108.93 °C 122.64 °C 108.84 °C 108.65 °C 108.16 °C 109.25 °C ***** 108.70 °C 108.58 °C

Realizado por: ____________________________________ Fecha: ______________

Revisado por: ____________________________________ Fecha: _______________ Página 8 de 32


Impreso el 31-Jul-2023 a las 12:38:58

Grupo 1 - autoclave - Entradas de sensores


Id. del equipo - EQ-AUT-INY-01 SOP/Número de protocolo - MEV-EQU-AUT-01-029/00/23
Descripción de la carga - BIOBASE 3
Comentario - BIOBASE 3
31-Jul-2023
2-04
Ptmp-16
10:47:40 *** Fallo del sensor ***
90.10 °C
10:47:56 *** Fallo del sensor ***
91.02 °C
10:48:00 91.23 °C
10:48:46 *** Fallo del sensor ***
93.47 °C
10:49:00 94.28 °C
10:49:04 *** Fallo del sensor ***
94.35 °C
10:49:08 *** Fallo del sensor ***
94.58 °C
10:49:12 *** Fallo del sensor ***
94.75 °C
10:49:32 *** Fallo del sensor ***
95.51 °C
10:49:52 *** Fallo del sensor ***
96.44 °C
10:49:58 *** Fallo del sensor ***
96.78 °C
10:50:00 96.93 °C
10:50:16 *** Fallo del sensor ***
97.43 °C
10:50:32 *** Fallo del sensor ***
98.31 °C
10:50:58 *** Fallo del sensor ***
99.23 °C
10:51:00 99.23 °C
10:51:32 *** Fallo del sensor ***
100.60 °C
10:52:00 *** Fallo del sensor ***
101.73 °C
10:53:00 104.19 °C
10:54:00 106.61 °C
10:55:00 108.83 °C

Realizado por: ____________________________________ Fecha: ______________

Revisado por: ____________________________________ Fecha: _______________ Página 9 de 32


Impreso el 31-Jul-2023 a las 12:38:58

Grupo 1 - autoclave - Entradas de sensores


Id. del equipo - EQ-AUT-INY-01 SOP/Número de protocolo - MEV-EQU-AUT-01-029/00/23
Descripción de la carga - BIOBASE 3
Comentario - BIOBASE 3
31-Jul-2023
1-01 1-02 1-03 1-04 1-05 1-06 1-07 1-08 1-09 1-10 1-11 1-12 2-01 2-02 2-03
Ptmp-1 Ptmp-2 Ptmp-3 Ptmp-4 Ptmp-5 Ptmp-6 Ptmp-7 Ptmp-8 Ptmp-9 Ptmp-10 Ptmp-11 Ptmp-12 Ptmp-13 Ptmp-14 Ptmp-15
10:55:02 *** Fallo del sensor ***
108.30 °C 108.88 °C 108.99 °C 108.45 °C MENOS DE 108.64 °C 109.02 °C 125.25 °C 108.92 °C 108.72 °C 108.23 °C 109.36 °C ***** 108.77 °C 108.66 °C
10:55:36 *** Fallo del sensor ***
109.53 °C 110.13 °C 110.17 °C 109.68 °C ***** 109.80 °C 110.11 °C 125.36 °C 110.08 °C 109.93 °C 109.47 °C 110.46 °C ***** 110.02 °C 109.90 °C
10:55:50 *** Fallo del sensor ***
110.03 °C 110.57 °C 110.64 °C 110.23 °C MENOS DE 110.32 °C 110.64 °C 112.93 °C 110.59 °C 110.44 °C 109.98 °C 110.87 °C ***** 110.49 °C 110.41 °C
10:55:56 *** Fallo del sensor ***
110.24 °C 110.86 °C 110.89 °C 110.37 °C ***** 110.53 °C 110.86 °C 111.48 °C 110.78 °C 110.64 °C 110.20 °C 111.10 °C ***** 110.73 °C 110.64 °C
10:56:00 110.40 °C 110.87 °C 110.98 °C 110.55 °C 110.54 °C 110.68 °C 111.03 °C 108.57 °C 110.93 °C 110.77 °C 110.35 °C 111.29 °C ***** 110.87 °C 110.75 °C
10:56:12 *** Fallo del sensor ***
110.81 °C 111.46 °C 111.44 °C 110.99 °C ***** 111.08 °C 111.38 °C 112.62 °C 111.35 °C 111.21 °C 110.81 °C 111.66 °C ***** 111.29 °C 111.17 °C
10:56:20 *** Fallo del sensor ***
111.08 °C 111.79 °C 111.73 °C 111.28 °C MENOS DE 111.35 °C 111.65 °C 111.80 °C 111.58 °C 111.49 °C 111.08 °C 111.92 °C ***** 111.55 °C 111.46 °C
10:56:40 *** Fallo del sensor ***
111.79 °C 112.25 °C 112.33 °C 112.00 °C MENOS DE 112.00 °C 112.33 °C 116.18 °C 112.27 °C 112.17 °C 111.70 °C 112.57 °C ***** 112.23 °C 112.17 °C
10:57:00 112.41 °C 112.85 °C 112.90 °C 112.60 °C 112.78 °C 112.63 °C 112.90 °C 105.19 °C 112.82 °C 112.80 °C 112.30 °C 113.16 °C ***** 112.82 °C 112.78 °C
10:58:00 114.19 °C 114.62 °C 114.59 °C 114.42 °C 114.46 °C 114.35 °C 114.59 °C 82.72 °C 114.56 °C 114.53 °C 114.40 °C 114.81 °C ***** 114.73 °C 114.57 °C
10:58:26 *** Fallo del sensor ***
114.93 °C 115.30 °C 115.31 °C 115.13 °C ABIERTO 115.09 °C 115.34 °C 60.93 °C 115.26 °C 115.27 °C 115.14 °C 115.50 °C ***** 115.42 °C 115.22 °C
10:58:48 *** Fallo del sensor ***
115.54 °C 115.85 °C 115.87 °C 115.81 °C MENOS DE 115.70 °C 115.98 °C 64.24 °C 115.90 °C 115.92 °C 115.76 °C 116.12 °C ***** 116.02 °C 115.84 °C
10:59:00 115.88 °C 116.20 °C 116.22 °C 116.15 °C MENOS DE 116.03 °C 116.34 °C 50.00 °C 116.25 °C 116.25 °C 116.06 °C 116.46 °C ***** 116.36 °C 116.23 °C
10:59:28 *** Fallo del sensor ***
116.67 °C 117.01 °C 117.03 °C 116.94 °C ***** 116.83 °C 117.12 °C 58.24 °C 117.06 °C 117.04 °C 116.82 °C 117.19 °C ***** 117.15 °C 116.97 °C
10:59:36 *** Fallo del sensor ***
116.92 °C 117.32 °C 117.32 °C 117.18 °C ABIERTO 117.05 °C 117.37 °C 58.94 °C 117.30 °C 117.29 °C 117.08 °C 117.45 °C ***** 117.41 °C 117.20 °C
10:59:50 *** Fallo del sensor ***
117.34 °C 117.76 °C 117.77 °C 117.62 °C ***** 117.49 °C 117.81 °C 49.10 °C 117.76 °C 117.59 °C 117.48 °C 117.85 °C ***** 117.83 °C 117.63 °C
11:00:00 117.64 °C 118.02 °C 118.05 °C 117.92 °C 118.05 °C 117.80 °C 118.14 °C 55.80 °C 118.06 °C 117.83 °C 117.78 °C 118.16 °C ***** 118.08 °C 117.96 °C
11:00:04 *** Fallo del sensor ***
117.75 °C 118.14 °C 118.15 °C 118.04 °C MENOS DE 117.91 °C 118.25 °C 58.94 °C 118.18 °C 118.01 °C 117.91 °C 118.26 °C ***** 118.17 °C 118.06 °C
11:00:38 *** Fallo del sensor ***
118.77 °C 119.15 °C 119.18 °C 119.05 °C ***** 118.92 °C 119.27 °C 32.50 °C 119.23 °C 119.13 °C 118.93 °C 119.25 °C ***** 112.96 °C 119.05 °C
11:00:52 *** Fallo del sensor ***
119.16 °C 119.56 °C 119.59 °C 119.46 °C MENOS DE 119.33 °C 119.67 °C 10.43 °C 119.63 °C 119.54 °C 119.31 °C 119.63 °C ***** 113.62 °C 119.46 °C

Realizado por: ____________________________________ Fecha: ______________

Revisado por: ____________________________________ Fecha: _______________ Página 10 de 32


Impreso el 31-Jul-2023 a las 12:38:58

Grupo 1 - autoclave - Entradas de sensores


Id. del equipo - EQ-AUT-INY-01 SOP/Número de protocolo - MEV-EQU-AUT-01-029/00/23
Descripción de la carga - BIOBASE 3
Comentario - BIOBASE 3
31-Jul-2023
2-04
Ptmp-16
10:55:02 *** Fallo del sensor ***
108.91 °C
10:55:36 *** Fallo del sensor ***
110.11 °C
10:55:50 *** Fallo del sensor ***
110.62 °C
10:55:56 *** Fallo del sensor ***
110.84 °C
10:56:00 110.99 °C
10:56:12 *** Fallo del sensor ***
111.41 °C
10:56:20 *** Fallo del sensor ***
111.68 °C
10:56:40 *** Fallo del sensor ***
112.42 °C
10:57:00 112.99 °C
10:58:00 114.79 °C
10:58:26 *** Fallo del sensor ***
115.47 °C
10:58:48 *** Fallo del sensor ***
116.08 °C
10:59:00 116.43 °C
10:59:28 *** Fallo del sensor ***
117.19 °C
10:59:36 *** Fallo del sensor ***
117.44 °C
10:59:50 *** Fallo del sensor ***
117.87 °C
11:00:00 118.17 °C
11:00:04 *** Fallo del sensor ***
118.29 °C
11:00:38 *** Fallo del sensor ***
119.30 °C
11:00:52 *** Fallo del sensor ***
119.70 °C

Realizado por: ____________________________________ Fecha: ______________

Revisado por: ____________________________________ Fecha: _______________ Página 11 de 32


Impreso el 31-Jul-2023 a las 12:38:58

Grupo 1 - autoclave - Entradas de sensores


Id. del equipo - EQ-AUT-INY-01 SOP/Número de protocolo - MEV-EQU-AUT-01-029/00/23
Descripción de la carga - BIOBASE 3
Comentario - BIOBASE 3
31-Jul-2023
1-01 1-02 1-03 1-04 1-05 1-06 1-07 1-08 1-09 1-10 1-11 1-12 2-01 2-02 2-03
Ptmp-1 Ptmp-2 Ptmp-3 Ptmp-4 Ptmp-5 Ptmp-6 Ptmp-7 Ptmp-8 Ptmp-9 Ptmp-10 Ptmp-11 Ptmp-12 Ptmp-13 Ptmp-14 Ptmp-15
11:01:00 119.39 °C 119.82 °C 119.83 °C 119.69 °C 119.81 °C 119.57 °C 119.91 °C 35.50 °C 119.86 °C 119.78 °C 119.54 °C 119.86 °C ***** 114.05 °C 119.68 °C
11:01:08 *** Fallo del sensor ***
119.62 °C 120.06 °C 120.06 °C 119.93 °C ***** 119.77 °C 120.13 °C 33.04 °C 120.09 °C 119.86 °C 119.75 °C 120.07 °C ***** 114.78 °C 119.91 °C
11:01:12 *** Fallo del sensor ***
119.74 °C 120.15 °C 120.16 °C 120.04 °C MENOS DE 119.89 °C 120.25 °C 26.43 °C 120.22 °C 120.03 °C 119.85 °C 120.18 °C ***** 114.95 °C 120.02 °C
11:01:24 *** Fallo del sensor ***
120.08 °C 120.45 °C 120.45 °C 120.38 °C MENOS DE 120.22 °C 120.57 °C 20.02 °C 120.55 °C 120.37 °C 120.19 °C 120.50 °C ***** 115.28 °C 120.37 °C
11:02:00 121.14 °C 121.48 °C 121.47 °C 121.40 °C 121.48 °C 121.24 °C 121.57 °C 12.17 °C 121.57 °C 121.42 °C 121.19 °C 121.49 °C ***** 117.04 °C 121.34 °C
11:02:04 *** Fallo del sensor ***
121.23 °C 121.56 °C 121.56 °C 121.49 °C MENOS DE 121.35 °C 121.68 °C 15.73 °C 121.67 °C 121.53 °C 121.29 °C 121.60 °C ***** 117.30 °C 121.46 °C
11:02:08 *** Fallo del sensor ***
121.34 °C 121.68 °C 121.67 °C 121.60 °C MENOS DE 121.46 °C 121.79 °C 19.19 °C 121.79 °C 121.66 °C 121.42 °C 121.70 °C ***** 117.47 °C 121.58 °C
11:02:24 *** Fallo del sensor ***
121.65 °C 121.99 °C 121.97 °C 121.91 °C MENOS DE 121.75 °C 122.09 °C -3.43 °C 122.09 °C 121.96 °C 121.72 °C 121.98 °C ***** 117.89 °C 121.83 °C
11:03:00 121.50 °C 121.88 °C 121.86 °C 121.84 °C MENOS DE 121.66 °C 121.98 °C -3.04 °C 121.99 °C 121.87 °C 121.58 °C 121.88 °C ***** 119.21 °C 121.74 °C
11:03:16 *** Iniciar Exposición *** Manual RODOLFO ARELLANO
121.40 °C 121.77 °C 121.74 °C 121.76 °C 121.82 °C 121.56 °C 121.87 °C -23.53 °C 121.89 °C 121.78 °C 121.45 °C 121.77 °C ***** 119.52 °C 121.64 °C
11:03:36 *** Fallo del sensor ***
121.38 °C 121.73 °C 121.71 °C 121.73 °C 121.80 °C 121.54 °C 121.84 °C ***** 121.88 °C 121.76 °C 121.42 °C 121.75 °C ***** 119.77 °C 121.61 °C
11:04:00 121.41 °C 121.77 °C 121.70 °C 121.73 °C 121.83 °C 121.57 °C 121.89 °C -133.38 °C 121.86 °C 121.81 °C 121.45 °C 121.79 °C ***** 120.11 °C 121.66 °C
11:04:28 *** Fallo del sensor ***
121.42 °C 121.79 °C 121.78 °C 121.75 °C MENOS DE 121.59 °C 121.90 °C -22.84 °C 121.93 °C 121.83 °C 121.48 °C 121.80 °C ***** 120.71 °C 121.67 °C
11:05:00 121.29 °C 121.65 °C 121.63 °C 121.62 °C MENOS DE 121.46 °C 121.75 °C -49.43 °C 121.80 °C 121.70 °C 121.34 °C 121.65 °C ***** 120.50 °C 121.53 °C
11:06:00 121.32 °C 121.67 °C 121.66 °C 121.62 °C ***** 121.46 °C 121.79 °C -13.62 °C 121.83 °C 121.71 °C 121.34 °C 121.66 °C ***** 121.27 °C 121.54 °C
11:07:00 121.29 °C 121.65 °C 121.64 °C 121.61 °C MENOS DE 121.44 °C 121.78 °C 3.47 °C 121.82 °C 121.68 °C 121.34 °C 121.66 °C ***** 120.95 °C 121.54 °C
11:08:00 121.33 °C 121.69 °C 121.67 °C 121.64 °C MENOS DE 121.48 °C 121.80 °C -30.60 °C 121.85 °C 121.70 °C 121.27 °C 121.68 °C ***** 121.64 °C 121.56 °C
11:09:00 121.36 °C 121.70 °C 121.70 °C 121.68 °C MENOS DE 121.50 °C 121.82 °C -6.37 °C 121.88 °C 121.74 °C 121.40 °C 121.71 °C ***** 121.55 °C 121.59 °C
11:10:00 121.36 °C 121.70 °C 121.69 °C 121.68 °C MENOS DE 121.49 °C 121.81 °C -8.65 °C 121.88 °C 121.76 °C 121.41 °C 121.79 °C ***** 121.51 °C 121.58 °C
11:11:00 121.36 °C 121.70 °C 121.69 °C 121.69 °C MENOS DE 121.50 °C 121.83 °C 14.51 °C 121.88 °C 121.79 °C 121.43 °C 121.71 °C ***** 121.58 °C 121.60 °C
11:12:00 121.32 °C 121.65 °C 121.63 °C 121.64 °C MENOS DE 121.45 °C 121.76 °C 13.05 °C 121.82 °C 121.73 °C 121.37 °C 121.65 °C ***** 121.05 °C 121.54 °C
11:12:14 *** Fallo del sensor ***
121.32 °C 121.66 °C 121.65 °C 121.66 °C MENOS DE 121.46 °C 121.78 °C -3.85 °C 121.85 °C 121.75 °C 121.39 °C 121.67 °C ***** 120.93 °C 121.55 °C
11:13:00 121.36 °C 121.67 °C 121.66 °C 121.67 °C MENOS DE 121.47 °C 121.80 °C 15.73 °C 121.85 °C 121.76 °C 121.40 °C 121.67 °C ***** 121.73 °C 121.57 °C
11:13:58 *** Fallo del sensor ***
121.32 °C 121.64 °C 121.63 °C 121.65 °C MENOS DE 121.43 °C 121.76 °C 36.77 °C 121.82 °C 121.74 °C 121.36 °C 121.64 °C ***** 121.64 °C 121.53 °C

Realizado por: ____________________________________ Fecha: ______________

Revisado por: ____________________________________ Fecha: _______________ Página 12 de 32


Impreso el 31-Jul-2023 a las 12:38:58

Grupo 1 - autoclave - Entradas de sensores


Id. del equipo - EQ-AUT-INY-01 SOP/Número de protocolo - MEV-EQU-AUT-01-029/00/23
Descripción de la carga - BIOBASE 3
Comentario - BIOBASE 3
31-Jul-2023
2-04
Ptmp-16
11:01:00 119.94 °C
11:01:08 *** Fallo del sensor ***
120.17 °C
11:01:12 *** Fallo del sensor ***
120.27 °C
11:01:24 *** Fallo del sensor ***
120.59 °C
11:02:00 121.59 °C
11:02:04 *** Fallo del sensor ***
121.70 °C
11:02:08 *** Fallo del sensor ***
121.81 °C
11:02:24 *** Fallo del sensor ***
122.09 °C
11:03:00 122.00 °C
11:03:16 *** Iniciar Exposición *** Manual RODOLFO ARELLANO
121.88 °C
11:03:36 *** Fallo del sensor ***
121.87 °C
11:04:00 121.91 °C
11:04:28 *** Fallo del sensor ***
121.92 °C
11:05:00 121.78 °C
11:06:00 121.79 °C
11:07:00 121.79 °C
11:08:00 121.81 °C
11:09:00 121.85 °C
11:10:00 121.85 °C
11:11:00 121.85 °C
11:12:00 121.81 °C
11:12:14 *** Fallo del sensor ***
121.81 °C
11:13:00 121.82 °C
11:13:58 *** Fallo del sensor ***
121.79 °C

Realizado por: ____________________________________ Fecha: ______________

Revisado por: ____________________________________ Fecha: _______________ Página 13 de 32


Impreso el 31-Jul-2023 a las 12:38:58

Grupo 1 - autoclave - Entradas de sensores


Id. del equipo - EQ-AUT-INY-01 SOP/Número de protocolo - MEV-EQU-AUT-01-029/00/23
Descripción de la carga - BIOBASE 3
Comentario - BIOBASE 3
31-Jul-2023
1-01 1-02 1-03 1-04 1-05 1-06 1-07 1-08 1-09 1-10 1-11 1-12 2-01 2-02 2-03
Ptmp-1 Ptmp-2 Ptmp-3 Ptmp-4 Ptmp-5 Ptmp-6 Ptmp-7 Ptmp-8 Ptmp-9 Ptmp-10 Ptmp-11 Ptmp-12 Ptmp-13 Ptmp-14 Ptmp-15
11:14:00 121.33 °C 121.64 °C 121.63 °C 121.65 °C MENOS DE 121.44 °C 121.76 °C 34.02 °C 121.82 °C 121.74 °C 121.35 °C 121.64 °C ***** 121.64 °C 121.53 °C
11:15:00 121.32 °C 121.64 °C 121.63 °C 121.67 °C MENOS DE 121.43 °C 121.77 °C 13.14 °C 121.82 °C 121.75 °C 121.36 °C 121.65 °C ***** 121.62 °C 121.54 °C
11:16:00 121.39 °C 121.70 °C 121.69 °C 121.73 °C MENOS DE 121.50 °C 121.83 °C 10.17 °C 121.88 °C 121.80 °C 121.43 °C 121.71 °C ***** 121.69 °C 121.60 °C
11:16:58 *** Fallo del sensor ***
121.32 °C 121.63 °C 121.62 °C 121.66 °C MENOS DE 121.44 °C 121.77 °C 72.86 °C 121.81 °C 121.73 °C 121.36 °C 121.63 °C ***** 121.60 °C 121.52 °C
11:17:00 121.31 °C 121.62 °C 121.60 °C 121.66 °C MENOS DE 121.42 °C 121.77 °C 68.21 °C 121.80 °C 121.71 °C 121.35 °C 121.62 °C ***** 121.59 °C 121.52 °C
11:18:00 121.38 °C 121.69 °C 121.68 °C 121.73 °C MENOS DE 121.49 °C 121.84 °C 83.54 °C 121.88 °C 121.80 °C 121.42 °C 121.70 °C ***** 121.70 °C 121.59 °C
11:19:00 121.31 °C 121.63 °C 121.62 °C 121.67 °C MENOS DE 121.44 °C 121.79 °C 52.79 °C 121.78 °C 121.75 °C 121.36 °C 121.64 °C ***** 121.43 °C 121.54 °C
11:20:00 121.41 °C 121.70 °C 121.70 °C 121.74 °C MENOS DE 121.52 °C 121.86 °C 81.90 °C 121.89 °C 121.82 °C 121.45 °C 121.71 °C ***** 121.49 °C 121.63 °C
11:21:00 121.39 °C 121.69 °C 121.68 °C 121.73 °C MENOS DE 121.50 °C 121.85 °C 110.79 °C 121.87 °C 121.74 °C 121.43 °C 121.70 °C ***** 120.81 °C 121.60 °C
11:22:00 121.31 °C 121.61 °C 121.60 °C 121.65 °C MENOS DE 121.42 °C 121.77 °C 102.62 °C 121.78 °C 121.73 °C 121.35 °C 121.61 °C ***** 121.06 °C 121.51 °C
11:23:00 121.37 °C 121.66 °C 121.66 °C 121.71 °C MENOS DE 121.47 °C 121.82 °C 84.14 °C 121.84 °C 121.80 °C 121.48 °C 121.69 °C ***** 121.29 °C 121.58 °C
11:24:00 121.28 °C 121.58 °C 121.57 °C 121.63 °C MENOS DE 121.39 °C 121.74 °C 53.23 °C 121.76 °C 121.72 °C 121.33 °C 121.59 °C ***** 121.43 °C 121.50 °C
11:25:00 121.42 °C 121.70 °C 121.69 °C 121.73 °C MENOS DE 121.51 °C 121.86 °C 99.79 °C 121.87 °C 121.82 °C 121.45 °C 121.74 °C ***** 121.62 °C 121.60 °C
11:26:00 121.45 °C 121.67 °C 121.66 °C 121.71 °C MENOS DE 121.49 °C 121.84 °C 116.94 °C 121.85 °C 121.81 °C 121.43 °C 121.68 °C ***** 121.04 °C 121.58 °C
11:27:00 121.42 °C 121.72 °C 121.71 °C 121.75 °C MENOS DE 121.52 °C 121.88 °C 139.09 °C 121.88 °C 121.85 °C 121.47 °C 121.73 °C ***** 121.67 °C 121.62 °C
11:27:44 *** Finalizar Exposición *** Manual RODOLFO ARELLANO
120.76 °C 121.04 °C 121.02 °C 121.06 °C MENOS DE 120.79 °C 121.15 °C 136.88 °C 121.11 °C 121.06 °C 120.66 °C 120.89 °C ***** 120.83 °C 120.75 °C
11:28:00 118.78 °C 119.04 °C 119.02 °C 119.07 °C MENOS DE 118.82 °C 119.16 °C 126.89 °C 119.12 °C 119.06 °C 118.67 °C 118.91 °C ***** 118.85 °C 118.78 °C
11:29:00 113.72 °C 113.98 °C 113.97 °C 114.02 °C MENOS DE 113.82 °C 114.14 °C 93.56 °C 114.14 °C 114.08 °C 113.76 °C 113.95 °C ***** 113.88 °C 113.84 °C
11:30:00 109.72 °C 109.95 °C 109.94 °C 109.99 °C MENOS DE 109.78 °C 110.09 °C 111.91 °C 110.07 °C 110.01 °C 109.67 °C 109.86 °C ***** 109.80 °C 109.77 °C
11:31:00 106.34 °C 106.58 °C 106.58 °C 106.64 °C MENOS DE 106.45 °C 106.75 °C 70.86 °C 106.75 °C 106.71 °C 106.40 °C 106.57 °C ***** 106.53 °C 106.51 °C
11:32:00 103.53 °C 103.75 °C 103.75 °C 103.83 °C MENOS DE 103.63 °C 103.93 °C 118.01 °C 103.90 °C 103.85 °C 103.56 °C 103.69 °C ***** 103.65 °C 103.65 °C
11:33:00 101.05 °C 101.27 °C 101.26 °C 101.33 °C ABIERTO 101.18 °C 101.45 °C 58.94 °C 101.43 °C 101.39 °C 101.11 °C 101.25 °C ***** 101.24 °C 101.20 °C
11:34:00 98.94 °C 99.15 °C 99.15 °C 99.22 °C MENOS DE 99.06 °C 99.33 °C 102.62 °C 99.29 °C 99.25 °C 98.97 °C 99.11 °C ***** 99.07 °C 99.06 °C
11:35:00 97.08 °C 97.30 °C 97.30 °C 97.38 °C ABIERTO 97.22 °C 97.49 °C 99.34 °C 97.46 °C 97.42 °C 97.17 °C 97.28 °C ***** 97.32 °C 97.25 °C
11:36:00 95.62 °C 95.81 °C 95.82 °C 95.89 °C ABIERTO 95.75 °C 96.03 °C 76.13 °C 96.00 °C 95.95 °C 95.71 °C 95.82 °C ***** 95.85 °C 95.79 °C
11:37:00 94.42 °C 94.62 °C 94.63 °C 94.71 °C 94.69 °C 94.58 °C 94.84 °C 117.49 °C 94.79 °C 94.76 °C 94.51 °C 94.63 °C ***** 92.58 °C 94.61 °C
11:38:00 93.58 °C 93.76 °C 93.77 °C 93.85 °C 93.82 °C 93.72 °C 93.96 °C 84.61 °C 93.93 °C 93.89 °C 93.65 °C 93.77 °C ***** 90.99 °C 93.76 °C
11:39:00 92.95 °C 93.15 °C 93.16 °C 93.24 °C 93.23 °C 93.11 °C 93.36 °C 39.93 °C 93.32 °C 93.28 °C 93.04 °C 93.16 °C ***** 90.04 °C 93.17 °C
11:40:00 92.64 °C 92.84 °C 92.85 °C 92.93 °C 92.91 °C 92.80 °C 93.05 °C 13.81 °C 93.02 °C 92.98 °C 92.74 °C 92.86 °C ***** 92.53 °C 92.87 °C
11:41:00 92.44 °C 92.63 °C 92.64 °C 92.72 °C 92.71 °C 92.62 °C 92.84 °C -76.86 °C 92.81 °C 92.77 °C 92.54 °C 92.66 °C ***** 90.49 °C 92.67 °C
11:42:00 92.43 °C 92.60 °C 92.60 °C 92.71 °C 92.70 °C 92.60 °C 92.78 °C 44.30 °C 92.69 °C 92.76 °C 92.52 °C 92.60 °C ***** 90.37 °C 92.65 °C
11:42:14 *** Fallo del sensor ***
92.40 °C 92.58 °C 92.59 °C 92.69 °C ABIERTO 92.59 °C 92.75 °C 53.36 °C 92.66 °C 92.74 °C 92.51 °C 92.59 °C ***** 90.35 °C 92.64 °C

Realizado por: ____________________________________ Fecha: ______________

Revisado por: ____________________________________ Fecha: _______________ Página 14 de 32


Impreso el 31-Jul-2023 a las 12:38:58

Grupo 1 - autoclave - Entradas de sensores


Id. del equipo - EQ-AUT-INY-01 SOP/Número de protocolo - MEV-EQU-AUT-01-029/00/23
Descripción de la carga - BIOBASE 3
Comentario - BIOBASE 3
31-Jul-2023
2-04
Ptmp-16
11:14:00 121.79 °C
11:15:00 121.80 °C
11:16:00 121.86 °C
11:16:58 *** Fallo del sensor ***
121.79 °C
11:17:00 121.78 °C
11:18:00 121.86 °C
11:19:00 121.80 °C
11:20:00 121.88 °C
11:21:00 121.87 °C
11:22:00 121.77 °C
11:23:00 121.84 °C
11:24:00 121.75 °C
11:25:00 121.86 °C
11:26:00 121.84 °C
11:27:00 121.88 °C
11:27:44 *** Finalizar Exposición *** Manual RODOLFO ARELLANO
121.01 °C
11:28:00 119.03 °C
11:29:00 114.08 °C
11:30:00 110.00 °C
11:31:00 106.72 °C
11:32:00 103.84 °C
11:33:00 101.40 °C
11:34:00 99.27 °C
11:35:00 97.46 °C
11:36:00 96.00 °C
11:37:00 94.80 °C
11:38:00 93.94 °C
11:39:00 93.33 °C
11:40:00 93.03 °C
11:41:00 92.83 °C
11:42:00 92.81 °C
11:42:14 *** Fallo del sensor ***
92.80 °C

Realizado por: ____________________________________ Fecha: ______________

Revisado por: ____________________________________ Fecha: _______________ Página 15 de 32


Impreso el 31-Jul-2023 a las 12:38:58

Grupo 1 - autoclave - Entradas de sensores


Id. del equipo - EQ-AUT-INY-01 SOP/Número de protocolo - MEV-EQU-AUT-01-029/00/23
Descripción de la carga - BIOBASE 3
Comentario - BIOBASE 3
31-Jul-2023
1-01 1-02 1-03 1-04 1-05 1-06 1-07 1-08 1-09 1-10 1-11 1-12 2-01 2-02 2-03
Ptmp-1 Ptmp-2 Ptmp-3 Ptmp-4 Ptmp-5 Ptmp-6 Ptmp-7 Ptmp-8 Ptmp-9 Ptmp-10 Ptmp-11 Ptmp-12 Ptmp-13 Ptmp-14 Ptmp-15
11:43:00 92.32 °C 92.49 °C 92.51 °C 92.65 °C ABIERTO 92.56 °C 92.65 °C 18.10 °C 92.51 °C 92.68 °C 92.43 °C 92.50 °C ***** 90.29 °C 92.58 °C
11:44:00 92.21 °C 92.36 °C 92.40 °C 92.58 °C 92.45 °C 92.50 °C 92.50 °C 80.84 °C 92.31 °C 92.58 °C 92.34 °C 92.40 °C ***** 90.31 °C 92.50 °C
11:44:20 *** Fallo del sensor ***
92.15 °C 92.30 °C 92.34 °C 92.54 °C ABIERTO 92.46 °C 92.43 °C 65.20 °C 92.22 °C 92.52 °C 92.29 °C 92.34 °C ***** 90.25 °C 92.46 °C
11:45:00 92.05 °C 92.19 °C 92.23 °C 92.48 °C ABIERTO 92.39 °C 92.31 °C 54.34 °C 92.10 °C 92.43 °C 92.19 °C 92.24 °C ***** 90.28 °C 92.36 °C
11:46:00 91.90 °C 92.01 °C 92.05 °C 92.33 °C ABIERTO 92.25 °C 92.14 °C 74.87 °C 91.90 °C 92.26 °C 92.02 °C 92.07 °C ***** 90.14 °C 92.21 °C
11:47:00 91.71 °C 91.84 °C 91.88 °C 92.18 °C 91.99 °C 92.10 °C 91.95 °C 109.18 °C 91.70 °C 92.09 °C 91.85 °C 91.91 °C ***** 89.83 °C 92.05 °C
11:48:00 91.54 °C 91.65 °C 91.69 °C 91.99 °C 91.85 °C 91.92 °C 91.76 °C 188.11 °C 91.50 °C 91.90 °C 91.66 °C 91.71 °C ***** 89.78 °C 91.86 °C
11:49:00 91.35 °C 91.47 °C 91.51 °C 91.78 °C 91.66 °C 91.71 °C 91.59 °C 215.38 °C 91.32 °C 91.72 °C 91.46 °C 91.53 °C ***** 89.56 °C 91.67 °C
11:49:44 *** Fallo del sensor ***
91.22 °C 91.34 °C 91.38 °C 91.61 °C ABIERTO 91.54 °C 91.45 °C 241.27 °C 91.18 °C 91.57 °C 91.29 °C 91.41 °C ***** 89.41 °C 91.52 °C
11:50:00 91.17 °C 91.30 °C 91.33 °C 91.53 °C 91.47 °C 91.47 °C 91.40 °C 218.64 °C 91.13 °C 91.52 °C 91.23 °C 91.36 °C ***** 89.37 °C 91.46 °C
11:51:00 90.93 °C 91.09 °C 91.11 °C 91.23 °C 91.24 °C 91.19 °C 91.19 °C 234.22 °C 90.92 °C 91.28 °C 90.96 °C 91.14 °C ***** 89.10 °C 91.22 °C
11:51:46 *** Fallo del sensor ***
90.79 °C 90.95 °C 90.97 °C 91.01 °C ABIERTO 90.98 °C 91.06 °C 263.17 °C 90.79 °C 91.12 °C 90.77 °C 90.99 °C ***** 88.71 °C 91.03 °C
11:52:00 90.74 °C 90.91 °C 90.92 °C 90.94 °C ABIERTO 90.91 °C 91.02 °C 254.84 °C 90.74 °C 91.06 °C 90.71 °C 90.95 °C ***** 88.59 °C 90.97 °C
11:52:50 *** Fallo del sensor ***
90.52 °C 90.74 °C 90.75 °C 90.68 °C ABIERTO 90.67 °C 90.84 °C 260.89 °C 90.56 °C 90.84 °C 90.45 °C 90.76 °C ***** 86.85 °C 90.72 °C
11:53:00 90.48 °C 90.70 °C 90.71 °C 90.63 °C ABIERTO 90.62 °C 90.79 °C 243.58 °C 90.52 °C 90.79 °C 90.41 °C 90.72 °C ***** 86.97 °C 90.66 °C
11:54:00 90.22 °C 90.48 °C 90.48 °C 90.30 °C ABIERTO 90.33 °C 90.57 °C 249.45 °C 90.31 °C 90.51 °C 90.13 °C 90.49 °C ***** 87.32 °C 90.36 °C
11:55:00 89.94 °C 90.26 °C 90.25 °C 89.97 °C ABIERTO 90.04 °C 90.35 °C 241.41 °C 90.09 °C 90.23 °C 89.85 °C 90.25 °C ***** 87.02 °C 90.07 °C
11:56:00 89.67 °C 90.04 °C 90.02 °C 89.65 °C ABIERTO 89.80 °C 90.11 °C 232.71 °C 89.86 °C 89.96 °C 89.59 °C 90.01 °C ***** 86.52 °C 89.79 °C
11:57:00 89.40 °C 89.81 °C 89.79 °C 89.38 °C 63.01 °C 89.52 °C 89.87 °C 247.44 °C 89.63 °C 89.70 °C 89.35 °C 89.75 °C ***** 85.77 °C 89.50 °C
11:57:18 *** Fallo del sensor ***
89.31 °C 89.73 °C 89.71 °C 89.28 °C MENOS DE 89.42 °C 89.79 °C 250.07 °C 89.55 °C 89.61 °C 89.27 °C 89.68 °C ***** 85.74 °C 89.43 °C
11:58:00 89.15 °C 89.57 °C 89.54 °C 89.08 °C ***** 89.22 °C 89.62 °C 218.52 °C 89.40 °C 89.45 °C 89.12 °C 89.49 °C ***** 85.40 °C 89.23 °C
11:59:00 88.87 °C 89.33 °C 89.31 °C 88.79 °C -80.47 °C 88.96 °C 89.37 °C 218.60 °C 89.17 °C 89.21 °C 88.86 °C 89.26 °C ***** 84.95 °C 88.95 °C
11:59:10 *** Fallo del sensor ***
88.83 °C 89.29 °C 89.27 °C 88.73 °C MENOS DE 88.90 °C
89.33 °C 222.58 °C 89.14 °C 89.17 °C 88.81 °C 89.22 °C ***** 84.81 °C 88.92 °C
12:00:00 88.62 °C 89.11 °C 89.08 °C 88.49 °C ***** 88.66 °C
89.12 °C 199.04 °C 88.93 °C 88.97 °C 88.57 °C 89.02 °C ***** 84.02 °C 88.68 °C
12:01:00 88.34 °C 88.87 °C 88.85 °C 88.20 °C MENOS DE 88.38 °C
88.88 °C 199.95 °C 88.71 °C 88.70 °C 88.31 °C 88.79 °C ***** 83.32 °C 88.40 °C
12:02:00 88.10 °C 88.64 °C 88.61 °C 87.93 °C MENOS DE 88.11 °C
88.64 °C 191.84 °C 88.49 °C 88.46 °C 88.03 °C 88.56 °C ***** 82.99 °C 88.15 °C
12:02:48 *** Finalizar Cualificación *** Manual RODOLFO ARELLANO
87.89 °C 88.45 °C 88.40 °C 87.71 °C MENOS DE 87.90 °C 88.44 °C 200.57 °C 88.31 °C 88.26 °C 87.83 °C 88.38 °C ***** 82.35 °C 87.91 °C

Realizado por: ____________________________________ Fecha: ______________

Revisado por: ____________________________________ Fecha: _______________ Página 16 de 32


Impreso el 31-Jul-2023 a las 12:38:58

Grupo 1 - autoclave - Entradas de sensores


Id. del equipo - EQ-AUT-INY-01 SOP/Número de protocolo - MEV-EQU-AUT-01-029/00/23
Descripción de la carga - BIOBASE 3
Comentario - BIOBASE 3
31-Jul-2023
2-04
Ptmp-16
11:43:00 92.74 °C
11:44:00 92.66 °C
11:44:20 *** Fallo del sensor ***
92.61 °C
11:45:00 92.52 °C
11:46:00 92.35 °C
11:47:00 92.19 °C
11:48:00 92.01 °C
11:49:00 91.82 °C
11:49:44 *** Fallo del sensor ***
91.68 °C
11:50:00 91.62 °C
11:51:00 91.38 °C
11:51:46 *** Fallo del sensor ***
91.18 °C
11:52:00 91.12 °C
11:52:50 *** Fallo del sensor ***
90.88 °C
11:53:00 90.83 °C
11:54:00 90.52 °C
11:55:00 90.22 °C
11:56:00 89.94 °C
11:57:00 89.65 °C
11:57:18 *** Fallo del sensor ***
89.57 °C
11:58:00 89.37 °C
11:59:00 89.09 °C
11:59:10 *** Fallo del sensor ***
89.06 °C
12:00:00 88.81 °C
12:01:00 88.53 °C
12:02:00 88.27 °C
12:02:48 *** Finalizar Cualificación *** Manual RODOLFO ARELLANO
88.05 °C

Realizado por: ____________________________________ Fecha: ______________

Revisado por: ____________________________________ Fecha: _______________ Página 17 de 32


Impreso el 31-Jul-2023 a las 12:38:58

Grupo 1 - autoclave - Cálculos de letalidad


Id. del equipo - EQ-AUT-INY-01 SOP/Número de protocolo - MEV-EQU-AUT-01-029/00/23
Descripción de la carga - BIOBASE 3
Comentario - BIOBASE 3
31-Jul-2023 La letalidad se expresa en minutos
1-01 1-02 1-03 1-04 1-05 1-06 1-07 1-08 1-09 1-10 1-11 1-12 2-01 2-02 2-03
Ptmp-1 Ptmp-2 Ptmp-3 Ptmp-4 Ptmp-5 Ptmp-6 Ptmp-7 Ptmp-8 Ptmp-9 Ptmp-10 Ptmp-11 Ptmp-12 Ptmp-13 Ptmp-14 Ptmp-15
11:03:16 *** Iniciar Exposición *** Manual RODOLFO ARELLANO
0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 ***** 0.00 0.00
11:03:36 *** Fallo del sensor ***
0.36 0.39 0.38 0.39 0.39 0.37 0.40 ***** 0.40 0.39 0.36 0.39 ***** 0.24 0.38
11:04:00 0.78 0.85 0.84 0.85 0.86 0.81 0.87 ***** 0.88 0.86 0.79 0.85 ***** 0.55 0.83
11:04:28 *** Fallo del sensor ***
1.29 1.40 1.39 1.39 ***** 1.34 1.43 ***** 1.44 1.41 1.30 1.40 ***** 0.95 1.36
11:05:00 1.85 2.01 2.00 2.00 ***** 1.92 2.06 ***** 2.07 2.03 1.87 2.02 ***** 1.42 1.96
11:06:00 2.90 3.15 3.13 3.13 ***** 3.01 3.23 ***** 3.25 3.18 2.93 3.16 ***** 2.35 3.06
11:07:00 3.95 4.29 4.27 4.25 ***** 4.09 4.40 ***** 4.43 4.33 3.98 4.29 ***** 3.38 4.17
11:08:00 5.00 5.43 5.41 5.38 ***** 5.18 5.57 ***** 5.62 5.48 5.05 5.43 ***** 4.50 5.28
11:09:00 6.06 6.58 6.55 6.52 ***** 6.27 6.75 ***** 6.81 6.63 6.12 6.58 ***** 5.62 6.40
11:10:00 7.12 7.73 7.70 7.66 ***** 7.36 7.93 ***** 8.01 7.79 7.19 7.73 ***** 6.71 7.51
11:11:00 8.18 8.87 8.84 8.80 ***** 8.46 9.11 ***** 9.20 8.96 8.26 8.88 ***** 7.82 8.63
11:12:00 9.23 10.01 9.98 9.94 ***** 9.55 10.28 ***** 10.39 10.12 9.33 10.02 ***** 8.87 9.74
11:12:14 *** Fallo del sensor ***
9.48 10.28 10.25 10.21 ***** 9.80 10.56 ***** 10.67 10.39 9.58 10.28 ***** 9.09 10.00
11:13:00 10.29 11.15 11.12 11.08 ***** 10.63 11.46 ***** 11.58 11.28 10.40 11.16 ***** 9.95 10.85
11:13:58 *** Fallo del sensor ***
11.31 12.25 12.21 12.18 ***** 11.68 12.59 ***** 12.72 12.40 11.43 12.26 ***** 11.06 11.92
11:14:00 11.35 12.29 12.25 12.22 ***** 11.72 12.63 ***** 12.76 12.44 11.46 12.29 ***** 11.09 11.96
11:15:00 12.40 13.42 13.38 13.36 ***** 12.80 13.79 ***** 13.95 13.60 12.53 13.43 ***** 12.23 13.06
11:16:00 13.46 14.56 14.51 14.50 ***** 13.88 14.97 ***** 15.13 14.77 13.60 14.56 ***** 13.36 14.18
11:16:58 *** Fallo del sensor ***
14.50 15.67 15.62 15.62 ***** 14.95 16.12 ***** 16.29 15.90 14.64 15.68 ***** 14.46 15.26
11:17:00 14.53 15.71 15.66 15.66 ***** 14.98 16.16 ***** 16.33 15.94 14.68 15.71 ***** 14.50 15.30
11:18:00 15.59 16.84 16.79 16.80 ***** 16.07 17.33 ***** 17.51 17.11 15.74 16.85 ***** 15.64 16.41
11:19:00 16.65 17.98 17.93 17.95 ***** 17.16 18.51 ***** 18.70 18.28 16.82 17.99 ***** 16.76 17.52
11:20:00 17.72 19.13 19.07 19.11 ***** 18.25 19.70 ***** 19.90 19.45 17.89 19.14 ***** 17.87 18.64
11:21:00 18.78 20.26 20.21 20.26 ***** 19.34 20.88 ***** 21.09 20.62 18.97 20.28 ***** 18.82 19.76
11:22:00 19.85 21.41 21.35 21.41 ***** 20.44 22.06 ***** 22.28 21.80 20.04 21.42 ***** 19.87 20.88
11:23:00 20.90 22.54 22.48 22.55 ***** 21.52 23.24 ***** 23.46 22.96 21.11 22.56 ***** 20.92 21.99
11:24:00 21.97 23.68 23.61 23.70 ***** 22.61 24.42 ***** 24.64 24.14 22.19 23.70 ***** 22.01 23.10
11:25:00 23.02 24.81 24.74 24.85 ***** 23.70 25.59 ***** 25.82 25.30 23.26 24.83 ***** 23.11 24.21
11:26:00 24.10 25.96 25.88 26.00 ***** 24.79 26.78 ***** 27.01 26.49 24.34 25.98 ***** 24.21 25.33

Realizado por: ____________________________________ Fecha: ______________

Revisado por: ____________________________________ Fecha: _______________ Página 18 de 32


Impreso el 31-Jul-2023 a las 12:38:58

Grupo 1 - autoclave - Cálculos de letalidad


Id. del equipo - EQ-AUT-INY-01 SOP/Número de protocolo - MEV-EQU-AUT-01-029/00/23
Descripción de la carga - BIOBASE 3
Comentario - BIOBASE 3
31-Jul-2023 La letalidad se expresa en minutos
2-04 LtACM Mín LtACM Mín
Ptmp-16 Valor Ubicación
11:03:16 *** Iniciar Exposición *** Manual RODOLFO ARELLANO
0.00 0.00 1-01
11:03:36 *** Fallo del sensor ***
0.40 0.24 2-02
11:04:00 0.88 0.55 2-02
11:04:28 *** Fallo del sensor ***
1.44 0.95 2-02
11:05:00 2.07 1.42 2-02
11:06:00 3.25 2.35 2-02
11:07:00 4.42 3.38 2-02
11:08:00 5.59 4.50 2-02
11:09:00 6.78 5.62 2-02
11:10:00 7.96 6.71 2-02
11:11:00 9.15 7.82 2-02
11:12:00 10.33 8.87 2-02
11:12:14 *** Fallo del sensor ***
10.60 9.09 2-02
11:13:00 11.51 9.95 2-02
11:13:58 *** Fallo del sensor ***
12.65 11.06 2-02
11:14:00 12.69 11.09 2-02
11:15:00 13.86 12.23 2-02
11:16:00 15.04 13.36 2-02
11:16:58 *** Fallo del sensor ***
16.19 14.46 2-02
11:17:00 16.23 14.50 2-02
11:18:00 17.41 15.59 1-01
11:19:00 18.60 16.65 1-01
11:20:00 19.78 17.72 1-01
11:21:00 20.97 18.78 1-01
11:22:00 22.16 19.85 1-01
11:23:00 23.33 20.90 1-01
11:24:00 24.52 21.97 1-01
11:25:00 25.70 23.02 1-01
11:26:00 26.89 24.10 1-01

Realizado por: ____________________________________ Fecha: ______________

Revisado por: ____________________________________ Fecha: _______________ Página 19 de 32


Impreso el 31-Jul-2023 a las 12:38:58

Grupo 1 - autoclave - Cálculos de letalidad


Id. del equipo - EQ-AUT-INY-01 SOP/Número de protocolo - MEV-EQU-AUT-01-029/00/23
Descripción de la carga - BIOBASE 3
Comentario - BIOBASE 3
31-Jul-2023 La letalidad se expresa en minutos
1-01 1-02 1-03 1-04 1-05 1-06 1-07 1-08 1-09 1-10 1-11 1-12 2-01 2-02 2-03
Ptmp-1 Ptmp-2 Ptmp-3 Ptmp-4 Ptmp-5 Ptmp-6 Ptmp-7 Ptmp-8 Ptmp-9 Ptmp-10 Ptmp-11 Ptmp-12 Ptmp-13 Ptmp-14 Ptmp-15
11:27:00 25.16 27.10 27.02 27.15 ***** 25.88 27.97 ***** 28.20 27.66 25.42 27.12 ***** 25.30 26.45
11:27:44 *** Finalizar Exposición *** Manual RODOLFO ARELLANO
25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:28:00 25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:29:00 25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:30:00 25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:31:00 25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:32:00 25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:33:00 25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:34:00 25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:35:00 25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:36:00 25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:37:00 25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:38:00 25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:39:00 25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:40:00 25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:41:00 25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:42:00 25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:42:14 *** Fallo del sensor ***
25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:43:00 25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:44:00 25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:44:20 *** Fallo del sensor ***
25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:45:00 25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:46:00 25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:47:00 25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:48:00 25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:49:00 25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:49:44 *** Fallo del sensor ***
25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:50:00 25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:51:00 25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:51:46 *** Fallo del sensor ***
25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26

Realizado por: ____________________________________ Fecha: ______________

Revisado por: ____________________________________ Fecha: _______________ Página 20 de 32


Impreso el 31-Jul-2023 a las 12:38:58

Grupo 1 - autoclave - Cálculos de letalidad


Id. del equipo - EQ-AUT-INY-01 SOP/Número de protocolo - MEV-EQU-AUT-01-029/00/23
Descripción de la carga - BIOBASE 3
Comentario - BIOBASE 3
31-Jul-2023 La letalidad se expresa en minutos
2-04 LtACM Mín LtACM Mín
Ptmp-16 Valor Ubicación
11:27:00 28.07 25.16 1-01
11:27:44 *** Finalizar Exposición *** Manual RODOLFO ARELLANO
28.93 25.94 1-01
11:28:00 28.93 25.94 1-01
11:29:00 28.93 25.94 1-01
11:30:00 28.93 25.94 1-01
11:31:00 28.93 25.94 1-01
11:32:00 28.93 25.94 1-01
11:33:00 28.93 25.94 1-01
11:34:00 28.93 25.94 1-01
11:35:00 28.93 25.94 1-01
11:36:00 28.93 25.94 1-01
11:37:00 28.93 25.94 1-01
11:38:00 28.93 25.94 1-01
11:39:00 28.93 25.94 1-01
11:40:00 28.93 25.94 1-01
11:41:00 28.93 25.94 1-01
11:42:00 28.93 25.94 1-01
11:42:14 *** Fallo del sensor ***
28.93 25.94 1-01
11:43:00 28.93 25.94 1-01
11:44:00 28.93 25.94 1-01
11:44:20 *** Fallo del sensor ***
28.93 25.94 1-01
11:45:00 28.93 25.94 1-01
11:46:00 28.93 25.94 1-01
11:47:00 28.93 25.94 1-01
11:48:00 28.93 25.94 1-01
11:49:00 28.93 25.94 1-01
11:49:44 *** Fallo del sensor ***
28.93 25.94 1-01
11:50:00 28.93 25.94 1-01
11:51:00 28.93 25.94 1-01
11:51:46 *** Fallo del sensor ***
28.93 25.94 1-01

Realizado por: ____________________________________ Fecha: ______________

Revisado por: ____________________________________ Fecha: _______________ Página 21 de 32


Impreso el 31-Jul-2023 a las 12:38:58

Grupo 1 - autoclave - Cálculos de letalidad


Id. del equipo - EQ-AUT-INY-01 SOP/Número de protocolo - MEV-EQU-AUT-01-029/00/23
Descripción de la carga - BIOBASE 3
Comentario - BIOBASE 3
31-Jul-2023 La letalidad se expresa en minutos
1-01 1-02 1-03 1-04 1-05 1-06 1-07 1-08 1-09 1-10 1-11 1-12 2-01 2-02 2-03
Ptmp-1 Ptmp-2 Ptmp-3 Ptmp-4 Ptmp-5 Ptmp-6 Ptmp-7 Ptmp-8 Ptmp-9 Ptmp-10 Ptmp-11 Ptmp-12 Ptmp-13 Ptmp-14 Ptmp-15
11:52:00 25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:52:50 *** Fallo del sensor ***
25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:53:00 25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:54:00 25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:55:00 25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:56:00 25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:57:00 25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:57:18 *** Fallo del sensor ***
25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:58:00 25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:59:00 25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
11:59:10 *** Fallo del sensor ***
25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
12:00:00 25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
12:01:00 25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
12:02:00 25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26
12:02:48 *** Finalizar Cualificación *** Manual RODOLFO ARELLANO
25.94 27.93 27.85 27.99 ***** 26.68 28.83 ***** 29.07 28.52 26.21 27.95 ***** 26.12 27.26

Realizado por: ____________________________________ Fecha: ______________

Revisado por: ____________________________________ Fecha: _______________ Página 22 de 32


Impreso el 31-Jul-2023 a las 12:38:58

Grupo 1 - autoclave - Cálculos de letalidad


Id. del equipo - EQ-AUT-INY-01 SOP/Número de protocolo - MEV-EQU-AUT-01-029/00/23
Descripción de la carga - BIOBASE 3
Comentario - BIOBASE 3
31-Jul-2023 La letalidad se expresa en minutos
2-04 LtACM Mín LtACM Mín
Ptmp-16 Valor Ubicación
11:52:00 28.93 25.94 1-01
11:52:50 *** Fallo del sensor ***
28.93 25.94 1-01
11:53:00 28.93 25.94 1-01
11:54:00 28.93 25.94 1-01
11:55:00 28.93 25.94 1-01
11:56:00 28.93 25.94 1-01
11:57:00 28.93 25.94 1-01
11:57:18 *** Fallo del sensor ***
28.93 25.94 1-01
11:58:00 28.93 25.94 1-01
11:59:00 28.93 25.94 1-01
11:59:10 *** Fallo del sensor ***
28.93 25.94 1-01
12:00:00 28.93 25.94 1-01
12:01:00 28.93 25.94 1-01
12:02:00 28.93 25.94 1-01
12:02:48 *** Finalizar Cualificación *** Manual RODOLFO ARELLANO
28.93 25.94 1-01

Realizado por: ____________________________________ Fecha: ______________

Revisado por: ____________________________________ Fecha: _______________ Página 23 de 32


Impreso el 31-Jul-2023 a las 12:38:58

Grupo 1 - autoclave - Cálculos Estadísticos


Id. del equipo - EQ-AUT-INY-01 SOP/Número de protocolo - MEV-EQU-AUT-01-029/00/23
Descripción de la carga - BIOBASE 3
Comentario - BIOBASE 3
31-Jul-2023
Mín Mín Máx Máx Exp Ciclo
Valor Ubicación Valor Ubicación Máx - Mín Media Desv. típica Máx - Med Med - Mín Hora Hora
10:23:10 *** Iniciar cualificación *** Manual RODOLFO ARELLANO
19.77 1-05 21.39 1-07 1.62 20.76 0.51 0.63 0.99 00:00
10:24:00 19.97 1-05 21.73 1-03 1.76 20.94 0.54 0.79 0.97 00:50
10:25:00 20.28 1-05 21.99 1-03 1.71 21.13 0.52 0.86 0.85 01:50
10:26:00 20.46 1-01 22.55 1-03 2.09 21.49 0.61 1.06 1.03 02:50
10:27:00 20.57 1-01 22.98 1-03 2.41 21.88 0.71 1.10 1.31 03:50
10:28:00 20.74 1-01 25.09 1-12 4.35 22.48 1.09 2.61 1.74 04:50
10:29:00 21.32 1-01 26.14 1-12 4.82 23.03 1.21 3.11 1.71 05:50
10:30:00 21.98 1-10 28.68 1-12 6.70 23.83 1.63 4.85 1.85 06:50
10:31:00 22.51 1-10 29.47 1-12 6.96 24.73 1.72 4.74 2.22 07:50
10:32:00 19.90 1-01 28.81 1-12 8.91 25.58 2.20 3.23 5.68 08:50
10:33:00 19.27 1-01 30.45 1-03 11.18 27.03 2.84 3.42 7.76 09:50
10:34:00 22.74 1-01 35.96 1-03 13.22 29.31 3.42 6.65 6.57 10:50
10:35:00 24.31 1-01 86.10 1-05 61.79 35.39 15.14 50.71 11.08 11:50
10:35:16 *** Fallo del sensor ***
24.57 1-01 39.77 1-03 15.20 31.88 4.18 7.89 7.31 12:06
10:35:22 *** Fallo del sensor ***
24.66 1-01 41.10 1-03 16.44 32.24 4.54 8.86 7.58 12:12
10:35:28 *** Fallo del sensor ***
24.76 1-01 41.52 1-03 16.76 32.54 4.62 8.98 7.78 12:18
10:35:32 *** Fallo del sensor ***
24.80 1-01 40.60 1-03 15.80 32.48 4.39 8.12 7.68 12:22
10:35:38 *** Fallo del sensor ***
24.93 1-01 41.48 1-03 16.55 32.77 4.61 8.71 7.84 12:28
10:36:00 -50.74 1-05 42.02 1-03 92.76 27.44 22.92 14.58 78.18 12:50
10:36:08 *** Fallo del sensor ***
25.58 1-01 40.47 1-03 14.89 33.54 4.17 6.93 7.96 12:58
10:36:16 *** Fallo del sensor ***
25.78 1-01 41.12 1-03 15.34 33.86 4.26 7.26 8.08 13:06
10:36:28 *** Fallo del sensor ***
26.08 1-01 42.80 1-03 16.72 34.42 4.57 8.38 8.34 13:18
10:36:58 *** Fallo del sensor ***
26.95 1-01 42.65 1-03 15.70 35.48 4.29 7.17 8.53 13:48
10:37:00 26.98 1-01 42.81 1-03 15.83 35.57 4.31 7.24 8.59 13:50

Realizado por: ____________________________________ Fecha: ______________

Revisado por: ____________________________________ Fecha: _______________ Página 24 de 32


Impreso el 31-Jul-2023 a las 12:38:58

Grupo 1 - autoclave - Cálculos Estadísticos


Id. del equipo - EQ-AUT-INY-01 SOP/Número de protocolo - MEV-EQU-AUT-01-029/00/23
Descripción de la carga - BIOBASE 3
Comentario - BIOBASE 3
31-Jul-2023
Mín Mín Máx Máx Exp Ciclo
Valor Ubicación Valor Ubicación Máx - Mín Media Desv. típica Máx - Med Med - Mín Hora Hora
10:37:10 *** Fallo del sensor ***
27.49 1-01 44.60 1-03 17.11 36.12 4.62 8.48 8.63 14:00
10:37:48 *** Fallo del sensor ***
28.29 1-01 43.53 1-03 15.24 37.25 4.08 6.28 8.96 14:38
10:37:56 *** Fallo del sensor ***
28.50 1-01 44.56 1-03 16.06 37.62 4.23 6.94 9.12 14:46
10:38:00 28.61 1-01 45.59 1-03 16.98 37.97 4.48 7.62 9.36 14:50
10:38:26 *** Fallo del sensor ***
29.26 1-01 45.20 1-03 15.94 38.93 4.25 6.27 9.67 15:16
10:38:38 *** Fallo del sensor ***
29.26 1-01 45.89 1-03 16.63 39.54 4.43 6.35 10.28 15:28
10:39:00 30.24 1-01 46.69 1-03 16.45 40.65 4.44 6.04 10.41 15:50
10:39:44 *** Fallo del sensor ***
37.90 1-10 49.24 1-03 11.34 44.15 3.48 5.09 6.25 16:34
10:39:58 *** Fallo del sensor ***
38.82 1-10 50.55 1-03 11.73 44.97 3.61 5.58 6.15 16:48
10:40:00 38.91 1-10 50.65 1-03 11.74 45.19 3.62 5.46 6.28 16:50
10:40:10 *** Fallo del sensor ***
39.59 1-10 51.59 1-03 12.00 45.87 3.70 5.72 6.28 17:00
10:40:24 *** Fallo del sensor ***
33.21 1-01 53.45 1-03 20.24 46.00 5.47 7.45 12.79 17:14
10:40:40 *** Fallo del sensor ***
41.55 1-09 54.57 1-03 13.02 48.06 4.03 6.51 6.51 17:30
10:41:00 42.84 1-10 53.66 1-03 10.82 48.81 3.40 4.85 5.97 17:50
10:41:02 *** Fallo del sensor ***
43.01 1-10 54.85 1-03 11.84 49.28 3.69 5.57 6.27 17:52
10:41:52 *** Fallo del sensor ***
46.34 1-09 57.45 1-03 11.11 52.40 3.67 5.05 6.06 18:42
10:42:00 46.77 1-09 58.51 1-03 11.74 52.97 3.86 5.54 6.20 18:50
10:42:52 *** Fallo del sensor ***
50.42 1-09 62.09 1-03 11.67 56.61 3.74 5.48 6.19 19:42
10:43:00 32.63 1-01 62.08 1-03 29.45 55.12 7.56 6.96 22.49 19:50
10:44:00 -239.36 2-01 67.13 1-03 306.49 39.10 80.28 28.03 278.46 20:50
10:44:06 *** Fallo del sensor ***
-200.16 2-01 66.55 1-03 266.71 41.49 72.68 25.06 241.65 20:56

Realizado por: ____________________________________ Fecha: ______________

Revisado por: ____________________________________ Fecha: _______________ Página 25 de 32


Impreso el 31-Jul-2023 a las 12:38:58

Grupo 1 - autoclave - Cálculos Estadísticos


Id. del equipo - EQ-AUT-INY-01 SOP/Número de protocolo - MEV-EQU-AUT-01-029/00/23
Descripción de la carga - BIOBASE 3
Comentario - BIOBASE 3
31-Jul-2023
Mín Mín Máx Máx Exp Ciclo
Valor Ubicación Valor Ubicación Máx - Mín Media Desv. típica Máx - Med Med - Mín Hora Hora
10:44:30 *** Fallo del sensor ***
-100.42 2-01 68.69 1-03 169.11 51.04 45.62 17.65 151.46 21:20
10:44:54 *** Fallo del sensor ***
-29.61 2-01 72.13 1-03 101.74 59.24 25.91 12.89 88.85 21:44
10:45:00 *** Fallo del sensor ***
-12.93 2-01 72.89 1-11 85.82 61.04 21.71 11.85 73.97 21:50
10:45:24 *** Fallo del sensor ***
57.87 2-01 349.64 1-05 291.77 88.40 72.45 261.24 30.53 22:14
10:45:34 *** Fallo del sensor ***
67.94 1-01 349.92 1-05 281.98 92.20 71.39 257.72 24.26 22:24
10:45:40 *** Fallo del sensor ***
70.87 1-09 93.48 2-01 22.61 77.38 5.96 16.10 6.51 22:30
10:45:50 *** Fallo del sensor ***
71.56 1-10 114.22 2-01 42.66 79.51 10.51 34.71 7.95 22:40
10:45:56 *** Fallo del sensor ***
-226.45 1-08 129.70 2-01 356.15 61.45 80.80 68.25 287.90 22:46
10:46:00 *** Fallo del sensor ***
74.64 1-10 122.89 2-01 48.25 82.16 12.13 40.73 7.52 22:50
10:46:28 *** Fallo del sensor ***
-185.11 1-01 232.07 2-01 417.18 63.57 92.59 168.50 248.68 23:18
10:46:42 *** Fallo del sensor ***
-82.13 1-08 287.93 2-01 370.06 87.51 72.88 200.42 169.64 23:32
10:46:54 *** Fallo del sensor ***
-90.76 1-08 340.29 2-01 431.05 91.21 82.61 249.08 181.97 23:44
10:47:00 -65.28 1-08 356.17 2-01 421.45 94.05 79.53 262.12 159.33 23:50
10:47:06 *** Fallo del sensor ***
-13.46 1-08 375.88 2-01 389.34 99.98 80.65 275.90 113.44 23:56
10:47:14 *** Fallo del sensor ***
45.06 1-08 395.71 2-01 350.65 106.00 80.93 289.71 60.94 24:04
10:47:18 *** Fallo del sensor ***
39.43 1-08 90.63 1-03 51.20 85.19 13.22 5.44 45.76 24:08
10:47:22 *** Fallo del sensor ***
45.34 1-08 90.48 1-12 45.14 85.74 11.67 4.74 40.40 24:12
10:47:26 *** Fallo del sensor ***
57.72 1-08 90.52 1-12 32.80 86.77 8.41 3.75 29.05 24:16

Realizado por: ____________________________________ Fecha: ______________

Revisado por: ____________________________________ Fecha: _______________ Página 26 de 32


Impreso el 31-Jul-2023 a las 12:38:58

Grupo 1 - autoclave - Cálculos Estadísticos


Id. del equipo - EQ-AUT-INY-01 SOP/Número de protocolo - MEV-EQU-AUT-01-029/00/23
Descripción de la carga - BIOBASE 3
Comentario - BIOBASE 3
31-Jul-2023
Mín Mín Máx Máx Exp Ciclo
Valor Ubicación Valor Ubicación Máx - Mín Media Desv. típica Máx - Med Med - Mín Hora Hora
10:47:40 *** Fallo del sensor ***
54.53 1-08 91.44 1-12 36.91 87.19 9.44 4.25 32.66 24:30
10:47:56 *** Fallo del sensor ***
76.86 1-08 93.14 1-12 16.28 89.79 3.84 3.35 12.93 24:46
10:48:00 82.14 1-08 93.14 1-12 11.00 90.29 2.40 2.85 8.15 24:50
10:48:46 *** Fallo del sensor ***
92.21 1-01 94.65 1-12 2.44 93.30 0.66 1.35 1.09 25:36
10:49:00 92.83 1-01 116.57 1-08 23.74 95.41 5.89 21.16 2.58 25:50
10:49:04 *** Fallo del sensor ***
93.08 1-01 117.30 1-08 24.22 95.73 6.24 21.57 2.65 25:54
10:49:08 *** Fallo del sensor ***
93.29 1-01 124.81 1-08 31.52 96.45 8.19 28.36 3.16 25:58
10:49:12 *** Fallo del sensor ***
93.45 1-01 120.61 1-08 27.16 96.32 7.02 24.29 2.87 26:02
10:49:32 *** Fallo del sensor ***
94.46 1-11 123.81 1-08 29.35 97.35 7.64 26.46 2.89 26:22
10:49:52 *** Fallo del sensor ***
95.36 1-11 137.69 1-08 42.33 99.18 11.10 38.51 3.82 26:42
10:49:58 *** Fallo del sensor ***
95.63 1-11 148.76 1-08 53.13 100.23 13.98 48.53 4.60 26:48
10:50:00 95.71 1-11 155.33 1-08 59.62 100.74 15.72 54.59 5.03 26:50
10:50:16 *** Fallo del sensor ***
96.39 1-11 152.96 1-08 56.57 101.26 14.89 51.70 4.87 27:06
10:50:32 *** Fallo del sensor ***
97.09 1-11 148.62 1-08 51.53 101.58 13.55 47.04 4.49 27:22
10:50:58 *** Fallo del sensor ***
98.19 1-11 141.91 1-08 43.72 102.07 11.48 39.84 3.88 27:48
10:51:00 98.27 1-11 401.13 1-05 302.86 122.10 78.00 279.03 23.83 27:50
10:51:32 *** Fallo del sensor ***
99.66 1-11 150.28 1-08 50.62 103.97 13.34 46.31 4.31 28:22
10:52:00 *** Fallo del sensor ***
100.90 1-11 147.28 1-08 46.38 104.89 12.21 42.39 3.99 28:50
10:53:00 102.89 1-08 104.96 1-12 2.07 104.00 0.50 0.96 1.11 29:50
10:54:00 105.83 1-11 107.09 1-12 1.26 106.46 0.33 0.63 0.63 30:50
10:55:00 108.03 1-05 122.64 1-08 14.61 109.57 3.63 13.07 1.54 31:50

Realizado por: ____________________________________ Fecha: ______________

Revisado por: ____________________________________ Fecha: _______________ Página 27 de 32


Impreso el 31-Jul-2023 a las 12:38:58

Grupo 1 - autoclave - Cálculos Estadísticos


Id. del equipo - EQ-AUT-INY-01 SOP/Número de protocolo - MEV-EQU-AUT-01-029/00/23
Descripción de la carga - BIOBASE 3
Comentario - BIOBASE 3
31-Jul-2023
Mín Mín Máx Máx Exp Ciclo
Valor Ubicación Valor Ubicación Máx - Mín Media Desv. típica Máx - Med Med - Mín Hora Hora
10:55:02 *** Fallo del sensor ***
108.23 1-11 125.25 1-08 17.02 109.94 4.42 15.31 1.71 31:52
10:55:36 *** Fallo del sensor ***
109.47 1-11 125.36 1-08 15.89 111.05 4.13 14.31 1.58 32:26
10:55:50 *** Fallo del sensor ***
109.98 1-11 112.93 1-08 2.95 110.63 0.71 2.30 0.65 32:40
10:55:56 *** Fallo del sensor ***
110.20 1-11 111.48 1-08 1.28 110.73 0.34 0.75 0.53 32:46
10:56:00 108.57 1-08 111.29 1-12 2.72 110.64 0.63 0.65 2.07 32:50
10:56:12 *** Fallo del sensor ***
110.81 1-01 112.62 1-08 1.81 111.33 0.44 1.29 0.52 33:02
10:56:20 *** Fallo del sensor ***
111.08 1-01 111.92 1-12 0.84 111.53 0.26 0.39 0.45 33:10
10:56:40 *** Fallo del sensor ***
111.70 1-11 116.18 1-08 4.48 112.46 1.10 3.72 0.76 33:30
10:57:00 105.19 1-08 113.16 1-12 7.97 112.26 1.97 0.90 7.07 33:50
10:58:00 82.72 1-08 114.81 1-12 32.09 112.42 8.22 2.39 29.70 34:50
10:58:26 *** Fallo del sensor ***
60.93 1-08 115.50 1-12 54.57 111.38 14.52 4.12 50.45 35:16
10:58:48 *** Fallo del sensor ***
64.24 1-08 116.12 1-12 51.88 112.19 13.80 3.93 47.95 35:38
10:59:00 50.00 1-08 116.46 1-12 66.46 111.49 17.70 4.97 61.49 35:50
10:59:28 *** Fallo del sensor ***
58.24 1-08 117.19 1-12 58.95 112.80 15.71 4.39 54.56 36:18
10:59:36 *** Fallo del sensor ***
58.94 1-08 117.45 1-12 58.51 113.09 15.59 4.36 54.15 36:26
10:59:50 *** Fallo del sensor ***
49.10 1-08 117.87 2-04 68.77 112.78 18.33 5.09 63.68 36:40
11:00:00 55.80 1-08 118.17 2-04 62.37 113.83 16.05 4.34 58.03 36:50
11:00:04 *** Fallo del sensor ***
58.94 1-08 118.29 2-04 59.35 113.86 15.81 4.43 54.92 36:54
11:00:38 *** Fallo del sensor ***
32.50 1-08 119.30 2-04 86.80 112.48 23.08 6.82 79.98 37:28
11:00:52 *** Fallo del sensor ***
10.43 1-08 119.70 2-04 109.27 111.29 29.07 8.41 100.86 37:42

Realizado por: ____________________________________ Fecha: ______________

Revisado por: ____________________________________ Fecha: _______________ Página 28 de 32


Impreso el 31-Jul-2023 a las 12:38:58

Grupo 1 - autoclave - Cálculos Estadísticos


Id. del equipo - EQ-AUT-INY-01 SOP/Número de protocolo - MEV-EQU-AUT-01-029/00/23
Descripción de la carga - BIOBASE 3
Comentario - BIOBASE 3
31-Jul-2023
Mín Mín Máx Máx Exp Ciclo
Valor Ubicación Valor Ubicación Máx - Mín Media Desv. típica Máx - Med Med - Mín Hora Hora
11:01:00 35.50 1-08 119.94 2-04 84.44 113.75 21.70 6.19 78.25 37:50
11:01:08 *** Fallo del sensor ***
33.04 1-08 120.17 2-04 87.13 113.37 23.16 6.80 80.33 37:58
11:01:12 *** Fallo del sensor ***
26.43 1-08 120.27 2-04 93.84 113.01 24.96 7.26 86.58 38:02
11:01:24 *** Fallo del sensor ***
20.02 1-08 120.59 2-04 100.57 112.86 26.76 7.73 92.84 38:14
11:02:00 12.17 1-08 121.59 2-04 109.42 113.84 28.15 7.75 101.67 38:50
11:02:04 *** Fallo del sensor ***
15.73 1-08 121.70 2-04 105.97 113.65 28.21 8.05 97.92 38:54
11:02:08 *** Fallo del sensor ***
19.19 1-08 121.81 2-04 102.62 114.01 27.31 7.80 94.82 38:58
11:02:24 *** Fallo del sensor ***
-3.43 1-08 122.09 1-07 125.52 112.68 33.44 9.41 116.11 39:14
11:03:00 -3.04 1-08 122.00 2-04 125.04 112.71 33.32 9.29 115.75 39:50
11:03:16 *** Iniciar Exposición *** Manual RODOLFO ARELLANO
-23.53 1-08 121.89 1-09 145.42 111.89 37.47 10.00 135.42 00:00 40:06
11:03:36 *** Fallo del sensor ***
119.77 2-02 121.88 1-09 2.11 121.56 0.54 0.32 1.79 00:20 40:26
11:04:00 -133.38 1-08 121.91 2-04 255.29 104.61 65.84 17.30 237.99 00:44 40:50
11:04:28 *** Fallo del sensor ***
-22.84 1-08 121.93 1-09 144.77 111.34 38.62 10.59 134.18 01:12 41:18
11:05:00 -49.43 1-08 121.80 1-09 171.23 109.30 45.69 12.50 158.73 01:44 41:50
11:06:00 -13.62 1-08 121.83 1-09 135.45 111.93 36.14 9.90 125.55 02:44 42:50
11:07:00 3.47 1-08 121.82 1-09 118.35 113.12 31.56 8.70 109.65 03:44 43:50
11:08:00 -30.60 1-08 121.85 1-09 152.45 110.75 40.68 11.10 141.35 04:44 44:50
11:09:00 -6.37 1-08 121.88 1-09 128.25 112.51 34.22 9.37 118.88 05:44 45:50
11:10:00 -8.65 1-08 121.88 1-09 130.53 112.35 34.83 9.53 121.00 06:44 46:50
11:11:00 14.51 1-08 121.88 1-09 107.37 114.01 28.64 7.87 99.50 07:44 47:50
11:12:00 13.05 1-08 121.82 1-09 108.77 113.82 29.00 8.00 100.77 08:44 48:50
11:12:14 *** Fallo del sensor ***
-3.85 1-08 121.85 1-09 125.70 112.62 33.52 9.23 116.47 08:58 49:04
11:13:00 15.73 1-08 121.85 1-09 106.12 114.08 28.31 7.77 98.35 09:44 49:50
11:13:58 *** Fallo del sensor ***
36.77 1-08 121.82 1-09 85.05 115.55 22.68 6.27 78.78 10:42 50:48

Realizado por: ____________________________________ Fecha: ______________

Revisado por: ____________________________________ Fecha: _______________ Página 29 de 32


Impreso el 31-Jul-2023 a las 12:38:58

Grupo 1 - autoclave - Cálculos Estadísticos


Id. del equipo - EQ-AUT-INY-01 SOP/Número de protocolo - MEV-EQU-AUT-01-029/00/23
Descripción de la carga - BIOBASE 3
Comentario - BIOBASE 3
31-Jul-2023
Mín Mín Máx Máx Exp Ciclo
Valor Ubicación Valor Ubicación Máx - Mín Media Desv. típica Máx - Med Med - Mín Hora Hora
11:14:00 34.02 1-08 121.82 1-09 87.80 115.36 23.41 6.46 81.34 10:44 50:50
11:15:00 13.14 1-08 121.82 1-09 108.68 113.87 28.99 7.95 100.73 11:44 51:50
11:16:00 10.17 1-08 121.88 1-09 111.71 113.71 29.80 8.17 103.54 12:44 52:50
11:16:58 *** Fallo del sensor ***
72.86 1-08 121.81 1-09 48.95 118.12 13.03 3.69 45.26 13:42 53:48
11:17:00 68.21 1-08 121.80 1-09 53.59 117.78 14.27 4.02 49.57 13:44 53:50
11:18:00 83.54 1-08 121.88 1-09 38.34 118.95 10.19 2.93 35.41 14:44 54:50
11:19:00 52.79 1-08 121.80 2-04 69.01 116.68 18.39 5.12 63.89 15:44 55:50
11:20:00 81.90 1-08 121.89 1-09 39.99 118.84 10.63 3.05 36.94 16:44 56:50
11:21:00 110.79 1-08 121.87 1-09 11.08 120.83 2.90 1.04 10.04 17:44 57:50
11:22:00 102.62 1-08 121.78 1-09 19.16 120.20 5.06 1.58 17.58 18:44 58:50
11:23:00 84.14 1-08 121.84 1-09 37.70 118.95 10.02 2.89 34.81 19:44 59:50
11:24:00 53.23 1-08 121.76 1-09 68.53 116.68 18.26 5.08 63.45 20:44 1:00:50
11:25:00 99.79 1-08 121.87 1-09 22.08 120.12 5.85 1.75 20.33 21:44 1:01:50
11:26:00 116.94 1-08 121.85 1-09 4.91 121.28 1.27 0.57 4.34 22:44 1:02:50
11:27:00 121.42 1-01 139.09 1-08 17.67 122.94 4.65 16.15 1.52 23:44 1:03:50
11:27:44 *** Finalizar Exposición *** Manual RODOLFO ARELLANO
120.66 1-11 136.88 1-08 16.22 122.07 4.26 14.81 1.41 24:28 1:04:34
11:28:00 118.67 1-11 126.89 1-08 8.22 119.51 2.13 7.38 0.84 1:04:50
11:29:00 93.56 1-08 114.14 1-07 20.58 112.50 5.45 1.64 18.94 1:05:50
11:30:00 109.67 1-11 111.91 1-08 2.24 110.04 0.55 1.87 0.37 1:06:50
11:31:00 70.86 1-08 106.75 1-07 35.89 104.03 9.55 2.72 33.17 1:07:50
11:32:00 103.53 1-01 118.01 1-08 14.48 104.75 3.82 13.26 1.22 1:08:50
11:33:00 58.94 1-08 101.45 1-07 42.51 98.25 11.31 3.20 39.31 1:09:50
11:34:00 98.94 1-01 102.62 1-08 3.68 99.39 0.94 3.23 0.45 1:10:50
11:35:00 97.08 1-01 99.34 1-08 2.26 97.46 0.55 1.88 0.38 1:11:50
11:36:00 76.13 1-08 96.03 1-07 19.90 94.44 5.27 1.59 18.31 1:12:50
11:37:00 92.58 2-02 117.49 1-08 24.91 96.04 5.96 21.45 3.46 1:13:50
11:38:00 84.61 1-08 93.96 1-07 9.35 93.00 2.43 0.96 8.39 1:14:50
11:39:00 39.93 1-08 93.36 1-07 53.43 89.43 13.72 3.93 49.50 1:15:50
11:40:00 13.81 1-08 93.05 1-07 79.24 87.59 20.41 5.46 73.78 1:16:50
11:41:00 -76.86 1-08 92.84 1-07 169.70 81.23 43.74 11.61 158.09 1:17:50
11:42:00 44.30 1-08 92.81 2-04 48.51 89.27 12.46 3.54 44.97 1:18:50
11:42:14 *** Fallo del sensor ***
53.36 1-08 92.80 2-04 39.44 89.66 10.47 3.14 36.30 1:19:04

Realizado por: ____________________________________ Fecha: ______________

Revisado por: ____________________________________ Fecha: _______________ Página 30 de 32


Impreso el 31-Jul-2023 a las 12:38:58

Grupo 1 - autoclave - Cálculos Estadísticos


Id. del equipo - EQ-AUT-INY-01 SOP/Número de protocolo - MEV-EQU-AUT-01-029/00/23
Descripción de la carga - BIOBASE 3
Comentario - BIOBASE 3
31-Jul-2023
Mín Mín Máx Máx Exp Ciclo
Valor Ubicación Valor Ubicación Máx - Mín Media Desv. típica Máx - Med Med - Mín Hora Hora
11:43:00 18.10 1-08 92.74 2-04 74.64 87.07 19.86 5.67 68.97 1:19:50
11:44:00 80.84 1-08 92.66 2-04 11.82 91.53 3.01 1.13 10.69 1:20:50
11:44:20 *** Fallo del sensor ***
65.20 1-08 92.61 2-04 27.41 90.29 7.25 2.32 25.09 1:21:10
11:45:00 54.34 1-08 92.52 2-04 38.18 89.44 10.12 3.08 35.10 1:21:50
11:46:00 74.87 1-08 92.35 2-04 17.48 90.75 4.60 1.60 15.88 1:22:50
11:47:00 89.83 2-02 109.18 1-08 19.35 92.96 4.52 16.22 3.13 1:23:50
11:48:00 89.78 2-02 188.11 1-08 98.33 98.06 24.92 90.05 8.28 1:24:50
11:49:00 89.56 2-02 215.38 1-08 125.82 99.70 32.01 115.68 10.14 1:25:50
11:49:44 *** Fallo del sensor ***
89.41 2-02 241.27 1-08 151.86 101.99 40.09 139.28 12.58 1:26:34
11:50:00 89.37 2-02 218.64 1-08 129.27 99.73 32.90 118.91 10.36 1:26:50
11:51:00 89.10 2-02 234.22 1-08 145.12 100.55 36.98 133.67 11.45 1:27:50
11:51:46 *** Fallo del sensor ***
88.71 2-02 263.17 1-08 174.46 103.11 46.07 160.06 14.40 1:28:36
11:52:00 88.59 2-02 254.84 1-08 166.25 102.46 43.86 152.38 13.87 1:28:50
11:52:50 *** Fallo del sensor ***
86.85 2-02 260.89 1-08 174.04 102.58 45.58 158.31 15.73 1:29:40
11:53:00 86.97 2-02 243.58 1-08 156.61 101.32 40.96 142.26 14.35 1:29:50
11:54:00 87.32 2-02 249.45 1-08 162.13 101.53 42.58 147.92 14.21 1:30:50
11:55:00 87.02 2-02 241.41 1-08 154.39 100.71 40.50 140.70 13.69 1:31:50
11:56:00 86.52 2-02 232.71 1-08 146.19 99.83 38.26 132.88 13.31 1:32:50
11:57:00 63.01 1-05 247.44 1-08 184.43 98.10 41.88 149.34 35.09 1:33:50
11:57:18 *** Fallo del sensor ***
85.74 2-02 250.07 1-08 164.33 100.73 43.00 149.34 14.99 1:34:08
11:58:00 85.40 2-02 218.52 1-08 133.12 98.30 34.62 120.22 12.90 1:34:50
11:59:00 -80.47 1-05 218.60 1-08 299.07 86.15 56.95 132.45 166.62 1:35:50
11:59:10 *** Fallo del sensor ***
84.81 2-02 222.58 1-08 137.77 98.29 35.79 124.29 13.48 1:36:00
12:00:00 84.02 2-02 199.04 1-08 115.02 96.37 29.58 102.67 12.35 1:36:50
12:01:00 83.32 2-02 199.95 1-08 116.63 96.16 29.91 103.79 12.84 1:37:50
12:02:00 82.99 2-02 191.84 1-08 108.85 95.34 27.81 96.50 12.35 1:38:50
12:02:48 *** Finalizar Cualificación *** Manual RODOLFO ARELLANO
82.35 2-02 200.57 1-08 118.22 95.75 30.21 104.82 13.40 1:39:38

Realizado por: ____________________________________ Fecha: ______________

Revisado por: ____________________________________ Fecha: _______________ Página 31 de 32


Impreso el 31-Jul-2023 a las 12:38:58

Mensajes del Sistema

Eventos durante la cualificación


31-Jul-2023 10:23:10 *** Iniciar cualificación *** Manual RODOLFO ARELLANO
31-Jul-2023 11:03:16 *** Iniciar Exposición *** Manual RODOLFO ARELLANO
31-Jul-2023 11:27:44 *** Finalizar Exposición *** Manual RODOLFO ARELLANO
31-Jul-2023 12:02:48 *** Finalizar Cualificación *** Manual RODOLFO ARELLANO

Realizado por: ____________________________________ Fecha: ______________

Revisado por: ____________________________________ Fecha: _______________ Página 32 de 32

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