Autoclave Validation Report

Digitally signed
by Tom Holm
Date:
2013.02.06
11:12:03 -06'00'

Instruments used in this validation have been certified by or have been referred to instruments certified
by the National Institute of Standards and Technology (NIST).

Equipment
Owner:
Sample Lab
Address: 1877 125th Street
Yourtown, MN 55099
Tel:
(651) 555-1234
Eq. Type: Autoclave
Mfg:
Market Forge
Model:
STM-E
Serial#: 1097186
Location: Laboratory at above address
Val. Date: 1/04/2013

Validation Performed By
Tom Holm
BME Lab and Science
79 County Road B E
Little Canada, MN 55117
(651) 646-5339
[email protected]

Next Val. Date: 1/2014

Purpose.
The purpose of this validation test is to perform an annual maintenance test of the
autoclaves temperature and pressure as required by MN Rules Chapter 4740.2110 subp.
11 and the National Environmental Laboratory Accreditation Conference (NELAC now
referred to as TNI).

Test Equipment.
The test equipment consisted of 6 MPIII DataTrace NIST certified and traceable
collectors manufactured by Mesa Labs, Inc. Technical specifications for the collectors
used in this validation are included in Attachment 1.
Procedure.
To perform the stated tests, 6 data logger collectors were placed in the autoclave as
illustrated in the Attachment 2, Collector Mapping Diagram. Of the 6 probes, 2
measured pressure and temperature, while 4 measured temperature only. The autoclave
was then programmed for a 60 minute cycle time at 250 0F (122 0C). The collectors
were programmed to record readings every 60 seconds throughout the cycle, which
began at approximately 12:15 PM and ended at approximately 1:20 PM. The probes
were also used to verify the autoclave timer. All of the recorded readings from the
collectors were then downloaded to a computer and the results tabulated and graphed.

Copyright BME Labstore

Page 1 of 2

Autoclave Validation Report

Test Findings Summary.

The test indicated that the autoclave is performing very well and within
specifications. Specifically, the autoclave reached and held a temperature of 249 0F
and a pressure of 28.9 PSIA. Our test on the timer also indicated that the timer is
working properly. Additionally, the safety valve was inspected and tested.
More specifically, the attached data and graph indicate that the autoclave reached target
temperature quickly (approximately 8 minutes) and maintained the temperature and
pressure throughout the 60 minute cycle. The data from all of the probes was very
consistent and indicate that there are no hot or cool spots in the chamber. The
fluctuations shown on the pressure chart are caused by the initial venting process.

Recommendations.
Perform regular cleaning and annual testing. This test follows closely to the results of
the test from one year ago.
Data.
Attachments and Data from this validation include the following:
Attachment 1:
Attachment 2:
Attachment 3:
Attachment 4:
Attachment 5:
Attachment 6:

Collector Technical Specifications

Collector Mapping Diagram
Temperature Graph
Pressure Graph
F0 Graph
Data

Copyright BME Labstore

Page 2 of 2

Collector Technical Specifications

Attachment 2

Collector Type
Serial #
Mesa Labs DataTrace Micropack III Pressure
Data Logger
M3P15108,
M3P15120,
M3P15157
Temperature
Range
Temperature
Accuracy
Pressure
Range
Pressure
Accuracy
Mesa Labs DataTrace Micropack III
Temperature Data Logger
M3T22042,
M3T22621,
M3T22629
Temperature
Range

+10C (+50F) to +140C (+284F)

0.25C ( 0.45F)
0 PSIA (0 BAR) to 150 PSIA (10BAR)
0.3 PSIA ( 0.02 BAR)

MPIII Temp -20C (-4F) to +140C (+284F)

MPIII HiTemp * +100C (+212F) to +360C
(+680F) with Thermal Pack

Temperature
Accuracy

MPIII HiTemp EXT * -20C (-4F) to +400C

(+752F) with Thermal Pack
MPIII Temp 0.1C (+/- 0.2F)
MPIII HiTemp 0.5C (+/- 0.9F)
MPIII HiTemp EXT 0.25C (+/- 0.45F) at
< 200C / 0.50C (+/- 0.90F) at > 200C

Copyright BME Labstore

Page 1 of 1

BME Labstore

Attachment 2
Sample Customer
Manufacturer: Market Forge
Model: STM-E
Serial #: 1097186

Collector Mapping Diagram

T1

T2

Validation Date: Jan. 04, 2013

Top Shelf
Bottom Shelf
Legend

TP1

TP3

T1
T2

M3T12154
M3T21982

T4
T5
TP3
TP1

M3T21990
M3T21991
M3P15157
M3P15108

T5

T4

Door

Copyright BME Labstore

BME Labstore
Sample Customer
Manufacturer: Market Forge
Model: STM-E
Serial #: 1097186

Attachment 3
Autoclave Temperature Validation Test
Validation Date: Jan. 04, 2013

300.0

Hold Time
250.0

Come-up
Cool Down/
Exhaust

Collector

Temperature (0F)

200.0
M3T21991
M3T21990
M3T12154
M3T21982
M3P15108
M3P15157

150.0

Hold Time Temperatures

100.0
Minimum: 243.8 0F
Median:
249.0 0F
Maximum: 249.9 0F
Std. Dev.: 0.9

50.0

0.0
0:00

0:10

0:20

0:30

0:40

0:50

1:00

1:10

1:20

1:30

Validation Time

Copyright BME Labstore

Report Date: 02/06/13

BME Labstore
Sample Customer
Manufacturer: Market Forge
Model: STM-E
Serial #: 1097186

Attachment 4
Autoclave Pressure Validation Test
Validationt Date: Jan. 04, 2013

35.0
Hold Time
30.0
Cool
Down/

Come-up

Pressure (PSIA)

25.0
Collector
20.0
M3P15108
M3P15157
15.0
Hold Time Pressures
10.0

Minimum:
Median:
Maximum:
Std. Dev.:

5.0

0.0
0:00

0:10

0:20

0:30

26.2 PSIA
28.9 PSIA
30.3 PSIA
0.80

0:40

0:50

1:00

1:10

1:20

1:30

Validation Time

Copyright BME Labstore

Report Date: 02/06/13

BME Labstore
Sample Customer
Manufacturer: Market Forge
Model: STM-E
Serial #: 1097186

Attachment 5
Autoclave F0 Value
Validation Date: Jan. 04, 2013
50.0
45.0

Cool Down
Hold Time F0 Values

40.0

Collector

Minimum: 1.0
Median:
24.5
Maximum: 46.8

35.0

M3T21991
M3T21990
M3T12154
M3T21982
M3P15108
M3P15157

F0 Value

30.0
Hold Time
25.0
20.0
15.0
F0 = 8 @ 2 min prior to Hold Time due to first
aborted start

10.0
5.0
Come-up
0.0
0:00

0:10

0:20

0:30

0:40

0:50

1:00

1:10

1:20

1:30

Validation Time

Copyright BME Labstore

Report Date: 02/06/13

BME Labstore
Attachment 6
Validation Data Jan. 04, 2013

Sample Customer
Manufacturer: Market Forge
Model: STM-E
Serial #: 1097186

Legend
Start
Hold Time - Start/Stop
F0 =8
M3T21991
Sample Time
Reading#
1/0/00 0:00
1
1/0/00 0:01
2
1/0/00 0:02
3
1/0/00 0:03
4
1/0/00 0:04
5
1/0/00 0:05
6
1/0/00 0:06
7
1/0/00 0:07
8
1/0/00 0:08
9
1/0/00 0:09
10
1/0/00 0:10
11
1/0/00 0:11
12
1/0/00 0:12
13
1/0/00 0:13
14
1/0/00 0:14
15
1/0/00 0:15
16
1/0/00 0:16
17
1/0/00 0:17
18
1/0/00 0:18
19
1/0/00 0:19
20
1/0/00 0:20
21
1/0/00 0:21
22
1/0/00 0:22
23
1/0/00 0:23
24
1/0/00 0:24
25
1/0/00 0:25
26
1/0/00 0:26
27
1/0/00 0:27
28
1/0/00 0:28
29
1/0/00 0:29
30
1/0/00 0:30
31
1/0/00 0:31
32
1/0/00 0:32
33

Copyright BME Labstore

Temp F
67.9
66.5
66.3
66.6
71.3
91.3
146.5
187.6
209.5
234.0
240.2
243.7
245.4
246.5
247.5
248.2
248.8
249.3
249.7
249.9
249.7
249.6
249.4
249.2
249.1
249.0
249.0
249.4
249.9
249.9
249.6
249.3
249.0

M3T21990

Fo
Temp F
0.0
64.9
0.0
64.0
0.0
64.4
0.0
65.1
0.0
70.8
0.0
97.5
0.0
136.7
0.0
177.4
0.0
207.4
0.1
233.6
0.4
239.9
0.9
243.3
1.4
245.0
2.1
246.1
2.8
247.3
3.6
248.0
4.4
248.7
5.3
249.2
6.3
249.6
7.3
249.7
8.3
249.6
9.2
249.4
10.1
249.2
11.0
249.0
11.9
248.9
12.8
248.8
13.7
249.0
14.6
249.4
15.6
249.7
16.6
249.7
17.5
249.4
18.5
249.1
19.3
248.9

M3T12154

Fo
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.1
0.4
0.8
1.3
2.0
2.7
3.4
4.3
5.2
6.1
7.1
8.1
9.0
9.9
10.8
11.6
12.5
13.4
14.3
15.3
16.2
17.1
18.0
18.9

Temp F
66.0
65.4
65.6
66.3
74.5
101.3
153.2
187.7
212.8
235.6
240.4
243.9
245.7
246.6
247.5
248.1
248.7
249.2
249.7
249.8
249.7
249.5
249.4
249.2
249.0
248.9
249.0
249.4
249.8
249.9
249.6
249.3
249.0

M3T21982

Fo
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.2
0.5
0.9
1.5
2.1
2.9
3.7
4.5
5.4
6.4
7.3
8.3
9.2
10.2
11.1
11.9
12.8
13.7
14.6
15.6
16.6
17.5
18.5
19.3

Temp F
65.4
64.9
65.1
65.9
71.6
95.4
146.7
184.8
209.9
233.9
240.2
243.8
245.4
246.5
247.4
248.1
248.8
249.3
249.7
249.8
249.7
249.5
249.3
249.2
249.0
249.0
249.1
249.5
249.8
249.8
249.5
249.2
249.0

Page 5 of 7

M3P15108

Fo
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.1
0.4
0.9
1.4
2.1
2.8
3.6
4.4
5.3
6.3
7.3
8.2
9.2
10.1
11.0
11.9
12.7
13.6
14.6
15.6
16.5
17.5
18.4
19.2

Temp F
62.0
62.4
62.8
63.1
63.7
66.7
80.4
143.9
187.7
218.6
235.9
241.3
243.9
245.8
247.5
248.5
249.0
249.2
249.3
249.3
249.3
249.3
249.3
249.3
249.4
249.5
249.6
249.6
249.5
249.3
249.2
249.1
249.1

Fo
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.2
0.5
1.0
1.6
2.3
3.1
4.0
4.9
5.8
6.7
7.6
8.5
9.5
10.4
11.3
12.2
13.2
14.1
15.1
16.0
16.9
17.8
18.7

M3P15157
PSIA
15.3
15.2
15.2
15.2
15.2
15.2
15.6
17.8
23.5
30.6
30.5
30.5
30.2
30.0
29.9
29.8
29.8
30.1
30.3
30.3
30.2
30.1
29.9
29.8
29.7
29.6
29.7
29.9
30.2
30.4
30.0
29.9
29.7

Temp F
58.9
59.9
60.5
61.0
61.9
65.8
78.5
127.4
179.8
216.7
235.9
241.2
243.8
245.6
247.3
248.3
248.9
249.2
249.2
249.3
249.2
249.2
249.2
249.3
249.3
249.5
249.6
249.6
249.5
249.3
249.1
249.1
249.1

Fo
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.2
0.5
1.0
1.5
2.2
3.0
3.9
4.8
5.7
6.6
7.5
8.4
9.3
10.2
11.2
12.1
13.1
14.0
14.9
15.9
16.7
17.6
18.5

PSIA
15.3
15.2
15.2
15.2
15.2
15.2
15.4
17.8
23.5
30.6
30.3
30.5
30.2
30.0
29.9
29.8
30.0
30.1
30.3
30.3
30.2
30.1
29.9
29.8
29.7
29.6
29.7
29.9
30.2
30.2
30.0
29.9
29.7

BME Labstore
Attachment 6
Validation Data Jan. 04, 2013
1/0/00 0:33
1/0/00 0:34
1/0/00 0:35
1/0/00 0:36
1/0/00 0:37
1/0/00 0:38
1/0/00 0:39
1/0/00 0:40
1/0/00 0:41
1/0/00 0:42
1/0/00 0:43
1/0/00 0:44
1/0/00 0:45
1/0/00 0:46
1/0/00 0:47
1/0/00 0:48
1/0/00 0:49
1/0/00 0:50
1/0/00 0:51
1/0/00 0:52
1/0/00 0:53
1/0/00 0:54
1/0/00 0:55
1/0/00 0:56
1/0/00 0:57
1/0/00 0:58
1/0/00 0:59
1/0/00 1:00
1/0/00 1:01
1/0/00 1:02
1/0/00 1:03
1/0/00 1:04
1/0/00 1:05
1/0/00 1:06
1/0/00 1:07
1/0/00 1:08
1/0/00 1:09
1/0/00 1:10
1/0/00 1:11

Copyright BME Labstore

34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
71
72

248.8
248.7
248.9
249.3
249.6
249.8
249.5
249.3
249.0
248.8
248.6
248.5
248.5
248.7
249.1
249.4
249.5
249.5
249.4
249.3
249.0
248.8
248.7
248.5
248.4
248.3
248.3
248.2
248.2
248.2
248.2
245.2
211.1
210.9
182.2
108.8
112.3
91.8

20.2
21.0
21.9
22.8
23.8
24.7
25.7
26.6
27.5
28.3
29.2
30.0
30.8
31.7
32.6
33.5
34.4
35.4
36.3
37.2
38.1
38.9
39.8
40.6
41.4
42.2
43.0
43.8
44.6
45.4
46.2
46.8
46.8
46.8
46.8
46.8
46.8
46.8

248.7
248.6
248.8
249.2
249.5
249.6
249.3
249.1
248.8
248.6
248.4
248.4
248.4
248.7
249.0
249.3
249.4
249.4
249.2
249.0
248.9
248.7
248.5
248.3
248.2
248.2
248.1
248.1
248.1
248.1
248.1
245.2
211.1
210.8
199.7
94.3
98.3
92.7

19.7
20.6
21.4
22.3
23.3
24.2
25.1
26.0
26.9
27.7
28.5
29.4
30.2
31.0
31.9
32.8
33.7
34.7
35.6
36.5
37.3
38.2
39.0
39.8
40.6
41.4
42.2
43.0
43.7
44.5
45.3
45.9
45.9
45.9
45.9
45.9
45.9
45.9

248.8
248.7
248.9
249.3
249.6
249.7
249.5
249.2
249.0
248.7
248.5
248.5
248.5
248.7
249.1
249.3
249.5
249.5
249.4
249.2
249.0
248.8
248.6
248.5
248.4
248.3
248.2
248.2
248.1
248.1
248.2
245.2
211.1
210.9
199.4
120.5
123.7
104.5
108.6

Sample Customer
Manufacturer: Market Forge
Model: STM-E
Serial
20.2 #: 1097186
248.8
20.1
21.0
21.9
22.8
23.8
24.7
25.7
26.6
27.5
28.3
29.1
29.9
30.8
31.6
32.5
33.4
34.4
35.3
36.2
37.1
38.0
38.9
39.7
40.5
41.3
42.1
42.9
43.7
44.5
45.3
46.1
46.6
46.6
46.6
46.6
46.6
46.6
46.6
46.6

Page 6 of 7

248.8
249.0
249.4
249.6
249.7
249.4
249.2
248.9
248.7
248.6
248.5
248.6
248.8
249.2
249.4
249.5
249.5
249.3
249.1
248.9
248.7
248.6
248.5
248.4
248.3
248.2
248.2
248.2
248.2
248.3
245.4
211.4
211.0
204.1
113.0
121.7
103.8
100.9

21.0
21.8
22.8
23.7
24.7
25.6
26.5
27.4
28.2
29.1
29.9
30.7
31.6
32.5
33.4
34.3
35.3
36.2
37.1
38.0
38.8
39.6
40.5
41.3
42.1
42.9
43.7
44.5
45.3
46.1
46.6
46.6
46.6
46.6
46.6
46.6
46.6
46.6

249.2
249.3
249.4
249.4
249.3
249.1
249.0
248.9
248.8
248.9
249.0
249.1
249.2
249.2
249.2
249.1
249.0
248.9
248.8
248.7
248.6
248.6
248.6
248.6
248.6
248.7
248.7
248.8
248.8
248.8
248.9
247.1
224.2
217.2
215.2
205.4
192.1
181.3
172.1

19.6
20.5
21.4
22.3
23.3
24.2
25.0
25.9
26.8
27.6
28.5
29.4
30.3
31.2
32.1
33.0
33.9
34.7
35.6
36.5
37.3
38.1
39.0
39.8
40.6
41.5
42.3
43.2
44.0
44.9
45.8
46.5
46.5
46.5
46.5
46.5
46.5
46.5
46.5

29.6
29.5
29.6
29.8
30.0
30.1
30.0
29.8
29.7
29.5
29.4
29.4
29.6
29.5
29.7
29.9
29.7
30.0
30.0
29.9
29.7
29.6
29.5
29.4
29.4
29.3
29.3
29.2
29.2
29.2
29.2
27.5
13.7
14.1
14.2
13.9
14.3
14.5
14.5

249.2
249.3
249.4
249.4
249.3
249.1
249.0
248.9
248.8
248.9
248.9
249.1
249.2
249.2
249.2
249.1
249.0
248.9
248.8
248.7
248.6
248.6
248.6
248.6
248.6
248.7
248.7
248.8
248.8
248.8
248.9
247.1
225.3
218.3
215.5
201.2
184.7
173.1
164.4

19.4
20.3
21.3
22.2
23.1
24.0
24.9
25.8
26.6
27.5
28.3
29.2
30.1
31.0
31.9
32.8
33.7
34.6
35.4
36.3
37.1
38.0
38.8
39.6
40.5
41.3
42.2
43.0
43.9
44.7
45.6
46.3
46.3
46.4
46.4
46.4
46.4
46.4
46.4

29.6
29.5
29.6
29.8
30.0
30.1
30.0
29.8
29.7
29.5
29.4
29.4
29.4
29.5
29.7
29.9
30.0
30.0
30.0
29.9
29.7
29.6
29.5
29.4
29.4
29.3
29.3
29.2
29.2
29.2
29.2
27.5
13.7
14.1
14.2
13.9
14.3
14.5
14.5

BME Labstore
Attachment 6
Validation Data Jan. 04, 2013
Min
Max
Median
Std. Dev.

Min. All
Median All
Max. All
Std. Dev. A

Copyright BME Labstore

245.2
249.9
249.0
0.95
Temp.
243.8
249.0
249.9
0.9

1.4
46.8
24.7
13.78
F0
1.0
24.5
46.8

245.0
249.7
248.9
0.97

1.3
45.9
24.2
13.53

245.2
249.9
249.0
0.92

Sample Customer
Manufacturer: Market Forge
Model: STM-E
Serial #: 1097186
1.5
46.6
24.7
13.72

PSIA
27.5
29.8
30.4
0.4

Page 7 of 7

245.4
249.8
249.0
0.93

1.4
46.6
24.7
13.74

243.9
249.6
249.1
0.93

1.0
46.5
24.2
13.75

27.5
30.4
29.7
0.44

243.8
249.6
249.1
0.96

1.0
46.3
24.0
13.72

27.5
30.3
29.8
0.44