Autoclave Validation Report
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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 Validation Performed By Owner: Sample Lab Tom Holm Address: 1877 125th Street BME Lab and Science Yourtown, MN 55099 79 County Road B E Tel: (651) 555-1234 Little Canada, MN 55117 Eq. Type: Autoclave (651) 646-5339 Mfg: Market Forge [email protected] Model: STM-E Serial#: 1097186 Location: Laboratory at above address Val. Date: 1/04/2013 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.
Autoclave Validation Report
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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: Collector Technical Specifications Attachment 2: Collector Mapping Diagram Attachment 3: Temperature Graph Attachment 4: Pressure Graph Attachment 5: F0 Graph Attachment 6: Data
Collector Technical Specifications
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Attachment 2
Collector Type Serial #
Mesa Labs DataTrace Micropack III Pressure Data Logger
M3P15108, M3P15120, M3P15157
Temperature Range
+10C (+50F) to +140C (+284F)
Temperature Accuracy
0.25C ( 0.45F)
Pressure Range
0 PSIA (0 BAR) to 150 PSIA (10BAR)
Pressure Accuracy
0.3 PSIA ( 0.02 BAR)
Mesa Labs DataTrace Micropack III Temperature Data Logger
M3T22042, M3T22621, M3T22629
Temperature Range
MPIII Temp -20C (-4F) to +140C (+284F)
MPIII HiTemp * +100C (+212F) to +360C (+680F) with Thermal Pack
MPIII HiTemp EXT * -20C (-4F) to +400C (+752F) with Thermal Pack
Temperature Accuracy
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
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Collector Mapping Diagram
Validation Date: Jan. 04, 2013
Top Shelf
Bottom Shelf
T1 M3T12154T2 M3T21982
T4 M3T21990T5 M3T21991TP3 M3P15157TP1 M3P15108
Door
Attachment 2
Legend
T1
T4
T2
TP1
TP3
Sample CustomerManufacturer: Market ForgeModel: STM-ESerial #: 1097186
T5
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Report Date: 02/06/13Copyright BME Labstore
Attachment 3Autoclave Temperature Validation Test
Validation Date: Jan. 04, 2013
0.0
50.0
100.0
150.0
200.0
250.0
300.0
0:00 0:10 0:20 0:30 0:40 0:50 1:00 1:10 1:20 1:30
Validation Time
T
e
m
p
e
r
a
t
u
r
e
(
0
F
) M3T21991M3T21990M3T12154M3T21982M3P15108M3P15157
Collector
Hold Time Temperatures
Minimum: 243.8 0F Median: 249.0 0F Maximum: 249.9 0F
Std. Dev.: 0.9
Come-up
Hold Time
Cool Down/ Exhaust
Sample CustomerManufacturer: Market ForgeModel: STM-ESerial #: 1097186
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Report Date: 02/06/13Copyright BME Labstore
Attachment 4Autoclave Pressure Validation Test
Validationt Date: Jan. 04, 2013
0.0
5.0
10.0
15.0
20.0
25.0
30.0
35.0
0:00 0:10 0:20 0:30 0:40 0:50 1:00 1:10 1:20 1:30
Validation Time
P
r
e
s
s
u
r
e
(
P
S
I
A
)
M3P15108M3P15157
Collector
Come-up
Hold Time
Cool Down/
Hold Time Pressures
Minimum: 26.2 PSIA Median: 28.9 PSIA Maximum: 30.3 PSIA Std. Dev.: 0.80
Sample CustomerManufacturer: Market ForgeModel: STM-ESerial #: 1097186
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Report Date: 02/06/13Copyright BME Labstore
Attachment 5Autoclave F0 Value
Validation Date: Jan. 04, 2013
0.0
5.0
10.0
15.0
20.0
25.0
30.0
35.0
40.0
45.0
50.0
0:00 0:10 0:20 0:30 0:40 0:50 1:00 1:10 1:20 1:30
Validation Time
F
0
V
a
l
u
e
M3T21991M3T21990M3T12154M3T21982M3P15108M3P15157
Collector
F0 = 8 @ 2 min prior to Hold Time due to first aborted start
Hold Time F0 Values
Minimum: 1.0 Median: 24.5 Maximum: 46.8
Come-up
Hold Time
Cool Down
Sample CustomerManufacturer: Market ForgeModel: STM-ESerial #: 1097186
BME Labstore
Temp F Fo Temp F Fo Temp F Fo Temp F Fo Temp F Fo PSIA Temp F Fo PSIA1/0/00 0:00 1 67.9 0.0 64.9 0.0 66.0 0.0 65.4 0.0 62.0 0.0 15.3 58.9 0.0 15.31/0/00 0:01 2 66.5 0.0 64.0 0.0 65.4 0.0 64.9 0.0 62.4 0.0 15.2 59.9 0.0 15.21/0/00 0:02 3 66.3 0.0 64.4 0.0 65.6 0.0 65.1 0.0 62.8 0.0 15.2 60.5 0.0 15.21/0/00 0:03 4 66.6 0.0 65.1 0.0 66.3 0.0 65.9 0.0 63.1 0.0 15.2 61.0 0.0 15.21/0/00 0:04 5 71.3 0.0 70.8 0.0 74.5 0.0 71.6 0.0 63.7 0.0 15.2 61.9 0.0 15.21/0/00 0:05 6 91.3 0.0 97.5 0.0 101.3 0.0 95.4 0.0 66.7 0.0 15.2 65.8 0.0 15.21/0/00 0:06 7 146.5 0.0 136.7 0.0 153.2 0.0 146.7 0.0 80.4 0.0 15.6 78.5 0.0 15.41/0/00 0:07 8 187.6 0.0 177.4 0.0 187.7 0.0 184.8 0.0 143.9 0.0 17.8 127.4 0.0 17.81/0/00 0:08 9 209.5 0.0 207.4 0.0 212.8 0.0 209.9 0.0 187.7 0.0 23.5 179.8 0.0 23.51/0/00 0:09 10 234.0 0.1 233.6 0.1 235.6 0.2 233.9 0.1 218.6 0.0 30.6 216.7 0.0 30.61/0/00 0:10 11 240.2 0.4 239.9 0.4 240.4 0.5 240.2 0.4 235.9 0.2 30.5 235.9 0.2 30.31/0/00 0:11 12 243.7 0.9 243.3 0.8 243.9 0.9 243.8 0.9 241.3 0.5 30.5 241.2 0.5 30.51/0/00 0:12 13 245.4 1.4 245.0 1.3 245.7 1.5 245.4 1.4 243.9 1.0 30.2 243.8 1.0 30.21/0/00 0:13 14 246.5 2.1 246.1 2.0 246.6 2.1 246.5 2.1 245.8 1.6 30.0 245.6 1.5 30.01/0/00 0:14 15 247.5 2.8 247.3 2.7 247.5 2.9 247.4 2.8 247.5 2.3 29.9 247.3 2.2 29.91/0/00 0:15 16 248.2 3.6 248.0 3.4 248.1 3.7 248.1 3.6 248.5 3.1 29.8 248.3 3.0 29.81/0/00 0:16 17 248.8 4.4 248.7 4.3 248.7 4.5 248.8 4.4 249.0 4.0 29.8 248.9 3.9 30.01/0/00 0:17 18 249.3 5.3 249.2 5.2 249.2 5.4 249.3 5.3 249.2 4.9 30.1 249.2 4.8 30.11/0/00 0:18 19 249.7 6.3 249.6 6.1 249.7 6.4 249.7 6.3 249.3 5.8 30.3 249.2 5.7 30.31/0/00 0:19 20 249.9 7.3 249.7 7.1 249.8 7.3 249.8 7.3 249.3 6.7 30.3 249.3 6.6 30.31/0/00 0:20 21 249.7 8.3 249.6 8.1 249.7 8.3 249.7 8.2 249.3 7.6 30.2 249.2 7.5 30.21/0/00 0:21 22 249.6 9.2 249.4 9.0 249.5 9.2 249.5 9.2 249.3 8.5 30.1 249.2 8.4 30.11/0/00 0:22 23 249.4 10.1 249.2 9.9 249.4 10.2 249.3 10.1 249.3 9.5 29.9 249.2 9.3 29.91/0/00 0:23 24 249.2 11.0 249.0 10.8 249.2 11.1 249.2 11.0 249.3 10.4 29.8 249.3 10.2 29.81/0/00 0:24 25 249.1 11.9 248.9 11.6 249.0 11.9 249.0 11.9 249.4 11.3 29.7 249.3 11.2 29.71/0/00 0:25 26 249.0 12.8 248.8 12.5 248.9 12.8 249.0 12.7 249.5 12.2 29.6 249.5 12.1 29.61/0/00 0:26 27 249.0 13.7 249.0 13.4 249.0 13.7 249.1 13.6 249.6 13.2 29.7 249.6 13.1 29.71/0/00 0:27 28 249.4 14.6 249.4 14.3 249.4 14.6 249.5 14.6 249.6 14.1 29.9 249.6 14.0 29.91/0/00 0:28 29 249.9 15.6 249.7 15.3 249.8 15.6 249.8 15.6 249.5 15.1 30.2 249.5 14.9 30.21/0/00 0:29 30 249.9 16.6 249.7 16.2 249.9 16.6 249.8 16.5 249.3 16.0 30.4 249.3 15.9 30.21/0/00 0:30 31 249.6 17.5 249.4 17.1 249.6 17.5 249.5 17.5 249.2 16.9 30.0 249.1 16.7 30.01/0/00 0:31 32 249.3 18.5 249.1 18.0 249.3 18.5 249.2 18.4 249.1 17.8 29.9 249.1 17.6 29.91/0/00 0:32 33 249.0 19.3 248.9 18.9 249.0 19.3 249.0 19.2 249.1 18.7 29.7 249.1 18.5 29.7
M3T21982
F0 =8
Sample Time Reading#
Attachment 6
LegendStart
Validation Data Jan. 04, 2013
Hold Time - Start/Stop
M3P15108 M3P15157M3T21990M3T21991 M3T12154
Sample CustomerManufacturer: Market ForgeModel: STM-ESerial #: 1097186
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Attachment 6
Validation Data Jan. 04, 2013
Sample CustomerManufacturer: Market ForgeModel: STM-ESerial #: 10971861/0/00 0:33 34 248.8 20.2 248.7 19.7 248.8 20.2 248.8 20.1 249.2 19.6 29.6 249.2 19.4 29.6
1/0/00 0:34 35 248.7 21.0 248.6 20.6 248.7 21.0 248.8 21.0 249.3 20.5 29.5 249.3 20.3 29.51/0/00 0:35 36 248.9 21.9 248.8 21.4 248.9 21.9 249.0 21.8 249.4 21.4 29.6 249.4 21.3 29.61/0/00 0:36 37 249.3 22.8 249.2 22.3 249.3 22.8 249.4 22.8 249.4 22.3 29.8 249.4 22.2 29.81/0/00 0:37 38 249.6 23.8 249.5 23.3 249.6 23.8 249.6 23.7 249.3 23.3 30.0 249.3 23.1 30.01/0/00 0:38 39 249.8 24.7 249.6 24.2 249.7 24.7 249.7 24.7 249.1 24.2 30.1 249.1 24.0 30.11/0/00 0:39 40 249.5 25.7 249.3 25.1 249.5 25.7 249.4 25.6 249.0 25.0 30.0 249.0 24.9 30.01/0/00 0:40 41 249.3 26.6 249.1 26.0 249.2 26.6 249.2 26.5 248.9 25.9 29.8 248.9 25.8 29.81/0/00 0:41 42 249.0 27.5 248.8 26.9 249.0 27.5 248.9 27.4 248.8 26.8 29.7 248.8 26.6 29.71/0/00 0:42 43 248.8 28.3 248.6 27.7 248.7 28.3 248.7 28.2 248.9 27.6 29.5 248.9 27.5 29.51/0/00 0:43 44 248.6 29.2 248.4 28.5 248.5 29.1 248.6 29.1 249.0 28.5 29.4 248.9 28.3 29.41/0/00 0:44 45 248.5 30.0 248.4 29.4 248.5 29.9 248.5 29.9 249.1 29.4 29.4 249.1 29.2 29.41/0/00 0:45 46 248.5 30.8 248.4 30.2 248.5 30.8 248.6 30.7 249.2 30.3 29.6 249.2 30.1 29.41/0/00 0:46 47 248.7 31.7 248.7 31.0 248.7 31.6 248.8 31.6 249.2 31.2 29.5 249.2 31.0 29.51/0/00 0:47 48 249.1 32.6 249.0 31.9 249.1 32.5 249.2 32.5 249.2 32.1 29.7 249.2 31.9 29.71/0/00 0:48 49 249.4 33.5 249.3 32.8 249.3 33.4 249.4 33.4 249.1 33.0 29.9 249.1 32.8 29.91/0/00 0:49 50 249.5 34.4 249.4 33.7 249.5 34.4 249.5 34.3 249.0 33.9 29.7 249.0 33.7 30.01/0/00 0:50 51 249.5 35.4 249.4 34.7 249.5 35.3 249.5 35.3 248.9 34.7 30.0 248.9 34.6 30.01/0/00 0:51 52 249.4 36.3 249.2 35.6 249.4 36.2 249.3 36.2 248.8 35.6 30.0 248.8 35.4 30.01/0/00 0:52 53 249.3 37.2 249.0 36.5 249.2 37.1 249.1 37.1 248.7 36.5 29.9 248.7 36.3 29.91/0/00 0:53 54 249.0 38.1 248.9 37.3 249.0 38.0 248.9 38.0 248.6 37.3 29.7 248.6 37.1 29.71/0/00 0:54 55 248.8 38.9 248.7 38.2 248.8 38.9 248.7 38.8 248.6 38.1 29.6 248.6 38.0 29.61/0/00 0:55 56 248.7 39.8 248.5 39.0 248.6 39.7 248.6 39.6 248.6 39.0 29.5 248.6 38.8 29.51/0/00 0:56 57 248.5 40.6 248.3 39.8 248.5 40.5 248.5 40.5 248.6 39.8 29.4 248.6 39.6 29.41/0/00 0:57 58 248.4 41.4 248.2 40.6 248.4 41.3 248.4 41.3 248.6 40.6 29.4 248.6 40.5 29.41/0/00 0:58 59 248.3 42.2 248.2 41.4 248.3 42.1 248.3 42.1 248.7 41.5 29.3 248.7 41.3 29.31/0/00 0:59 60 248.3 43.0 248.1 42.2 248.2 42.9 248.2 42.9 248.7 42.3 29.3 248.7 42.2 29.31/0/00 1:00 61 248.2 43.8 248.1 43.0 248.2 43.7 248.2 43.7 248.8 43.2 29.2 248.8 43.0 29.21/0/00 1:01 62 248.2 44.6 248.1 43.7 248.1 44.5 248.2 44.5 248.8 44.0 29.2 248.8 43.9 29.21/0/00 1:02 63 248.2 45.4 248.1 44.5 248.1 45.3 248.2 45.3 248.8 44.9 29.2 248.8 44.7 29.21/0/00 1:03 64 248.2 46.2 248.1 45.3 248.2 46.1 248.3 46.1 248.9 45.8 29.2 248.9 45.6 29.21/0/00 1:04 65 245.2 46.8 245.2 45.9 245.2 46.6 245.4 46.6 247.1 46.5 27.5 247.1 46.3 27.51/0/00 1:05 66 211.1 46.8 211.1 45.9 211.1 46.6 211.4 46.6 224.2 46.5 13.7 225.3 46.3 13.71/0/00 1:06 67 210.9 46.8 210.8 45.9 210.9 46.6 211.0 46.6 217.2 46.5 14.1 218.3 46.4 14.11/0/00 1:07 68 182.2 46.8 199.7 45.9 199.4 46.6 204.1 46.6 215.2 46.5 14.2 215.5 46.4 14.21/0/00 1:08 69 108.8 46.8 94.3 45.9 120.5 46.6 113.0 46.6 205.4 46.5 13.9 201.2 46.4 13.91/0/00 1:09 70 112.3 46.8 98.3 45.9 123.7 46.6 121.7 46.6 192.1 46.5 14.3 184.7 46.4 14.31/0/00 1:10 71 91.8 46.8 92.7 45.9 104.5 46.6 103.8 46.6 181.3 46.5 14.5 173.1 46.4 14.51/0/00 1:11 72 108.6 46.6 100.9 46.6 172.1 46.5 14.5 164.4 46.4 14.5
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Attachment 6
Validation Data Jan. 04, 2013
Sample CustomerManufacturer: Market ForgeModel: STM-ESerial #: 1097186
Min 245.2 1.4 245.0 1.3 245.2 1.5 245.4 1.4 243.9 1.0 27.5 243.8 1.0 27.5Max 249.9 46.8 249.7 45.9 249.9 46.6 249.8 46.6 249.6 46.5 30.4 249.6 46.3 30.3Median 249.0 24.7 248.9 24.2 249.0 24.7 249.0 24.7 249.1 24.2 29.7 249.1 24.0 29.8Std. Dev. 0.95 13.78 0.97 13.53 0.92 13.72 0.93 13.74 0.93 13.75 0.44 0.96 13.72 0.44
Temp. F0 PSIAMin. All 243.8 1.0 27.5Median All 249.0 24.5 29.8Max. All 249.9 46.8 30.4Std. Dev. A 0.9 0.4
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Sample 1-4-2013.pdfMappingTemperature GraphPressure GraphF GraphTemp Data
2013-02-06T11:12:03-0600Tom Holm
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