Sample Autoclave Validation Report 1-04-2013

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


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


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


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


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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


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Attachment 5Autoclave F0 Value


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


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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



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Attachment 6


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



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


Sample 1-4-2013.pdfMappingTemperature GraphPressure GraphF GraphTemp Data

2013-02-06T11:12:03-0600Tom Holm

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Sample Autoclave Validation Report 1-04-2013