Sample Autoclave Validation Report 1-04-2013

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  • Autoclave Validation Report

    Copyright BME Labstore Page 1 of 2

    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 service@bmelabstore.com 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

    Copyright BME Labstore Page 2 of 2

    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

    Copyright BME Labstore Page 1 of 1

    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

  • BME Labstore

    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

    Copyright BME Labstore

  • BME Labstore

    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

  • BME Labstore

    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

  • BME Labstore

    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,