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 th Address: 1877 125 Street Yourtown, MN 55099 Tel: (651) 555-1234 Eq. Type: Autoclave Mfg: Market Forge Model: STM-E Serial#: 1097186 Location: Laboratory at above 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 autoclave’s 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).
Autoclave Validation Report
Test Findings Summary. The test indicated that the autoclave is performing very well and within 0 specifications. Specifically, the autoclave reached and held a temperature of 249 F 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.
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
+10°C (+50°F) to +140°C (+284°F) ± 0.25°C (± 0.45°F) 0 PSIA (0 BAR) to 150 PSIA (10BAR) ± 0.3 PSIA (± 0.02 BAR)
MPIII Temp -20°C (-4°F) to +140°C (+284°F) MPIII HiTemp
*
+100°C (+212°F) to +360°C
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
At tachm ent 3 Auto clave Temp eratur e Validation Test Validation Date: Jan. 04, 2013
300.0
Hold Time
250.0
Come-up Cool Down/ Exhaust
Collector
200.0 ) F ( e r u t a 150.0 r e p m e T
M3T21991
0
M3T21990 M3T12154 M3T21982 M3P15108 M3P15157
Hold Time Temperatures
100.0 0
Minimum: 243.8 F Median:
0
249.0 F 0
Maximum: 249.9 F 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
Attachm ent 4 Auto cl ave Pressu re Vali dation Test Validation t Date: Jan. 04, 2013
35.0 Hold Time
30.0 Cool Down/
Come-up
25.0 Collector
) A I S 20.0 P ( e r u s s e 15.0 r P
M3P15108 M3P15157
Hold Time Pressures
10.0
Minimu m: Median : Maxim um : Std. Dev.:
5.0
26.2 PSIA 28.9 PSIA 30.3 PSIA 0.80
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
At tachm ent 5 Autocl ave F 0 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
30.0
M3T21990
Hold Time
e u l a 25.0 V
M3T12154 M3T21982
0
F
M3P15108 20.0
M3P15157
15.0 F0 = 8 @ 2 min prior to Hold Time due to fir st
10.0
aborted start
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 At tachm ent 6 Validation Data J an. 04, 2013 Min Max Median Std. Dev.
Min. All Median All Max. All Std. Dev.
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 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
