1710 Preston, Suite A • Pasadena, TX 77503Phone: 713-477-9247 • Fax: 713-477-9248
1-888-561-2932Website: www.slsi.net
Email: [email protected]
EMPOWER PHARMACY
CLEANROOM REPORT
July 31, 2013
12123 Jones Rd.Houston, Texas 77070
-2-
1 Test Outline Page 3
2 HEPA Filter Locations Page 4
3 HEPA Filter Integrity Leak Test Page 5 - 8
4 Particle Counts Point Locations Page 9
5 Room Particle Counts Page 10
6 Airflow Volume Readings Page 11
7 Air Changes Per Hour Page 12
8 Room Pressure Differentials Page 13
9 Secondary Test Page 14
10 Viable Sample Test Page 15
11 Equiment List Page 16
12 Summary Page 17
13 Clean Bench Certification Reports Page 18 - 19
14 Copy of Room Certificates Page 20 - 21
15 Copy of Calibration Reports Page 22 - 27
TABLE OF CONTENTS
SUPERIOR LABORATORY SERVICES, INC.EMPOWER PHARMACY
Clean room report
-3-
1
2
3
4
5Make Airflow Adjustments as Needed
6
7
8
9
SUPERIOR LABORATORY SERVICES, INC.EMPOWER PHARMACY
Clean room report
Perform Site Analysis
TEST OUTLINE
Perform Room Particle Count
Perform Airflow Profile
Perform Pressure Tests
Perform Clean Benches Certification
Generate Report
Perform Viable Samples Test
Perform HEPA Filter Leak Test
Perform Temperature and Humidity Test
-4-
3.76 m
1 Light
Light
Light Light
2.946 m
Light
SUPERIOR LABORATORY SERVICES, INCEMPOWER PHARMACY
HEPA FILTER LOCATIONS
148"
(m) = Meters
(") = Inches
2
3
Drawing not to scale
Light HF
3.048 m120"
116"
NOTES:
HF
HF
HF
1 Ceiling height: 2.44 meters or 96 inches or 8 feet
(HF) = HEPA Filter
4
CLEAN ROOM
ANTE ROOM
-5-
Notes:Acceptance Criteria: The preferred industry standard for patch size is 3% of the entire filter facearea and a single patch can be not greater than 1.5 inches (3.8 cm) in the lesser dimension.
Drawing not to scale
Patch Size Dimensions (Inches) 0
Patch Size Percentage 0%
Acceptance (Pass / Fail) Pass
Acceptance (Pass / Fail) Pass
Acceptance Criteria: The aerosol penetration shall not exceed 0.03% of the upstreamconcentration at any point.
HEPA FILTER MEDIA PATCH SIZE
Media Area Square Feet 7.02
leak test results indicated on diagram.
Upstream PAO concentration 100%
Airflow Avg (cfm) 581
Final Penetration ≤ 0.01%
AR = Leakage after repair with RTV silicone.1.22 m (m) = Meters
48" (") = Inches
A minimum 10 micro-grams/liter PAO introduced upstream, 100% scan conducted dowstream,
0.6 m leak detected.Zero leak 24" /// = HEPA filter media repairBR = Leakage before repair.
SUPERIOR LABORATORY SERVICES, INCEMPOWER PHARMACY
HEPA FILTER No 1 (CLEANROOM)
HEPA FILTER INTEGRITY LEAK TEST
MM = Media leak detected.XX = HEPA filter frame, gasket and glue joint
-6-
Notes:Acceptance Criteria: The preferred industry standard for patch size is 3% of the entire filter facearea and a single patch can be not greater than 1.5 inches (3.8 cm) in the lesser dimension.
Drawing not to scale
Patch Size Dimensions (Inches) 0
Patch Size Percentage 0%
Acceptance (Pass / Fail) Pass
Acceptance (Pass / Fail) Pass
Acceptance Criteria: The aerosol penetration shall not exceed 0.03% of the upstreamconcentration at any point.
HEPA FILTER MEDIA PATCH SIZE
Media Area Square Feet 7.02
leak test results indicated on diagram.
Upstream PAO concentration 100%
Airflow Avg (cfm) 561
Final Penetration ≤ 0.01%
AR = Leakage after repair with RTV silicone.1.22 m (m) = Meters
48" (") = Inches
A minimum 10 micro-grams/liter PAO introduced upstream, 100% scan conducted dowstream,
0.6 m leak detected.Zero leak 24" /// = HEPA filter media repairBR = Leakage before repair.
SUPERIOR LABORATORY SERVICES, INCEMPOWER PHARMACY
HEPA FILTER No 2 (CLEANROOM)
HEPA FILTER INTEGRITY LEAK TEST
MM = Media leak detected.XX = HEPA filter frame, gasket and glue joint
-7-
SUPERIOR LABORATORY SERVICES, INCEMPOWER PHARMACY
HEPA FILTER No 3 (ANTEROOM)
HEPA FILTER INTEGRITY LEAK TEST
MM = Media leak detected.XX = HEPA filter frame, gasket and glue joint
0.6 m leak detected.Zero leak 24" /// = HEPA filter media repairBR = Leakage before repair.AR = Leakage after repair with RTV silicone.
1.22 m (m) = Meters48" (") = Inches
A minimum 10 micro-grams/liter PAO introduced upstream, 100% scan conducted dowstream,leak test results indicated on diagram.
Upstream PAO concentration 100%
Airflow Avg (cfm) 510
Final Penetration ≤ 0.01%
Acceptance (Pass / Fail) Pass
HEPA FILTER MEDIA PATCH SIZE
Media Area Square Feet 7.02
Patch Size Dimensions (Inches) 0
Acceptance Criteria: The aerosol penetration shall not exceed 0.03% of the upstreamconcentration at any point.
area and a single patch can be not greater than 1.5 inches (3.8 cm) in the lesser dimension.
Drawing not to scale
Patch Size Percentage 0%
Acceptance (Pass / Fail) Pass
Notes:Acceptance Criteria: The preferred industry standard for patch size is 3% of the entire filter face
-8-
SUPERIOR LABORATORY SERVICES, INCEMPOWER PHARMACY
HEPA FILTER No 4 (ANTEROOM)
HEPA FILTER INTEGRITY LEAK TEST
MM = Media leak detected.XX = HEPA filter frame, gasket and glue joint
0.6 m leak detected.Zero leak 24" /// = HEPA filter media repairBR = Leakage before repair.AR = Leakage after repair with RTV silicone.
1.22 m (m) = Meters48" (") = Inches
A minimum 10 micro-grams/liter PAO introduced upstream, 100% scan conducted dowstream,leak test results indicated on diagram.
Upstream PAO concentration 100%
Airflow Avg (cfm) 550
Final Penetration ≤ 0.01%
Acceptance (Pass / Fail) Pass
Acceptance Criteria: The aerosol penetration shall not exceed 0.03% of the upstreamconcentration at any point.
HEPA FILTER MEDIA PATCH SIZE
Media Area Square Feet 7.02
Notes:Acceptance Criteria: The preferred industry standard for patch size is 3% of the entire filter facearea and a single patch can be not greater than 1.5 inches (3.8 cm) in the lesser dimension.
Drawing not to scale
Patch Size Dimensions (Inches) 0
Patch Size Percentage 0%
Acceptance (Pass / Fail) Pass
-9-
3
112 5
conditions.
is not applicable".
10
11
1 4
Drawing not to scale
locations exceeding nine counts per each room. ISO 14644.1:1999(E) " When only a single3
minute air volume (28.3 L/min). (Exceeding the require 2 liters, with a minimum sampling
Room Particle Counts conducted 42 inches (1.07 meters) above floor under "Operational"
Statistical analysis and 95% Upper Confidence Limit (UCL) were not performed due to count
location is sampled, or when more than nine are sampled, the 95% upper confidence limit
Each Particle Count was conducted using one minute sample time at one cubic feet per a
time at each location of 1 minute).
1
2
4 7
7 10
2 5
3
8
6 9
SUPERIOR LABORATORY SERVICES, INCEMPOWER PHARMACY
PARTICLE COUNTS POINT LOCATIONS
8
1
Notes:
12
6 9 12
-10-
ROOM GRID POINT PER CUBIC FEET PER CUBIC METER Pass / FailISO CLASS 7 1 2 71 Pass
2 5 177 Pass3 1 35 Pass4 1 35 Pass0 6 212 Pass0 0 0 Pass7 24 848 Pass8 9 318 Pass9 6 212 Pass10 90 3,178 Pass11 34 1,201 Pass12 61 2,154 Pass
Mean Size 20 703
ROOM GRID POINT PER CUBIC FEET PER CUBIC METER Pass / FailISO CLASS 7 1 124 4,379 Pass
2 142 5,015 Pass3 194 6,851 Pass4 142 5,015 Pass5 331 11,689 Pass6 321 11,336 Pass7 148 5,227 Pass8 241 8,511 Pass9 329 11,619 Pass10 428 15,115 Pass11 348 12,290 Pass12 231 8,158 Pass
Mean Size 248 7,063Acceptance: < 352,000 Particles Per Cubic Meter.
SUPERIOR LABORATORY SERVICES, INC.EMPOWER PHARMACY
Particle Count Cleanroom Report Tested at 0.5 Micron or largerClass ISO 7. Tested "Dynamic"
Class ISO 7. Tested "Dynamic"
Clean room report
Particle Count Ante Room Report Tested at 0.5 Micron or larger
Acceptance: < 352,000 Particles Per Cubic Meter.
-11-
FILTER FPM CFM Meters Per Second Liters Per Second
1 83 581 0.420 2742 80 561 0.406 265
Total 1142 539
FILTER FPM CFM Meters Per Second Liters Per Second
3 73 510 0.369 2414 78 550 0.398 260
Total 1060 500
12
Metric (S-1) figures have been calculated from English (I-P) using standard conversion factors.Airflow volumes were taken with a (2 x 4)' Flow hood and digital volume meter.
EMPOWER PHARMACYSUPERIOR LABORATORY SERVICES, INC.
ANTE ROOM
NOTES:
CLEAN ROOM
AIR FLOW VOLUME READINGS
Clean room report
-12-
Room Area(m²)
Room Volume(m³)
Room Area(ft²)
Room Volume (ft³)
Total Air Volume (cfm)
Air Change Rate (ACH)(*)
(m²) = Square meter(m³) = Cubic meter(ft²) = Square feet(ft³) = Cubic feet(cfm) = Cubic feet per a minute.(ACH) = Air changes per a hour.(*) Air Changes Per Hour = Total Air Volume * 60 / Room Volume
1,142 1,060
69.4 66.7
123.33 119.2
986.64 953.6
11.46 11.07
27.94 27.00
SUPERIOR LABORATORY SERVICES, INC.EMPOWER PHARMACY
Clean room report
AIR CHANGES PER HOUR
ROOM CLEAN ROOM ANTE ROOM
-13-
Drawing not to scale
Design room pressurazation direction.=
Pass / FailClean room
(" W.G.) = Measured in inches water gage.= Actual room pressurazation direction.
(*) = IEST-RP-CC006.3
Ante room ≥ 0.02 0.037≥ 0.02
Pass
Room Pressurization (*) Test Criteria Test Results0.045 Pass
CLEAN ROOM
ANTE ROOM
Adjustable dampers
SUPERIOR LABORATORY SERVICES, INCEMPOWER PHARMACY
ROOM PRESSURE DIFFERENTIALS
-14-
SUPERIOR LABORATORY SERVICES, INCEMPOWER PHARMACY
SECONDARY TEST
Drawing not to scale
Temperature(°C) - (°F)
(°F) = Farenheit degree.(%RH) = Percentage of Relative Humidity.
(°C) = Celsius degree.
45.8(% RH)
- 23.10
ANTE ROOMCLEAN ROOMROOM
TP 2
TP 1
-
52.3Relative Humidity
24.10 75.3 73.6
TP = Test Point Locations.TEMPERATURE AND RELATIVE HUMIDITY TEST
-15-
MEA 1314300 9/12/2013
Control LOT No EXP. DATETryptic Soy Agar 1314202 8/28/2013
EXP. DATETryptic Soy Agar 1314202 8/28/2013
MEA 1314300 9/12/2013
Ante Room LOT No
Tryptic Soy Agar 1314202 8/28/2013MEA 1314300 9/12/2013
MEA 1314300 9/12/2013
Clean Room LOT No EXP. DATE
8/28/20131314300 9/12/2013
Tryptic Soy Agar 1314202 8/28/2013Clean Bench 2 LOT No EXP. DATE
CLEAN ROOM
Control
Clean Bench 1Tryptic Soy Agar
MEA
LOT No
ANTE ROOM
1314202EXP. DATE
VIABLE SAMPLE POINT LOCATIONS
EMPOWER PHARMACYSUPERIOR LABORATORY SERVICES, INC
Drawing not to scale
VS = Viable Sample point
VS 1
VS 2VS 3
VS 4
-16-
EQUIPMENT DATA PURPOSE
1 TSI Thermoanemometer Airflow VelocityModel: 8386A Pressure testS/N: 03040053 Temperature testExp: Sept. 2013 Humidity Test
2 Particle Counter Particle CountModel 8240S/N: 70838128Exp: Aug. 2013
3 Flow Hood AccuBalance Volume (CFM)Model 8375S/N: 91002004Exp: Feb. 2014
4 Smoke tubes Airflow direction
5 ATI Phototmeter Detect PAOTDA-2GS/N: 13611Exp: Feb. 2014
6 ATI Aerosol Generator Produce PAOExp: n/a
SUPERIOR LABORATORY SERVICES, INC.EMPOWER PHARMACY
Clean room report
EQUIPMENT LIST
-17-
IEST-RP-CC-006.3IEST-RP-CC-034.2USP 797:2004
Faustino Diaz IIICertification specialist
SLSI will, upon request, provide a cost quotation to perform any repairs, replace-ments or correction you may deem necessary to achieve the level of performanceyou desire. Thank you for the opportunity to inspect your Cleanrooms. We valueEmpower Pharmacy as a client, as well as the opportunity to continue serving you.
We will contact you to schedule the next certification service. Please call if you haveany questions or need further assistance.
SUPERIOR LABORATORY SERVICES, INC.EMPOWER PHARMACY
Clean room report
SUMMARY
On July 31, 2013 Superior Laboratory Services, Inc. performed the cleanroomperformance test on the cleanroom at Empower Pharmacy located at 12123 Jones
The Cleanroom and the Ante room were tested "Dynamic" as specified by
Superior Laboratory Services, Inc particle count locations exceeds ISO minimum
Documents and guidelines for this test were:ISO 14644.1:1999
We calculated the grid point layout using this formula NL= √A where "NL" is the minimum number of sampling locations, and "A" is the area of the cleanroom orclean zone in square meters. ISO 14644-1:1999(E).
requirements.
USP 797:2004.
clean benches certifications.
The Clean room and the Ante room meet or exceed class ISO 7 at 0.5 micrometers(<352,000 particles per cubic meter) as specified by ISO 14644.1:1999.The Clean room and the Ante room meet or exceed USP 797.
Rd, Houston Texas, 77070.Testing including HEPA filter leak test, room airflow volume test, particle count test,pressure differential test, viable sample test, temperature test, humidity test and two
The Cleanroom and the Anteroom were tested "Dynamic" and at 0.5 microns and larger class ISO 7 (<352,000 particles per cubic meter) as specifiedby ISO 14644.1:1999.
Yes √ No
7 31 1 A1
JobPORmPhFax
√ √
105 102 96 91 98 101 101 92 10199 97 88 93 84 80 81 89 8293 87 74 86 91 95 88 90 106
106 104 95 100 103 104 90 99 102
Width
ft²fpm 80 to 100cfm 1332 to 1665
M = Media LeakX = Frame / Glue joint / Gasket leak
Left Right
%μg/L
12.25 x 36.25 x 1 2 No
1710 Preston, Suite A • Pasadena, TX 77503Phone: 713-477-9247 • Fax: 713-477-9248
1-888-561-2932Website: www.slsi.net
Email: [email protected]
CLEAN BENCH CERTIFICATION REPORT
Unit Certified
Test Date 2013 Exp. Date 2014 Certification # S-3374
Company Empower Pharmacy S-3374 Hood Mfr GERMFREEContact Model BZ-6SSRXAddress 12123 Jones Rd. Clean Room Serial 6S-15-BH-13751City, State Houston, Tx.77070 832-678-4417 I.D. n/aE-mail [email protected] 832-678-4419 Class ISO 5 (100)
ISO 14644.1:1999 Man. Specs. Other:
Supply Velocities (fpm) HEPA filter particle test
0 0 0 0 0
0 0 0 0 0
Tested at 0.5 micron and larger70.5 Height 34
Supply Area 16.65 Man. Specs. Magnehelic: (Inches of water) N/ASupply Velocity 94 Supply Voltage: (Voltage AC) N/ASupply Volume 1569 Electric and Polarity Test: N/A
HEPA FILTER LEAK TEST
Supply HEPA filter 0 PassPAO Concentration: 17 Calculate method: (13,500 * Laskin nozzle #) / Total airflow CFM
A minimum of 10 μgrams/liter PAO or equivalent Challenge introduced upstream.Acceptance: Aerosol penetration shall not exceed 0.01% of the upstream concentration at any point.
Prefilter size: Amount of pre-filters: Replaced the filters
Comments:
Ruben Contreras
Yes √ No
7 31 1 A2
JobPORmPhFax
√ √
82 86 87 91 89 89 86 92 8282 84 82 89 96 90 80 87 9499 95 89 94 92 96 91 90 9498 95 95 101 102 100 99 109 111
Width
ft²fpm 80 to 100cfm 1332 to 1665
M = Media LeakX = Frame / Glue joint / Gasket leak
Left Right
%μg/L
12.25 x 36.25 x 1 2 No
1710 Preston, Suite A • Pasadena, TX 77503Phone: 713-477-9247 • Fax: 713-477-9248
1-888-561-2932Website: www.slsi.net
Email: [email protected]
CLEAN BENCH CERTIFICATION REPORT
Unit Certified
Test Date 2013 Exp. Date 2014 Certification # S-3374
Company Empower Pharmacy S-3374 Hood Mfr GERMFREEContact Model BZ-6SSRXAddress 12123 Jones Rd. Clean Room Serial 6S-15-BH-13752City, State Houston, Tx.77070 832-678-4417 I.D. n/aE-mail [email protected] 832-678-4419 Class ISO 5 (100)
ISO 14644.1:1999 Man. Specs. Other:
Supply Velocities (fpm) HEPA filter particle test
0 0 0 0 0
0 0 0 0 0
Tested at 0.5 micron and larger70.5 Height 34
Supply Area 16.65 Man. Specs. Magnehelic: (Inches of water) N/ASupply Velocity 92 Supply Voltage: (Voltage AC) N/ASupply Volume 1534 Electric and Polarity Test: N/A
HEPA FILTER LEAK TEST
Supply HEPA filter 0 PassPAO Concentration: 18 Calculate method: (13,500 * Laskin nozzle #) / Total airflow CFM
A minimum of 10 μgrams/liter PAO or equivalent Challenge introduced upstream.Acceptance: Aerosol penetration shall not exceed 0.01% of the upstream concentration at any point.
Prefilter size: Amount of pre-filters: Replaced the filters
Comments:
Ruben Contreras
THIS IS TO CERTIFY THAT
EMPOWER PHARMACY - CLEAN ROOM
12123 JONES RD.
HOUSTON, TX 77070
MEETS OR EXCEEDS USP 797
MEETS OR EXCEEDS ISO CLASS 7 @ .5 MICROMETERS(<352,000 PARTICLES PER CUBIC METER)
ISO 14644.1:1999
THIS ROOM WAS TESTED "OPERATIONAL"
CERTIFICATION DATE: 07/201,
EXPIRATION DATE: 01/2014
CERTIFYING SUPERVISOR rPerformed by: Superior Laboratory Services, Inc.1710 Preston Road, Suite A, Pasadena, Texas 77503Office: 713-477-9247 / Fax: 713-477-9248
Toll Free: 888-561-2932 E:mail:[email protected]
; I I
II
THIS IS TO CERTIFY THAT
EMPOWER PHARMACY - ANTEROOM
12123 JONES RD.
HOUSTON, TX 77070
MEETS OR EXCEEDS USP 797
MEETS OR EXCEEDS ISO CLASS 7 @ .5 MICROMETERS(<352,000 PARTICLES PER CUBIC METER)
ISO 14644.1:1999
THIS ROOM WAS TESTED "OPERATIONAL"
CERTIFICATION DATE: 07/201
EXPIRATION DATE: 01/2014
CERTIFYING SUPERVISOR
Performed by: Superior Laboratory Services, Inc.1710 Preston Road, Suite A, Pasadena, Texas 77503Office; 713-477-9247 / Fax: 713-477-9248
Toll Free: 888-561-2932 E:mail:[email protected]
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CERTIFICATE OF CALIBRATIONTSI Incorporated, 500 Cardigan Road. Shorcview, MN 55126 I SA
Tel: 1-800-874-2811 1-651-490-281 1 Fax: 1-651-490-3824 liltp:/Av\\\v.tsi.com
En VIRON .Mt NT Con DITION
Thmperatiiri- 69.6 (20.9)
F<.r.LATIVF. Himiditn 48
Barometric 1'ri;ssiri.29.11
(985.78)ini-ig (hi'a)
Model 8240
Skrial Niimukr 70838128
0 AS LHM S In Toleranci;
• AS Folnd • OLT Ol TOILRANCl:
At:RoTR.4K Calibration Kn
M E.ASUR KM E Nr V A R1 V1$ 1.F S^'.stem id D.\te Last Caliiikated Calibr.\tion Di;e Dai e
hl.OW MKTHR ()5-(U-2C!2 05-03-20
Flow Mi ter E003586 08-15-201 1 08-15-2012
Fl.OW MliTE.R F003759 05-02-2012 05-02-2013
7201-02F n004434 05-L5-2012 05-15-2013
TSf does hereby certify that the above described instrtnuent conforms to the original manufacturer's specification (not applicable to .45Found data) and has been calibrated using standards whose accuracies are traceable to the United States National Institute ofStandards and Technology (MIST) or has been verified with respect to instrumentation whose accuracy is traceable to /S'JST, or isderived from accepted values ofphysical constants. TS/'s calibration system meets ISO-9001:200Q and meets the requirements of ISO10012:2003.
August 10, 2012
3RATED Dat[-:
Model 8240 SN''083R1.2H |-ndav. Aiieusi 10, 2012 Paec I of 2
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CERTIFICATE OF CALIBRATIONTSI Incorporated. 500 Cardigan Road. Shore-view, .VI.N 55126 I SA
Tel: 1-800-874-281 1 1-651-490-281 1 Fa\: 1-651-490-3824 hItp:/Avw\v.tsi.com
Parhci.k Standards
PARTICLt
Size
SIZK
Dkni.aiionl.o r .No. Kxpir.ation Date
0.3 urn 0.0051 urn 36225 12-31-2012
0.5 pm 0.0079 urn 35946 10-31-2012
I pm 0.010 urn 38726 04-01-2014
10 urn 1 (.tm 36031 1 1-31-2012
3 urn 0.029 urn 37979 1 1-01-2013
5 pm 0 5 pm 38084 11-31-2013
Particle Standards: All particles are /VIST traceable Polystyrene Latexspheres (PSL).
ISO 21501-4 COl NT EKKICItNCV
.Measirement Allow able Range .•\CTllAl.
0.3 urn 50':b ± 10 49'.'u
0 5 urn I00%± 10 91%,
Count Efficiency: during calibration, 0.3 ftni count
efficiency is set to 50% ±10 by adjusting the signal
threshold. Count efficiency is then checked at 0.5 fan
and must he 100% ±10 when compared to a
Condensation Particle Counter.
ISO 21501-4 ClTPOINT CALIBRATION
Nomlnal Partici.e
Size
c;ain
Stage
Digital
CUTl'OLNT
CLTPOINT AC CUIMC
Range
•ACTLAL Cutpoint
A(CURAC\
0.3 )im A 0 40% - 60"/u 49%
0.5 pm A 80 40';'o - 60% 50%
1.0 (im A 282 40'>0 ~ 60'; ., 52%
3.0 )im B 25 40'>0 ~ 60';'« 52%
5.0 urn H 88 40% - 60% 51 %
10.0 tim B 365 40'M,60% 50%
ISO 21501-4 Zkro Coi NT
i'ASSHD
0 0 /
ISO 21501-4 Flow Rate (L/min)
Nominal Ac rUAL Tolerance
28 3 28 3 ±5%
The Zero Count test is performed using a HEPA filter assembly.
The instrument must count less than I particle per 5 minutes at
a 95% confidence level in accordance n ith JJS 9921 and ISO21501-4.
The volumetric Flow Rate at the inlet is verified at 28.3 LAnin
±5% using a calibratedflowmeter.
Model 8240 SN 70838128 l-riday, August 10. 2012 Pa-c 2 or 2
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Certificate of CalibrationTSl Incorporated. 500 Cardigan Road. Shoreview. MN 55126 USA
Tel: I-800-874-2811 1-651-490-2811 Fax: 1-651-490-3824 www.tsi.com
Environment Condition
Temperature 71 4 op
Relative Humidity 140 %RH
Barometric Pressure 29.19 inHg
Calibration Standards Used
Manometer Calibration Bench 1
ModelAccuBalance
8375
Serial No. 91002004
^As Left K In Tolerance
• As Found • Out of Tolerance
Calibjiation Data
IKSTING
Points
Barometric Pressure Measured in in.Hg Differen 1lAL Pressure Measured in in.HiO
Calibration
Standard
Instrument
Output
Allowable
R-ANGE
Caiibration
Standard
INSTRUMLNI
Output
Allowable
R.ange
1 19.70 19.67 19.31-20.09 0.105 0.104 0102-0108
2 29.22 29.22 28.64 - 29.80 0.469 0.469 0 459 - 0.479
3 34.48 34.48 33.80- 35.16 2.86 2.86 2.81-2,91
4 -12.1 12.1 11.9-123
5-
- 14.9 14.9 14,7-15.1
Testing
Points
Temperature Measured in °F Humidity Measured in %RH
Calibration
Standard
Instrument
Output
Allowable
Range
Calibration
Standard
Instrument
OUTI'UI
Allowable
I^ngk
1 -38.0 -38.0 -37.0 - -39.0 71.4 71.5 71.3-71.5
2 5.0 5.0 4.7-5.3 5.6 5.7 5.5-5.7
3 77.0 77.0 76.8 - 77.2 -
4 158.0 158.0 157.8- 158.2
5 230.0 229.9 229.7 - 230.3-
-
* Indicates out oftolerance condition
TSI Incorporated does hereby certify that the above described instrument conforms to the original manufacturer's specifications ( notapplicable to As Found data) and has been calibrated using standards whose accuracies are traceable to the National Institute ofStandards and Technology within the limitations ofNIST's calibration ser\ices or have been derivedfrom accepted values ofnaturalphysical constants or have been derived by the ratio type ofselfcalibration techniques. The calibration ratiofor this instrument is atleast 6.7:1 for barometric pressure and 3:1for differential pressure. TSI is registered to ISO-900I:2008 and complies withISO 10012:2003, Quality Assurance Requirementsfor Measuring Equipment. This report may not be reproduced, except in full, unlesspermissionfor the publication ofan approved abstract is obtained in writingfrom the calibration organization issuing this report
Measurement Variable
DC VoltageDC VoltagePressure
Pressure
System ID Number
F002798
E002797
E002173
E002447
Calibration procedure used: 1000000078'
Caiib(a^ By
Date Last Calibrated
07-13-12
07-13-12
12-06-12
06-12-12
Cal 1brMipjlPiLe_Date
01-13-14
01-13-14
06-06-13
06-12-13
Feb. 15. 2013
Calibration Date
M
TEC Services, Inc,25 Little Avenue
New Oxford, PA 17350Phone: 717-624-3191
Fax: 717-624-3549
www.tecservicesinc.com
Controlled Environment Products
Calibration & Sen/ices
EQUIPIVIENT CALIBRATION REPORT
Date Received:
Customer:
Address:
Manufacturer:
02/22/13
Superior Laboratory Services
1710 Preston Ave Suite A
Pasadena. TX 77503
Air Techniaues
Instrument Type: Aerosol Photometer
Date Returned
Contact
Phone #
Customer PC #
Model #
Serial #
INSTRUMENT DATA
02/22/13
Rick Meyer
713-477-9247
Verbal
TDA-2G
13611
As Found Final Mfa. Tolerances As Found Final Mfa. Tolerances
Straylight (3) .0024% .0020% Not Applicable U4-3 (1) -11.86 •11.86 -12V ±. ,5V
Sample Flow (2) 22.0 30.0 28.3 T 2.8SLPM U8-1 (1) 11.87 11.87 +12V= .5V
0.001% (1) .80 X 10'"^ .80 X .80 1.04x 10''°' U12-6 (V 5.00 5.00 +5V±20mV
0.01% (1) .80 X 10'^ .80x10''-' .80 + .04 x 10"®* U13-1 (1) 10.02 10.02 +10V+,1V/ -,4V
0.1% (1) .BOX 10'" .80 X 10'" .80 ±.04x10"®* J6-Wh (1) 327 327 > 220mV/Def
1,0% (1) .80 X 10'' .80 X 10'' .80 ±.04x10'^* J9-1 (1) 5.07 5,07 +5V± ,1V
10% (1) .80 X 10'*^ .80 X 10''" .80 ±.04x10'®" J9-5 (1) 14.97 14.97 +15V± ,45V
100% (1) .80 X 10'^ .80 X 10'̂ ' .80 ± .04 X 10"® * J9-6 (1) -14.97 -14.97 -15V± ,45 V
(1} In Tolerance (2) Out of Tolerance (3) No effect on instrument operation (N/A) Not Applicable 'Amperes
Received in Tolerance: • Yes ^ No • Not Operable nTolerance Not Applicable
Calibrated for: Temperature: 22.0 Relative Humidity: 35.0 %
Clean / Rebuild Chamber
Check Wiring & Hardware
MAINTENANCE PERFORMED
S Realign OpticsD Replace Gaskets
^ Flush Hosesn Replace Cell Lamp
Notes: Removed debris from clooQed vacuum
Leak Test Sampling SystemVerify Max Gain Stability
FINAL VERIFICATION PERFORMED^ Test Scanning Probe [Kl Performance Test
Description
PicoamDere Source
Thermohvqrometer
Flowmeter
NIST TRACEABLE EQUIPMENT USED
ModelKeithlev 6220
Fluke 87 V
Oakton 35700-00
Dwver VFB-69
Serial #
1272482
95880169
CP69900
22400
Certificate #
073236
275178
275180
275179
Perform Voltage Check
Cal Date
24 FEB 12
10 OCT 12
10 OCT 12
15 OCT 12
Due Date
24 FEB 13
10 OCT 13
10 OCT 13
15 OCT 13
Calibrated per Procedure; TEC001
TEC006
TEC002 •TEC003 • TEC004 ^ TEC005TEC007 E TECOOB Kl TEC009 •TEC010
CALIBRATION BY: DATE: 02/22/13 DUE DATE: 02/22/14