empower pharmacy - steroid .com · 2013. 10. 9. · (*) = iest-rp-cc006.3 ante room ≥ 0.02 0.037...

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 0 - 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


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.


Patch Size Dimensions (Inches) 0

Patch Size Percentage 0%

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.


HEPA FILTER No 1 (CLEANROOM)

HEPA FILTER INTEGRITY LEAK TEST

MM = Media leak detected.XX = HEPA filter frame, gasket and glue joint

-6-










leak test results indicated on diagram.




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.


HEPA FILTER No 2 (CLEANROOM)



-7-


HEPA FILTER No 3 (ANTEROOM)



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.









area and a single patch can be not greater than 1.5 inches (3.8 cm) in the lesser dimension.




Notes:Acceptance Criteria: The preferred industry standard for patch size is 3% of the entire filter face

-8-


HEPA FILTER No 4 (ANTEROOM)



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.













-9-

3

112 5

conditions.

is not applicable".

10

11

1 4


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


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.


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


Clean room report

AIR CHANGES PER HOUR

ROOM CLEAN ROOM ANTE ROOM

-13-


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


ROOM PRESSURE DIFFERENTIALS

-14-


SECONDARY TEST


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


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


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.


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




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

mailto:[email protected]

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




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

mailto:[email protected]

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

%

IBM.

milk fflVA '̂̂ ' fflM tUili\ lm%1^ 1^In

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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

-sS:

:5v^

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