ML18348A561

NRC-2018-000497 - Resp 2 - Final, Agency Records Subject to the Request Are Enclosed

ML18348A561
Person / Time
Issue date:	12/06/2018
From:	NRC/OCIO
To:
References
FOIA, NRC-2018-000497
Download: ML18348A561 (192)

Text

May 31 , 2017 U.S. Nuclear Regulatory Commission Materials Safety Licensing Branch Office of Nuclear Material Safety and Safeguards ATIN: SSDR Washington, DC 20555-0001 RE: Request for device evaluation for the Valeo Instruments Company TGA 3000 and an exempt distribution license To whom it may concern:Stane Valeo Instruments Company, Inc. ("Valeo"), requests that the NRC evaluate the Valeo TGA 3000 for a radioactive device registration and exempt distribution license. The TGA 3000 is a gas detector capable of detecting problematic impurities in Ultra High Purity Gases in order to alert the end user to unacceptable levels of contaminants that may be detrimental to their product quality. The TGA 3000 has been designed to be an addition to already in place detection systems rather than a stand-alone device.

To support this request Valeo has included the following information:

1. The completed summary data application and the completed NRC Form 313 for this request are included in attachment 1.

2. A description of use for the TGA 3000 is included in attachment 2.

3. Testing on the Ion Mobility Spectroscopy Cell Assembly (IMS) was performed as outlined in NRC NU REG 1556, Vol. 3, Rev. 2. The results of this testing are enclosed in attachment 3

4. A detailed description of the construction and design of the TGA 3000 is included in Attachment 4.

5. Valeo confirms it shall use a quality assurance program compliant with Append ix G of NUREG 1556, Vol. 3, Rev. 2. A copy quality assurance procedures can be found within the TGA 3000 Manufacturing manual which can be found in Attachment 5.

6. Attachment 6 contains drawings and pictures of:

• the product label indicating Valeo.as the Manufacturer of the Model TGA 3000;

• drawings which show the location of the label which shall be placed on the external surface of the IMS Cell Assembly, Page 1 of 72

7. A copy of the user manual for the TGA 3000 that will be included with each TGA 3000 is provided in Attachment 7.

8. A copy of the Model TGA 3000 Datasheet that will be provided to potential customers of the TGA 3000 is included in Attachment 8.

9. Attachment 9 is Valeo Instruments Company, Inc. request to withhold information from public disclosure under 10 CFR 2.390.

10 Valeo is currently requesting an amendment to their State of Texas license

1. L01572 to authorize the possession of the NRD Model A-001 Am-241 sealed source and to manufacture the Model TGA 3000 -see Attachment 10 for a copy of the current Radioactive Materials License.

11 . Enclosed with this submittal is a Compact Disc of the technical drawings and pictures which can be used, in part, for inclusion in the registration certificate.

If you have any questions please call me at (713)688-9345 or email me at Stan@vici.com .

Sin,rly, ' /J ltW11bdl)/f('{vlt)1 I StJnley ~ S~~arns President and Radiation Safety Officer Valeo Instruments Company, Inc.

Post Office Box 55603 Houston, Texas 77255 Page 2 of 72

Attachment I

SUMMARY

DATA Name and Comploto Mailing Address of Name, Title, and Telephone Number of tho Individual To Be the Applicant: Contacted If Additional lnfonnaUon or Clarlflcation Is Needed by the Valeo Instruments Company, Inc NRC: Stanley D Stearns Jr President and Radiation Safety Officer PO Box 55603 Houston. Texas 77255 The Applicant Is (checkori'e'f: If the Applicant Is Not the Manufacturer, Provide the Name and Custom User Complete Mailing Address or tho Manufac turer : N/A Manufacturer Distributor X Manufacturer and D1st,1butor If the Applicant Is a Custom User, Provide Provide the Name, Complete Malling Addroas, and Func tion o f the Name and Complete Malling Address Other Companies Involved:

or the Distributor : NRD- 2937 Alt Boulevard, PO Box 3 10 , Grand Island. NY 14072-0310/ Sealed Source Provider Modol Number: TGA 3000 Principal Use Code (see Appendix C):32222

-

Name Used by tho Industry to Identify tho

--+-----

For Use by:

---

i Product (e.g., Radiography Exposure Speciflc Licensees Only Device, Teletherapy Source, Calibration Source): General Licensees Only Both Specific and General Licensees Gas and Aerosol Detector X Persons Exempt from Licensing Leak-Test Frequency : Principal Section of the 10 CFR that Applies t o the User (e.g.,

General Licensees under 10 CFR 31.5): Exempt License 10 CFR

\ Periodic Leak Testing ,s Not Required 30 20 6 Months Radionuclides and Maximum Activities (including loading tolerance): Am-24 1 Maximum Ac11111ty 20 µCi (0 74 MBq)

Attached 1s 1ust1ficahon for a leak test frequency of greater than 6 (NRD Model A-001) months - - _ _ _ _ _..___ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _--1 CERTIFICATION:

THE APPLICANT UNDERSTANDS THAT ALL STATEMENTS AND REPRESENTATIONS MADE IN THIS APPLICATION ARE BINDING UPON THE APPLICANT THE APPLICANT ANO ANY OFFICIAL EXECUTING THIS CERTIFICATION ON BCHALF or THC APPLICANT, NAMED ABOVE, CERTIFY THAT THIS APPLICATION IS PREPARED IN CONFORMITY WITH TITLE 10 OF THE CODE OF FEDERAL REGULATIONS, PARTS 30 AND 32, AND THAT ALL INFORMATION CONTAINED HEREIN IS TRUE AND CORRECT TO THE BEST OF THEIR KNOWLEDGE AND BELIEF Stanley D. Stearns Radiation Safety Officer Signature:

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Attachment 2 Conditions of Use:

a) The Valeo Instruments Company Inc. TGA 3000 Ion Mobilty Spectrometer, (IMS), Gas/Particulate Analyzer Module will be primarily used for detec tion of impurities, s.uch as H20 and 0 2, in Ultra High Purity, (UHP) gases widely used in the semiconductor, LED, and many other manufacturing processes that utilize UHP gases in their manufacturing process. These processes require continuous monitoring for levels of impurities that would be detrimental to quali ty and product throughput.

b) Some other uses and/or applications could include but not limited to the followin g; I ) Detection of trace level surface contaminants on wafers used in the semiconductor industry.

2) Air quality monitoring.

3) Narcotics Detection.

c) The expected usefu l life of the product through normal usage, and with proper care, should be between IO to 15 years.

d) No Access to the ionization source is afforded by the end user or any individual other than authorized users once the TGA 3000 module has been assembled in accordance with the Valeo Instrument Company Inc. assembly and safety manuals. There is no direct access point to the AM-241 source once assembly has been completed.

e) Due to the design and manufacture of the TGA 3000 module, it is highly unlikely that there wi ll be a significant reduction in the effectiveness of the containment, shielding, or other safety features of the product from wear and abuse likely to occur in norma l handl ing and use of the product during its useful life.

f) Due to the design and manufacture of the TGA 3000 module and if used under normal use and specified operational guidelines the probabi lity is low that the containment, shielding or other sa fety features of the product wou ld fai l, under such circumstances, that a person wou ld 1 of 72

rec i e an external radiation do e or do e commitment in exce s of the do e to the appropriate organ as speci tied in olumn II of the table in 10 CFR 32.2 , and the probability i negligible that a per on would receive an external radiation do e r do e commitment in exces of the dos to the appropriate organ a specified in Column Ill of the tab I in IO FR 32.28. Under nonnal use and conditi n any disposal of a ingle unit or handling, shipping and storage of unit are unlikely to accumulate in one location.

2 of 72

Attachment 3 Valeo TGA 3000 Prototype Testing Objective The objective of this testing is to provide sufficient infonnation and data that verifies the IMS design of the Valeo TGA 3000 will maintain its integrity when subjected to conditions of nom,a l use and Likely accident conditions. Normal use and likely accident conditions may include, but not limited to, those conditions experienced during installation, use, handling, maintenance, storage, and transportation (only normal conditions during transportation need to be considered).

Radioactive Source associated with the Valeo TGA 3000 Each TGA 3000 module wi ll use one scaled Foil Source NRD model number A-00 I. Source material is AM-241 at no less than 17 microcuries and no more than 20 microcuries.

Americium-24 1 Characteristics Americium-241 is a silver-grey metal which decays primarily by alpha panicle emission to Neptunium-237. Low energy gamma radiation accompanies these decays. with the 59.5 kcV gamma emission being of the most imponance.

Alpha 5485 kcV 84.5 %

Alpha 5443 keV 13.0%

Gamma 59.5 kcV 35.9%

Gamma 26.3 keV 2.4 %

Gamma 13.9 keV 42.0 %

Radiation Instrumentation For purposes of measuring stray radiation fo r gamma radiation before and after each of the three (3) tests listed below, A Ludlum model 3 survey meter with a model 44-9 Beta/Gamma detector pancake probe was used for making the radiation measurements in the series of tests described in this section.

The survey meter used for stray radiation measurements before and after each test shall be cal ibrated within 12 months at the time of testing and shall be calibrated against a gamma radiation standard to an acCLLracy o f +/- 10 percent of fu ll scale at a point within the rated energy range.

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Test Parameters:

The Valeo Instruments Co1111pany TGA 3000 shall be manufactured by Valeo Instruments Company located in Houston Texas under the authority of State of Texas issued Radioactive Materials License No LO1572.

The tests and measurements defin ed in this document shall be performed on the standard Jon Mobility Spectrometer (IMS) cell assembly which contains, in part, a single Americium 24 1 (Am-24 1) sealed fo il source (- 20 micro curies). Testing of the IMS assembly was chosen as opposed to the testing of the final Model TGA 3000 detector as this cell is the primary containment for the source and contains all the protective equipment.

The prototype testing was accomplished by assembling three TGA 3000 modules in accordance with the assembly manual, as fo und in attachment 5 of this application. The assembled TGA 3000 modules were numbered I, 2, and 3 consecutively, and are referred to as TGA 3000 module# I, TGA 3000, module #2, and TGA 3000 module # 3 for these tests. The AM-241 source serial numbers were recorded for each assembly. TGA 3000 module # 1 was used! as the control test assembly.

External Radiation Levels Three TGA 3000 modules assembled with three different AM-241 sources, @ ~ 20 micro-curies each, were used for the external radiation level testing. The testing was done using a Ludlum model 3 survey meter having a model 44- 9 Beta/Gamma detector pancake probe attached. The detailed description of the tests and the results are in table I below.

Drop testing.

Cell # I was not drop tested and was used as the control device for these tests. Cells # 2 and # 3 were dropped four times each from heights of 36 inches and 48 inches on to a designated safe area with a concrete surface, for a total of eight drops for each cell. The drop area background radiation was measured and recorded.

The cells were pushed from a nat top surface simulating an accidental fa ll from desk top heights and counter top heights. The cells were examined after each drop for visible damage and then radial ion measurements were made at 5 cm, IOcm, 30, and I 00 cm around the entire surface area. The condition and radiation measurements were recorded after each drop. Sec table 2 fo r test results. After completion of the drop test, the designated drop area was surveyed for surface contamination using the Ludlum model 3 Geiger counter.

Thermal breakdown testing.

Cell # I used as control device and was not heated for these tests. Cell # 2 and # 3 were disassembled down to the ceramic and Kovar cell body. A flexible Kapton heater with RTD 2 of 72

thermocouple attached was then wrapped around each cell and re-assembled. The heaters were placed under control of a digital Fuji temperat.ure controller. Radiation measurements were made at 5 cm, IO cm, 30, and I 00 cm around the entire surface area from the surface area of each cell assembly at room ambient temperature. Results were recorded. Cell # 2 and Cell # 3 were then heated to 300 degrees C and held at that temperature for a period of 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />. Radiation measurements were taken ac temperature fo r each cell at distances of 5 cm, IOcm, 30 crn and I00 cm and recorded. Background measurements of the designated test area around each cell were made and recorded prior to beginning of the testing. The cells were then allowed to cool to room ambient and radiation measurements were again made and recorded.

Water emersion testing.

IMS Cell # I, used as the control device. Background measurements of the designated test area and water container were made and recorded prior to the start of testing. All cells were measured and recorded for radiation levels from all surfaces at distances of 5 cm, IO cm, 30 cm and I00 cm. IMS Cell # 2 was completely submerged in a container of water for a period of ten minutes.

The surface of the water was surveyed for any contamination above background before removing the cell from the water. The cell was dried and radiation measurements were taken at 5 cm, 10 cm, 30 cm, and I00 cm and recorded. Test repeated for cell # 3.

Results of the prototype testing of the product.

The procedures and results fo r the prototype testing of the TGA 3000 modu les are listed below.

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External Radiation Level Measurements THREE TGA 3000 IONIZATION DETECTORS WERE ASSEMBlED IN ACCORDANCE WITtl Of VICI VAi.CO INSTRUMENTS ASSEMBlY &SAFETY INSTRUCTIONS.

THE ASSEMBLES WERE MARKEDNUMBERSONE, TWO ANDTHREE, EACH HA~GONE AM-241@ 20 MICR.CURIES SOURCE INSTAl.LED WITH SERIAL NUMBERS RECORDED AS INDICATED BElOW.

THE FOLLOWING RADIATIONLEVEL MEASUREMENTS WERE PERFORMED BY USE Of AU.O.lll MODEL 3 SURVEY METER WITH AMOOEL 44..9 BETA.'GAMMA PANCAKE PROBE.

MREM.IHR CALCULATIONSBASEDON Lllll.tll MOOEL 3 SlRVEY METER SCALE, 1MRE.WHR

• 3300 CPM ASSEMBLY MEASUREMENTS BACK GROUt() I.EASURMENTS FOR TlE ASSE"'8l.YAA.EA WERE AVERAGED ATO 0125 mRitr, (41 CPM)

AVERAGE EXPQSURE UME NORIIAL WORKliG QISTAHCE FROM SQWCE

~ASSEMBlY SMIN <1CM HOUStlG A$EMSLY 5MIN AT I CM DISTANCE 1CM HOUStlG ASSEMBly 2MIN AT3CMD1STANCE 3CM ELECTROOK:S ASSEMBlY SM!N 8CM AW. ASSSSEMllYITEST ~ 50CM ESTMATED ANNUAL EXPOSREBASED ON ESTIMATED 100 UNITSPERYEAR MEASUREM TOTAL EXPOSURE PER UNCALCULATED ANNUAL EXPOSURE IIREltAVERMREM MREM 0.02 73 CP 018 0.02 73CPO 0.18 0.02 56CP001 06 0.01 46CPO 012 BACKGROUt-1> 2 1.08 ESTIMATED ANNUAL DOSAGE 1.08 MREM PER YEAR POST ASSEMBLYMEASUREMENTS tf ~ S WERE TAKEN ARST WITH PHYSICAL SWIPE AT CARRIER lttET CI.OSEST TO ~ TIEN AT 5, 10, 30 and 100 CENTl~ETERS FROW Ttf EXTERNALSLWACE Of THREE TGA3000NSCELLS, EAOiOM: HAVINGA AM-2410 20 ~ E SOURCE INSTAl.lfD. THE AA.EA SlRvEYED W~ AVERAGED OVER AN AREA LESS~ 10 SOUARE CENTIAETERS MREIMR CALCULATIONS BASEDON LUDLUMMODEL 3SURVEY METERSCAl.f, 1MREWHR

• 3300 CPU TGA TEST CELL 11 TEST AREA BACKGROUNDACTMTY FOR CELL I 1AVERAGEDAT0.0125 mR/hr (41CPM)

AM-2410 20 uQ SWIPE TAKEN AT CARRIER INLET Q.OSEST TOSOURCE RES\!.T sou<<:E SN-0001 .l!JillHCf mB/tE ~

SWPE 0.0125 41 CPM 5CM 0.0125 41 CPM 10 CM 0.0125 41 CPt.l JOCM 0.0125 41 CPM 100 CM 0.0125 41 CPM TGA TESTCELL12 TEST AREA BACKGROUNDACTMTY FOR CELL I 1AVERAGEDAT 0.0125 mR/hr (41CPM)

A.M-2410 20 uCi DISTANCE MREWHR coorrs sou<<:E $N,QKl2 SWPE 0.0125 41CPM SCM 0.0125 41CPM 10CM 0.0125 41CPM 30CM 0.0125 41CPM 100 CM 0.0125 41 CPM 4 of 72

Water Emer ion Test Data 5 of 72

HE~'I1 AVAIIAHrn COPY TABlE 2 ALL TGA 3000 ION!ZATION DETECTOR CELLS WERE ASSEMBlEO COMPLETE PER ASSEMB;.YAW SAFETY HSTRUCTIONS THE RADIATION ACTMTY LEVELS WERE ~ E D USING A. Lt.nUM GEIGER OOUNTER MOOEl. 3 WfTHA MODEL 44-0 PAHCAXE DETECTOR ALL INSTRVIENTS USED ARE 1H ~RENT CALIBRATION PERIOD lE FOU~\'NG TESTS \\'ERE PERFORMED BYFW. EMER~ Of CB.LS I 2 AK) f 3 IN A CONTAINER RU.ED Willi UNFILTERED TAP *YATER f'-0 A PERIOD OF 10 MNJTES EACH THE SURFACE Of THE WATER~ THE CCHTA.1-lER WAS SURVEYED FOR Atl'f A.CTMTY MJ<Nf. BACKGROUND BEFORE TIE CELLS WERE REMOVED FROM THE WATER nE CELLS WERE Tl£N REMOJED FROM THE WATER. DRAINED a EXCESS WATER TO SHEWED CCHTA.tlER. THE CEI.LS WERE THEN DRIED IN AN OYEN AT 2e04C ANO AFTER COOLING EACH CEU WAS S\.flVEYED AAIO RESll.l AAE SHO,YN saCM LUOlUII MOOEl.3 SURVEY METER WITH AUODE1. U.S BETA.IGAMMA PANCAKE DETECTOR PROBE USED FOR RADIATION UEASUREMOO}, 111@!

• 3300 CPM Pl! lllfMl SURVEY Of ntEWATERII THE CONTAINER WAS AT BACKGROUND, 40 CPII f0..012SmR/hr)

TGA TEST CEll.11 CONTROL DEVICE NOT EMERSED TEST AREA BACXGROUNO ACTMTY AVERAGED AT , 1 CPM

.w.2410:llhO COHTROLDEVICUURVEY ~ ~ ~

SOURCE St+-QXl1 SWIPE 0.0125 41 5CM 0.0125 41 10CM 0.0125 41 30CM 0.0125 41 IOOCM 00125 41 TGA TEST CEll. '2 TEST AREA BACKGROlNl ACTMTY AVERAGED AT , 1 CPM AM-241 20uQ DETECTOR ACTMTY BEFORE EUERSJQN ~ mR.'lw ~

SOURCESH-Om S', \1PE. 0.0125 41 5CM 00125 41 IOCM 0.0~ 41 30CM 00125 41 IOOCM 0.0125 41 YIET MEASURMBff DETECTOR ACTMTY AFTER 10 MIIUTE EMER$1QN ~~ .ctM.

S\\1PE 00125 41

~CM D.11125 41 IOCM 00125 41 30CM 0.0125 41 IOOCM 0.0125 41 OREO MEASlREMEJfl

~~ .ctM.

S\\1PE 0.0125 41 5CM 0.0125 41 10 CM 0.0125 41 30CM 0.0125 41 1000/I 00125 41 TGA T'f§TCEU '3 TESTAREA BACXGROUND ACTMTY AVERAGED AT , 1 CPM AM-2'11 20uCi DETECTOR ACTMTY BEFORE EMERSION DISTANCE mRlhr CPU

~ CESM.am S\\1PE 0.0125 41 5CM 0.0125 41 IOCM 0.0125 41 30CM 0.012:5 41 IOOCM 00125 41 YET MEASURMOO OETJiCTOR ACTMTY AFTER 10 MNUTE EMERSION ~ mR,'tw .ctM.

SWIPE 0.0125 41 5CM 0.0125 41 10 CM 0.0125 41 30CM D.O~ 41 IOOCM 00125 41 OREO MEASlHIIENT

~~ m!

S\'t'tPE 0.0125 41 5CM 0.0125 41 IOCM 0.0125 41 30CM 0.0125 41 IOOCM 0.0125 41 Thcm1al Breakdown Testing 6 of72

TABLE3 All TGAml ON!ZATIOO IEECTOR CfilS WERE ASSSBfD COlfl.flE PER AS!alll.Y00SAffiY ~

1lf RADATION AClMTY LOOS WERE t.fASUfD USN; ALlO.l.11 GEIGER COOlTER t.aE. 3W11H Amt 44-9 PN(A.l(E IEECT~

All lNSTIUIEHTS USEDARfVt'ITKHC\fflHT ~TION PERIOO.

ME>SmENTS WERE~ AT AWfifNTTSflERATUf ,APROX. 26'C MIU'd 1HE ENTIRE OUTSia: fflACE Cfllf TGA ml IMS MOOU.ES lHlR TEST AT Aasl'~EOf 5CM, 10 CM, ll CM Nil 100CM.

1lf RESllTS ARE All A'lfPJl:I. Of 1lf IIGH Atl) LOW REAWlS FOO1lf ACTMTY 00 1lf SAME lofTl<<Xl WAS USED AFTER TSFERATllf Of '1J! CWA.S llAfflAtfD Fal ,. IIX.RS ON EACH TEST CELL 1lf SWIPE WAS TAKEN AT 1lf CAMiER llfT Q.OSEST TO 1rf SMCE.

Ti£ RXJ.oo<<i TESINlWAS NXOlfUSIEDSY.&.SS8llHl AflEXlli!£ATER IJONlTi£ TG\ m, IISCB.lASSalil.ES !WON()llffl lHER 1IS1 aeRliEI\AONlIT Jm 1lE NSUATO\NO INSllA~IOJSM. 1lEIQTERS WEA£ o:MIWJDSY TBffRATI.R!: IXW1ICl B.KOOl(S ~ 1lE IIS CSL MBflaBQIRlll'l1H IIIXI (HI RTtl llEIID!XlRfS t<<:Ol'ORA.!ED ti1lE ~ OF 1lE IEATER~ y f,ETVicNTiE CEU .IS'SEIG.YI.Ill1lE IEATER OF &.CHCSL l.l<<R TEST.

ll£ lBf9,All.R!: OF EAOl CSL Em1 n£ COO'RCl CSL f IWAS Sl<lm.Y R.WD0.9U PEROO OF1lffl ~ TOA 'IBftRAll.R!: OF lXl't NO WAS IMTAl!EDAT m\T l'Df81All.R!: Fa!A PEROOOF ~ fWlS. CSL.SN.UlEJH~'O>JO TiffiMR! Tl9 SIRl£1HlAT 5Cll,t.:I C11. ,e1100 K1J CIINWCI 1lE SClm AA£AOF OF &.CHC81 lN& TEST 1lE S\\"ff WAS TAAENAT1lECJJRER NEH10SES1 TO TIE ~

TGA TESTCfil fl CotllllOI. DE\1CEIIOT lfATBl TEST AREABACKriROUllAClMTY AVBIAGEDAT6.012511mr, (41CPII)

Ali-241@Il~ SWIPE O0125 41

~Sll,Q'.01 TGA TESTCfil #2 TESTAREABACKriROUllACTMTY AVBIAGEDAT0.0125~.11, (41CPII)

AM,2410Il~ QETfCTQR ACTMTY I ROOM AIIBIBIT rum lllltr ~

~SN<<m SWIPE 0.0125 41 5CM 0.0125 41 10CM 0.0125 41 JlCM 00125 41 100CM Q.0125 41 DffiCTORACTMTYAITTR241WlSI JOO'C .!mm~ CPM SWIPE 0.0125 41 5CM 0.0125 41 10CM 0.0125 41 JlCM 00125 41 100CM 0.0125 41 TGA TfSTCfil :'l TESTAREA BACKGROIJll ACTMTY AffllAGEO AT Q.0125 Mrilv, (41 CPM)

All,2410II~ DrnCJORACTMTYIROOMAIIBl8fI mim ~ mt

~m<<m SWIPE D0125 41 SCM 0.0125 41 10 CM ll.0125 41 JI CM 0.0125 41 100CM ll.0125 41 DETECTOR ACJMTYAFTER 24HOURS I JOO'C OSTAl(E llri1r ~

Sl'l'IPE 0.0125 41 SCM 00125 41 10CM Q.0125 41 JlCM OD12S 41 100 CM 0.0125 41 7 of 72

Drop Test Data TABLE 4 All TGA 3000 IMS CEllS WERE ASSEM8lED COt.R.ETE PER ASSa.161.Y>Kl SAFETY INSlRUCTIONS THE RAIXATIONACTMTY ~ S WERE MEASURED USING Alwt.t.NGBGER COlfflER MOOE1.3WITH AMOOE!. 44-9 DETECTOR All tlSTRt.t.!EHTS USED ARE WITHIN MRfNT CALIBRATION PERIOD.

t.£ASUREt,1ENTS WERE MADE AROU'IO ENTIRE StJRFACf OF THE~ TEST CEU ATS CM, 10 CM, ll CM,At() 100 CM.

1l£ RESU.TS ARE AN AVSWiEOF 1l£ ttGH At,D LOWS FOR BACKGROlN> ACTMTY ANO 1l£ SAAi: IETliOO WAS USED AFTER ClROP SWIPES WERE TAKEN ATM CARRIER INLET Q.OSEST TO THE 5CX.fiCE.

AllOOJM t.<<>OEl. 3 SUIMY METER Willi At.fJOEL 44-9 /GAWMA DETECTOR ~ E WAS USED FOR RAIJATION l,I.EASllB£HTS TGA TEST CEll '1 COt/TROL DEVICE IIOT DROPPED TEST AREA BACKGROOIO ACTMTY AVERAGED AT 0.0125 mRllw rmage (41 CPMI AM-2410 20 uC1 somcE SN,m,1 TEST MlfA BAO<GROIH> ACTMTY AVERAGED AT 0.0125 rr&r, (41CPM)

TGA TEST Cal #2 AM-2410 20 uC1 omcTOR ACTIVITY BEFORE DROP JEST SOURCE SK.0002 ~ mRlhr QM SWIPE 00125 41 SCM 0.0125 41 10CM 00125 41 JOCM 0.0125 41 100CM 00125 41 AfTE.!! OROP ACTMTY !I !!!R.!!J OROPHElGHT 06SERVEO DAMAGE l!~At!CE F~ DETECTQB S~RFACE Mr/II ~

CROP I 36" NONE SWIPE 00125 41 SCM 0.0125 41 10CM 0.0125 41 llCM 00125 41 100CM 00125 41 CROP2 SWIPE 0.0125 41 SCM 0.0125 41 10CM 00125 41 llCM 0.0125 41 100CM 00125 41 CROP3 NONE SWIPE 00125 41 SCM 0.0125 41 10CM 00125 41 llCM 0.0125 41 100CM 00125 41 SWIPE 00125 41 SCM 0.0125 41 10CM 00125 41 llCM 0.0125 41 100CM 0.0125 41 CROPS SWIPE 00125 41 SCM 0.0125 41 10CM 0.0125 41 llCM 0.0125 41 100CM 00125 41 OROP6 SWIPE 0.0125 41 SCM 0.0125 41 10CM 0.0125 41 llCM 0.0125 41 100CM 00125 41 8 of 72

Drop Test Data Continued TGA TEST CE1H3 TEST AREA BACKGROUN) ACTMTY A\'CRAGEO AT 0.0125 mRnr,(41CPM)

AM-241@ ~ uCi DETECTORACTIVITY BEFORE DROP TEST SOURCE~ IXSTAtlCE rnR/hr CPM SCM 0.0125 41 10CM 0.0125 41 30CM 0.0125 41 100CM 0.0125 41 AFTER DR<f ACTIVITY 11mR'lv DROP HEIGHT OBSERVED DAMAGE IXSTAtlCE ~ DETECTOR SURFACE Mrlh CPU

[)R(f 1 y; to{E SWIPE 0.0125 41 SCM 0.0125 41 10CM 0.0125 41 30CM 0.0125 41 100CM 0.0125 41 ORCP2 36' SWIPE 0.0125 41 SCM 0.0125 41 10CM 0.0125 41 llCM 0.0125 41 100CM 0.0125 41

[)R(f 3 to{E SWIPE 0.0125 41 SCM 00125 41 10CM 0.0125 41 30CM 0.0125 41 100CM 0.0125 41 Oftal 4 Siji bend II meta exit l\j)e SWIPE 0.0125 41 5CM 0.0125 41 10CM 0.0125 41 llCM 0.0125 41 100CM 0.0125 41 DR(j) 5 No FIIIM D.1nage SWIPE 0.0125 41 SCM 0.0125 41 10CM 0.0125 41 30CM 0.0125 41 100CM 0.0125 41 DR(j) 6 No FIIIM D.1nage SWIPE 0.0125 41 SCM 0.0125 41 10CM 0.0125 41 30CM 0.0125 41 100CM 0.0125 41 9 of 72

Attachment 4 Details of constmction and design of the product (as related to containment and shielding of the byproduct material and any other safet y features under normal and severe conditions of handling, storage, use, and disposal of the product):

The Valeo Instruments Company Inc. TGA 3000 modules are designed to be rugged, compact, and tamper resistant, using materials and constmction methods to provide proper containment and shielding of the radioactive source to maintain minimal exposure of individuals to radiation from the AM-241 source and to prevent unauthorized or accidental access to the AM-24 1 source. Drawing 22 100 I04 below shows the overall design of the TGA 3000 OEM module.

Ionization Source Assembly The AM-241 source assembly NRD LLC model A-00 I is purchased fully assembled from NRD LLC of 2937 ALT BLVD, PO BOX 3 10, Grand Island, NY 14072-0310 per Valeo Instrument Company drawings. Sec drawings 44100 I04 and 44100 I 16 below TGA 3000 Ion Mobility Spectrometer, (IMS) cell assembly The TGA 3000 Module IMS cell assembly is purchased as a complete assembly, less the AM-241 source, from Omlcy Industries Inc. of 150 Corporate Way, Grants Pass, OR. 97526, per Valeo Instruments Company specifications and drawings, sec assembly drawings 44100126 and 44100 127 below TGA 3000 Module Source Assemblv Installation The RD Model A-00 I source assembly installation into the TGA 3000 module IMS Cell Assembly is performed by following the procedures, guidelines and drawings as set forth in attachment 5 of this application. The related safety procedures and safety requirements as set forth in Valeo Instruments Inc.

Radiation Protection Program as authorized by the State of Texas Radioactive Materials License number L01572.

Installation of the TGA 3000 IMS cell assembly into the TGA 3000 Insulator and Insulator Housing.

The TGA 3000 IMS cell assembly is installed into the insulator and insulator housing by following the procedures, drawings, figures, and guidelines, as set forth in Attachment 5 of this applicat ion. Drawings

1. 1. 1. 1. below represent this assembly.

Installation of the TGA 3000 IMS cell assembly to control electronics.

The TGA 3000 IMS module assembly is installed onto the electronic board assembly per figures, drawings and instructions set forth in Attachment 5 of this application.

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Materials used in the construction of the TGA 3000 module.

The materials used fo r the construction of the TGA 3000 IMS cell assembly and directly or indirectly related to the containment and shielding of the radioactive source, AM-241 @ max 20 micro curies, are shown in drawings below.

The TGA 3000 IMS module was submitted to 12 months of usage under normal operating conditions as well as periods of severe conditions. At no time did the measured external radiation levels exceed or even come close to levels required to take action during the period or operating at normal or extreme conditions. The extreme condition testing is described in detail in Attachment 3 of this application.

Storage, handling and disposal of the TGA 3000 module.

After each TGA 3000 module is assembled and tested, they arc placed in ESD resistant protective bags which arc labeled with model, serial number and date. The bagged assemblies are then placed in appropriately labeled storage containers and shelved to wait for forther processing. Every TGA 3000 module distributed comes with an operating manual containing required, safety and handling instructions, as well as labeling per IO CFR 32.29(b), and instructions for safe disposal or return to manufacturer. (sec Attachment 7 for a copy of the user manual) 2 of 72

(b)(4)

VALCO INSTRUMENTS CO., INC.

PN 48100101 TGA 3000 OEM MODULE MANUFACTURING MANUALWITH QUALITY ASSURNACE CHECK POINT PROCEDURES.

TGA 3000 OEM MODULE PN 22100104 I of72

Contents

• Section I- Safety guidelines.

• Section 2- Part Numbers Required.

• Section 3-AM-241 Source Assembly Installation.

• Section 4- Heater Assembly Installation.

• Section 5- Insulator/Insulator Housing/IMS Cell Assembly Installation.

• Section 6- IMS Cell Interface PCA to Processor PCA assembly.

• Section 7- IMS cell assembly installation onto PC board assembly.

• Section 8- Completed assembly views.

• Section 9- Quality Assurance Check List Reference.

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Section 1: Safety Guidelines.

I. Prior to assembly of the TGA 3000 OEM Module, read and understand the Valeo Radiation Protection procedures.

2. Wear disposable latex free, powder free, protective gloves, and lab coat while assembling the AM-241 Source assembly into the IMS cell assembly.

3. Wear the protective g loves throughout the assembly process until the TGA 3000 IMS module is assembled onto the PC boards.

4. Have the Ludlum Model 3 with 44-9 probe readily available during assembly process.

5. Always use the same designated work bench for the AM-24 I source installation.

6. No food or drink is allowed at assembly station.

7. Immediately report to RSO/Acti ng RSO, any survey or wipe test result that exceeds action level of:::200-500 cpm / 0.05 to 0.1 Mr/hr.

8. Do not proceed to next section unti l the QA checkpoint has been cleared for each section as required.

Assessment and Conversion chart for Ludlum Model 3 mc*ter readings.

Survey Meter Readings A1susmen1 ol Measurements Converting radiation meter readings Uni ts Meter Readings op, 0 2.5 111.0 J, J.

mRJhr .... 0 .2 u.3 0.5 J

• • !)/hr lutOl\\f'r\ IOC'Jllll l:l)'l. \bO tp111 3 of72

Section 2: Parts and Part/Drawing Numbers Required.

I. 44100 I 00- IMS Cell Assembly.

2. 441 00104- NRD Model A-001 SourceAssy.

3. 34 100 IO 1- IMS heater Assy.

4. 44100126- IMS Cell Insulator Housing, Upper.

5. 44 J 00 J 27- IMS Cell Insulator Housing, Lower.

6. 44I00 128- JMS Cell Insulator, Upper.

7. 44 1001 29- IMS Cell Insulator, Lower.

8. 28 100 IO I- JMS Cell Interface PCA.

9. 28 100 I 02- IMS Processor PCA.

I0. 44 100 152- PCA Mounting Plate.

11 . 44100 153- Upper Support Mounting Bracket.

12. 46 100 101 - Radiation Warning Label.

I 3. Roll of Mil Spec PTFE tape, W' wide by 0.0032" thick, white in color.

14. Yiton tubing Y.."ID by 1/2"00 cut into I" pieces.

15. Daflon SH24 I PTFE shrink tubing, SH24 1-5/8 and SH24 l-7/8 cut into I" pieces.

16. Torx Head SS machine screws 4/40 X Yi" quantity 4.

17. Zinc Plated Steel stand offs Male-Female Thread 1,'4" hex, 6/32 X 5/8" quantity 9.

18. Stainless Steel (SS) Standoff 5/ 16 Female-Female Hex SS 6/32 X 3" quantity 2.

19. Stainless Steel 6/32 X 3/8"PHMS and number 6 SS flat washers, quantity 11 ea.

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Section 3: AM-24 1 Source Installation.

Note: Refer to figures 1-3 of this procedure for source installation.

I. Put on approved protective gloves and lab coat.

2. Obtain a new manufacturing/quality report check list.

3. Place a clean sheet of industrial grade aluminum foil on surface of work bench w here the AM-24 1 source w ill be installed into the JMS cell assembly. Tape edges of foil down to work surface.

4. Obtain a IMS cell assembly from inventory. Assign and record serial number. This wi ll become the TGA 3000 Module serial number.

5. Remove protective wrap and all caps and plugs.

6. Place on clean aluminum foil surface, prepared in step 2 above.

7. Obtain one AM-241 , 44100 I04, source assembly from the RSO, or authorized us,er.

Record serial number and assign to the TGA 3000 module serial number.

8. Using Zero Grade air with appropriate nozzle, blow air through cell from both ends and side exit tube.

9. Using designated 3/32" Hex driver, Install source into the threaded source holder located inside the IMS cell. T he access is through the '/.i" VCR fitti ng.

Make sure the source assembly is threaded into the source holder properly. Be very careful to not cross thread the assembly.

10. uality Check point I.

• QA check for proper installation of source assembly. Note on QA checklist.

11. Survey check.

• RSO or authorized user, using the Ludlum Model 3 and place the detector surface of the 44-9 probe within '/.i" of the end of the VCR fitting. Record average mR/hr reading in manufacturing quality report check list.

12. Install all caps and proceed to section 4 , Heater installation.

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Figure 2 6of72

Figure 3 M -241 SOURCE ASSEMBLY SHOWN BEING INSERTED Section 4: Heater Installation.

Note: Refer to figures 4-5 of this procedure for heater installation.

I . Make sure all caps are installed prior to heater installation.

2. Obtain heater assembly, 34 100 I OI .

3. Place a I" piece of 1/.i ID, black Viton tubing over the drift end fitting so that it is tight against the back end of the end cap.

4. Take a W' piece of 1-i" ID, black Viton tubing and slit it lengthwise, one cut, and then fit it over the Y..,' tube between the front end cap of the IMS cell and the back of the Y..,' VCR nut.

5. Wrap the heater assembly tightly around IMS cell assy. with the heater connector at the drift, (back end), of the IMS cell assy.

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6. Obtain a roll of white Mil Spec PTFE tape, -W' wide, 0.0032" thick. Cut a piece that is approximately 20" long. Holding the IMS cell securely in one hand, then starting at the front edge of the frontend cap, wrap the tape tightly around cell with overlapping turns the entire length oft:he IMS cell. Make sure the heater is tight against the IMS ce ll surface as the tape is being wrapped around the IMS cell. See figures 4 and 5.

7. uality Check Point 2.

• QA inspect entire IMS cell assembly at this point to ensure the heater is a tight fit to IMS cell surface and proper placement of Viton tube pieces and Teflon wrap.

8. Obtain a l" long section of 5/8" Dia. DAFLON PTFE 4: I ratio,shrink tubing and slip it over rear section of IMS cell assy. The heater connector must go through first, then the shrink tubing will easily slip over the other end section of the IMS cell. The back end of the shrink tube must be even with the back end of the IMS cell end cap. See figures 4, 5.

9. Obtain a l " long section of 7/8" Dia. DAFLON PTFE 4: 1 ratio shrink tubing and place it over the VCR nut and over the front section of the heater assy. Place it over the IMS cell so that the front end of the shrink tubing will be even with the front end of the IMS cell end cap.

10. Obtain heat gun and set the temperature for 327°C or 62 1°F. Place the IMS cell, with heater assembly installed, into a small bench vise by placing the legs of the IMS cell between the jaws of the vice and clamp the assembly securely. Remove all flammable materials away from area where the heat gun will be directed. Make sure all components arc properly aligned and then tum on the heat gun and direct the heated air evenly around the shrink tube, one end at a time. Heat until tubing is at maximum shrinkage then remove heat and repeat at the other end. Let the entire assembly cool to touch before proceeding to next step.

11 . uality Check Point 3.

• Check proper placement of all components.

• Check proper grounding between ground lug of the heater, the drift end metal component and the carrier end metal component. Reading should be less than .5 ohms. Refer to figure 5.

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Figure 4 VITON TUBE SPACER VITON TUBE SPACER PTFE TAPE WRAP HEATER CONNECTOR Figure 5 Ground Resistance Check 9of72

Section 5: Insulator and Insulator Housing Assembly.

Note: Refer to figures 6, 7, and 8 for this section.

I. Obtain PN 44 100126, insulator Housing Upper.

PN 44 100 127, Insulator Housing Lower.

PN 441001 28, Insulator Upper.

PN 44 100 129, Insulator lower.

2. Insert SS 6/32 X W' PHMS through hole in top of the upper insulator housing. Secure with SS #6 lock washer and SS 6/32 hex nut. See fi gure 8.

3. Install Radiation Warning label, 46 100 IOI, and TGA 3000 serial number and date of manufacture label as shown in figure 8.

4. Insert upper and lower insulators into upper and lower insulator housings so that the insulator material is flush to the edges of the insulator housings. See fi gure 6 and 7.

5. Install the IMS cell/heater assembly into the lower insulator housing assembly by placing the legs of the IMS cell assembly into the cut out slot at the bottom of the lower insulator housing assembly. Make sure the exit port tube is aligned with the back most cutout in the lower insulator housing. See figure 6.

6. Holding the bottom assembly securely, place the upper insulato r housing assembly, fi gure 7, over the lower assembly and snap closed. Make sure the 4 screw holes are aligned, figure 8. Secure upper housing to lower housing using four 4/40 X W' Torx head machine screws. Secure heater ground lug in position 2 as shown in fi gure 9. Tighten securely being careful not to overtighten.

7. Quality Check Po int 4.

• Check for proper fastening of screws and ground lug position.

• Check for proper installation of Radiation Protection Label.

• Make sure drift, carrier and exit ports are capped/plugged.

• Survey check. RSO or authorized user, using the Ludlum Model 3 and place the detector surface of the 44-9 probe within Y4" of the end of the VCR fitting. Record average mR/hr reading in the manufacturing quality report check list.

10 o f 72

Figure 6 INSULATOR FLUSH TO INSULATOR HOUS G Figure 7 6/32 PHMS INSTALLED FROM BOTTOM PRIOR TO INSTALLING INSULATOR.

ECURE WITH #6 LOCKWASHER AND 6/32 HEX NUT MAKE SURE TOP AND BOTTOM ASSEMBLIES NAP TOGETHER AND ALL HOLES ARE LOWER INSULATOR HOUSING ASSEMBLY

~ EATERCONECTOR 11 of72

Figure 8 NfATUGflOUNOlUG 12 of72

Section 6: IMS Cell Interface PCA to Processor PCA assembly.

I. Obtain IMS Cell Interface PCA, 28100 IO I, and IMS Processor PCA, 28100 I 02.

2. Obtain PCA Mounting Plate, 44100152.

3. Obtain hardware items 16 through 19 listed in section 2.

4. Install 5 zinc plated steel standoffs to bottom of the IMS Cell Interface PC A, the male threaded section goes through the bottom of the PCA, install 4 of same into rear section of IMS Cell Interface PCA by threading them onto the male threaded portion sticking up through the PCA, install 2 of the SS 5/16 hex X 3" lon g standoffs on the two front holes in the PCA by threading them onto the male threads projecting through the bottom o f the PCA. See figure 9 for hardware positions.

5. Once all standoffs are installed and tightened install the Processor PCA onto the rear standoffs. Be very care ful to properly align the two connectors on the bottom of the processor PCA, Female receivers to the male connectors on the top of the IMS Cell Interface PCA.

6. Secure the Processor board to the IMS Cell Interface PCA with the three nylon 6/32 threaded standoffs.

7. Quality Check Point 5.

• Check alignment of the mating connectors from the top of the IMS Cell Interface PCA to the Mating connectors on the bottom of the Processor PCA. No pins should be showing.

• Check tightness of all fasteners.

Caution Note: Improper alignment will cause immediate electrical damage to the Processor PCA upon power up.

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Figure 9 Hardware Positions.

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Section 7: IMS cell assembly installation onto PC board assembly.

I. Obtain QA checked IMS assembly and install assembly in single row terminal block connector on the IMS cell interface PCA as shoWTll in figure I0.

2. Install as shown in figures IO and 11 . It is critical to make sure every pin is properly positioned when inserted and that the screws on the terminal block for each IMS cell pin is tightened securely, then double checked for each screw. Start front to back then double check from back to front. See figure 11 .

3. Install heater connector onto IMS Cell Interface male heater connector. See figure 12.

4. Install Upper support and mounting bracket, 44100 153. Obtain mounting bracket, two SS 6/32 X 3/8" PHMS, with flat washers and one 6/32 lock nut. Fit support bracket onto the 3" standoffs as shown in figure 13. Secure the upper support and mounting bracket as shown in figure 14.

5. Install IMS Cell Interface PCA ground wire to position 2 of the upper insulator housing as shown in figure 13.

6. Quality Check Point 6. Final QA check complete assembly.

• Check alignment of IMS pins to terminal block.

• Check each screw in IMS cell mounting terminal block for tightness.

• Check all mounting hardware for proper installation and tightness.

• Check for proper ground at all ground points. From carrier inlet fitting to IMS cell interface ground point on the board, same from drift end fitting, same for IMS insulator housing surface to 1MS cell interface ground.

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Figure I 0 Figure 11 16 of72

Figure 12 Figure 13

• ,

17 of 72

Figure 14 ONE SS 6/32 PHMS WITH SS FLAT WASHER HERE 18 of72

Section 8. TGA 3000 Finished Assembly Views.

Right Side View. Exit Port Side.

Left Side View. Ground Stud Side 19 of72

Front View (Drift Inlet End)

Rear View (Carrier Inlet End) 20 of72

Section 9. T G A 3000 OE M Module Quality Assurance C heck List.

Valeo Instruments Co., Inc.

TGA 3000 OEM MODULE QA CHECK LIST DATE: _ _ _ _ __

TG A 3000 SERIA L NUMBER: - - - - - - -

QA INSPECTOR NAME: - - - - - - - - -

QA CHEC K POINT 1- Source Assembly Insta llation C heck.

PASS 0 FAI L 0 COMM ENTS: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __

QA C HECK POINT 2- IMS Heater Assembly C heck.

PASS 0 FAIL 0 C OMMENTS: _ _ _ _ _ _ _ __ _ _ __ _ _ _ _ _ _ _ _ _ __

QA C HECK POINT 3- Heater Shrink Tubing Assembl.y and G round C heck.

INST ALLATION PASS 0 FAIL 0 C OMMENTS: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __

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QA CHECK POINT 4- l nsulator/l nsulator Housing Assembly C heck.

PASS 0 FAIL 0 COMMENTS: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __

QA CHECK PO INT 5- IMS Cell Interface PCA to Processor PCA Assembly C heck.

PASS 0 FAIL 0 COMMENTS: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __

QA CHECK POINT 6- Final Assembly C heck.

PASS D FA IL D COMMENTS: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __

ADD ITONAL COMMENTS: _ _ __ _ _ _ _ _ __ _ __ _ _ _ _ __ _ __ __

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Attachment 6 Radioactive Labeling Each Valeo Instruments TGA 3000 wi ll be labeled in accordance with IO CFR 32.29(b) as shown below. Pictures of the placement of this label can be found in the Valeo TGA 3000 manufacturing manual which is included in attachment 5 of this application.

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i--- - - - - - - 2.5 0 0 - - - - - - --

1*

0.680 CONTAINS RADIOACTI~ MATERIAL RAOIONUCI..UOE: AM-241 ACllVllY: 20 uCI J0.450 MANUFACl\JRED BY VALCO INSTRUMENTS L.

COMPANY INC. UNOER U.S. LICENSE ANO 0.340 IN COMPLIANCE \\llH NRC I OCF'R 32.26

~ -- - - - - - - - - - - , - - *_ l R 0.100 4 PLACES U o.275 LABELS: RED TEXT ON CHROME BACKING, MINIMUM 10 POINT PRINT. RADIATION SYMBOL- MAJENTA ON YELLOW. PERM>\NENT ADHESIVE BACKING, (PEEL AND Sl1CK LABELS)

VICI Valeo tnstr ....., nt~ Co.

2 of 72

li:il _ _ _

CiJ--

...--

---

W&taa*--

441N1*1H' . . CIU lalAMII IG8NII IMII, Ill IH>~TQIIHILDNt 0-t:==1-+1 r-T'--b--~~u

'ataxc~~"U.<nON

......... l"IOMUT,

~a.II

- --

.. ,..,.

-*-

3 of 72

6/32 PHMS INSTflllEO FROM BOTIOM PRIOR TO INSTALLING INSULATOR.

ECURE WrTH 116 LOCKWASHER ANO 6/32 HEX NUT 4 of 72

VALCO INSTRUMENTS CO., INC.

TGA 3000 OPERATOR MANUAL PN 48100102 PN 22 100104 I of72

CONTENTS Section I: Unpacking and safety considerations.

Section 2: Document Package Contents.

Section 3: Familiarization.

Section 4: PC and Power Suppl y requirements.

Section 5: TGA 3000 Software Installation Section 6: Set up.

Section 7: Operation.

Section 8: Shutdown 2 of72

Section 1: Unpacking and safety considerations.

CAUTION:*.*

THE TGA 3000 OEM MODULE CONTAINS RADIOACTNE MATERIAL, RADIONUCLIDE: AM-241 ACTIVITY S 20 MICROCURJES MANUFACTURED BY VALCO INSTRUMENTS CO., INC.

THE RADIOACTIVE SOURCE IS SHIELDED SO THAT NO RADIATION ABOVE NORMAL BACKGROUND LEVELS BACKGROUND ARE EMITTED.

1. Locate Wipe Test document with shipping documents and retain for safe keeping.

2. Remove TGA 3000 OEM module, AC/DC power supply from packaging and examine for damage. If damage is evident notify shipper and Valeo Customer Service Immediately. Have serial number and order number ready for Valeo customer service. Contact infonnation will be with the shipping documents.

3. Place TGA 3000 OEM module on a clean static free work surface.

4. The TGA 3000 OEM module bas areas of high heat and high voltage, observe labels and take necessary precautions. The high voltage areas are shown in figure 2 of this manual.

5. Keep liquids away from work area.

6. Handle with care always.

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Section 2: Document Package Contents.

1. Valeo Instrument Co., Inc. Wipe Test Letter.

2. TGA 3000 OEM Module Operator Manual.

3. Valeo Customer Service Contact Information.

4. TGA 3000 Software Disc and Software Installation Guide.

5. Return Shipping Documentation for TGA 3000 OEM Module ifneede~.

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Section 3: TGA 3000 OEM Module Familiarization.

1. See figure I for nomenclature.

Figure I MO\JNTIIIG PIATt

2. The carrier inlet, drift inlet, and exit port surfaces will be hot when the TGA 3000 OEM Module is powered up and running at normal operating parameters. These surfaces could get as hot as 200°C (392°F) during a bake out run.

3. To prevent contamination, the carrier inlet plug, drift inlet plug, and exit port plug should be left in place until the TGA 3000 Module is made ready for use.

4. There is a AC/DC converter power supply provided with the TGA 3000 OEM module. See figure 3. It is recommended that this power supply or 5 of 72

equivalent be used with the TGA 3000 OEM Module. Section 4 will detail power requirements.

Figure 3

'C/OC CONV(Rl(R POWlR SUPPlY* INPUl VOllAGf 80-26-' VAC.

CURRENl IIANG[ CH.QA. OUlPUT VOllAG[ IS VOC. l~W. WOIIKING T[MP{RATUR[ *l010*60C.

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Section 4: PC and Power Supply requirements.

1. Desktop, laptop with Windows 7, Windows 10 OS. Must have at least one USB port and one ethernet port for connection to TGA 3000 OEM Module.

CD/DVD player/reader, internal or external.

2. There is a AC/DC converter power supply provided with the TGA 3000, however if application is such that another power supply is required. The alternate AC/DC converter power supply must be able to provide highly regulated l 5VDC output, 0 to 7 Amps minimum, with low ripple ~ 180 mVp-p, having continuous operational temperature range of -30°C to +60°C.

Section 5: TGA 3000 Software Installation.

1. Install CD

2. Folder TGA 3000_V J J .2.4 should appear

3. Open folder below icons should appear. Click on TGA3000.msi. icon.

Name Date mod1f1ed Type Size vcredisLx86 4/19/2017 4:52 PM File folder

t; setu p.exe 12/5/201611.05 PM Apphcatton 366 KB

{I TGA3000.msi 12/5/2016 1105 PM Windows Installer Pa ... 3.048 KB

4. The below window should appear, click next and follow installer instructions.

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~ TGA 3000 X Welcome to the TGA 3000 Setup Wizard The installer will guide you through the steps required to install TGA 3000 on your computer WARNING: This computer program is protected by copyright law and international treaties. Unauthorized duplication or distribution of this program. or any portion of it. may result in severe civil or criminal penalties. and will be prosecuted to the maximum extent possible under the law.

Cancel Next >

5. Create Desktop Shortcut Icon if desired.

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Section 6: Setup

1. Place the TGA 3000 Module on a clean, flat, static free surface.

2. Remove all caps and plugs from carrier, drift and exit port fittings. Be particularly careful with the drift and exit pori fittings, these are fragile and could break if improperly tightened or loosened. Always use two wrenches, one on interior fitting and one on outer fitting to loosen or tighten hardware,

3. Make sure UHP gas supply is off during installation to the TGA 3000 Module. Install desired U HP regulated gas lines with proper fittings, one to carrier and one to drift. The exit port can be left open or plumbed to vent in another area. Ensure ID of exit port tubing used is sufficient to avoid any back pressure on the TGA 3000 module. It is highly recommended that the VCR gaskets and Valeo fitting gaskets be of high quality to ensure leak free connections.

4. The maximum flow through TGA 3000 IMS cell is 300 cc/m for a stable spectrum. The typical desired flow would be I00cc carrier and I00cc drift.

This is all measured at the exit port for total flow of 200 to 300 cc/m.

5. See table below fo r approximate regulator pressure in psig that will provide 200cc to 300cc total fl ow. In line restrictors may be used to optimize flows.

UHP SUPPLY GAS INLET PRESSURE Argon 20 psig Nitrogen 25 psig Oxygen 22 psig Helium 15 psig 9 of 72

6. Tum on UHP gas supply in accordance with table above. Note the TGA 3000 may be run in static condition with ports open in room air with a brushless DC pump with suction side attached to exit port to create flow of ambient room air through the TGA 3000. This would be the desired method for monitoring room ai r contaminants etc.

7. Install AC/DC converter power supply provided.

8. Slide on/off switch to on. Listen for one short beep. This indicates that self-check is complete and is TGA 3000 is ready. A series of beeps indicates error.

9. Open the TGA 3000 folder on the PC desktop and use shortcuts a select program on desktop and wait for window to appear. Follow instructions in figures 4, Sand 6.

10 of72

Figure 4 Operation The on board PC will have a "TGA 3000" folder located on the desktop, open the folder then use the shortcuts labeled for the analyte and base gas for which it was tested. For example, if the TGA3000 was shipped to measure H20 in nitrogen, the icon located in the "TGA 3000" desktop folder will be labeled, "H20 in nitrogen.

1. After the initial power up, verify the sample in is the correct base gas.

2. Double click the appropriate shortcut located in the 'TGA 3000" desktop folder.

3. Click OK on the following screen(s) which will allow the PC to connect to the detector cell

4. Click on the wvf tab to verify the "CONNECT" tab is active on the top row. If t he tab shows CONNECT, the user o press this tab and the name should change to DISCONNECT.

11 of72

Figure 5

5. The initial analyte concentration will read > 30 ppb until the system is purged with "clean" gas. The total internal TGA300o volume Is < 10 cubic centimeters and typical drydown / purge times can vary depending on the previous use (shut down procedure) and quality of sample gas being used. Start up times of< 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> to reach

< 10 ppb H20 or 02 readings can be achieved The concentration is displayed on the main screen:

IH20 in Nitrogen I - l ppb

~ -=--

2013-02-18 [

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12 of72

Figure 6 Concentration Screen The actual spectrum is also available by clicking on the VfVF tab:

,,

Spectrum Screen The user can save a spectrum "snapshot" by clicking on the Windows FILE/SAVE icons.

This spectrum file should default to a ".bwv format which can be sent to a qualified service agent for review.

The CFG, MEAS, CAL and ID tabs/screens are for qualified service personnel reference only.

13 of72

Figure 7 Shows typical dry Spectrum in Argon.

After connection are made allow several hours of dry down time for stable spectrum.

Section 8: Shutdown I. Turn off the power.

2. Cap the exit port

3. Shut off regulator or supply gas.

14of72

• Real-time ,esulu, in situ or on&ne

• Sample flow less than 200 ml/min

• No Vilwum pump. no moving parts

• Operating rilflgt of 0-30 ppb U11diluted or 0-1000 ppb dauted

• Onboard PC operation/concentration dispby

• Variety of ,vailable outputs:

RS-232. ethernet. **20mA. log file f<< many ye~ the Ion Mobility Sped,ometer OMS) has been successfully used to detect ~ phase trace con~ts in a v-ty of ;appl,uuons. In general tenm. the IMS is an elewONC. 4PS phase, atmospheric preiS!Ke, trace chemical -lyzer provicmg Sl.b-ppb detection limits with chemical disoinw,ation b~ upon ion mobility.

IMShas been shown to bt an effectM technique for the detection of many imporUnt trace conlilminilnts in five major UHP bullc gases. OetK1Jon limits less than 0.1 ppb have been demonstrated.

1 of 72

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Atfachmcnt 9 REQUEST TO WIT IIOLO INFORMATION FROM PUBLIC DISCLOSURE UNDER 10 CFR 2.390 The technical drawings marked " PROPRIETARY" in red capital letters included in the Attachments of this appli cation for the Valeo Instruments Company, Inc. Model TGA 3000 OEM Module are considered the property or Valeo Instruments Comp.my, Inc. and represent information or a proprietary nature. Valeo Instruments Company, Inc. hereby requests that thi s information be withheld from public disclosure.

This information contains details on the design or the Model TGA 3000 and would cause substantial harm irrcvcalcd lo our competitors.

This information is sent to the NRC in confidence and is unavailable in any other public document.

If the NRC determines that this information is not necessary to our application, we request that it be returned to us or destroyed.

For the applicant:

Signature ~ [)Amw,IJ _ Date: ~ 2S)2[,/y-Print Name: Stanley D. Stearns Title: President and Radiation Safety Officer Valeo Instruments Company, Inc.

Post Office Box 55603 I louston, Texas 77255 (7 13)688-9345 Stan@V ICl.com 68 of 72

Attachment l 0

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11 . F.nch ,i1e shall ma1mai11 documcnh and record~ penmenl 10 1hc opcm1io11\ a, 1h.11 ~ire Copii:~ of all documc111, Jnd rc.:unl~ required by 1his license ,hall he rru,imamcd for AgcllC) review .11 Sile 003.

12. Radioac1i,*c 11~11crial shall he u~,-J only by St1111lcy D. S1car11>. John Durr, Sieve Wcrocr. fananU~,n MadJhu,h, and/or Uob Sternberg.

13. I he md1v1dual dcs1gna1cd 10 perform lhc func11ons of Rall1a1 ion Sa(i:1) Officer (RSO) lorac11vi1ii.::. cowrcd by thi5 license is S1anle) 0. S1cam,.

14. lklt.'1:lllr cells containing 11-3 foil , hall only he UM!d in coniunc11on wnh a properly operating 1cmpcmturc conrml mcchani\m "hich prc,enls foil tc111r1en11urc from cxcc,'lling 225° CcrlliJ.lmdc lor 1i1an1um 1ri11dc lo1b and 325° <.:cnt1grJ1lc f11r 'IC:tndium rritide foil5.

15. Dctt."<:lnr cell\ contninmg 11 3 shall be umalled ~) chm lltc e,tmun L, ,coled to 1hc ouhidc uuno:.pherc. to a hood ;)',tent vcnls'll tn 1hc uumdc alnM11rli.:rc, or 11110 1hc procc~* \trc.,m lb. n ,c ltccn~--c <hnll r*'f)l>n to rhc Al(cne)* all 11111~,rcr\ of llcvicc,i dis1rihu1ed unller 1his licen\e 10 perwll.\

gcncmlly licemoo un.Jcr the pruvhiuns uf 25 TAC ~.!89.2.S 1(1)(4)(11). Such rcpon ,h11ll u.lc1111l)' each j!cncral liccn<cc by rumc and addrcs\, 1hc type of device cmnsfcrrcd, and the qua111i1y and t)pc of r,1llt0acmc nJJtcrial comninl'\J 1111hc device. I he rcpon ,hull he ,uhmmed wnhin th1ny day, after 1he end of c.u.:h c.ilendnr quaner in "hich any such de, ice i; tm lblcrr.'ll 10 a generally liccn<K-d pcrwn.

17 The licensee shall furmsh a copy of 2.S TAC §289.251(1)(4XHI 10 cmch gcncml lkcnsl'C 10 \\-hOm thc llcvN:c i, 1mn'lfcmd.

18. Ille liccrt~ <hall tc~t each dev,cc di,rribu"'<l under this ltcen~ for leJkage nr conra111in.11ion of m<lio.1ctl\e material 11rior to 1ra11~fcr.

1<> 1111: llcen'lec ,hall co110uc1a pll)Slcal lnvcmory cvef) \I, 111011111, io ac*ou111 ror nil ,cakd ,oun;cs n;'Cciv,'\l an<l po,-.c~~'ll under the ltccn...:. I he n;'Cord~ of the i111*cn1orie5 ma ll be maintained for t\\ O }Cars lrom the date of the inventory (or in~pcrnon b) the., Agency an<l ~hall iriclu<lc the l(UAnlitics an<l chi: kind) of rad t1>ac11vc ma1cnal. IC1Cn11on of 'ICalct.l ~ourcc~. and lhc dale of the m, cnlOI)

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22. 'I he hccn~cc i< a111hmiz~ 10 test for lca~ugc of Ni 63 u,i1111 the lice1l5CC', Lc.ik I <:.'II Ku. Such tcsu 5hall be cnpable uf detecting 0.005 microcuric:5 of contamin;ition on the test sample. The ~..,ult~ of <11th tc<t<

~hall he pmvided 10 the customer in micmc:uril.'S.

23. A. Pur,ll11111 to the Tcuu Katl1u1i1111 Control Act and 25 fAC §289 2S I un ucknowkdgcmcm is hcrchy

"~ut.*d to the hcclb(.'C li~tod in Condition I of thil Ike~ 115 a General Liceruee for Ilic possc.,s1un. use and tran<fcr of rndioacti~c m.1terial co111ain1,'tl III dcvic,-, oht~int.'tl under 1J1c pmvi,ion~ of 25 TAC

§289.251(g). The gcncral hccn~c i~ \llhJect ro all applicable mies. regulations and ortlers of the Ocpanmem of State llc:11th Services (Agency) now or hereon er in cffoc1.

8. *nic &cncral lic:ell)t.'C )hall con~>ly with the npplicahlc prov1,ion\ or2~ I AC §289.2:1 1, §289.201.

§289.202(w,q anu Cu). §289.2(),1, §289.205. and ~289.257.

C 'f11e lolluwin11 radiwcmc m:ucnal po~,.<,ci.St.'t.l under the a111hon1a11on of the general license gr:1n1cd m 25 Ti\C §289.251(g) sh.Ill he o,t'd only for rhr purpo-e for which the tlrvicc cnnrninina th~

l'lld10.1c11vc material WM approved as specified in the Kcgutry or Radioocti~c Scak'tl Source~ and De, ice!, Ponnhlt1 and/or mobile dovi<:cs may al'l<l he u,l'<l tit temporary <ttc,. in arca_1 not under c,clu,avc Fl'dcral 1uri$<l1cuun. 11trouglrou1 re~a5.

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24. l\~;c,s1on ,mtl ,tor.1gc nl thc ,oun:e identified m Cond11101\S 5. 6. 7111kl 8, P.in, C E of th1\ license" authori,c:d preparatory 10 lratl\ lcr ul tl1e5c ~oul'Ce:\ tu :rnuthcr hceu:,t:d cntity before: May 3 1, 2013.

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applica1iun diltt.'CI l\1Rrd1 15, 200S ,

lcucrs dated Jnmmry M. 2007. Murch 14. 2007, April 2.S. 2007 and l*cbruary 10. 2011.

25 TAC §289 )hnll pre, :iii mer s1ntcmcn1~ conu1incd m lhe above documcn1s unless i uch ~1atc111.:111* arc more rcs<<ricll\'c 1han the rcgulaiions.

KEE FOR TIIE DEPARTMENT 0 1* STATF. HFALTII Sl3RVICCS Date October 25. 2011 Rll)'Fltt1J!~'rugram Cuol'llillllmr A1hancoo Technology Liccn~ing Prugrnm 72 of72

November 20, 2017 Richard K. Struckmeyer and Hernando Torres Materials Safety Licensing Branch Division of Material Safety, State, Tribal, and Rulemaking Programs Office of Nuclear Material Safety and Safeguards U.S Nuclear Regulatory Commission 11555 Rockville Pike Rockville, MD 20852 RE: NRC Request for Additional Information, Valeo Instruments letter dated October 26, 2017; Docket# 030-39061

Dear Mr. Stryckmeyer and Torres:

In response to your letter of October 26, 2017, Valeo Instruments offers the information below. For your convenience, I have rewritten your questions prior to each response.

A.1 . The Valeo Instruments Company (Valeo) application dated May 28, 2017, provides a mailing address for Valeo. Please provide the address of the facility where the TGA 3000 will be manufactured.

The TGA 3000 will be manufactured at:

Valeo Instruments Company, Inc.

8300 Waterbury Drive Houston, Texas 77055 A.2. The Valeo application states that the TGA 3000 has been designed to be an addition to the already in place detection systems rather than a stand-alone device. Please discuss how the TGA 3000 will be distributed, whether it will be distributed as a component to a detection system, or separately. Please identify and provide details on the detection systems that will use the TGA 3000.

The TGA 3000 OEM Module is designed to be a stand-alone detector, with the core technology being Ion Mobility Spectrometry, (IMS}, which may be used in many different applications where IMS would be the technology of choice. The original reference to ualready in place detection systems" was to indicate that customers may install the device into existing gas sampling systems that may or may not use other radioactive devices. Depending on their application, the customer will have the option to choose whether to install the TGA 3000 as a singular gas detection device or in-line with another gas sampling system. The TGA 3000 will perform its detection and impurity analysis independent of any Page 1 of 11

other system. As described 1n section 4 of attachment 7 (The "TGA 3000 Operators Manual") after the TGA 3000 is plugged into a gas sampling line, the only additional requirement is a computer with a USB and an Ethernet port capable of running the Valeo TGA 3000 analysis software.

A.3. In your application you indicated that the expected useful life of the product through normal usage, and with proper care, should be between 10 to 15 years.

Please discuss what factors would cause the device to have a useful life of 15 years vs. lasting 10 years.

The expected useful life of the TGA 3000 OEM Module was determined by using the information supplied by the manufacturer of the custom heater used on the TGA 3000 IMS cell. The heater 1s the one component that would be under the most stress during normal operation. The TGA 3000 can be turned on and left on for as long as desired or it can be cycled on and off at various intervals. The heater manufacturer stated that given our design specs and operating parameters the heater life expectancy would be approximately 10 years if cycled on/off several times a day and approximately 15 years if cycled on/off on a monthly schedule. Thus the 10 to 15 years was indicated in the application. If it pleases, the 10-year expected useful life may be used rather than the 10 to 15 years stated.

A.4. The engineering drawings submitted did not include complete dimensions of the TGA 3000. Please resubmit the engineering drawings to include all of the overall dimensions and the units of measure.

If the TGA 3000 will be distributed as a component to a detection system, provide engineering drawings that include dimensions and units of measure for the de*tection systems.

See attachment 6 Rev 1 for complete dimensions in inches, unless otherwise specified, as well as labels to be used.

A.5. Discuss the assembly methods used by the detection systems.

The assembly methods are explained in attachment 5 along with the quality assurance check points

• A.6. Indicate if the ionization source assembly, assembled by NRD LLC, includes the installation of the source in to the source holder.

This is indicated in attachment 4 , paragraph 3, with reference to drawings 44 100104, and 44100116 of attachment 4 The 20uCi AM-241 foil source is installed into a specially designed stainless-steel source holder, and shipped as a sealed source assembly. The source cavity edges are peened so that the source cannot be removed or fall out. The cavity is so small that human contact with the source , once installed, is highly improbable. The sealed source is shipped completely installed and sealed in the source holder and leak tested and certified by NRD LLC. Prior to shipment to Valeo.

Page 2 of 11

A. 7. Provide the materials of construction used for the TGA 3000 and the detection systems.

The TGA 3000 is an OEM Module. See new attachment 11 for drawings and material call out lists.

A.8. Discuss whether there is any potential for corrosion between unlike materials used in the construction of the TGA 3000 and detection systems.

There 1s no potential for corrosion under normal operating cond1t1ons. The TGA 3000 OEM IMS Cell Assembly is constructed with Kovar, and 96-97.5% AL203, and 18-8 Stainless steel. These materials were selected for similar thermal expansion coefficients for high temp brazing, as well as non-corrosive properties.

A.9. Identify the material used for the label on the TGA 3000.

See 44100101 Rev 1, and 44100102, of attachment 6 for drawings and material specs.

A.10. Based on your description of the TGA 3000, it appears that the TGA 3000 will be incorporated in stand-alone device. Provide the labeling to be used on the stand-alone device to identify the use of radioactive material.

See Attachment 6 drawings 44100101 rev 1 and 44100102.

A.11 . Please provide the maximum allowable temperature, vibration, and shock for the TGA 3000.

Minimum operational temperature -25°C Maximum allowable operating temperature +75°C Vibration Failure at 35 Grms (Gravity Root Means Squared)

Shock 48" static drop failure was bent exit tube.

There were no measured radiation levels above background for any of the tests A.12. Please indicate where the IMS cells were hit when the drop test was performed.

Indicate which part of the cell will be more vulnerable when dropped.

The nature of the IMS cell construction has the majority of the weight being at the front end, or carrier inlet end where the ~- VCR fitting is placed. The majority of the static drops resulted in the IMS cell assembly impacting the concrete floor at approximately 45 degrees and the impact point would always be with the front, VCR fitting, making impact first. The IMS cells were always dropped from a flat surface by being pushed off the edge of the flat surface The drop tests showed that the weak point of the IMS cell would be around the side exit port. None of the cells tested resulted m any breakage of any sort that would diminish the shielding of the AM-241 source. This was shown in the drop test tables in attachment 4.

Page 3 of 11

A.13. Your application indicates that the TGA 3000 IMS module was submitted to 12 months of usage under normal operating conditions as well as periods of severe conditions. Please describe these severe conditions.

The periods of severe conditions were 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> operating at 0°F then removed from freezer environment, allowing for ambient equilibration while running . No failures during this course of action.

The other severe condition was operating in a closed lab oven set to 65°C for 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />. Again . there were no failures noted at 65°C These conditions were repeated 12 times over the course of several months The carrier and drift gas used for testing under these conditions was UHP Argon .

A.14. The Valeo application provided quality control procedures for the TGA 3000.

NUREG-1556, Volume 3, Revision 2 states that a minimum a Quality Assurance Program needs to ensure that (i) the materials of construction and the final assembly meet the design specifications; (ii) the final product is leak tested ; (iii) a final radiation profile is performed; (iv) a test if performed that verifies that the product operates as intended, including all safety features; and (v) a visual and mechanical inspection is performed of components that are considered related to safety or are expected to be susceptible to failure under extreme or unusual conditions.

Discuss how Valeo intends to meet these items and provide a description of the Valeo Quality Assurance Program on how Valeo will ensure oversight and control over all activities applicable to the design, fabrication, inspection, testing ,

maintenance, repair, modification, and distribution of the TGA 3000.

See the QA procedure checkpoints in Attachment 5 Rev 2 and the QA procedures found in New attachment 13 A.15. Please discuss whether the TGA 3000 or the stand-alone detection systems are fixed or portable.

The TGA 3000 can be either portable or fixed depending on application and end user requirements. Since the TGA is designed to be plug and play, the end user may choose to install the TGA 3000 into a fixed installation for gas sampling or to install into a portable format that could be moved to different sampling locations.

8 .1. Section 32.30(b)(3) requires the applicant to submit information concerning the chemical and physical form of the byproduct material in the product and changes in chemical and physical form that may occur during the useful life of the product.

The NRD A-001 Am-241 source used in the TGA 3000 is a foil source. The foil construction is comprised of a gold or silver overcoat and undercoat, gold or silver plus americium-241 oxide active layer and silver or gold backing 0.006-0.007 inch 1n thickness that are welded and rolled to give complete sealage. The entire surface of the sealed unit is gold plated. The standard foil is fabricated with the active layer centered between two inactive margins Page 4 of 11

The properties of the precious metals are well known and there will be no significant change in the chemical or physical form of the sources during their useful life. A study was made by R. G. Niemeyer ("Containment Integrity of 226 Ra and 241 Am Foils Employed in Smoke Detectors," ORNL-TM-2684 (1969) on foils which had been in normal use m smoke alarms for 5-14 years and no aging effects were observed. Niemeyer concluded that the foils could adequately contain the radioactive material, in normal use environments, for a 50-year lifetime. The projected useful life of the TGA 3000 is a maximum of 15 years.

B.2. Section 32.30(b)(4) requires the applicant to submit information concerning the solubility in water and body fluids of the forms of the byproduct material contained in the product.

REF: R. S. Neimeyer {ORNL-TM-2684) performed a total of 23 twenty four hour water leach tests and 15 three week water leach tests on eight Am241 foils which had been removed from five to six year old smoke alarms. The sources contained approximately 15 microcuries of Am241 each and half of the sources were deliberately damaged by drawing a sharp tool along the entire length of the foil before the leach tests. The maximum activity leached in these tests was 0.0045 microcuries. which was less than the 0.005 microcuries of leakage allowed by NRC's standard leak test condition for alpha sources. The average activity leached during the 38 tests was 0.9 nanocuries and 11 of the 38 tests leached less than 0.02 nanocuries.

Ref: Dale H. Denman, Batelle Pacific Northwest Laboratory, Health Physics 1.§.,

480 ( 1969} stated, with a literature citation to ICRP Report 11. "Because most of the compounds of the transplutonium elements are insoluble in biological fluids, ingestion and percutaneous absorption are unlikely to result in significant body burdens. For example, less than 0.01 %of the Americium 241 taken into the gut ultimately reaches the critical organ, bone. Hence, at least 500 Micro C1 of insoluble Am241 must be ingested to product one bone burden (0.05 Micro Ci}."

Since the Am241 used in the Valeo TGA 3000 is Am02, intimately bound in a matrix of precious metals, leaching of Am241 into body fluids from these sources would be less than stated above for insoluble compounds of Americium .

8.3. Section 32.30(b)(5) requires the applicant to submit information concerning details of construction and design as related to containment and shielding and other safety features under normal and severe conditions of handling, storage, use, and disposal. The response to this item may be provided in conjunction with items 4 through 7 in Part A of this enclosure.

See the responses A4 through A?.

8.4. Section 32.30(b)(6) requires the applicant to submit information concerning maximum external radiation levels at 5 and 25 cm from external surface of product and the method of measurement. Your application provided radiation profiles at 5, 10, 30, and 100 cm, but not 25 cm as required by Section 32.30(b}(6). The response to this item may be provided in conjunction with item 14(iii} in Part A of this enclosure.

Page 5 of 11

See the revised test results found in attachment 3 rev 1.

8.5. Section 32.30(b}(7) requires the applicant to submit information concerning the degree of access to human beings during normal use.

In Enclosure 2, Item (d) of your application, you stated: "No access to the ionization source is afforded by the end user or any individual other than authorized users once the TGA 3000 module has been assembled in accordance with the Valeo Instrument Company Inc. assembly and safety manuals. There is no direct access point to the AM-241 source once assembly has been completed."

Please explain what is meant by "authorized users" and how they differ from "end users." The statement as written appears to be self-contradictory.

As shown and explained in the attachments under normal use conditions there is no access to the source. The source can only be accessed by disassembly of the IMS cell which is only authorized to be done by Valeo employees. Authorized users, as listed in enclosure 2 should have been defined as only Valeo employees trained in all aspects of operation, assembly, radiation safety and quality control for the TGA 3000. This is what was meant by authorized user.

8 .6. Section 32.30(b)(8) requires the applicant to submit information concerning the total quantity of byproduct material expected to be distributed annually.

Projections for demand and manufacturing schedules indicate that in the first year of production a maximum of 25 units would be distributed. Within 3 years 1t is anticipated that the maximum manufacture and distribution of TGA 3000 will be 100 units per year.

8 .7. Section 32.30(b)(10) requires the applicant to submit information concerning the proposed method of labeling or marking the product and its point of sale package to satisfy the requirements of§ 32.32(b}. Although you provided information concerning this requirement that pertains to Sections 32.26 and 32.29, you should submit such information to show how you would satisfy Sections 32.30 and 32.32. The response to this item may be provided in conjunction with Items 9 and 10 in Part A of the enclosure. Please provide revised drawings that show labeling that complies with § 32.30 and § 32.32.

As noted in response A9 and A10 above, attachment 6 contains the requested information showing labels.

Section 32.32(b) provides the details of the requirements of Section 32.30(b)(10) pertaining to labeling. Section 32.32(b) requires the applicant to submit the following information concerning product labeling:

Label or mark each device and its point-of-sale package so that:

Each item has a durable, legible, readily visible label or marking on the external surface of the devi,ce containing:

Page 6 of 11

The following statement: "CONTAINS RADIOACTIVE MATERIAL";

The name of the radionuclide(s) and quantity(ies) of activity; An identification of the person licensed under§ 32.30 to transfer the device for use under § 30.22 of this chapter or equivalent regulations of an Agreement State; and Instructions and precautions necessary to assure safe installation, operation, and servicing of the device (documents such as operating and service manuals may be identified in the label and used to provide this information).

The external surface of the point-of-sale package has a legible, readily visible label or marking containing:

The name of the radionuclide and quantity of activity; An identification of the person licensed under§ 32.30 to transfer the device for use under § 30.22 of this chapter or equivalent regulations of an Agreement State; and The following or a substantially similar statement: "THIS DEVICE CONTAINS RADIOACTIVE MATERIAL AND HAS BEEN MANUFACTURED IN COMPLIANCE WITH U.S. NUCLEAR REGULATORY COMMISSION SAFETY CRITERIA IN 10 CFR 32.31. THE PURCHASER IS EXEMPT FROM ANY REGULATORY REQUIREMENTS.

See the label in Attachment 6 The following two requirements from Section 32.30 will be satisfied provided that sufficient information is supplied that addresses the referenced portions of Section 32.31 , which is discussed in greater detail below.

Section 32.30(b)(13) requires the applicant to submit information concerning the estimated external radiation doses and committed doses resulting from the intake of byproduct material in any one year relevant to the safety criteria in § 32.31 and the basis for these estimates; Section 32.30(b)(14) requires the applicant to submit information concerning the determination that the probabilities with respect to the doses referred to in § 32.31 (a)(4) meet the criteria of that paragraph; With regard to items 8 and 9 below, you provided statements, without supporting evidence, that were intended to address the requirements of 10 CFR 32.28. The requirement that should be addressed is 10 CFR 32.31, which is similar.

Specifically, in Enclosure 2, Item (e) of your application, you stated:

Due to the design and manufacture of the TGA 3000 module, it is highly unlikely that there will be a significant reduction in the effectiveness of the containment, shielding, or other safety features of the product from wear and abuse likely to occur in normal handling and use of the product during its useful life.

Page 7 of 11

Also, in Enclosure 2, Item (f) of your application, you stated:

Due to the design and manufacture of the TGA 3000 module and if used under normal use and specified operational guidelines the probability is low that the containment, shielding or other safety features of the product would fail, under such circumstances, that a person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in Column II of the table in 10 CFR 32.28, and the probability is negligible that a person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in Column Ill of the table in 10 CFR 32.28. Under normal use and conditions any disposal of a single unit or handling, shipping and storage of units are unlikely to accumulate in one location.

The quoted statements do not by themselves satisfy the requirements of 1O CFR 32.31 . To do so, you should provide the details requested in Items 8 and 9 .

See the "Radiological Assessment of The Valeo TGA 3000" found in the new Attachment 14.

B.8. Section 32.31(a) requires an applicant for a license under § 32.30 to demonstrate that the device is designed and will be manufactured so that:

In normal use, handling, and storage of the quantities of exempt units likely to accumulate in one location, including during marketing, distribution, installation, and servicing of the device, it is unlikely that the external radiation dose in anyone year, or the committed dose resulting from the intake of radioactive material in any one year, to a suitable sample of the group of individuals expected to be most highly exposed to radiation or radioactive material from the device will exceed 200 µSv (20 mrem).

Please provide an evaluation which demonstrates that this requirement will be met. Methodologies for making such a demonstration are provided in NUREG-1717, "Systematic Radiological Assessment of Exemptions for Source and Byproduct Materials," available at: https://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1717/. Note that NUREG-1717 was published pirior to the establishment of the regulations in 10 CFR 30.22 and 10 CFR 32.30; however, the methodologies provided for gas and aerosol detectors are generally applicable to the type of industrial device in your application.

It is unlikely that the external radiation dose in any 1 year, or the committed dose resulting from the intake of radioactive material in any 1 year, to a suitable sample of the group of individuals expected to be most highly exposed to radiation or radioactive material from disposal of the quantities of units likely to accumulate in the same disposal site will exceed 10 µSv (1 mrem).

Please provide an evaluation which demonstrates that this requirement will be met.

Page 8 of 11

It is unlikely that there will be a significant reduction in the effectiveness of the containment, shielding, or other safety features of the device from wear and abuse likely to occur in normal handling and use of the device during its useful life.

Please provide an evaluation which demonstrates that this requirement will be met.

In use, handling, storage, and disposal of the quantities of exempt units likely to accumulate in one location, including during marketing, distribution, installation, and servicing of the device, the probability is low that the containment, shielding, or other safety features of the device would fail under such circumstances that a person would receive an external radiation dose or committed dose in excess of 5 mSv (500 mrem), and the probability is negligible that a person would receive an external radiation dose or committed dose of 100 mSv (10 rem) or greater.

See the "Radiological Assessment of The Valeo TGA 3000" found in the new Attachment 14.

(The footnote to Section 32.31 (a)(4) states: "It is the Intent of this paragraph that as the magnitude of the potential dose Increases above that permitted under normal conditions, the probability that any individual will receive such a dose must decrease. The probabilities have been expressed In general terms to emphasize the approximate nature of the estimates that are to be made. The following values may be used as guides In estimating compliance with the criteria: Low - not more than one such failure/incident per year for each 10,000 exempt units distributed.

Negligible - not more than one such failure/incident per year for each one million exempt units distributed.")

Please provide an evaluation which demonstrates that this requirement will be met.

B.9. Section 32.31(b) requires an applicant for a license under§ 32.30 to demonstrate that, even in unlikely scenarios of misuse, including those resulting In direct exposure to the unshielded source removed from the device for 1,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> at an average distance of 1 meter and those resulting in dispersal and subsequent intake of 10-4 of the quantity of byproduct material (or in the case of tritium, an intake of 10 percent), a person will not receive an external radiation dose or committed dose in excess of 100 mSv (10 rem), and, if the unshielded source is small enough to fit in a pocket, that the dose to localized areas of skin averaged over areas no larger than 1 square centimeter from carrying the unshielded source in a pocket for 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> will not exceed 2 Sv (200 rem).

Please provide an evaluation which demonstrates that this requirement will be met.

Page 9 of 11

See the "Rad1olog1cal Assessment of The Valeo TGA 3000" found in the new Attachment 14 I believe that the above and the attached answers your request for more information concerning the Valeo TGA 3000. Should you have any questions please call me at (713)688-9345 or email me at Stan@vici.com .

Sincerely, ~dh Stanley D. Steams President and Radiation Safety Officer Valeo Instruments Company, Inc.

Post Office Box 55603 Houston, Texas 77255 Page 10 of 11

Attachment 2 Conditions of Use:

a) The Valeo Instruments Company Inc. TGA 3000 Ion Mobilty Spectrometer.

(IMS). Gas/Particulate Analyzer Module will be primarily used for detection of impurities. such as H20. 0 2. and NH3, in Ultra High Purity. (UHP) gases widely used in the semiconductor, LED, and many other manufacntring processes that uti lize UJ-IP gases in their manufacturing process. These processes require continuous monitoring for levels orimpurities that would be detrimental to qu..ility and product throughput.

b) Some other uses and/or applications could include, but are ceriainl y not Iimited to the followi ng; I) Detection of trace level surface contaminants on wafers used in the semiconductor industry.

2) Air quality mon itoring for personnel safety.

3) Narcotics Detection.

4) Explosives Detection.

c) The expected useful life of the product through normal usage, and with proper care, should be IO years. Since the TGA 3000 has no mov ing parts the I 0 year life expectancy was determined by using the shortest end of life spec for any electronic components crncial to operation of the TGA 3000 instrument.

d) No Access to the ionization source is afforded by the end user or any individual other than authorized users once the TGA 3000 module has been assembled in accordance with the Valeo Instrument Company Inc. assembly and safety manuals. There is no direct access point to the AM-241 source once assembly has been completed .

e) Due to the design and manufacture of the TGA 3000 modul e, it is highly unlikely that there will be a significant reduction in the effectiveness of the containment., shielding, or other safety features of the product from wear and abuse likely to occur in normal handling and use of the producl during its useful life.

5 of72

f) Due to the design and manufacture of the TGA 3000 module and if used under normal use and specified operational guidelines the probability is low that the containment. shielding or other safety features of the product would fail. under such circumstances, that a person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in Column II of the table in l 0 CFR 32.28, and the probability is negligible that a person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in Column m of the table in 10 CFR 32.28. Under normal use and conditions any disposal of a single unit or handling, shipping and storage of units are unl ikely to accumulate in one location.

6 of 72

c1 mrem = 0.01 mSv; 1 rem= 0.01 Sv.

d Dose estimate applies to an operator who is exposed to a single chemical detector unit during routine use (see Section 2.15.5.2 of NUREG 1717).

e Limit on whole-body dose and active blood-forming organs during normal use and handling of a single exempt unit (see Section 2.15.1 of NUREG 1717).

, Dose estimate applies to a person who vandalizes a chemical detector unit and ingests radioactive material due to contamination of hands (see Section 2.15.5.4 of NUREG 1717).

9 Limit on whole-body dose and dose to active blood-forming organs when probability of failure of safety features in product is less than one failure per year for each 10,000 exempt units, distributed (see Section 2.15.1 of NUREG 1717).

11 Limit on whole-body dose and dose to active blood-forming organs when probability of failure of safety features in product is less than one failure per year for each 1 million exempt units distributed (see Section 2.15. 1 of NUREG 1717).

1Dose estimate applies to local parcel-delivery driver who is exposed to multiple chemical detector units during distribution and transport (see Section 2.15.5.1 of NUREG 1717).

1Limit on whole-body dose and dose to active blood-forming organs during normal handling and storage of multiple exempt units (see Section 2.15.1 of NUREG 1717) .

... Dose estimate applies to a worker who inhales radioactive material from multiple chemical detector units during cleanup after a transportation fire (see Section 2.15.5.4 of NUREG 1717).

1Bone surface dose or red marrow dose to a person who vandalizes a chemical detector unit and Ingests radioactive material due to contamination of hands (see Section 2.15.5.4 of NUIREG 1717) m Bone surface dose or red marrow dose to worker who Inhales radioactive material from multiple chemical detector units during cleanup after a transportation fire (see Section 2.15.5.4 of NUREG 1717).

n Limit on "other organ" doses when probability of failure of safety features of the product is less than one failure per year for each 10,000 exempted units distributed (see Section 2 .15.1 of NUREG 1717).

" Limit on "other organ doses when probability of failure of safety features of the product is less than one failure per year for each 1 million exempt units distributed (see Section 2.15.1 of NUREG 1717).

estimates are slgnilicanlly Jess for workers at landfills, off-site members of the public, and future on-site residents (see Section 2.15.5.3 of NUREG 1717).

f Dose estimate applies to waste collectors exposed to multiple chemical detectors during disposal at incinerators; dose estimates are significantly less for other workers at incinerators and off-site members of the public (see Section 2.15.5.3 of NUREG 1717).

g Dose estimate applies to a worker who are involved In the cleanup following the transportation fire involving multiple chemical detectors with 241Am sources (see Section 2.15.5.4 of NUREG 1717).

h Dose estimate applies to ingestion of 241Am by a person who finds and destroys a chemical detector containing an 241Am source. (see Section 2.15.4.4 NUREG 1717).

Table 2 Comparison of Estimated Maximum Individual Doses from the TGA 3000 and limiting Organ Doses from 10 CFR 32.27 Exposure Conditions* Maximum Individual Regulatory limit for Doseb Organ Dose (mREM, REM, mREM/vr)* (m/REM, REM, or mREM/yr)*

Effective dose equivalent Routine Use a nd disposal 0.25 mREM/yr" 5 mREM/yre of a sinqle exempt unit Accidents involving single 7.5 mREM1 0.5 REM 9 exempt unit 15 REMh Normal handling and 0.05 mREM/yr1 5 mREM/yr storage of multiple exempt units Accidents involving multiple 3.75 mREM* 0.5 REM 0 exempt units 15 REMh Dose equivalent to red marrow Accidents involving a single 11.25 mREM' 0.5 REMO exempt unit 15 REMh Accidents involving multiple 5 mREM"' 0.5 REMO exempt units 15 REMh Dose equivalent to bone surfaces Accidents involving a single 0.125 REM' 1.5 REM" exempt unit 50 REM 0 Accidents involving multiple 62.5 mREM'" 1.5 REM" exempt units 50 REM 0 See following page for footnotes a See Section 2.15.4 of NUREG 1717.

b Maximum individual dose based on the typical quantity used (i.e ...02 mCi) of 241Am).

However, the activity of the source could be increased until the regulatory limit for organ dose is reached .

Radiological Assessment Of the Valeo TGA 3000 Discussion:

In order, to evaluate the potential doses from the distribution of the TGA 3000, existing data on chemical detectors containing Am-241 was gleaned from NU REG 1717. NU REG 1717 presents dose data for the distribution of chemical detectors containing 160 µCi of Am-241 . The TGA 3000 only contains a maximum activity of 20 µCi of Am-241. This is an activity red uction of 87.5%. Additionally, Collective Effective Dose Equivalent estimates were made assuming an annual distribution of 10,000 detectors, while it is anticipated that the TGA 3000 will have a maximum distribution of just 100 units annually which is a 99%

difference. Thus, the results given in the dose tables below for the TGA 3000 were reduced by 87.5% for Individual Annual Effective Dose Equivalent and by 99% for the "Collective Effective Dose Equivalent". All other conclusions and assumptions discussed in NU REG 1717, rega rding the analysis of chemical detectors (including Distribution and Transport; Routine Use; Disposal; Accidents and Misuse; and Safety Criteria), were considered to be applicable to the TGA 3000 estimates of dose.

Tables:

Table 1 Potential Radiation Doses From The TGA 3000 Exposure Pathway Individual Annual Collective Effective Dose Effective Dose Equivalent Equivalentb (mREM)* (Person-REM)

Distribution and transport 0.05< 0.00075 Routine use 0.25d 1 Disposal Landfills 0.00375* 0.05 Incinerators 0.0251 0.0008 Accidents and Misuse Fire 3.75*

Vandalism of detector unit 7.5*

a 1 mrem = 0.0 1 mSv; 1 person-rem = 0.01 person-Sv.

b Collective doses are based on (1) an assumed annual distribution of 100 TGA 3000's containing 0.2 mCi of 241Am each and (2) an assumed 10-year effective lifetime for the detectors.

c Dose estimate applies to local parcel-delivery drivers exposed to multiple exempt units in wholesale warehouses during distribution and transport; dose estimates are significantly less for other truck drivers, workers in truck terminals, and members of public along truck routes (see Section 2. 15.5.1 of NUREG 1717).

d Dose estimate applies to a user of a portable chemical detector containing an 241Am source: dose estimates are less for a user of a fixed chemical detector containing an 241Am source (see Section 2.15.5.2 of NUREG 1717).

e Dose estimate applies to waste collectors exposed to multiple chemical detectors during disposal at landfills; dose

VALCO INSTRUMENTS CO., INC.

WI 1005 IMS UPPER/LOWER HEATER INSULATORS RECEIVING INSPECTION ACTION YES/NO NOTES/ QTY/ PO#/ ETC INSPECT PACKAGE/ OK USING NITRILE NON-POWDERED GLOVES OR EQUIVALENT PACKING LIST PURCHASE ORDER NUMBER QTY RECEIVED QTY ORDERED coc INSPECT RANDOM 3 UPPER AND LOWER INSULATORS FOR DIMENSIONS PER Y25939 AND Y25940 INSPECT ALL HOUSINGS FOR ANY DAMAGE MAKE SURE UPPER AND LOWER SECTIONS ALIGN PROPERLY 3 COPIES OF DOCS DISTRIBUTION OF DOCS PURCHASING, QUALITY, MANUFACTURING INFORM QUALITY OF ANY DISCREPANCIES.

List any discrepancies_ _ __ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __

Receiving Inspector: Print Name_ _ _ _ _ __

Receiving Inspector: Signature_ _ _ _ _ _ __ Date:_ _ _ _ _ Time:_ _ __

Quality Assurance: Print Name_ _ _ _ _ __

Quality Assurance: Signature_ _ _ _ _ _ __ Date:_ _ _ __ Time: _ _ __

Wl-1005

VALCO INSTRUMENTS CO., INC.

WI 1004 IMS UPPER/LOWER HEATER HOUSINGS RECEIVING INSPECTION ACTION YES/NO NOTES/ QTY/PO#/ ETC INSPECT PACKAGE/ OK USING NITRILE NON-POWDERED GLOVES OR EQUIVALENT PACKING LIST PURCHASE ORDER NUMBER QTY RECEIVED QTY ORDERED CDC INSPECT RANDOM 3 UPPER AND LOWER HOUSINGS FOR DIMENSIONS PER Y25937 AND Y25938 INSPECT ALL HOUSINGS FOR ANY DAMAGE MAKE SURE UPPER AND LOWER SECTIONS SNAP TOGETHER AND SCREW HOLE BOSSES ARE ALIGNED 3 COPIES OF DOCS DISTRIBUTION OF DOCS PURCHASING, QUALITY, MANUFACTURING INFORM QUALITY OF ANY DISCREPANCIES.

List any discrepancies_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __

Receiving Inspector: Print Name _ _ _ _ _ _ __

Receiving Inspector: Signature_ _ _ _ _ _ __ Date: Time:

---

-----

Quality Assurance: Print Name_ _ _ _ _ __

Quality Assurance: Signature_ _ _ _ _ _ __ Date: _ _ _ _ _ Time:_ _ __

Wl-1004

VALCO INSTRUMENTS CO., INC.

WJ 1003 IMS HEATER ASSEMBLY RECEJVTNG INSPECTION ACTION YES/NO NOTES/ QTY/ PO#/ ETC INSPECT PACKAGE/ OK USING NITRILE NON-POWDERED GLOVES OR EQUIVALENT PACKING LIST PURCHASE ORDER NUMBER QTY RECEIVED QTY ORDERED coc INSPECT RANDOM 3 HEATERS FOR DIMENSIONS PER Y25942 INSPECT ALL HEATERS FOR ANY DAMAGE, CRACKS/TEARS, DELAMI NATION 3 COPIES OF DOCS DISTRIBUTION OF DOCS PURCHASING, QUALITY, MANUFACTURING INFORM QUALITY OF ANY DISCREPANCIES.

List any discrepancies_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __

Receiving Inspector: Print Name_ _ _ _ _ __

Receiving Inspector: Signature_ _ _ _ _ _ __ Date: _ _ __ Time :_ _ __

Quality Assurance: Print Name_ _ _ _ _ __

Quality Assurance: Signature_ _ _ _ _ _ __ Date:_ _ _ __ Time:_ _ __

Wl-1003

VALCO INSTRUMENTS CO., INC.

WI I002 IMS ASS EMBLY RECEIVING INSPECTION ACTION YES/NO NOTES/ QTY/PO#/ ETC INSPECT PACKAGE/ OK INSPECT INDIVIDUAL CELL PACKAGING/OK USING NITRILE NON-POWDERED GLOVES OR EQUIVALENT PACKING LIST PURCHASE ORDER NUMBER QTY RECEIVED QTY ORDERED coc HELIUM LEAK TEST CERTIFICATE MEGGER TEST CERTIFICATE MAKE SURE ALL CELL OPENINGS ARE CAPPED AS RECEIVED MAKE SURE EACH CELL HAS DOCUMENTATION CHECK 3 CELLS FOR OVERALL DIMENSIONS PER Y25894 CHECK ALL CELLS FOR EXCESS This is dark lines sourcing from the metal guard ring BRAZING FLOW across the white ceramic isolator. Transition across ceramic, ring to ring, is a failure.

3 COPIES OF DOCS DISTRIBUTION OF DOCS PURCHASING, QUALITY, MANUFACTURING INFORM QUALITY OF ANY DISCREPANCIES.

list any discrepancies_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __

Receiving Inspector: Print Name_ _ _ _ _ _ __

Receiving Inspector: Signature_ _ _ _ _ _ __ Date: _ _ _ __ Time: _ _ __

Quality Assurance: Print Name_ _ _ _ _ __

Quality Assurance: Signature_ _ _ _ _ _ __ Date: _ _ _ _ _ Time:_ _ __

Wl-1002

V ALCO INSTRUMENTS CO., INC.

WI 1001 AM-241 RECEIVING INSPECTION ACTION YES/NO NOTES/ QTY/PO#/ ETC RSO CONTACTED INCOMING LEAK TEST CONDUCTED BY RSO INCOMING LEAK TEST OK PER RSO PURCHASE ORDER NUMBER QTY RECEIVED QTY ORDERED coc LEAK TEST CERTIFICATE SEALED SOURCE CERTIFICATE 3 COPIES OF DOCS LEAK TESTCERTIFICATE, SEALED SOURCE CERTIFICATE, AND CERTIFICATE OF COM PLIANCE (COC)

DISTRIBUTION OF DOCS PURCHASING, QUALITY, MANUFACTURING RSO HAS POSSESION OF AM-241 SOURCE SHIPMENT INFORM QUALITY OF ANY DISCREPANCIES.

list any discrepancies_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __

Receiving Inspector: Print Name_ _ _ _ _ __

Receiving Inspector: Signature_ _ _ _ _ _ __ Date:_ _ _ _ _ Time:_ _ __

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Wl-1001

VALCO INSTRUMENTS CO., INC.

RECEIVING INSPECTION WORK INSTRUCTION FOR TGA 3000 IMS CRITI CAL COMPONENTS

.>>- Use Valeo Work Instruction Wl-1004- Upper and Lower Heater Housing Assembly Check List for receiving inspection.

• !* Receiving inspection for Upper and Lower Heater Insulators PN Y25939 and Y25940.

};:- Open packaging and inspect for any damage .

.>>- Inform purchasing that order has been received. Make 3 copies of packing list, and COC.

.>>- Use Nitrile Powder Free gloves for handling and inspection of Heater assembly. Never allow handling with bare hands, always provide a clean dry surface for inspection. Clean industrial grade aluminum foil is preferred .

.>>- Use Valeo Work Instruction W l-1005- Upper and Lower Heater Insulator Assembly Check List for receiving inspection.

Valeo WI-1000

VALCO INSTRUMENTS CO., INC.

RECEIVING INSPECTION WORK INSTRUCTION FOR TGA 3000 IMS CRITICAL COMPONENTS

>" Use Valeo Work Instruction W l-1001- AM-241 Source Assy. Check List for receiving.

,.. Inform RSO, Purchasing and Manufacturing of any discrepancies.

~ Retain copy of completed checklist for records .

• !* Receiving inspection of IMS Cell Assy. PN Y25894.

~ Open packaging and inspect for any damage.

).- Inform purchasing that order has been received. M ake 3 copies of packing list, COC, Helium Leak Test and Megger resistance test docs.

).- Use Nitrile Powder Free gloves for handling and inspection of IMS cell assemblies. Never allow handling with bare hands, always provide a clean dry surface for inspection. Clean industrial grade aluminum foi l is preferred .

Y Use Va leo Work Instruction Wl-1002- IMS Cell Assy. Check List for receiving inspection.

• !* Receiving inspection for Minco Heater Assy. PN Y25942/HSFAP228674.

Y Open packaging and inspect for any damage.

).., Inform purchasing that order has been received. Make 3 copies of packing list, and COC.

Y Use Nit rile Powder Free gloves for handling and inspection of Heater assembly. Never allow handling with bare hands, always provide a clean dry surface for inspection. Clean industrial grade aluminum foil is preferred.

};.- Use Valeo Work Instruction Wl -1003- Minco Heat er Assy. Check List for receiving inspecti on.

• !* Receiving inspect ion for Upper and Lower Heater Housings PN Y25937 and Y25938.

);.- Open packaging and inspect for any damage.

);.- Inform purchasing that order has been received. Make 3 copies of packing list, and COC.

);.- Use Nitrile Powder Free gloves for handling and inspection of Heater assembly. Never allow handling with bare hands, always provide a clean dry surface for inspection. Clean industrial grade aluminum foil is preferred.

Valeo WI-1000

VALCO INSTRUM ENTS CO., INC.

RECEIVING INSPECTION WORK INSTRUCTION FOR TGA 3000 IMS CRITICAL COMPONENTS Copies of this Work Instruction are to be issued to Receiving Department, Quality, RSO, and M anufacturing Departments.

The intent of thi s Work Instruction (WI) is Quality Assurance that the Va leo designed/ engineered critical components rece ived, meet all the requi rements as specified, per purchase order, Valeo drawings, and all Val eo required certifications.

Table of Critical Components.

Table 1 COMPONENT P/N VENDOR POii coc OTHER REQUIREMENTS REQUIRED REQUIRED lms Cell Assy. Y2S894 Omley yes yes Helium leak test and Industries /Megger resistance test result sheet Source Assy. Y25897 NRD LLC

- yes yes Sealed Source Certificate/Leak Test Certificate/Lot #/Total Activity Heater Assy. Y25942/HSFAP228674 Minco Yes yes none Upper/Lower Y25937/Y25938 30 yes yes none Heater Housings Solutions Inc Upper/Lower Y25939/Y25940 ZIRCI, Inc. Yes yes none Heater Insulators Actions Required for each component.

• !* Receiving inspection of AM-241 sources.

)., Do not open package. Make sure the package is placed in a safe area away from workers.

).- Notify RSO immediat ely of receipt of sources.

,.. When RSO has wipe tested, checked documents and cleared package for handling, receive package, and make 3 copies of th e packing list, Sealed Source Certificate, and Leak Test Certificate. RSO wi ll retain the originals of each, send one copy, each, to Quality, Purchasing, and retain one copy of each for receiving records. Once the copies have been made have the RSO take control of the received source package/container for proper storage.

Valeo WI-1000

(b)(4)

(b)(4)

(b)(4)

(b)(4)

(b)(4)

(b)(4)

(b)(4)

(b)(4)

(b)(4)

(b)(4)

(b)(4)

(b)(4)

(b)(4)

Figure 7 Shows typical dry Spectrum in Argon.

After connection are made allow several hours of dry down time for stable spectrum.

Section 8: Shutdown I . Turn off the power.

2. Cap the exit port

3. Shut off regulator or supply gas.

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Figure 6 Concentration Screen The actual spectrum is also available by clicking on the vyvF tab:

,

Spectrum Screen The user can save a spectrum "snapshot" by clicking on the Windows FILE/SAVE icons.

This spectrum file should default to a *.bwv format which can be sent to a qualified service agent for review.

The CFG, MEAS, CAL and ID tabs/screens are for qualified service personnel reference only.

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Figure 5

5. The initial analyte concentration will read > 30 ppb until the system is purged with "clean" gas. The total internal TGA300o volume is < 1 O cubic centimeters and typical drydown I purge times can vary depending on the previous use (shut down procedure) and quality of sample gas being used. Start up times of< 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> to reach

< 10 ppb H20 or 02 readings can be achieved.

The concentration is displayed on the main screen:

IH20 in Nitrogen ID*te

-Time Status

-F 2013-02-18 11:26:49 Off-line r 63 of72

Figure 4 Operation The on board PC will have a "TGA 3000" folder located on the desktop, open the folder then use the shortcuts labeled for the analyte and base gas for which it was tested. For example, if the TGA3000 was shipped to measure H20 in nitrogen, the icon located in the "TGA 3000" desktop folder will be labeled, "H20 in nitrogen.

1. After the initial power up, verify the sample i11 is the correct base gas.

2. Double click the appropriate shortcut located in the "TGA 3000" desktop folder.

3. Click OK on the following screen(s) which will allow the PC to connect to the detector cell.

4 . Click on the wvf tab to verify the "CONNECT" tab is active on the top row. If the tab shows CONNECT, the user press this tab and the name should change to DISCONNECT.

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6. Turn on UHP gas supply in accordance with table above. Note the TGA 3000 may be run in static condition with ports open in room air with a brushless DC pump with suction side attached to exit port to create flow o f ambient room air through the TGA 3000. This would be the desired method for monitoring room air contamina11ts etc.

7. Jnstall AC/DC converter power supply provided.

8. Slide on/off switch to on. Listen for one short beep. This indicates that self-check is complete and is TGA 3000 is ready. A series of beeps indicates error.

9. Open the TGA 3000 folder on the PC desktop and use shortcuts a select program on desktop and wait for window to appear. Follow instructions in figures 4, Sand 6.

61 uf72

Section 6: Setup

1. Place the TGA 3000 Module on a clean, flat, static free surface.

2. Remove all caps and plugs from carrier, drift and exit port fittings. Be particularly careful with the drift and exit port fittings, these are fragile and could break if improperly tightened or loosened. Always use two wrenches, one on interior fitting and one on outer fitting to loosen or tighten hardware,

3. Make sure UHP gas suppl y is off during installation to the TGA 3000 Module. Install desired UHP regulated gas lines wi th proper fittings, one to carrier and one to drift. The exit port can be left open or plumbed to vent in another area. Ensure ID of exit port tubing used is sufficient to avoid any back pressure on the TGA 3000 module. Jt is highly recommended that the VCR gaskets and Valeo fitting gaskets be of high quali ty to ensure leak free connections.

4. The maximum flow through TGA 3000 IMS cell is 300 cc/m for a stable spectrum. The typical desired flow would be 100cc carrier and l 00cc drift.

This is all measured at the exit port for total flow of 200 to 300 cc/m.

5. See table below for approximate regulator pressure in psig that will provide 200cc to 300cc total fl ow. In line restrictors may be used to optimize flows.

UHP SUPPLY GAS INLET PRESSURE Argon 20 psig Nitrogen 25 psig Oxygen 22 psig Helium 15 psig 60 of 72

r/!) TGA 3000 X Welcome to the TGA 3000 Setup Wizard The installer will guide you through the steps required to install TGA 3000 on your computer WARNING: This computer program is protected by copyright law and international treaties. Unautho,r ized duplication or distribution of this program. or any portion of it. may result in severe civil or criminal penalties, and will be prosecuted to the maximum extent possible under the law.

Cancel Next >

5. Create Desktop Shortcut Icon if desired.

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Section 4: PC and Power Supply requirements.

1. Desktop, laptop with Windows 7, Windows IO OS. Must have at least one USB port and one ethemet port for connection to TGA 3000 OEM Module.

CD/DVD player/reader, internal or external.

2. There is a AC/DC converter power supply provided with the TGA 3000, however if application is such that another power supply is required. The alternate AC/DC converter power supply must be able to provide highly regulated I 5VDC output, 0 to 7 Amps minimum, with low ripple :S 180 mVp-p, having continuous operational temperature range of -30°C to +60°C.

Section 5: TGA 3000 Software Installation.

1. lnstall CD

2. Folder TGA 3000_ V 11 .2.4 should appear

3. Open folder below icons should appear. Click on TGA3000.msi. icon.

Name Date modified Type Size vcredist_x86 4/19/2017 4:52 PM File folder

D setup.exe 12/5/2016 11.05 PM ApplJCat1on 366 KB r/J TGA3000.msi 12/5/2016 11.05 PM Windows Installer Pa.. 3,048 KB

4. The below window should appear, click next and follow installer instructions.

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equivalent be used with the TGA 3000 OEM Module. Section 4 will detail power requirements.

Figure 3

'AC/OC CONVERlER POWER SUPPLY* INPUl VOLTAGE 80-264 VAC, CURRENT RANG[ ().7.0A, OUTPUT VOlTAGE 15 V0C. IOSW, WORKING T!MPERATURE ,]OTO *60C.

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Section 3: TGA 3000 OEM Module Familiarization.

1. See figure 1 for nomenclature.

Figure 1 Shown with Top Plate Removed MOUNTING PLAT(

2. The carrier inlet, drift inlet, and exit port surfaces wilJ be hot when the TGA 3000 OEM Module is powered up and mnning at normal operating parameters. These surfaces could get as hot as 200°C (392°F) during a bake out mn.

3. To prevent contamination, the carrier inlet plug, drift inlet plug, and exit port plug should be left in place until the TGA 3000 Module is made ready for use.

4. There is a AC/DC converter power supply provided with the TGA 3000 OEM module. See figure 3. It is recommended that this power supply or 56 of 72

Section 2: Document Package Contents.

J. Valeo Instrument Co., Inc. Wipe Test Letter.

2. TGA 3000 OEM Module Operator Manual.

3. Valeo Customer Service Contact In formation.

4. TGA 3000 Software Disc and Software Installation Guide.

5. Return Shipping Documentation for TGA 3000 OEM Module if needed.

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Section 1: Unpacking and safety considerations .

CAUTION: a ***

THE TGA 3000 OEM MODULE CONTAfNS RADIOACTIVE MATERIAL, RADIONUCLIDE: AM-241 ACTIVITY ~ 20 MICROCURJES MANUFACTURED BY V ALCO fNSTRUMENTS CO., fNC.

THE RADIOACTIVE SOURCE IS SHIELDED SO THAT NO RADIATION ABOVE NORMAL BACKGROUND LEVELS BACKGROUND ARE EMITTED.

I. Locate Wipe Test document with shipping documents and retain for safe keeping.

2. Remove TGA 3000 OEM module, AC/DC power supply from packaging and examine for damage. If damage is evident notify shipper and Valeo Customer Service Immediately. Have serial number and order number ready for Valeo customer service. Contact information wi ll be with the shipping documents.

3. Place TGA 3000 OEM module on a clean static free work surface.

4. The TGA 3000 OEM module has areas of high heat and high voltage, observe labels and take necessary precautions. The high voltage areas are shown in figure 2 of this manual.

5. Keep liquids away from work area.

6. Handle with care always.

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CONTENTS Section I: Unpacking and safety considerations.

Section 2: Document Package Contents.

Section 3: Familiarization.

Section 4: PC and Power Supply requirements.

Section 5: TGA 3000 Software Installation Section 6: Set up.

Section 7: Operation.

Section 8: Shutdown 53 of72 L

VALCO INSTRUMENTS CO., INC.

TGA 3000 OPERATOR MANUAL PN 48 100102 PN 22100104 52 of72

Figure 4 Top Plate Cover Labeling YA&CO INSTIUMENTS CDM/IAHY INC.

tKIC)[Vl(X<XlN!AINS~ ..., _NC HASICE>l - .-ct\ROIYV...C,:,INSTIU,OC=

a.-- NC " ' ~ W I T M U I ""JClV,11 ROI.U l OIIY coY,tss,o,. INOY CJl<lt.lllA IN THE PURCHASER IS EXEMPT FROM I ANY REGULATORY REQUIREMENTS 51 of 72

Figure 3 Point of Sale Label l

THIS DEVICE CONTAl'IIS RADIOACTIVE MATERIAL AND HAS BEEN MANUFACTURED BY VALCO INSTRUMENTS COMPANY INC., IN COMPLIA'ICE WITH U.S NUCLEAR REGULATORY COVMISSION SAFETY CRITERIA IN 10 CFR 32 31 THE PURCHASER IS EXEMPT FROM ANY 1.:ioo

..._R_E_G_ L_LA_T_O_R_Y_R-EO_U_I_R-EM_E_N_T_S_ _ _ _ __.J i - - - -- - - - - - 3.000 - - - - - - - --

LABELS: BLACK TEXT ON WHITE BACKGOUND. MINIMUW 10 POINT PRINT FOR RADIATION WARNING SECTION AND '2 POINT FOR PURCHASER SECTIO'II.

MATERIAL S?EC: 2 MIL POLYIWIDE PERMANENT ACRYLIC PSA ADHESIVE BA.CKING OPERATIOI\AL TEMPERATURE -60f TO 450F OTY POI DASH NO rT[1,1 Ml P,RJ OR IOOIT -.0 q(T O£SIC 1 Sl'CC/STD SO of72

Figure 2 Radiation Warning Label 1--- - - - - - - 2.500 - - - - - - -~

I 1.,00 CONTAINS RADICW:T1VE MATERIAL.

RADtONUCWOE: ~41 ACTMTY: 20 uCI MANLFACT\JRED BY V ~

NSTRUMENTB COIPAHV IC. l.N>ER U.S.

UCEHSE AND .. OQMll..lANCE wrTH IR:

-l o *oo OCT.AIL "A" 0 100 L 10CRISUO PRlOR TO UBE RER:R TO TOA 3000 OPERATOR MAM.JAL.. PN 41100102. FOR OPERATIOfW. GlJIONa.

.SAFETY

_AND _ ____

LABELS. RED TEXT ON ALUt.llNUM SACKGO\.J'IIO,

~INIMUM 10 POINT PRINT RADIATION SVM80L-

'

\4AJE'.TA OR BLACK TREFOIL ON YELLOW BACKGROUND.

0 450 MATERIAL SPEC: .003" Mil PHOTO CTCHED AI..U\AINUM _1 PERt.lANENT ACRYLIC AOHESM: BACKING OPERARTIONAL TEMPERATURE - 60F TO t.50F ~ Q.t.50 i--

49 of 72

Attachment 6 Radioactive Labeling Each Valeo Instruments TGA 3000 will be labeled in accordance with IOCFR 32.32(b) as shown below. Placement location oflabcls arc shown in figure I below. Figures 2 and 3 of attachment 6, are the engineering drawings for the labels. Figure 4 shows proposed labeling of top cover.

Figure I

-N!Nl*llli&LM&**

. . . . ._ . . . JU&

fll.MIII . . .

---......~ /

--

___

1--- - - - - - - - - - - - - a . - - - - - - - - - - - - -----1

---

**---------

=--=-.r.:.-==:---..,_

~a.::-:-:..-==.-::-

~.------fillllll6.

---

...a.l'*-..&11. . . .

,.._..._......, .............

. . , . . . _ _ _ _ _ _ _ _ _ _ca&,.

.... -.....llal......- ..........

---

=.-==-.:.::-.=:-.::.:..

48 of 72

VALCO INSTRUMENTSCO., INC FORM QA 1001 TGA 3000 OEM FINAL TEST CHECK SHEET Record Yes- Notes spectrum No CONC tab Yes-working No CONC table Yes-showing No CFG tab Yes

-

working No CFG columns Yes

-

showing No CFG Polarity Yes-Positive No CFG Drift Yes

-

Temp SP No-120.0°c CFG Date and Yes

-

Time Correct No CFG MCDQ Ver Yes

-

2.13.0 No CFG SN Correct Yes-No CFG Source Yes

-

Volt SP 850.0 No CFG Drift Volt Yes-SP 690.6 No MEAS Tab Yes

-

working No MEAS Table Yes-showing No CAL Tab Yes-working No CAL tab Table Yes

-

showing No-Name of Quality Tester: Printed _ _ _ _ _ _ __

Name of Quality Tester: Signature _ __ _ _ __ Dat e: _ _ _ _ __

TGA 3000 OEM Serial Numb e r - - - - - --

FORM QA 1001

VALCO INSTRUMENTSCO., INC FORM QA 1001 TGA 3000 OEM FINAL TEST CHECK SHEET Test Equipment Required.

• DVM, capable of measuring 1000 VDC off ground or appropriate High Voltage Adapter Probe to be used with DVM without the HV capability.

• PC- laptop or desk top with Windows 7 minimum OS.

• USB cable- USB 8-Type to USB A-Type, minimum 3 feet in length.

• AC/DC power supply input voltage 80-264 VAC, current range 0-7.0A, Output Voltage 0

15+/-1 VDC, ambient operating temperature -30°C to+ 6D C.

Refer to TGA 3000 Quality Assurance Test Procedure for completion of this form.

Visual Checks.

TGA 3000 OEM Serial Notes Number Required labels attached correctly Yes-No No visible damage Yes

-

No All metal caps and plugs in place at carrier, drift, and Yes-exit ports No Powered up Checks.

Power up Yes Notes

-

No High Voltage Yes

-

measurement 850+/- s voe No

-

Connectivity to Yes

-

PC No TGA 3000 Yes

-

password No -

window open Program Yes-running No WVF tab Yes-working No Spectrum Yes -

Visible No FORM QA 1001

.,....~.,

l'\ll Pl.RIC 1rt111.-:,..w10

'000

'""..... *c.t r l'\AIC

....

UOl,

,ooo

• ~

0 .,,

58 of72

........ ._,_._ .

Figure 7. MEAS tab check

,

.f..... *

--

_...,,_

0 .1 1'1>11 !t 11 JJJI o..t r"""' u 11

,0111s-,.

llU't

'" ,..,..,

" ' l llDC

.

~~~----~*

,

DJ

°' ""

1101 1,oa, 11,.,

57 of72

arameter check.

• • WI 1 - ""'

.....

--..

-..

,,.

IIICCWlV"

--*

1111

• --..

"'°C..

lJ-IUOC

• I

-

tt,V t*fl' ISV \al'IC

_.,_

ru

........

IS A

,........., .-......

"""'

111.,aD

.......... .....

_., __ '° G..--.

c.........

"--.......

""""

_ , _,,

...--

• --

• • --..

IJM '(

~NW llllwC' Oollt...,11' *u<<

Mt~W 1111.ll 56 of 72

0.008 ppb 0.000 1017.03hPa 2017-11*16 12.32 16 400 400 OK 55 of 72

11 . Once the Final QA Test has been satisfactorily completed. Sign and date the QA 1001 form and make three copies of the completed form QA 1001. Retain one copy for Quality, one stays with the TGA 3000, and one for manufacturing. Notify the RSO that the testing has been completed and the TGA 3000 OEM is ready for further leak tests that may be required.

-.._

-,

" '-1 c... c-ooa,,,qv., 1"'

-.._

..

I/W V* Ut

• --

j/W

• Hilt 0- WUll

-*-

Drift,....

.........

Orih ,...

.,

IJU'(

111noc tJI 1Jl .....

-*-

_,,__ IIOa, c--.., fl,() . . ._

'-_,

'-""""') °""" *..,...

' - ~* a.,,- * ..,..

c-v_ ,

c-v_,

'°'"'-

• -*-

c-v_, UODH-

.uon,_

C-Y-

. *

. . . Ootl -*-

-0., ) .,,,.

• -*- ,,..,.

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3. Power up PC Refer to TGA 3000 Operator manual for start-up procedure.

4. Start the TGA 3000 Program and enter the assigned password to start the program. Allow at least 20 minutes for operational temperatures to stabilize.

5. Refer to Figures 4, 5, 6, 7, and 8, for reference to spectrum and tab selection.

6. Select the WVF tab at the bottom of the screen, refer to Figure 4 below. When the WVF tab is selected a typical spectrum similar to what is displayed in Figure 5 should be seen. This indicates the TGA 3000 is working. Check appropriate box on QA 1001 to confirm.

7. Next Click on the CONC tab. Reference Figure 5, This gives a table that shows concentrations of things like H20 , and Oxygen. The concentrations in the table will be different than shown in the figure. This is to only test and make sure the table is presented when the CONC tab is selected . Check appropriate box on QA 1001 to confirm CONC tab works.

8. Next click on the CFG tab and refer to Figure 6. Check appropriate box on form QA1001 that shows that some value was shown in each box under the Instr. Column . The values will differ and will depend on the calibration for gas chosen. This checks that the CFG tab is working and values are displayed.

9. Next click on the MEAS tab. Refer to Figure 7, the display table should look the same but may have different values in the blocks. Check the appropriate box on form QA 1001 to indicate the MEAS tab is working properly.

10. Next click on the CAL tab and refer to Figure 8 for what that display should look like.The numbers will appear different dependent upon user calibration selected. Check the appropriate box on form QA1001 to indicate that the CAL tab is working properly.

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Figure 2.

Section 2: TGA 3000 operational check.

1. Turn off power and install top plate.

2. Install USS cable between TGA 3000, reference Figure 3, and PC being used for testing.

Note: PC must have latest Rev. TGA 3000 Software Installed for proper configuration. This check is done at ambient pressure room air with zero gas flow.

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QUALITY ASSURANCE FINAL TEST

• Section 1: Power up and DC voltage check.

• Section 2: Spectrum Check.

Note: Fill out form QA 1001 TGA 3000 Final Test, during the course of this procedure Section 1: Initial power up.

1. Remove Top Plate for this procedure. Leave all plugs and caps in place.

2. Using AC/DC converter power supply as indicated in Figure 1. Turn on switch S1 on the TGA 3000.

3. Using a Volt Meter that can read a minimum of 1000 VDC off ground. Check to make sure there is a reading of 850 +/- 5 VDC between ground and R12. See Figure 2. Enter Voltage in designated box on form QA 1001.

Note: the Processor board is pre-programmed with firmware/software with TGA 3000 standard operational parameters prior to assembly.

Figure 1

'C/OC COIIV£RT£R POWER SIJPPLY, INPVl VOi.TAG£ 8().26' VA(,

CURRENT AANG[ 0-7.0A. OUTPUl VOlTAG[ 15 V0C. 105W, WORKING

'TEMPERATURE -30 TO *60C.

51 of 72

VALCO JNSTRUMENTS COMPANY, INC.

LEAK TEST CERTIFICATE SOURCE DATA D TGA 3000 Assembly S/N: - - - - - - - - Reason for Leak Test:

0 Sealed Source Lot #: _ _ _ __ __ Reason for Leak Test:

Source Owned by: VALCO INSTRUMENTS COMPANY, INC.

Sample Location:

Source Model No: A-001 Source Serial No:

---

Radioisotope: _AM-241 Activity: 20uCi Date Sample was Taken: Date of Last Leak Test:

INSTRUMENT DATA Ludlum Model 3 WITH 44-9 PANCAKE BETNGAMMA PROBE S/N: - - - - - -- -

Calibration Due Date:

---

CaIi bration to Cs137. Calculations based on 1mR/HR equa ls 3000CPM.

LEAK TEST RESULTS Background Carrier lnlet_ _ _cpm Sample Swipe Carrier Inlet___ cpm Background Drift Inlet cpm Sample Swipe Drift Inlet cpm Background Exit Port cpm Sample Swipe Exit Port cpm CERTIFICATION I hereby certify the results of this swipe analysis indicate the activity to be less than 0.005 µCi (185 Bq) of removable contamination.

Leak Test Performed By: Date: - - - - - - - -

50 of 72

QA C H ECK POI NT 7- Fiual Assembly C heck.

PASS 0 FAIL 0 COMMENTS: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __ __ _ _ _ __

ADDITONAL COMMENTS: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __

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PASS 0 FAIL 0 COMMENTS:_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __

QA CHECK P OINT 5- IMS Cell Interface PCA to Processor PCA Assembly Check.

PASS D FAIL D COMM ENTS: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __

QA CHECK POINT 6-Top PlateAssembly Check.

PASS 0 FAIL D COMMENTS: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __

ADDITONAL COMMENTS: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __

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Section 9. TGA 3000 OEM Module Qua lity Assurance Check List.

Valeo Instruments Co., Inc.

TGA 3000 OEM MODULE QA C HECK LIST TGA 3000 SERJAL NUMBER: - - - - - - - DATE: - - - - - -

QA INSPECTOR NAME: - - - - - - - - -

QA CHECK PO INT 1- Source Assembly Installation Check.

PASS 0 FAIL D COMMENTS: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __

QA C HEC K POINT 2- IMS Heater Assembly Check.

PASS 0 FAIL 0 COMMENTS:_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __ _ __

QA CHEC K PO INT 3- Heater Shrink T ubing Assembly and Ground Check.

INSTALLATION PASS 0 FAIL D COMMENTS: _ _ _ __ _ __ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __

47 of 72

46 of72 Section 8. TGA 3000 Finished Assembly Views.

Right Side View. Exit Port Side.

Left Side View. Ground Sttud Side 45 of 72

Figure 14 Top plate installation Section 9: Final Assembly Quality Inspection and Radiation Leak Test.

QA Check point I. Check all fasteners for tightness on upper and lower plates.

2. Check for required radiation labels on IMS cell upper housing and Pont of Sale label on top plate.

3. Ensure serial number on cell housing matches serial number on top plate.

4. Check screw tightness on cell assembly pins to cell interface tenninal block.

5. RSO Perfonn leak test at drift, exit, and carrier ports. Record readings on leak test certificate, make two copies keeping one for leak test records and one to stay with the assembled TGA 3000 OEM module 44 of 72

Section 8: Top plate assembly and final QC assembly inspection.

l. Obtain top plate assembly, 44100152 rev I, with required labels.

2. Obtain qty. 2, 6-32 X 5/8" zinc plated steel stand-offs, qty. 2, 6-32 X 3" zinc plated steel stand-offs, and qty.4, 6-32 SS nylon lock nuts.

3. Install as shown in figure 13.

4. Install top plate with required labels as shown in figure 14 .

5. Secure top plate with qty. 4, 6-32 SS nylon lock nuts as shown in figure 14.

Figure 13. Hardware for Top Plate assembly.

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Figure 11 Heater connector installation Figure 12 Upper IMS cell support bracket installation.

42 of 72

Figure IO Screw check.

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Figure 9 IMS CELL PIN ALIGNMENT TO PCA CONN ECTOR ASSEMBLY.

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Section 7: IMS cell assembly installation onto PC board assembly.

J. Obtain QA checked lMS assembly and install assembly in single row terminal block connector on the fMS cell interface PCA as shown in figure 9.

2. Install as shown in figures 9 and I 0. It is critical to make sure every pin is properly positioned when inserted and that the screws on the terminal block for each TMS cell pin is tightened securely, then double checked for each screw. Start front to back then double check from back to front. See figure I 0.

3. Install heater connector onto IMS Cell Interface male heater connector. See figure 11 .

4. Install Upper suppont and mounting bracket, 44 100153. Obtain mounting bracket, two 6-32 X 5/8" zinc plated steel stand-offs and one 6/32 lock nut. Fit support bracket onto the 3" standoffs as shown in figure 12. Secure the upper support and mounting bracket as shown in figure 12.

5. Install LMS Cell Interface PCA ground wire to position 2 of the upper insulator housing as shown in figure 12.

6. Quality Check Point 6. QA check PCA and upper support assembly.

• Check alignment of IMS pins to tenninal bl.ock.

• Check each screw in IM S cell mounting terminal block for tightness.

• Check all mounting hardware for proper installation and tightness.

• Check for proper ground at all ground points. From carrier inlet fitting to IMS cell interface ground point on the board, same from drift end fitting, same for IMS insulator housing surface to IMS cell interface ground.

• Check for no movement of IMS cell in any direction with upper support in place.

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Section 6: IMS Cell Interface PCA to Processor PCA assembly.

I. Obtain IMS Cell Interface PCA, 28100 IO I, and IMS Pre- Programmed Processor PCA, 28 100102.

2. Obtain 2 PCA Mounting Plate, 44 I 00 I52.

3. Obtain hardware items I6 through 19 listed in section 2.

4. Install 5 zinc plated steel standoffs to bottom of the IMS Cell Interface PCA, the male threaded section goes through the bottom of the PCA, install 4 of same into rear section of IMS Cell Interface PCA by threading them onto the male threaded portion sticking up through the PCA, install 2 of the SS 5/16 hex X 3" long standoffs on the two front holes in the PCA by threading them onto the male threads projecting through the bottom of the PCA. Sec figure 9 for hardware positions.

5. Once all standoffs are installed and tightened install the Processor PCA onto the rear standoffs. Be very carefu l to properly al ign the two connectors on the bottom of the processor PCA, Female receivers to the male connectors on the top of the IMS Cell Interface PCA.

6. Secure the Processor board to the IMS Cell Interface PCA with the three nylon 6/32 threaded standoffs.

7. uality Check Point 5.

• Check alignment of the mating connectors from the top of the IMS Cell Interface PCA to the Mating connectors on the bottom of the Processor PCA. No pins should be showing.

• Check tightness of all fasteners.

Caution Note: lmproper alignment will cause immediate electrical damage to the Processor PCA upon power up.

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Figure 8 M(ATtllC,.OUNDlUG 37 of72

Figure 6 INSULATOR FLUSH TO INSULATOR HOUS G Figure 7 6/32 PHMS INSTALLED FROM BOTIOM PRIOR TO INSTALLING INSULATOR.

ECURE WITH #6 LOCKWASHER AND 6/32 HEX NUT MAKE SURE TOP AND BOTIOM ASSEMBLIES NAP TOGETHER AND ALL HOLES ARE PROPERLY ALIGNED.

LOWER INSULATOR HOUSING ASSEMBLY

~ E A T ER CONECTOR 36 of72

Section S: Insulator and Insulator Housing Assembly.

Note: Refer to figures 6, 7, and 8 for this section.

1. Obtain PN 44100 126, Insulator Housing Upper.

PN 44I00127, Insulator Housing Lower.

PN 44100128, Insulator Upper.

PN 44100 I 29, Insulator lower.

2. lnsert SS 6/32 X W' PHMS through hole in top of the upper insulator housing. Secure with SS #6 lock washer and SS 6/32 hex nut. See figure 8.

3. Install Radiation Warning label, 46 100 IOI, and TGA 3000 serial number and date of manufacture label as. shown in figure 8.

4. Insert upper and lower insulators into upper and lower insulator housings so that the insulator material is flush to the edges of the insulator housings. See figure 6 and 7.

5. Install the IMS cell/heater assembly into the lower insulator housing assembly by placing the legs of the IMS cell assembly into the cut out slot at the bottom of the lower insulator housing assembly. Make sure the exit port tube is aligned with the back most cutout in the lower insulator housing. See figure 6.

6. Holding the bottom assembly securely, place the upper insulator housing assembly, figure 7, over the lower assembly and snap closed. Make sure the 4 screw holes are aligned, figure 8. Secure upper housing to lower housing using four 4/40 X Yi" Torx head machine screws. Secure heater ground lug in position 2 as shown in figure 9. Tighten securely being caref11.1l not to overtighten.

7. Quality Check Point 4.

• Check for proper fastening of screws and ground lug position.

• Check for proper installation of Radiation Protection Label.

• Make sure drift. carrier and exit ports are capped/plugged.

• Survey check. RSO or authorized user, using the Ludlum Model 3 and place the detector surface of the 44-9 probe within W' of the end of the VCR fitting. Record average mR/hr reading in the manufacturing quality report check list.

35 of 72

Figure 4 VITON TUBE SPACER VITON TUBE SPACER PTFE TAPE WRAP DAFLON 7/8" SHRINK TUBE IMS CELL CONNECTOR PINS HEATER CONNECTOR Figure 5 Ground Resistance Check 34 of72

6. Obtain a roll of white Mil Spec PTFE tape, % wide, 0.0032" thick. Cut a piece that is approximately 20" long. Holding the IMS cell securely in one hand, then starting at the front edge of the frontend cap, wrap the tape tightly around cell with overlapping turns the entire length of the IMS cell. Make sure the heater is tight against the IMS cell surface as the tape is being wrapped around the IMS cell. See figures 4 and 5.

7. Quality Check Point 2.

• QA inspect entire IMS cell assembly at this point to ensure the healer is a tight fit to IMS cell surface and proper placement of Vi ton tube pieces and Teflon wrap.

8. Obtain a 1" long section of 5/8" Dia. DAFLON PTFE 4: 1 ratio,shrink tubing and slip it over rear section of IMS cell assy. The heater connector must go through first, then the shrink tubing will easily slip over the other end section of the IMS cell. The back end of the shrink tube must be even with the back end of the IMS cell end cap. See figures 4, 5.

9. Obtain a I long section of7/8" Dia. DAFLON PTFE 4: l ratio shrink tubing and place it over the VCR nut and over the front section of the heater assy. Place it over the IMS cell so that the front end of the shrink tubing will be even with the front end of the IMS cell end cap.

I 0. Obtain heat gun and set the temperature for 327°C or 62 1°F. Place the IMS cell, with heater assembly installed, into a small bench vise by placing the legs of the IMS cell between the jaws of the vice and clamp the assembly securely. Remove all flammable materials away from area where the heat gun will be directed. Make sure all components are properly aligned and then tum on the heat gun and direct the heated air evenly around the shrink tube, one end at a time. Heat until tubing is at maximum shrinkage then remove heat and repeat at the other end. Let the entire assembly cool to touch before proceeding to next step.

11 . Quality Check Point 3.

• Check proper placement of all components.

• Check proper grounding between ground lug of the heater, the drift end metal component and the carrier end metal component. Reading should be less than .5 ohms. Refer to figure 5.

33 of 72

Figure 3 M-241 SOURCE ASSEMBLY SHOWN BEING INSERTED Section 4: Heater Installation.

Note: Refer to figures 4-5 of this procedure for heater installation.

I . Make sure all caps are installed prior to heater installation.

2. Obtain heater assembly, 3410010 I.

3. Place a I" piece of if.." ID, black Viton tubing over the drift end fitting so that it is tight against the back end of the end cap.

4. Take a %" piece of if.." ID, black Viton tubing and slit it lengthwise, one cut, and then fit it over the if.." tube between the front end cap of the IMS cell and the back of the if.." VCR nut.

5. Wrap the heater assembly tightly around IMS cell assy. with the heater connector at the drift, (back end), of the IMS cell assy.

32 of72

Figure 2 3 1 of72

Section 3: AM-24 1 Source Installation.

Note: Refer to figures 1-3 of this procedure for source installation.

I. Put on approved protective gloves and lab coat.

2. Obtain a new manufacturing/quality report check list.

3. Place a clean sheet of industrial grade aluminum foil on surface of work bench where the AM-241 source will be installed into the IMS cell assembly. Tape edges of foil down to work surface.

4. Obtain a IMS cell assembly from inventory. Assign and record serial number. This will become the TGA 3000 Module serial number.

5. Remove protective wrap and all caps and plugs.

6. Place on clean aluminum foil surface, prepared in step 2 above.

7. Obtain one AM-241, 44100 I04, source assembly from the RSO, or authorized user.

Record serial number and assign to the TGA 3000 module serial number.

8. Using Zero Grade air with appropriate nozzle, blow air through cell from both ends and s ide ex it tube.

9. Using designated 3/32" Hex driver, Install source into the threaded source holder located inside the TMS cell. The access is through the W' VCR fining.

Make sure the source assembly is threaded into the source holder properly. Be very careful to not cross thread the assembly.

10. Quality Check po int I.

• QA check for proper installation of source assembly. Note on QA checklis t.

11 . Survey check.

• RSO or authorized user, using the Ludlum Model 3 and place the detector surface of the 44-9 probe within W' of the end of the VCR fining. Record average mR/hr reading in manufacturing quality report check list.

12. Install all caps and proceed to section 4, Heater installation.

30 of72

Section 2: Parts and Part/Drawing Numbers Required.

I. 44100100- IMS Cell Assembly.

2. 44100 I 04- NRD Model A-00 I Source Assy.

3. 34100101- IMS heater Assy.

4. 44100126- IMS Cell Insulator Housing. Upper.

5. 44100127- IMS Cell Insulator Housing. Lower.

6. 44100128- IMS Cell Insulator. Upper.

7. 44100129- IMS Cell Insulator. Lower.

8. 28 100101- IMS Cell Interface PCA.

9. 28100 I02- IMS Processor PCA.

I0. 44100152 rev I - PCA Bottom Mounting and Top Plate quantity 2.

11. 44100 I 53- Upper Support Mounting Bracket.

12. 46 I 00 IO I rev I - Radiation Warning Label.

13. Roll of Mil Spec PTFE tape, 31,.** wide by 0.0032" thick, white in color.

14. Viton tubing 1/a"ID by 1/2"0D cut into I"' pieces.

I 5. Datlon SH24 I PTFE shrink tubing. SH24 1-5/8 and SH241-7/8 cut into 1** pieces.

I6. Torx Head SS machine screws 4/40 X 1/2** quantity 4.

17. Zinc Plated Steel stand offs Male-Female Thread Y.i" hex, 6 32 X 5/8" quantity 9.

18. Stainless Steel (SS) Standoff 5/ 16 Female-Female Hex SS 6/32 X 3" quantity 4.

19. Stainless Steel 6/32 X 3/8.'PHMS and number 6 SS flat washers. quantity I I ea.

29 of 72

Section 1: Safety Guidelines.

I. Prior to assembly of the TGA 3000 OEM Module, read and understand the Valeo Radiation Protection procedures.

2. Wear disposable latex free, powder free. protective gloves, and lab coat while assembling the AM-24 1 Source assembly into the TMS cell assembly.

3. Wear the protective gloves throughout the assembl y process unti l the TGA 3000 IMS module is assembledl onto the PC boards.

4. Have the Ludlum Model 3 with 44-9 probe readily available during assembly process.

5. Always use the same designated work bench for the AM-241 source installation.

6. No food or drink is allowed at assembly station.

7. Immediately report to RSO/Actin g RSO, any survey or wipe test result that exceeds action level of 2:200-500 cpm / 0.05 to 0.1 Mr/hr.

8. Do not proceed to next sect ion until the QA checkpoint has been cleared for each section as required.

Assessment and Convers ion chart for Ludlum Model 3 meter readings.

Survey Meter Reading> A!se>>menl of Measurements 0*.:00 ,vm IO 0 .05 mRtbt tl.Jt ..J,rVIIDd n-JdJn""

,4w rpm I ,0.1 mR. hr toOl,i.mln.1lklll Converting radiation met er readings Units Melt/ Rtadlngs

• r* n

• • ~ S,O 7.r, 10.0 J

HA:,$

u\ R/ h r .... 0 ,2 O ,;\ ...~ 0 .5

.L iiS/hr 0 .s ~ 5 1,. ,*nu*wrl tu qun cp, , (t(i

• C"f'IH 28 of72 L

Contents

• Section 1- Safety g uidelines.

• Section 2- Part Numbers Required.

• Section 3-AM-241 Source Assembl y Installation.

• Section 4- Heater Assembl y Installation.

• Section 5- Insulator/l nsulator Housing/IMS Cell Assembly Installation.

• Section 6- IMS Cell Interface PCA to Processor PCA assembly.

• Section 7- IMS cell assembly installation onto PC boardassembly.

• Section 8- Completed assembly views.

• Section 9- Quality Assurance Check List Reference.

27 of72

V ALCO INSTRUMENTS CO., INC.

PN 48100101 TGA 3000 OEM MODULE MANUFACTURIN,G MANUALWITH QUALITY ASSURNACE CHECK POINT PROCEDURES.

TGA 3000 OEM MODULE PN 22100104 26 of72

TABLE 4 DROP TEST DATA TABLE 4 Uni!$ undef 1es1 wwe , ..be dropped from a Rat table lop ~ to conc:rele lloor aurtace.

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TABLE 3 THERMAL BREAKDOWN TEST DATA REV 1 TABLE l AU JOA lOOO OHllATK>N OETlClOR CfLLS WEAi A.S1i08.EO ~ , a AS5llMII.., MO WUY M r-..cno,..

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TABLE 2 WATER EMERSION TEST DATA REV 1 "1.L TGA 3000 IONIZATION DETECTOR crus WERE ASSEM BLED COMPLETE PER ASSEMBI.YAND SAFETV "'STRUCTIONS THE RAOIATION ACTIVflY LEVELS WERE MEASURED USIN<<l A LUDLUM GEIGER COUNTER MODEL l Wl'!11 A MODEL *H PANCAKE DETECTOR AU. INSTRUMENTS USED ARE IN CURRENT CAl.l!lRATION PERIOD.

THE FOLLOW"'G TESTS WERE PER.ORMEO BYFUU EMERSION Of CEU.S t 2 ANO t 3 IN A CONTAINER FIi.LEO WITH \JNFILTEREO TN> WATER FOR A PERIOD Of 10 MINUTES EACH. THE SURFACE Of !11E WATER IN THE CONTAINER WAS SURVEYED FOR NN AC !MTV Al!OVE BACKCAOUNO BEFORE THE CELLS WERE REMOVED F"ROt.1 THE WATER THE CELLS WERE THEN REMOVl:O FROM THE WATER. ORAt<EO Of EXCESS WATER "'TO SHIE:lOEDCONTAINER.

Tl1E CELLS WERE THEN DRIED IN AN OVEN AT :2GO' C ANO AFTER coot.ING EACH CELL WAS SURVEYED ANO RESULTS ARE SHOWN BELOW.

t.UOLUM ._OOEU IURYEl IIIETER WITH AMOOEb44::f BEJA/GAMMA PANCAKE PEIECTOR PROB£ USED FOR RApfATIQH MEASYRP!EHTS, 1mMv * >>oo CPM et! m,nual.

SURVEY Of' THE WATER II THE CONTAINER W.U AT BACIKGROUND, 40 CPM (D.11125 mR/h!\

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SOURCE SN-0001 SWIPE 0.0125 41 5CM 0.0125 II 10 CM 0.012$ 41 2!CM 0,012$ 41 30CM 0.0125 41 TOAllSTCELLB TEST AREA IIACKOROUNO ACTMTY AVEAAOEO AT '1 CPM Ml,2410 20 uC< pmcTOR ACTMTY BEFORE EMERSK>N l!lllAIICE mlllllt Cf.II SOURCE SN-0002 SWIPE 00125 41 5 CM 0.0125 41 10 CM 0.0125 41 25 CM 0.0125 41 JOCM 0.0125 11 WET MEASURIIENT D£TECTQ1l ACTIYITY AFTER10 IIINUj[E EMERIIQH ~ !!!l!l!!! Cf!!

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TABlE 1 Ex.TERN.AL AAOIATION LEVEL ""l:.ASUREt.lE NT.S AEVIS£0 10 INCLUOE .l& GM M(A.SUR:f;M(t 4TS 1.-.Cll IQ,\ >OM IOHW.AllOfrtOIOlCIOQ.t'ill!.tel AHtMklD !If .-.CCCMtOAHCl wt'IH Of: YICt Y,l,l.CO flllMUMIH!a. ,UIUIIIM..' & IAJfl'i' NltltUCTIDHS THI: ~ I WCM M.U:KtO M.MM:IIS 1'.>>11[, 1'WO .\HI) lMIC:l. lA,Qt HA'I/INO ON(

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Valeo Instruments Co. Inc.

Analytical devices/systems January 5, 2018 Tomas Herrera Materials Safety Licensing Branch Division of Material Safety, State, Tribal, and Rulemaking Programs Office of Nuclear Material Safety and Safeguards U.S. NRC 11555 Rockville Pike Rockville, MD 20852 RE: NRC Request for Additional Information, Valeo Instruments letter dated December 13, 2017; Docket# 030-39061

Dear Mr. Herrera:

In response to your email of December 13, 2017, Valeo Instruments offers the information below. For your convenience, I have rewritten your questions prior to each response.

1. Please resubmit the drawing in Attachment 6 "Radioactive labeling," so that is legible. We intend to use this drawing in the sealed source and device registration certificate. In addition, please provide the overall width of the TGA 3000.

Please find a clean pdf of the requested "Radioactive Labeling" drawing in attachment 1 of this response. As for the overall dimensions of the TGA 3000, these are called out in drawing 22100104 Rev 1 sheet 3 of 4; sheet 4 of 4; and in drawing 44100152 Y25932 (found in attachment 2, 3, and 4 of this response) . As noted on these drawing the overall dimensions of a completed TGA 3000 are 10.250 inches (L) x 4. 75 inches (W) x 3.57 inches (Hor thickness).

2. In your letter dated November 20, 2017, in your response to A.6, you reference a drawing number 4410016. We were not able to locate a drawing with that number in the response. Please resubmit drawing number4410016.

The drawing number given as 4410016 was a typo and should have been 44100106 Y25903. Please see the correct drawing in attachment 5 of this response.

3. Please identify the material used in the in the construction of the frame for the Page 1 of 3 P.O. Box 55603 Houston, Texas 77255 Telephone (713) 688*9345 Fax (713) 688*8106 www.vici.com

TGA 3000.

As identified in sheet 4 of 4 of drawing 22100104 Rev 1 (Attachment 3 of this response), the top and bottom plates of the TGA 3000 are machined from 5052 H32 aluminum sheet. The supports are nickel plated stainless steel, 0.250 hex stand offs. The fasteners are made from 18-8 stainless steel.

4. Please confirm as part of Valco's Quality Assurance program that Valeo will perform a final radiation survey to verify that the radiation levels do not exceed the maximum values stated in the application prior to distribution of the product.

Valeo confirms that as a part of the quality assurance program each completed TGA will have a final radiation survey performed and documented as shown in the TGA 3000 shipping survey instructions PN 48100102 (attachment 6 of this response) the TGA 3000 Final Radiation Survey Form RAF 1001 (attachment 7 of this response), and Radioactive Material Container Survey Form RAF 1002 (attachment 8 of this response). A copy of this final survey will be included with each TGA 3000 shipped to the end user.

5. In response to Question 8.9 you stated that the required analysis can be found in "Radiological Assessment of The Valeo TGA 3000," Attachment 14. However, it does not appear that the requirement of Section 32.31(b) was addressed. As stated in our first RAI, Section 32.31(b) requires an applicant for a license undeir § 32.30 to demonstrate that, even in unlikely scenarios of misuse, including those resulting in direct exposure to the unshielded source removed from the device for 1,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> at an average distance of 1 meter and those resulting in dispersal and subsequent intake of 10-4 of the quantity of byproduct material (or in the case of tritium, an intake of 10 percent), a person will not receive an external radiation dose or committed dose in excess of 100 mSv (10 rem), and, if the unshielded source is small enough to fit in a pocket, that the dose to localized areas of skin averaged over areas no larger than 1 square centimeter from carrying the unshielded source in a pocket for 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> will not exceed 2 Sv (200 rem).

Please provide an evaluation which demonstrates that this requirement will be met.

Please find a revised version of the "Radiological Assessment of the Valeo TGA 3000" in attachment 9 of this response that includes these evaluations.

6. In Attachment 6, "Radiological Assessment of the Valeo TGA 3000," your evaluation appears to overestimate the potential doses from the distribution of the TGA 3000. You stated that the quantity of Am-241 in your product is 20 µCi, which is 12.5% (20 I 160 = 0.125) of the quantity used in NUREG-1717. Also, you Page 2 of 3

stated that 100 units would be distributed annually, which is 1% (100 I 10,000 :=

0.01) of the number assumed in NUREG-1717. Therefore, it appears that for "distribution and transport" the value for "Individual Annual Effective Dose Equivalent" should be (0.4)*(0.125)*(0.01) = 0.0005 mrem, and the other results should adjusted accordingly.

Please see the revised tables in attachment 9 of this response.

7. Question B.7 of our first RAI stated that Section 32.30(b)(10) requires the applicant to submit information concerning the proposed method of labeling or marking the product and its point of sale package to satisfy the requirements of§ 32.32(b). In addition to providing a new drawing for Attachment 6 , "Radioactive:

labeling," that is more legible and includes the overall width of the device, please ensure that all of the requirements stated in question B.7 are met and are described in your reply.

As stated in response 1 above, a cleaner copy of the radioactive warning label can be found in attachment 1 of this response. Additionally, in attachment 10 of this response please find a drawing showing the Point of Sale labeling that meiets the requirements of 32.32(b).

I believe that the above and the attached answers your request for more information concerning the Valeo TGA 3000. Should you have any questions please call me at (713)688-9345 or email me at Stan@vici.com .

Je~y, ))

-rti~~

President and Radiation Safety Officer Valeo Instruments Company, Inc.

Post Office Box 55603 Houston , Texas 77255 Page 3 of 3

Radiological Assessment Of the Valeo TGA 3000 Discussion:

In order, to evaluate the potential doses from the distribution of the TGA 3000, existing data on chemical detectors containing Am-241 was gleaned from NUREG 1717. NUREG 1717 presents dose data for the distribution of chemical detectors containing 160 µCi of Am-241. The TGA 3000 only contains a maximum activity of 20 µCi of Am-241 . This is an activity reduction of 87.5%. Additionally, Collective Effective Dose Equivalent estimates were made assuming an annual distribution of 10,000 detectors, while it is anticipated that the TGA 3000 will have a maximum distribution of just 100 units annually which is a 99%

difference. Thus, the results given in the dose tables below for the TGA 3000 were reduced by 87.5% for "Individual Annual Effective Dose Equivalent and by 99% for the "Collective Effective Dose Equivalent". All other conclusions and assumptions discussed in NUREG 1717, regarding the analysis of chemical detectors (including Distribution and Transport; Routine Use; Disposal; Accidents and Misuse; and Safety Criteria), were considered to be applicable to the TGA 3000 estimates of dose.

Tables:

Table 1 Potential Radiation Doses From The TGA 3000 Exposure Pathway Individual Annual Collective Effective Dose Effective Dose Equivalent Equivalentb (mREM)1 (Person-REM)

Distribution and transport 0.0005, 0.0000075 Routine use 0.0025d 0.01 Disposal Landfills 0.0000375* 0.0005 Incinerators 0.00025' 0.000008 Accidents and Misuse Fire 0.0375*

Vandalism of detector unit 0.075h a 1 mrem = 0.01 mSv; 1 person-rem= 0.01 person-Sv.

b Collective doses are based on (1) an assumed annual distribution of 100 TGA 3000's containing 0.2 mCi of 241Am each and (2) an assumed 10-year effective lifetime for the detectors.

c Dose estimate applies to local parcel-delivery drivers exposed to multiple exempt units in wholesale warehouses during distribution and transport; dose estimates are significantly less for other truck drivers, workers in truck terminals, and members of public along truck routes (see Section 2.15.5.1 of NUREG 1717).

d Dose estimate applies to a user of a portable chemical detector containing an 241Am source; dose estimates are less for a user of a fixed chemical detector containing an 241 Am source (see Section 2.15.5.2 of NU REG 1717).

e Dose estimate applies to waste collectors exposed to multiple chemical detectors during disposal at landfills; dosu

estimates are significantly less for workers at landfills, off-site members of the public, and future on-site residents (see Section 2.15.5.3 of NUREG 1717).

f Dose estimate applies to waste collectors exposed to multiple chemical detectors during disposal at incinerators; dose estimates are significantly less for other workers at incinerators and off-site members of the public (see Section 2.15.5.3 of NUREG 1717).

g Dose estimate applies to a worker who are involved in the cleanup following the transportation fire involving multiple chemical detectors with 241Am sources (see Section 2.15.5.4 of NUREG 1717).

h Dose estimate applies to ingestion of 241Am by a person who finds and destroys a chemical detector containing an 241Am source, (see Section 2.15.4.4 NUREG 1717).

Table 2 Comparison of Estimated Maximum Individual Doses from the TGA 3000 and Limiting Organ Doses from 10 CFR 32.27 Exposure Conditions* Maximum Individual Regulatory Limit for Doseb Organ Dose (mREM. REM, mREM/vr)< (m/REM, REM, or mREM/yr)<

Effective dose eauivalent Routine Use and disposal 0.0025 mREM/yr<! 5 mREM/yr" of a single exempt unit Accidents involving single 0.075 mREM1 0.5 REMg exempt unit 15 REMh Normal handling and 0.0005 mREM/yr 5 mREM/yri storage of multiple exempt units Accidents involving multiple 0.0375 mREMk 0.5 REMg exempt units 15 REMh Dose equivalent to red marrow Accidents involving a single 0.1125 mREM 0.5 REM0 exempt unit 15 REMh Accidents involving multiple 0.05 mREMm 0.5 REMo exempt units 15 REMh Dose equivalent to bone surfaces Accidents involving a single 0.00125 REM' 1.5 REM" exempt unit 50 REM 0 Accidents involving multiple 0.625 mREMm 1.5 REM" exempt units 50 REM0 See following page for footnotes a See Section 2.15.4 of NUREG 17 17 .

bMaximum individual dose based on the typical quantity used (i.e., .02 mCi) of 241Am).

However, the activity of the source could be increased until the regulatory limit for organ dose is reached.

c = =

1 mrem 0.01 mSv; 1 rem 0.01 Sv.

d Dose estimate applies to an operator who is exposed to a single chemical detector unit during routine use (see Section 2.15.5.2 of NUREG 1717).

e Limit on whole-body dose and active blood-forming organs during normal use and handling of a single exempt unit (see Section 2.15.1 of NU REG 1717).

1 Dose estimate applies to a person who vandalizes a chemical detector unit and ingests radioactive material due to contamination of hands (see Section 2.15.5.4 of NUREG 1717).

9 Limit on whole-body dose and dose to active blood-forming organs when probability of failure of safety features in product is less than one failure per year for each 10,000 exempt units distributed (see Section 2.15.1 of NUREG 1717).

h Limit on whole-body dose and dose to active blood-forming organs when probability of failure of safety features in product is less than one failure per year for each 1 million exempt units distributed (see Section 2.15.1 of NUREG 1717).

1 Dose estimate applies to local parcel-delivery driver who is exposed to multiple chemical detector units during distribution and transport (see Section 2.15.5.1 of NUREG 1717).

i Limit on whole-body dose and dose to active blood-forming organs during normal handling and storage of multiple exempt units (see Section 2.15.1 of NUREG 1717).

k Dose estimate applies to a worker who inhales radioactive material from multiple chemical detector units during cleanup after a transportation fire (see Section 2.15.5.4 of NUREG 1717).

1Bone surface dose or red marrow dose to a person who vandalizes a chemical detector unit and ingests radioactive material due to contamination of hands (see Section 2.15.5.4 of NUREG 1717) m Bone surface dose or red marrow dose to worker who inhales radioactive material from multiple chemical detector units during cleanup after a transportation fire (see Section 2.15.5.4 of NUREG 1717).

n Limit on "other organ" doses when probability of failure of safety features of the product is less than one failure per year for each 10,000 exempted units distributed (see Section 2.15.1 of NUREG 1717).

o Limit on "other organ" doses when probability of failure of safety features of the product is less than one failure per year for each 1 million exempt units distributed (see Section 2.15.1 of NUREG 1717).

Estimate of external dose commitment from exposure to the unshielded 20 1,1Ci Tl3A Am-241 source for 1000 hours0.0116 days <br />0.278 hours <br />0.00165 weeks <br />3.805e-4 months <br /> at an average distance of 1 meter from the source:

Per the guidance in NU REG 1717 Section 2.15.4.4 the dose rate at one meter from a 1

µCi Am-241 source is 9 nrem/hr. The TGA 3000 contains a 20 µCi source and therefom the dose rate can be calculated as 180 nrem/hr. Using this dose rate to calculate the total dose from a bare TGA 3000 source for 1000 hours0.0116 days <br />0.278 hours <br />0.00165 weeks <br />3.805e-4 months <br /> the result is 180 1,1rem (0.00018 rem).

Estimated Internal Dose Commitments do to the ingestion of 104 of the 20 µCurie foil from a TGA 3000:

The Am-241 is intimately bound in a foil matrix of precious metals which is then crimped into a metal holder. Ingestion of a source is virtually impossible except by deliberate disassembly of the TGA 3000 and deliberate destruction of the source. However, in the unlikely event that the 20 µCurie source was destroyed it is assumed that 1Q-4 is ingestHd.

The SO-year dose commitment is calculated as:

Ingestion Activity = 0.002 µCi Critical Organ = Bone Fraction of ingested Am02that reaches the bone = 1Q-4 Effective energy per disintegration = 5.5 MeV

= 0.002µCi x 10-4 x 2.2 x 106 d/m/u Ci x 5.5 MeV/d x 1.6 x 108 g. rad/MeV x 10 rem/rad J<

1/5 x 101 g bone x 60 m/hr x 24 hr/d x 365 d/y x oi5° e-'1dt Where:

A= 0.693/458y t =50y 0.002 µCi x 960 mrem/µCi = 1.92 mrem (0.00192 rem)

Dose Estimates to Skin due to carrying an unshielded 20 1,1Ci Am-241 source in a pocket for 80 hour9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br />s:

Per NUREG 1717 the dose equivalent to the skin at a nominal distance of 1 cm from handling a 1 µCi Am-241 source for 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br /> is calculated to be 30 mrem. Based on this information the dose equivalent to the skin for the 20 µCi Am-241 source for 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br /> would be 600 mrem or 60 mrem/hr. Using this information the result for the 20 µCi source in a pocket for 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> is 4800 mrem (4.8 rem)

VALCO INSTRUMENTS COMPANY, INC.

RADIOACTIVE MATERIAL SHIPPING CONTAINER RECEIPT/SHIPPED SURVEY Date: Instrument Model No: Ludlum 3 W ITH 44-9 PROBE Time: Instrument Serial No:

Received From: Calibration Due Date:

Received Bv: Backaround:

Descrlotion of Shipment:

Name of Authorized User Notified: Sianature of Authorized User Receivina Shioment:

Exeosure Rates Measured In mR/hr, unless otherwise noted Wi12e Sam12le shall be 300 cm 2 or the entire eackage if less than 300 cm2 {Note: 100 cm 2 Is - 4" x 4" areal Attached all wipe sample results to this survey form.

Limits:

< 0.5 mR/hr (500 uR/hr)

/ /

V Perform a radiation survey of the each package and record the highest exposure rate here mR/hr, and note the location of the highest exposure rate on the package with an ***. If the entire package is below 0.5 mR/hr (!>00 uR/hr),

enter< 0.5 in the space above.

Note: A separate radiation survey and removable contamination survey form shall be completed for EACH package shipped/received.

COMMENTS: _ __ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ ~

---

3 Survey Performed B y : - - - - - - - - - - - - - -- - Date: _______

Survey Approved By: - - - - - -- - - - - - - - - - Date: ______ _

I certify the package(s) received and surveyed do not exceed 0.5 mR/hr on contact with the package(s) and the removable contamination levels do not exceed 0.5 mR/hr Notify the Radiation Safety Officer immediately if a package is discovered damaged or any survey results exceed the limits stated above.

1 of 1

VALCO INSTRUMENTS COMPANY , INC.

FINAL RADIATION SURVEY

~ TGA 3000 OEM Assembly S/N: - - - - - - - -

1:8:1 Sealed Source Lot#: _ _ _ _ _ __

TGA 3000 OEM Shipped to: - - - - - - - - - - - - - - - - - - - - -

Survey Location:

Source Model No: A-001 Source Serial No: - - - - - - - - - - -

Radioisotope: _AM-241 Activity: 20uCi Date Survey was Taken: _ _ _ _ _ __

INSTRUMENT DATA Ludlum Model 3 WITH 44-9 PANCAKE BETA/GAMMA PROBE S/N: - - - - - - -

Calibration Due Date: - - - - - - - - - -

Calibration to Cs137.

Survey Results Background Swipe._ _ _mR/hr Sample Swipe Carrier Inlet _ _ _ mR/hr Sample Swipe Drift Inlet mR/hr Sample Swipe Exit Port mR/hr Sample Swipe Bottom Plate mR/hr Sample Swipe Top Plate mR/hr Limits < 0.5 mR/hr (500 uR/hr)

CERTIFICATION I hereby certify the results of this survey indicates the activity to be less than 0.5 mR/hr, (500 uR/hr), of removable contamination.

Date: _ _ _ _ _ _ __

~kTo~~~~~~: _ _ _ _ _ _ _ __

Print Name Date: - - - - - - - -

RSO Signature:. _ _ _ _ _ _ _ _ __

RAF 1001 1of 1

VALCO INSTRUMENTS CO.,

INC. PN 48100102 SHIPPING SURVEY INSTRUCTIONS.

Instructions for survey TGA 3000 OEM module prior to packaging.

I. After all exit and inlet ports have been sealed perform a survey using the Ludlum Model 3 with 44-9 pancake probe.

2. Use Sample Swab DSA PN: DSW8055. Use clean swab for each sample.

3. Use Valeo form RAF I 001, Final Radiation Survey fonn fill in all required spaces.

4. Swipe known clean area to obtain background reading.

5. Use clean swab for each swipe on places indicated on Valeo form RAF I00 I. Note readings on form.

6. Notify RSO if readings arc above limits indicated on form RAF I 00 I.

7. Print name and date and have RSO sign the form.

8. Make 2 copies, retain one for records and one goes inside document envelope shipped with instrument.

Instructions for survey of TGA 3000 OEM shipping container.

I. Once the TGA 3000 OEM unit has been properly packaged perform a survey using the Ludlum Model 3 with 44-9 pancake probe.

2. Use Sample Swab DSA PN: DSW8055. Use clean swab for each sample.

3. Use Valeo form RAF I002, Container Shipping/receiving Survey fom1.

4. Follow instructions on form RAF I 002.

5. Print name and date and have RSO sign the fom1

6. Make 2 copies, retain one for records and one goes inside document envelope shipped with instrument.

End of Instructions.

- -- - - - - - -- 2.500 - - - - - -- - -

t CONTAINS RADIOACTIVE MATERIAL RADIONUCLUDE: AM-241 0.100 ACTIVITY: 20 uCI DETAIL "A" MANUFACTUREDBY VALCO INSTRUMENTS COMPANY INC. UNDER U.S.

LICENSE AND IN COMPLIANCE WITH NRC

-I 0.100 10CFR32.31 PRIOR TO USE REFER TO TGA 3000 OPERATOR MANUAL, PN 48100102, FOR SAFETY AND OPERATIONAL GUIDANCE.

LABELS: RED TEXT ON ALUMINUM BACKGROUND, MINIMUM 10 POINT PRINT. RADIATION SYMBOL-MAJENTA OR BLACK TREFOIL ON YELLOW BACKGROUND. 1 0.450 MATERIAL SPEC: .003" MIL PHOTO ETCHED ALUMINUM ~

PERMANENT ACRYLIC ADHESIVE BACKING OPERARTIONAL TEMPERATURE -60F TO 450F -J 0.450 ~

ITEM PART OR REF NOMENCLATURE OR

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D:tv1ENSIONS ARE IN INCHES.

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THIS DEVICE CONTAINS RADIOACTIVE MATERIAL RADIONUCLIDE: AM-241 ACTIVl1Y: 20 microCI MANUFACTURED BY VALCO INSTRUMENTS COMPANY INC., IN COMPLIANCE WITH U.S. NUCLEAR REGULATORY COMMISSION SAFElY CRITERIA IN 10 CFR 32.31 1.500 THE PURCHASER IS EXEMPT FROM ANY REGULATORY REQUIREMENTS I 3.000 LABELS: BLACK TEXT ON WHITE BACKGROUND, MINIMUM 10 POINT PRINT FOR RADIATION WARNING SECTION AND 12 POINT FOR PURCHASER SECTION.

MATERIAL SPEC: 2 MIL POLYIMIDE PERMANENT ACRYLIC PSA ADHESIVE BACKING OPERATIONAL TEMPERATURE -60F TO 450F I I I 1TEMI PART OR IDESIG REF ;I NOMENCLATURE OR SPEC/STD QlY PER DASH NO I NO IDENT NO DESCRIPTION I PARTS UST OR MATERIAL UNLESS OTHER SPECIFIED:

D1tw1ENSJONS ARE IN INCHES.

DR 8.KAYE CHK 04/2017 w,n~n . .

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TOLERANCES ON XX DEC P +/- .02 FINISH 63 RMS ENG XXX DEC P +/-.005 VP 2* O' MFG TGA 3000 POINT OF SALE LABEL ANGLES +/- 30' QA MATERIAL: FINAL PROTECTIVE FINISH:  ::,A~ 14 6 10 0 1 0 2 I REV USED ON SEE NOTES I SEE NOTES FILENAME: SCALE 2 I SHEET 1 OF 1

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TOP AND BOTTOM PLATES ARE MACHINED FROM 5052 H32 ALUMINUM SHEET. REFERENCE DRAWING 44l00I52_Y25932 ATTACHED WITH THIS SECTION. SUPPORTS ARE NICKEL PLATED STAINLESS STEEL, 0.250 HEX STAND OFFS. FASTENERS ARE MADE FROM 18-8 STAINLESS STEEL.

TOP PLATE 3,570' SUPPORTS 2 .857'

+

BOTITOM PLATE

- - - - - - -- -4.750' - - - - -- ---

All. DRAWING DIMENSIONS IN INCHES UNLESS OlHERWISE SPECIFIED

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GA 3000 OEM MODULE FRONT VIEW DIMENSIONS ii' -- -- 22100104 -

,______________ ___.___ ____________ _ _ ________ __...____________ - __,

2.857'

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REVISIONS REV. DESCRIPTION DATE INt'TIATEO DATE APPROVED A. ECN#24034 NEWDWG 03123/17 DA.LE A.

8.900 - r - - -- - - -- - - - - - - - ,

8.650* - - - - j*

(2X) 8.275 (2X) -&

3.9 11

• MATL: 5052 H32 (ALUM)

NOTES:

1. ALL SURFACES TO BE SMOOTH, AND FREE OF DEFECTS.

0 .149THRU

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FILLETS: ~ , CORNERS~ X 45* UNLESS OTHERWISE SPECIFIED.

STAMP/ETCH TEXT

(.20 HGHT) THS DOCUMENT ANO THE N'ORMA.TlON WHICH IT CONTAINS SHAU. NOT 8E USED. EXP\.DITEO OR SOLO. ANO SHAU. NOT BE REVEAl£D OR OISCI.OSEO TO OTHERS WITHOUT THE EXPRESS8 WRITTEN PERMISSION OF VAi.CO. THS OOCUMENT SHAU.REMANllE PROPERTY OF VALCO ANO SHAU. BE RETURNED UPON DEw.NO.

VICI Valeo

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TOP AND BOTTOM PLATE, PCB MOUNTING REF. DWG: 44100152 (REV. 1) IMS-25932

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