ML20216B034

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Informs That as Result of Insp,Nrc Discovered That Models 902 & 902A Detector Cells Listed on License 29-28377-02G,not Properly Registered & Requests Chrompack,Inc,Submit Application to Register Detector Cells
ML20216B034
Person / Time
Issue date: 07/27/1992
From: John Lubinski
NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To: Hofslokken R
CHROMPACK, INC.
Shared Package
ML20216B030 List:
References
RTR-REGGD-10.010 SSD, NUDOCS 9805150013
Download: ML20216B034 (9)


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3 w asau,

+ 'o UNITED $TATES Ig NUCLEAR REGULATORY COMMISSION

[ g l

r. y WASmNG YON, D, C. 20555 ]

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\s . . . . . ,f JUL 2 1 1932  ;

i Mr. Rune Hofslokken j Chrompack, Inc. l 1130 Route 202 Raritan, NJ 08869

Dear Mr. Hofslokken:

)

l As a result of an inspection conducted by the Nuclear Regulatory l Commission (NRC), it was discovered that the Mcdels 902 and 902A  !

detector cells listed on your license (number 29-28377-02G) were l not properly registered with the NRC. Therefore, we requect that j you submit an application to NRC to register the detector cells. j 1

Enclosed is a copy of regulatory guide 10.10 " Guide for i Preparation of Applications for Radiation Safety Evaluation and ,

Registration of Devices Centaining Byproduct Material" to assist you in preparing the application. Please submit the application to:

U. G. Nuclear Regulatory Commission ATTN: John W. Lubinski M/S 6113 Washington, DC 20555 If you have any questions, please contact me at (301) 504-2689 or Mr. Steven Baggett at (301) 504-2542.

Sincerely,

/s' /k/ -~~~~

John W. Lubinski, Mechanical Engineer

< Sealed Source Safety Section Source Containment and Device 4 Branch Diviolon of Industrial and Medical Nuclear Safety, NMSS

Enclosure:

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x ' i li' pr5cludesNitsjuse Winf another/p'roductHan ,well:f as ' handling 'by . unauthorized ApersonshWJ t?ist physic' ally ~ protected jf rom . impact and ' puncture by. the ' solid

kECDgfasseintilygwhich psurroundsWit.?i@!t is; electrically Jisolated fromlthe

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  • exterior.Rhousing;by ceramicLinsulators.f Fluctuationsti nipressure will not i j Mffectg the $ source; M gThe$potentialy h'azardsy ofi[sffres and. flooding [are

!W addressedhby.cNENr;lingtheirMProducthCertificationaforpMode1ANER-7004 5 i are?.s util i z eddi n vl aboratory ? enbi rohment s1 'undeN the i . "sep sourceWJ M' The e'rvi s i dDf ffo?

d eVi pr i of ess ces )li cria17Nop e~ rat 6N@gI tE21 mgther of or e Ju t k L' %nus'ualgenUl roninent aljy condi fi ons[?[o f% temper atdri,$pr'Eshdrd k91 br atT on ,

i.mpact$ puncture,'compressionfloadsforicorrosive' atmospheres'toioccur.GV v, M

$Mw WWW _ Y f>f . :. , ,1 W , m l

f M@$%op%f Norma 1M erating M@$temperatureE f or: ga a%s@chromatographWitted$ wi thf ECD is a ,

g tom 93500C.y 9 Temperature M 11mit Q switchesM designed Ctoifprevent EflUc 10%)$ne're8beingGinstalledronnth'oselsystems lwhichg u p @'td hed$ E.Model1902 a t'i bn ECD.s Tatiovin3,@3150C Q' hTh ey r epeat ed l ygd i sen g ag ed MatQ t oogl ow pa% t emp efatur e ,

howese @'becadsedthey

{ ,r customers?'could knot #achi eve 7 proper: operating itemperatUres(1 'Irbaddi t i on , j '

i I ower$t'e%eratuhesM i ricreased M the# 1i kel i hood Vof fdetector.' cont a'minati on ,

[whi'chWRnecess'itate Q cleanind5McP h replacement l- i more : ; f requent1 y ./ than 4 desi rEtheQQWeM have $f theref or'ejk Fepl aced [the . thermal jl i mi t (swi cch',- wi th .

6 7

!alectronichemodi'ficationss to) .ithe / heating 'circui ts'in c the Model .143Xfailure. ;Ser.ies k $GC's% whdh eireduce$thFppassibility . ' of. :temperaturof control)

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.byggperai tti ngga% temperature 7maximumM of 5/4000C.T'"'Cperators

i n str,uc t ed ,)$t ogg se tQ the p.t e mper a t ur ey b e tweenp 3000 fand 3250C for optimal ,

iperf ormance;'MKThi s Ekeep the foils cleaner, lwhichglwil'1%reducep$ operating)temperaturenwilladompti'me $forg ou $ cu NEN supplies transportationAAof6theb sources #tof be ikopt' to'a minimum. l 4severalhother$ECDkmanuf acturer;sV withi the d same f oilniused in the Model i

+

-% );,902AbjWe;phave equipment"whichiimpose gnoy?;knowledgef anyupperjlimi't ofijdevices( of)3500C.4 onl.4 any other 'manuf acturer *s l l [EUQ'.htni%$ Y @ kWO, W W % *- . glfy ' \

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..dTheVusefulp life iof [f ttunneurce exceeds the normal usef ul life of the ECD I

Mee11QwhicNNmayf be.10.2.to f15' years./1Theref ore, the cells will be returned l "Mtofthe manufacturer for/ rec'onditiening;or proper disposal.

- 1 hMM AssuranEEM.add$G901C91 gyglit[%MXfl $?YME120 O ', VM -T l

@% .,c: i fc . a . ' test [* phase

((jy?Clirompac.

Jj A@c@k@,Wduring the'. final for these units, will verify i detsctor' through ~the performance evaluation test, i pyacceptanceyof(;the operation of the j N~ Wwhereby1 afdeterminatien nis;'made Eto:> confirm -proper ~

manufactured in Delft, l 3 Nickel-63H source < v .Since AthmW ECDiassembly .is andT'sent to: Chrompack:fordinstallation, quality assurance in the i MHo11and,$'and[

g, gassembly final /testisperformed"in' Holland.  !

dw?M&;' m manufacture of the source has used 'in ;the t ~ design: and e $pThe'ItechnologyL existed, fora years andlis;similar;tofthat used by most manufacturers. To 4 ino incidents af factivity leakage have occurred.

I jlour;. $$$$WQ knowledge,f '

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@pBangtion' Nn q MOMi Dose . i nRatg.

gSince MNickel- 63l is ' strictly a' beta emitter, the -of radiation levels will be

. l l

the surface the detector's metal f g;yfatW housingork near6 is k y/This background true regardless' values..at: of the operating temperature of the l p m devicevi Anfisodose measurement table is attached as Appendix N.

W('% . A e ,

1021e11e1190- # .

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The sourcesi'are  ? ' installed in- the ECD's by trained Chrompack personnel l

'duririgVma'n'uf acture . at b Chrompack :in' Delft Holland. The ECD may be ,

'the GCeither.at the factory 3 or in the field, according to !

inst'a11Edl fiistructi6 rial l fin;'rU the operation manuali Appendix I.

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sThea Nickei$63M source /is , -ini a configuretion which precludes an operator W om fhavind gahcessgtoh[theM eourceh1If_any malfunction would, occur, the

, ^sdurce$'r'emains%shieldedLQ0perating! instructions' are included as Appendix

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Thes whEn th e M'sou'rc Ni(@kel-63)io31s
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HATERIALs LICENSE M

p Purwa o the Asaewc !actsy A<s et 1954, se amended, she rettsy Reessandiation Act of 1974 (rw6he code .I redu. s,swewas. cur in t. run so, si, n n. 34. 3s. 4o a.d m. d a uhwe o. inn,m . d ,,r<nenia.

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I hentofore m>Je by the kenwe, a ktaw n hveby hwad ntheriting the bctswe le twtive, acquist, ron

,f I levne. and sental nwlew stenal desipiated hvlew; te see such maserial (w the twpow(s) sad as the riatts) d dehvet a Ismin sah snateralle persees aviherind le ressive M to screadance o ch the ersvlatwas et the a n

9 ( beenw skets be deemed se geniale the cond <wes spwined in settlee l&3 of the Atom 6ch Energy Act of i

wb;nt se all errhentle twies ##platams sad aden of the Nwirm Assulaswy Commhi6en som a he

{ Iq tonditions spnantd below.

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' l' Chrompack, Inc. 3 W'as* **=6" m

,i 29-28377 02G i

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f.1130Ponte202Raritan, New Jersey 06869 4 F5;*erise das*

October 31. 1994 1

i, 5. Docket or R4terence No 030-31323 l' 6 Dyprodws,towne,and/o#

7 chemual endlos phpital s. Wasenema amovat shas hcenste spe(NIawltN material (ets spay Poutts at say ese tune g

usetsthh herau l A. As specifled in A. As specified in A. Isot applicable i Condition 10 Condition 10 i

I , 9.

Authorizes use Pursuant to Section 32.51.10 CFR Part 32, the Itcensee it authorlied to distribute

[ A.

it the devices containing plated foils spuf fled in Condition 10 of this Itcense to 1

il persons generally licensed pursuant to Sestion 31.5.10 CfR Part 31 or equivalent provisions of the regulations of any Agreement State.  !

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,' 10. Each device distributed pursuant to the t4res and conditions of this license shall i o '

be in accordance with the following table I i

il i

Devfce Model Foil Model Maximum Activity I

mater (s) Nweer(s) Isotope _ Per roll (M1111 curies)

") l Chrcapack. Inc. Plated foil Mickel 63 10 l i Nodel 902 (Dupont(ktM I detector cell Products

.D I MER004)]Model Chrompack. Inc. Plated foil Nickel 63 10 i i Podel 902A (Dupont (NE!!

F ll detector cell Products nr3';UO

( ,i HER-004)]Model h 1

j 11. The Itcensee is authortred to distribute Itcensed material from the Itcensee's facility at 1130 Route 202. Raritan. Mes Jersey.

h! 12. 1his Itcense does not authoriza possession or use of Itcensed taaterial.

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QI a 2,:w.;. . ,, ;y w , . , : w . ' , M ;. CONDITIONS .

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dk b F9lI x,f' conduct its program in accordance with the statesents 4i L

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' procedures contained in the documents including any enclosures M;_; i i

9. ; '9The Nuclear., Regulatory Cornission's regulations shall lessgovern the un. listed bstatssents representations and procedures in the ifcensee's a p:;cI ,ki and~ corresp,ondence I

are more restrictive,,than the regulations. ppitcation-p w n,3.p + w . .

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[Af l A. Application dated April 10.'1989

.- #mq B. Letter dated August 10, 1989-1

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    • 'WV" % I By _ _ John D. Kinneman e ~ il Nuclear Materials Safety Branch '4 Region ! . '

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\/.: .. REGISTRY OF REICACTIVE S2AI2D SCurd25, AND EILVICES

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MjQg v, MrWji; DEVICE TYPE ' ; Electron Capture, Detector Unit (ECD) qTQys.

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g $w;,;{$ey Q,, 6d*q@M f.3,0.m rw,,s.i A @g. [ Qi y , 4 g,.iJth da,#r!st w <

c.

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3 .

. . v:,.;w?. ; p..

. . , , s,.

y g;' DISTRIBUTOR
l Chroispack, (Inc. ' - -

FJ .', y' 1130. Route <202. ..

?jk
C

~

I Raritan, New Jersey 08869 f%

v.

201/722-8930 .

3; ..

~ . q . a ; . r. . .

.w

%'t ' HANUIACTUREE: Chrompack'B.V. ..

2600, ANN /P.O'iBox;.519

,% .L. .

6', Delft,,, Holland, The Netherlands u.,

.~

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SEATED SOURCE MODEL DESIGNATION: E New England Nuclear - NER-004' Foil c,. ' ,

. ,r ,

., 9 a, ,

IISOTOPE:y,-  ; ,. . . -

n s .

T ' MAXIMUM ACTIVITY:  !

. [a '-

y.

G: A,  :. Nickel-63'. 10'n'illiduries y) l[E  %, ?.

.,c y ,~ .

M s

' f7AM TEST FREOUENCY: Thirty-six (36) sonths

[1, ll):~42BBCIPAL r..L

". ^ USE: (P) Ion Generators, Chromatography M,. i CUSTOM DEVICE: YES X NO I[) ; 7 ~

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y O h RADICACTIVITYrLEAKAGE TEST FOR i ELECTRON CAPTURE DETECTORS TM? , - -

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'qg g,j,TheM U.-*:8. < NuclearReW ,:latory; Commission" requires #that,yourl Electron ,

fg jgAcapture9 Detector. .conta ningt:10; mil 11 curies of Nickel-63 be tested.for hp J 1eakagedof radioactive material at no, longer than thirty-six (36) month h

% @/h^i? 'appropriatel intervals.3 4

.If syou;workiin an Agreement State, you should consult the

% V approvedpwipe-testt kit: supplied

!qgg underdtheir; program. c. state < authority.regarding-required wipe . testing frequency You may, satisfy this requirement by using the by Chrompack,' by using en approved kit My supplied by another company, or by, performing.the test yourself.

g t Q i'  ; i. o +w . . c ,

h,We Tol;.facilitato I

  1. C' wipe-test compliance-;with the: requirement, chrompack can supply a service for users ofliElectron Capture Detectors which I

1 h

J Jincludessa c ,

g7 1 [p u c + 7NA;Xit of supplies to be used when collecting the wipes, y&

j

  • , 2.. Directions for performing the wipes and submitting

{k m

them for analysis..

$ 3. A -leak- test certificate which reports the measure:aent

&W in microcuries- of Nickle-63 and provides information 9 'on the method used to assay the wipes.

m ,

".' This service is available by purchase order directed to Chrompack, Inc., 1130 Route 202, Raritan, NJ 08869. Please p include the following informations

1. Purchase Order Number h
2. Billing and shipping address p[' '
3. Description of order Wipe-Test Kit Part No. 7000348 ni 4. Special shipping instructions, if necessary.

Q If you should wish p]j to perform the wipe-test procedure yourself, proceed as-follows:

'a cd 1. Materials needed:

Wl . a) 2 small liquid scintillation vials

% b) 2. cotton swabs to fit inside vials P

c) Sul EITTA solution (0.1M) u

~ 1}. 2. Procedure for detector exterior wipe:

h

  1. h

. a) Dip swab.

swab f1 into the EDTA solution to dampen the F' .

b) With the wet swab, wipe the exterior surface (s) of the detecter (top ori chimney) and the output (s),

$g'

( which is in the block'containing thu signal cables, h

h; f Rotate the swab while wiping, c) After the wipe has been completed, insert the swab D' into vial overnight.

  1. 1 with cotton tip down and allow to dry

{.

W M t h}A 3 f dik, .L :sj

'Y mmmmmmag ma-mmmm nn'M' '*

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mgN % w c g  :

{ ONStFORH,usg20F leaks.TE IT VW QWM,'M 'N W.  ! d

@WDIRE'M 4TOsMON! TOR l REMOVABLE; NICKEL-63 rq i'6 '

$g 4 dMMIN;GASjcHROMATQQRAPHY ELECTRON CAPTURE: o -

D h . [Q n.n.

Y CONTENTE(OFJLEAKi,TESTKIT:

h h

,a ,,,.,s, , . . . . .<. # .

? $ h M,f h ( h h k h'; 3. a. M ,

3 .,2 Sam'ple7TubeseSlabeled

  • fl"A e S,"B" lN s ' ."C" , eac h wi t h . a co t t on swab

, g, %y , ;lW i ns i deY > ' ' ,g' %.1,5 a.;. Q. ,g.

, ,j sg t an w 4,qg+ouw g. nN s.._ . gvA ty ' - 1 j ,- o; j- f .

g s;3 M EDTA solutionsin; reagent,vlal'.f '

wn:

m ie= w e 4e . ~my. , . - 8 ~w ,.,., , .y , .

-pp ,

+

w

  1. D.#IMPrep'rihtedia!!!ng'1'abel'fordreturn of., samples to Chrompack tf p Msp%gk dfinen%hy ,v %w ar a +ev Myu D. 3 w4& %, m/sx4 W 2 - '. .. vy - 8 Z;p;.

7

' 3 . .

pfg M.%t a 1Qg"Sako_le[!dentificationy. Formeg,'to be. compteted and returned -

t y g J/;,twith2the: , Leak iTest' 5amples. .f Y .MQ n Directions'^.M' .qb g . - n W -

. W y[%2R_

  • ',; O

$ / .g L' a ,

. 4 ,.( -

W N

's PROCEDURE.FOR W!PE TESTING:

fi' , . ,

i

?gy ,'rg petor Exterior Wloe m$~h 1. Take the cwab from tube'"A" and dip into the EDTA volution >

t

, reagent viol to wet.the swab.

@hh

& Wi 2.

n, . . m W1thlthe' wet swab,' wipe [the exterior surf ace (s) of the .

i Rf detector immediately' adjacent)to the detector (top or R ,' . chimney), and output (sh whichXir. in; the block containing the W.W signal' cables.

1 >-

Rotate the Lewab wh!!w wiping.

g;p (yk ' AfteE the wipe has been completed, insert the swab into tube 3.

fp "A" with cotton tip up, and allow to dry overnight.

P ..

T / Baekoround Control i, '

k .1 . 5;

t. jTak'eithe swab from tube."B" and dip the swab into the EDTA

~

N(((V

. solution vial to wet,the swab.-

m-

g . r 2

2.- Insert the wetted swab.into tube "B" as above, and allow to g;RA' 1 dry?cvernight. (This control: swab witte therefores have the

)gfp 4samel drying time and handling.as the wipe test samples.) ..

v 'n Y c i s MWe -.,.~Note

  • ou s;:i Tube,L"; C" is a sparee to 4

be;used only if needed.

m w y). l' ' Af.terc the sample tubes have dried overnight e cap each tube.

N@V'RETURNPROCEDURE: ^

a;( , . . ,

j l

2. Nakelcertain the " Sample Identification" form has been hh,Ih ,: completed. 1 W ,,

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kHROMPAC[

1130 Route 202, Raritan, New Jersey 08869 (800)526 3687 * (201)722 8930 Fax. (201) 722-8365 gg '

August 10, 1989 Mr. John D. Kinneman, Chief U. S. Nuclear Regulatory Commission, T.egion I Nuclear Materials Safety Section B Division of Radiation Safety and Safeguards 475 Allendale Road King of Prussia, PA 19406 RE: Docket No. 030-31126 Control No. 110600

Dear Mr. Kinneman:

We are in receipt of your August i letter advising us that action is due on our application of March 3, 1989. We are able at this time to supply the additional information requested by Mr. Jensen on May 2, 1989.

Enclosed please find the supplemental inform: tion requested:

)

1. Samples (2) of the actual ECD tag-labels with revised information, including the leak test requirement and the model number. This particular label is attached only to ECDs distributed to persons under general license. Labels attached to ECDs distributed to persons under specific license do not bear the statement referring to a general license. The source serial number is engraved directly into the ECD hardware and on the protective cover, along with the nuclide identity and activity (see p. S-154).
2. The operations manual has been revised to include information on leak testing. The frequency (36 months) is i stated, which will now apply to both general and specific  !

licensees. Directions are given to the evner for the i performance and documentation of the leak test himself, or l

for the purchase of a leak test kit from Chrompack. Only i the revised pages to the manual are enclosed.

H6600 l 1

OfflCIAL RECORD COPY HL18 AUG 231989

( kHROMPAC 1130 Route 202, Raritan, New Jersey 08869 (800)526 3687 * (201)722 8930 4 Fax. (201) 722 8365 I

I Mr. John D. Xinneman, Chief August 10, 1989

3. Documentation on Packard's leak test procedure is enclosed i and is performed under Illinois license number 12-04 93.1-04 G . Illinois does not have any provision for

" registering" a leak test procedure or kit in any way.

4. A revised cover sheet for " Registry of Radioactive Sealed Sources and Devices" is submitted, showing t"e current manufacturer and distributer.

I a

trust that this additional information is sufficient to permit license to be issued. If you still have concerns regarding this application, please contact this office.

Sincerely,

[

Charles A. Emken Radiation Safety Officer k

t g g>A w e a.rn:. %p u* 3 "' '-

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, J RBIIlmt(CF RADICACnVE SEAZ2D SQLR23 NO IEVIGS T. -

.j gAFEIT EVAIIUCION OF IEVICE,

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q pid (Previously.NR-529-D-105-5)

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$1eN,iibn' Capture Det b er Unit b fd (ECD) o $.....non m x . 2 en.

at .,

02A n_u M.

' Tf"3),$DISTRIBUTbR:

N1 Chrospack, Inc.

1130 Route 202 hhf

~ Raritan, New Jersey 08869 l

[ f.YDMV 3%

201/722-8930 b b- [

v. ,

@f b y, g MANUFACTURER: Chrospack B.V.

2600 ANN /P.O. Box 519 Pd . 4 p.,e .

s Delft, Holland, The Netherlands 193

p. '

M u seat 2D SOURCE MODEL DESICNATION: New England Nuclear - NER-004 Foil l

(,7 L o yc ;L IISOTOPE: MAXIMUM ACTIVITY:

Q .s . Nickel-63 to millicuries 1 k a')'P .

$q ..rj MAX TEST FREQUENCY: Thirty-six (36) months

@ m j Q ;'. ; ~

l 4 M ,m3 .

i PRINCIPAL USE: (P) Ion Generators, Chromatography pg.t ,,

-U.( ,J . ^

F YES X NO p&;. CUSTOM.. DEVICE:

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  1. 9-I g j s% - i W*W. qwV1 M MATERIALS LICENSE ~

d i, n .%e 's.A M .'; u..

t. ~:yM* Energy Act of 1954, es amended, thetements Energy Reorganisation and reprewnf ations ' ,

Persvant to the Atomic g( code of Federal Regulations, Chapter I. Parts Jo,31,32,33,34,35,40 and 70, and in reliance  ;: i

< ;l l

on s l ( ) deusnated t>elow;to - l

. heretofore made by the Ikensee, a lkenne is hereby issued authorliing the Ikenwe I to i rece v l

I s ource, and special nuclear material designated below;to uw such fh material bcable Partis). for This -the I purrow I: deliver ce transfer such material to persons fauthorlied i ff t and to any to rece f'. subject to s!! spp!kable ruits, regulations and orders of the Nucirst Regulatory C f

conditions specif,cd below. ; j

a ,

utenue ( ji

, j ,

l l e 29-28377-01 I

3. Ucenw number

- 5I ;EChrompack.Inc.

I I

y  :

~

l J I L October 31. 1994 l g M ,ll j2.,1130 Route 202 4. Eiptritan 4,e, l Raritan. New Jersey 08869 i

/9,1 'l. s. Docket or 030-31126 g.

f r;?I f I

, Reference No l

s. Mazirnum amount that beenste bI -
7. Chemkal and/or physkal may poswu at any one tune I

y#y t 11 6. Byproduct, source,and/or form endes thalxenu I specla! nuclear material I

[ g A. Plated sources (Dupont A. Not to exceed 10 milli- I curies per source and si 1* A. Nickel 63 [NENProducts]Model 2 curies total t NER-004) in detector pf cells (ChrompackModels '

i [i 902and902A)

C I, N II 9. Authorized use i-f

? I For use, demonstration, installation and distributio

? [ A. .license issued by the Nuclear Regulatory Cornission or an Agreement sta -_

lp j, w n C0holliON5 C I y I Licensed material may be used at the Itcensee's fccility hat 1130 Route I

L 10.

N I

, Raritan. New Jersey and at temporary job sites of t Q l for regulating the use of licensed material.

i i ai I I 11. A.

Licensed material shall be used by, or under the supervision of.

pk.

p I The Radiation Safety Officer for this license is Charles A. Emken.

p,] [. B.

Sealed sources or detector cells containing licensed material shall not 6h I52. opened or sources removed from source holders or detector cells by th l

l$ licensee.

K l A.

Any sealed source (s) or detector cell (s) specified in Item (s) 7.

l13. tested for leakage and/or contamination at intervals not to exceed 3 yea y:. [

i l Any source or detector cell received from another I

months before the transfer shall not be put into use until tested.

$y '

nmCIAL RE000 COPY ML 10n(h g R4 l yll' c 4 0

m ue%

REG 1 LIC30 MTLSLICENSING ppg Clf[1,

===........... ......= -m g j .a "

- -- -- 4. g rj===.--- i

8 g o o . . . . . ,, ,,

y f "Dg5$""*"""r %%em Mhl ((i Mg 3 7 z.m .

.l fY ~

y+

i CONDlil045 (13, continued) f); A mind soorte er detector cell in storage and not being used need

& Mansensent. Jakenatheaseveseerweer bg) 4' %"Mdrg f' =

< . aw-

.m a C. of rodfpactive material en the test sample M' i presexe of 0.006 ofcrocurie er more of romerable conta 7"

! source or detector cell shall be removed from service a

?

repaired, or disposed of in know with the U.S. beclear Regulatory Ccesission Region accordance Chief, w fluclear Materfals Safety Srsach,476 Allendale Road, 81 8 fannsylysafa 19406, The report shall sp j

<g shall be kept la valts of afcrocurfn sad s :s Cassinfoe inspection. b l

1 the Ifcensee is authertred to collect feak test samples be f

packard Instrement Co. or tests for leakal 0, t tate to perform swch services.

In 11ev of utes the conventional redistfosbaths, caution col

, 14. en yellow backgroved) as provided in Section 20.20 the Itcensee is htreby authorlied to label detector cells and containing licensed material and used is requiresent. for cecords

15. The Itcessos shall conduct a physical faventory t ry. ev all sovrtes and/or devices received and hall pos d
15. Except as specifically provideditstedotherwise h below.

procedures contained in the documents including any enclo 2

Q The heclear Regulatory Consission's regu y and ccrrespondence are more restrictive than the reguistions.

g App 11catien dated May 31, 1949 N A.

Letter dated August 10,1989 For the U.S. Nuclear Pegulatory Commiss

i B.

S'8'"*' 8'S*' 85

[

John D. Kinneman OCT 041989 gy Nuclear Peterials 54tely Branch I[# gggg Region !

King of Prussia. Pennsylvania 19406 g

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New

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< 'ly (800)526 3687 * (201)722 8930

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yiAugust10, 1989 w & . y

% lm , ,

{

d;;gMr. John"D.Kinneman,ChisfsU.,S. Nuclear Regulatory commission, Region

. Nuclear Materials safety Section B

}d Division ~of Radiation Safety and Safeguards

[ cy 475 Allendale Road PA'.. 19406 p; y King of Prussia, 7 RE: - Docket No. 030-31126 g

wW ,.

W control No. 110600 i

M. ' l1

Dear Mr. Kinneman:

gc.

Ch iWe are 'n i receipt of your August i letter advising us that

' gp ,' action is due on our application of March 3, 1989. We are able Wj 3

at this time to supply the additional information requested by Mr. Jensen on May 2, 1989.

fh![. Enc 10 sed'pleasefindthesupplementalinformationrequested:

0 Y,q 1. Saaples (2) of the actual ECD tag-labels with revised T

g'f,!' -information,- including the leak test requirement and the 4g1 'modeln number.. This particular label is attached only to S. ECDsydistributed to persons under general license. Labels yj:' attached. to ECDs: distributedJto persons' under specific h license J do not bear the statement referring to a general

' license. The source serial. number is engraved directly Ap]=

b into .the ECD hardware and on the protective cover, along 6 with the nuclide identity and activity (see p. S-154).

pj

$; ~ 2. The,yoperations -manual has been revised to include W  ? ,

information on leak testing. The frequency (36 months) is jJh[j stated, which will now apply to both general and specific ng W '; licensees. Directions are given to the owner for the performance and documentation of the leak test himself, or

. Jo .

k for the purchase of a leak test kit from chrompack.

the-revised pages to the manual are enclosed, Only sq,,-

g  !

kn \

{W.~ kqg '

5 ,

h*s )

l. N AU6 231989

%m: c aemamos e Official. RECORD ww . CorY E1)

Ma 4 +i '

55 -

l g@g.fREGISTRY.0F,RADIDACTIVESEALED.~

6 .dh4 - SOURCES"ANDDEVICES

, Jfj ig K2;Abg F

~

'S ' SAFETY EVALUATION OF DEVICE l

t .wm .s (AMENDEDINITSENTIRETY)

$.w#

5.

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mj[JLO
1 IL-529-D-105-B DATE: July 28, 1988 "
Mb.Yht, ~N "If#

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PAGE: 1 0F 5

~

f/?hfE!".

~

s .

h.5,p0EVICETYPE: Electron Capture Detector Unit (ECD)

T, '

@-w @!([,5;MODEL: 902 and 902A.

.. g T tc a. o . ,

h, DISTRIBUTOR:

Packard Instrument Company

'A 2200 Warrenville Road [

M. '

Downers Grove, Illinois 60515

~

,fpI, -

~ . . . (312)969-6000

& a. k .

N MANUFACTURER: Chrompatie - Packard >

Q;i , , 2600 ANN /P.O. Box 519 qc, Delft Holland The Netherlands SEALED SOURCE MODEL DESIGNATION: New England Nuclear - NER-004 Foil y,._ ISOTOPE:. MAXIMUM ACTIVITY:

,.;c.

>g

Nickel-63 ,

1

,- 10 mil 11 curies

+,  ;

i

] LEAK TEST FREQUENCY: Thirty-six(36) months ,

. i 0 PRINCIPAL USE: (P) Ion Generators, Chromatography

a. CUSTOM DEVICE: YES X NO 1:

7.

1, Y 4 as; +

y.'$

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k

n. "5 . ' '%.g ' REGISTRY.0F RADIDACTIVE SEALED SOURCES'AND DEVICES o

~ . SAFETY EVALUATION Of DEVICE s

N b, I' f (AMENDED IN-ITS ENTIRETY)

NO::.Q;.,((,(e !L-529-D-105-8% '

' DATE: July 28, 1988 PAGE: 2 0F 5

{ ffR ;; ' ~ '

Jo p.~ r.

, s DEVICE TYPE: ElectronCaptureDetectorUnit(ECD)

M; g j ;v.

[nig%; , q7

[0ESCRIPTION:

! f k oetector Unit Ne%p. :: ' .

[>/ ,f';L D.f M T The Model 902 and 902A electron capture cell is constructed of 304 s.-

stainless steel and consists of an outer main body into which the source and source holder are screw fixed.- The ECD head and endcap is then 6

& [:

%~ affixed to the end of the main body. The coaxial cable protrudes from

,g,r , this encap.' Attachment 2 shows detail of construction.

a.u c Nyi ,

Once the cell-is a'ssembled the nickel 63 source cannot be accessed or

%y

$ f("o ' removed from the cell without extraordinary means or the use of special tool.,,Packards gas chromatographs are designed to allow similar use of l

a: 1 l any two detectors.The nickel-63 source is used for its emission of beta  !

radiation to ionize the column effluent.

[J:y" The device is designed to operate at temperature up to 400*C,

)

hs The'Model 902 and 902A differ only in electronic and electrical details;

"!b o the modifications have no effect on the radioactive source.

30 .

  • W <

In the Model 902A the electronics of the controller have been modified to

"%l. Q improve the signaling process. The pulse assembly now exits the device

.near the. source holder, instead'of,through the head. Also, the source is Kelectrically: insulated from the metal body to improve the signal 4 f S ~ characteristics.s To,further. eliminate noise from the signal, the detector

. j, g? ,

e Dis; purged with inert' gas. None of. these modifications detract in any way from the safety or efficacy of.the device. Their effect should be to cK;:i enhance operation and protection through increased electrical shielding.

_..e,. .. .

[p$[t B. Radioactive Source-k ,

Pure nickel in the form of a foil with dimensions, of 1.18" x 0.32" x C

0.002" is' electroplated with nickel-63 on one side only. The foil is bent F +

and inserted into,the source holder which is constructed of 2 millimeters

, f% I!(mm)' thick stainless steel Type AISI 304. This holder is then positioned 6 into the main cell. body, thereby providing another 5 mm of 304 stainless

.w . steel shielding.'. A ceramic layer f.eparates the radioactive source from i p$ .

' '

  • the body of the electron capture detector unit (ECD). The body assembly g is capped with a head assembly.

yp N .

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S-lo e w 7 g x- y q qen 5%; ' v'O ' ' 7 997, L g%dm@MREGISTRT;0F[Rh'DIDACTIV'El$EALE0300itCES AND i '.

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.  : SAFETY EVALUATION OF DEVICE -

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, JAMENDED'INITSENTIRETY)
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!' [f " IL-529-D-105-8 DATE: July 28, 1988 PAGE: 3 Of 5 t

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$ DEVICE TYPE: ElectronCaptureDetectorUnit(ECD)

( V N.L i fGsLABELING: LThe following label information is metal pop-rivited to the ECD l 4

A p N unit body:' .1) unique. serial numberL 2) date, 3) nuclide, 4) activity 5) fM ' standard radiation trefo11,.6) manufacturer's name and address, 7) yg instructions;to persons generally. licensed.-

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[? '.T Devices intended for distribution to persons specifically licensed will be

! labeled in accordance with the requirements of 32 Ill. Adm. Code 340.2030 4A ,

(10 CFR 20,203).

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  • Devices intended for distribution to persons generally licensed will be M labeled in accordance with the requirements of 32 Ill. Adm. Code

$; g 330.280(d)(1)(C)(10CFR32.51).

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y'p One label is affixed to the head of the Electron Capture Detector. This label a.

M; 7 combined with the label attached by a metal band and pop rivet provide the necessary information as required by 32 111. Adm. Code (10 CFit 32.51). 330.280(d)(1)(C) 3(. . ,

h[, DIAGRAM: See Attachment I and 2.

n .

hh CONDITIONS OF NORMAL USE: According to'the applicant the Model 902 and 902A '

Ahn 'ED is to be used on a gas chromatograph under controlled

.pW fp' laboratory conditions.

It is not a field device. Therefore. it will not be hf W

, extreme cold under normal operating conditions.'ubject trai to be Users will generally significant vibr

$h $ 'use.ned laboratory technicians or researchers. The device has no alternative

' )1t is'specifically designed for use with Packard Instrument Company gas chromatographs and cannot be used as a component on any other product.

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J E1 PROTOTYPE-TESTING: Prototype testing was performed by New England Nuclear F4 Corp. or April 14, 1978, and the ECD unit'and source successfully met the 6( 1 . required standards. This device was deemed acceptable for distribution to VA specifically licensed persons in July 1978 by the NRC. This augmented with a

) M% 1 reasonable use history data since 1978 vere used by the applicant to demonstrate integrity of the device design for distribution to general m N licensees.

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JREGISTRY OF. RADICACTIVEiSEALED SOURCES AND EVICE5 -i

$AFETY EVALUATION OF DEVICE H i, # , - -

-(AMENDE0INITSENTIRETY)

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J[ !LO: It.529-0-105-B OATJ: July 28, 1988 g PAH: 4 0F 5 l

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l pjyDEVICETYPE: ElectronCaptureDetectorUnit(ECO) h p, - a

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  • S q [i ' EXTERNAL RADIATION LEVELS: The distributor reports an exposure rate of less t e, . ,.f than or equal to 0.01 mr/hr on any accessible surface of the detector unit.

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-QUALITY ASSURANCE AND CONTROL: The quality control program was deemed

' acceptable by NRC in July 1978. ' According to the distributor, there have been no ;evisions to this program since 1978.

[ {h, 5

, $i ' . LIMITATIONS AND/OR OTHER CONS!0ERATIONS OF Devices USE: intended for g', distribution to persons specifically licensed by the NRC or an Agreement State i,

shall be labeled in accordance with 32 Ill. Adm. Code 340.2030 (10 CFR 20.203 h, y n . -} (f)).

g- Devices intended for distribution to persons generally licensed pursuant to 56:

' .l32 111. Adm. Code 330.220(d) shall be lebeled in accordance with 32 Ill. Adm.

Code 330.280 (d)(1)(C).

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. .The devi6e shall be leak tested at 36 month intervals using techniques capable of detecting 0.005 microcurie of removable contamination. Performance of the 8[

y/- leak testing shall be by:

h.

3:

a. Persons specifically licensed by the NRC or an Agreement State or,

? b. The general licensee in accordance with procedures contained in E. " Additional Information for U.S. Customers," the document supplied with g.g; .each. device..

D Detector cells shall be used with temperature control mechanism which will

!. ?, limit cell temperature to 350*C.

'. g$g. This registration document and the information contained within the references

cited below shall not be changed or transferred .without the written consent of g '  ;

the Illinois Department of Nuclear Safety.

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em OFFICIAL RECORD COPY . ,D @

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a E W f & # W O !Xt W h e{i % ' pmW4WitfMMig "Qg,py%'1

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,y . j@< pp$$. " REGISTRY " '

.0F RAD 10 ACTIVE 25EALEO SOURCE $ r ANO ; 0EVICES

@ 5AFETY EVALUATION OF DEVICE g, ," ,,

f1(AMENDEDINIf5 ENTIRETY)

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i

,  !@:'. !L-52t 0-105 8  ? fDATE:/ July 28, 1988. ,PAGE: 5 Of 5 l,N x .

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! $ DEVICE TYPE:' Electron Capture Detector Unit (ECD)

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. c si }AFETY ANALY31$'5UM4AAY:T;8ased on our review'of the information and test data j .Y g 038 contained in the referenceselisted below, we concludt that the Model 902 and I Mpurposes'and,canbesafele 902A gas chromatography detector cell;is acceptab f

~,

'" ]kgprotection.? Furthermore;y ;under ordinary; source' contained in the device cannot beiinadvertently removed for. either used by persons conditions (not having train of use, the nickel-63,

< 4. WJroutine or emergency conditions of,use end it,is unlikely that any person will M b f specified in 32 Ill.!Adm. Code # receive an~ external dose or" dose come r ,3under foreseeable accident conditions, 340.1010(a).(10CFR20.101(a)).-Additionally, y A :.any person will receive a' dose or dose commitment we conclude that:it is unlikely that '

<j in excess of the dose to the .

~ appropriate organ as specified in 32.I11. Adm. Code 330.260(d)(1)(B)(111)

. i(10 CFR 32.24, Column?IV).hFarther; wel conclude that the % del 902 and 902A i

%g@Q . ' device would be expected to' maintain its containment integrity for normal-conditions of- use and accident conditions which might occur during the uses spF specified in this certificate. y 2%' cQ ' '

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REFERENCES:

The following supporting documents for Model 902 and 902A art

,Q L EfL  %; document:;hereby. incorporated by reference and are made a part of this registry)

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1) Supercedes registration document NR-529-0-105-8 dated December 16,1985, .]

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n 4 1 p d 2) o United Technologies Packafd latters dated September 24, 1985, November 15,

(

1985, and Meycmber 22 1985 with enclosures thereto. I ppf - 3) Packard Instrument Company letters with attachmeni;: dated August 11, 1987.

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  1. v 9y W J55UINGAGENCY: Illinois Department of Nucle &T Safety I Sk 5 \

EM bM:1; DATE: . D28-- 6 kQp -

FEVIEWED BY:- M o b o

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j William Femandes 11

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May 15, 1991 JAFP 91-0302 i U.S. Nuclear Regulatory Connission 4

Mall Station PI-137 Washington, D.C. 20555 1

j Attention
Document Control Ltsk r . '.

SUBJECT:

OPERATING STATUS REPORT c3 ~

Reference:

DOCKET NO. 50 333

Dear Str:

Enclosed please find the James A. FitzPatrick Nuclear Power Plant Operating Status Report for the month of April 1991.

.- If there are any questions concerning this repJrt, please Contact John CJok at (315) 349 6591.

Very truly yours,

/

FERNAND WF:3C:1s Enclosures CC- JAF Department Heads White Plains Office TS File DCC yik "pt T

ADOCN 0"O.)o33- jf-ff

{ DRN W 210439 PDR Ik I

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