ML20205J969

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Registry of Radioactive Sealed Sources & Devices,Safety Evaluation of Device for Model 2314-0-0 Ds. Certificate:NR-345-D-104-S
ML20205J969
Person / Time
Issue date: 04/07/1999
From: Michele Burgess, Samson Lee
NRC
To:
Shared Package
ML20205J958 List:
References
SSD, NUDOCS 9904120280
Download: ML20205J969 (12)


Text

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! REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY) j NO.: NR-345-D-104-S' DATE: APR 011999 PAGE 1 OF 7 DEVICE TYPE 1 Cigarette Density Gauge MODEL: 2314-0-0 DS f-DISTRIBUTOR: Hauni-Richmond, Inc.

[ 2800 Charles City Road Richmond, VA 23231 l MANUFACTURER: Hauni Maschinenbau AG l Kampchaussee 8-32 L 21033 Hamburg 80 l Germany l

SEALED ROURCE'MODEL DESIGNATION: Amersham Model SIC.L7 I

I ISOTOPE: MAXIMUM ACTIVITY:

Strontium-90 25 millicuries (925 MBq)

I' LEAK TEST FREOUENCY: 6 Motiths I

PRINCIPAL USE: (E) Beta Gauge I

CUSTOM DEVICE: YES X NO 9904120280 990407 PDR RC

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF. DEVICE (AMENDED IN ITS ENTIRETY)

HQmi NR-345-D-104-S DATE: APS 0 71999 PAGE 2 OF 7 DEVICE TYPE: Cigarette Density Gauge DESCRIPTION:

1 The Model 2314-0-0 DS density gauge is designed to measure and control the density of tobacco rods during production. The device is mounted to a machine that manufactures cigarettes and is connected to an electronic package which controls the density of the tobacco in each cigarette rod. The device consists of an outer housing, an inner cylindrical shielding container and a moving source holder. The outer housing has dimensions of 25.8 cm (10.16 in) x 21.0 cm (8.27 in) x 16.2 cm (6.38 in) and is constructed of cast aluminum. The inner container is constructed primarily of leaded bronze with various other mechanical parts  !

and the source holder is constructed of stainless steel and tungsten. The device is used in a controlled environment and the housing is sealed to minimize moisture and dust inside the device. The inner container has an inlet tube or guide tube through which the cigarette rod passes. This tube is constructed of polyetheretherker,ne and has a 0.1 millimeter (0.004 in) thick window at the midpo . The cigarette rod does not directly contact the source. 3:e to the small diameter of the tube, it is not possible for the user to insert a finger in the beam. The housing contains two 12.5 mci (462.5 MBq) sources. The control program allows the shutter mechanism to open only when the cigarette rod is running through the inlet tube at a pre-specified speed. The end of the moveable source holder-functions as a source position indicator and located on top of the device.

If the indicator is' green, then the source is in the down or shielded position; if yellow is visible, the' source is in the working or exposed position. The legend is located next to the indicator. The source housing has a safety lock which prevents any unauthorized removal of the housing from the production equipment.

I REGISTRY'OF RADIOACTIVE SEALED SOURCES AND DEVICES l SAFETY-EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)

NO. NR-345-D-104-S JDATEi APR 0) 1999 PAGE 3 OF 7 DEVICE TYPE: Cigarette Density Gauge

. DIAGRAM:

See attachments 1 and 2.-

LABELING:

The device is labeled with the distributor's name, trefoil symbol, device model number and serial number, isotope and

. activity in MBq, date of assay, source model number and serial number, and the words, " Caution-Radioactive Material". The labels are aluminum and riveted to the front surface of the housing.

CONDITIONS OF NORMAL USE:

The source housing is used on a cigarette process line and is located.in climatically controlled facilities. The expected operational temperature range is 18 C (64 F) to 60 C (140 F). l PROTOTYPE TESTING:

A prototype device was drop tested from the mounted height of 105 cm (3.4 ft) and allowed to impact on a steel plate. Wipe tests before and after the test indicated no source leakage, and there was no loss of shielding.

The device passed shutter tests performed at 18300 cycles at 20*C (68 F) and 366470 cycles at 73 C (163.4 F). The cigarette line is maintained at approximately 50 C (122*F) during operation, so the number of cycles at the endpoints of the operational temperature range should be minimal. .

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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)

NO. NR-345-D-104-S DATE: AP B 0 7 1998 jggg_.4 OF 7 DEVICE TYPE: Cigarette Density Gauge EXTERNAL RADIATION LEVELS:

The dose rates around the device, measured in psv/hr (arem/hr) are:

6 cm 30 cm 100 cm Source in working position / rods in 10 (1) 3 (0.3) 0.3 (0.03) guide tube Source in rest position / no rods 8 (0.8) 2.5 (0.25) 0.3 (0.03) in gnide tube OUALITY ASSURANCE AND CONTROL:

The distributor will conduct periodic on-site inspections of the manufacturer to confirm that.the device is manufactured according to the statements and representations contained in their application. The audits will include checks of key external / internal dimensions, labeling. v'diation survey, safety features, sealed sources, documentatir - 3 a check to confirm that no design or material changes have .en implemented.

.The user will perform a leak test upon receipt. Upon initial installation or reinsta11ation, the device shall be inspected to verify: that the appropriate device has been received; proper operation of the source exposure mechanism and safety warning components; that the labeling is correct; and that the radiation levels around the device are in accordance with the information submitted in support of the application.

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y REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)

NO,* NR-345-D-104-S DATE: Apg 0160 PAGE 5 OF 7 DEVICE TYPE: Cigarette Density Gauge LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:

The device shall be distributed only to persons specifically licensed by the NRC or an Agreement State.

The device shall be leak' tested at six month intervals using techniques capable of detecting 0.005 pCi (185 Bq) of removable contamination and following the procedures in Hauni-Richmond users manual or equivalent procedures.

. Reviewer Note: The user may perform either a direct wipe test (of the source rod) or an indirect wipe test (of the outside surface of the measuring tube window).

. Handling, storage, use, transfer, and disposal: To be determined by the licensing authority.

. The device shall be initially installed (including mounting of the Optional Optical Rod System [ORIS]) or reinstalled by Hauni-Richmond, Inc., or oth'r e persons specifically licensed by the NRC.or an Agreement State to perform-such activities.

Initial installation or reinstallation shall include inspection of the device, in accordance with Hauni-Richmond procedures, to verify: that the appropriate device has been received;. proper operation of the source exposure mechanism and safety warning components; correct labeling; and that the external radiation levels around the device are in accordance with the information submitted in support of the application.

. The device shall be serviced, leak tested, and tested for correct operation of the ON/OFF mechanism only by Hauni-Richmond, Inc. or other persons specifically licensed by the NRC or'an Agreement State to' perform such activities.

. . Replacement of,the measuring' tube may betperformed by the user.

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l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY) i NO,: NR-345-D-104-S DATE: APR 011999 pAGE 6 OF 7 DEVICE TYPE: Cigarette Density Gauge LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE (Cont'd)-

  • This registration sheet and the information contained within the references shall not be changed without the written consent of the NRC.

SAFETY ANALYSIS

SUMMARY

Based on our review of the information and test data cited below, we continue to conclude that the Model 2314-0-0 DS cigarette density gauge is acceptable for licensing purposes.

Furthermore, we continue to conclude that this device would be expected to maintain containment integrity of the source for ,

normal conditions of use and accidental conditions which might occur during uses specified in this certificate.

REFERENCES:

The.following supporting documents for the Model 2314-0-0 DS cigarette density gauge are hereby incorporated by reference and are made a part of this registry document:

. Hauni-Richmond's letters dated July 28, 1996, December 5, 1996, February 17, 1997, March 3,_1997, and July 13, 1998, and letter received November 26, 1996, with enclosures thereto.

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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES j SAEETY EVALUATION OF DEVICE {

(AMENDED IN ITS ENTIRETY) .

NO.: NR-345-D-104-S DATE: APfl 011999 PAGE 7 OF 7 DEVICE TYPE: Cigarette Density Gauge REFERENCES (Cont'd):

. Hauni-Richmond's facsimiles dated March 26, 1997, April 23, 1997, April 30, 1997, November 30, 1998, February 22, 1999, and April 6, 1999, with enclosures thereto.

ISSUING AGENCY:

U.S. Nuclear Regulatory Commission

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Date: Reviewer: [ '

' Seuffg J. Lee Date: 8' Concurrence: 4 / ~#^

Michele L. Burgess

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SAFETY EVALUATION OF DEVICE NO. NR-345-D-104-S DATE: MB 01 M ATTACHMENT 2 Suction tape neight adjustment motor for rear rod (not shown) Suction tape height adjustment motor for Evaluation electronics in front rod (not shown)

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August 3,1998 ASSIGNMENT NUMBER: 98-79 l

l Mr. Darrell Basinger Hauni Richmond 2800 Charles City Road Richmond, VA 23231

SUBJECT:

ACKNOWLEDGMENT OF REQUEST FOR SAFETY EVALUATION

Dear Mr. Basinger:

This letter acknowledges the receipt of your July 13,1998, application that requested an safety evaluation of the Model 2314-0-0-DS, SRM Scanning Head (Density Measuring Head). We have performed a cursory review of your application and determined that enough information has been provided to allow a technical reviewer to initiate the evaluation process. Applications are assigned to technical reviewers on a first-in basis. Therefore, your application will be assigned in turn. Please note that the technical reviewer may contact you to request information that was omitted from your application or to obtain clarification of technicalissues concerning your application. If you have any questions concerning the status of your application, please contact me at (301) 415-7273. Please reference the assignment number listed above in your questions or correspondence.

Please be aware that your request may be subject to the NRC's application fees in accordance with 10 CFR Part 170. Therefore, a copy of your application has been forwarded to the License  ;

Fee and Debt Collection Branch for approval of the fee category and amount. If you have any  ;

questions concerning the fees associated with your application, please contact the License Fee ]

and Debt Collection Branch at (301) 415-7554.

Sincerely, M

Steven L. Baggett, Deputy Branch Chief Materials Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards Distribution:

IMNS r/f SSD-98-79 SBaggett NE01 yh ,

' DOCUMENT NAME:a:98-79.wpd Ta receive e copy of this document. Indicate in the boa: "C" = Copy without attachment / enclosure "E" = Copy with ettachmentrenclosure *N* = No copy OFFICE MSB /[7 lC l NAME SBaggett/kr 'M DATE- 8G /98 -

OFFICIAL RECORD COPY y $ If'

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( nftC FORM 567 U. S. NUCLEAR REOULATORY COMMISSION C)es) i REQUEST FOR A SEALED SOURCE OR DEVICE EVALUATION INSTRUCTIONS: Send this request AND a copy of all related istters/apphcottons and drawings to: The Sensed Source Safety Section, ATTN; CNef, OWFN Mail Stop 6 H3. Change the Ucense Tracidng System milestone to 19 and seeign to reviewer code N5.

NOTE: Retain a copy of tNs request with the apphcation and tieckground flies. I m uE . REGION / LOCATION:

A /l[] / /O #47 6/7 li U ll 111 IV V U HQ R LFDCB TELhPHONE NUMBER DATE TYPE OF ACTION REQWSTED (Check as appropride)

APPUCANTS N SOURCE REVIEW M p-M // hAMENDMENT OF

~X7 9 $/r? QCf- REGISTRATION SHEET MAIL CONrROL NUMBEites) V DEVICE REVIEW NUMBER (S)

LETTER '7-/ a-/ APPLICATION DA@ P LICENSE NUMBER (S) CUSTOM REVIEW d'[-3/T- /)_ /Oh-3 c?Y60 charles CNy Road Sichmon d, VA 2323I FOR SSSS USE ONLY ret 1 EWER MODEL NUMBERS NUMBER ASSIGNED DATE RECEwED aa M-o hs DATE ASSIONED DATE TO FEES 97-79

( '7-I'7-98 7-Ad- 98

/ TYPE OF ACTION (Indicate the number of each type)

/ COMMERCIAL DISTRIBUTION (FORMAL) l USE BY A SINGLE APPLICANT (CUSTOM)

SOURCE (90) DEVICE (9A) SOURCE (90) DEVICE (98)

~

NEW NEW NEW NEW AMENDMENT [ AMENDMENT AMENDMENT AMENDMENT j NO SAFETY EVALUATION REQUIRED

,NO FEES REQUIRED d UCENSING ACTION REQUIRED IF KNOWN -

NO ,

f,1)($ & (k TOTAL f4 UMBER OF Y &ld~VUfY0 NOTES - #

l$47 REVIEW HOURS M4/g (1/7/9M dMP MI 7

  • g//[-3/g h /0L[-3 8$ /-[ [e 4/n,$

NUMBER OF DEFICIENCY LETTERS NUMBER OF

, g g gy DEFICIENCY CALLS h0$c:7"ffd!A-76 C/CMrekfe dan Wpr FOR BILLING PURPOSES ONLY NAME CHANGE j NEW REGISTRATION - _j PRODUCT INACTIVE -

ADDRESS CHANGE ADD TO BILLING REMOVE FROM BILLING FOR FEE USE ONLY TYPE OF FEE FEE CATEGORY M,g)J. , [ 9A U 98 9C U 9D AMOUNiAECENED p ') g CHECK HUMBER j' MATANN UPDATED M[ / b f)M hh / @[ (/ AS REQUIRED DATE OF CHECK / / loo p fp gj) _j MATSYS UPDATED 1/T[N f ' 7[L7 /5 V AS REQUIRED APPROVED gy ( DATE N N DATE COMMENTS #

) I Y/'

NRC FORM 967 (s43)

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NRC FORM 567 U. S. NUCLEAR REaWLATORY COMMISSION c.es) s REQUEST FOR A SEALED SOURCE OR

,- DEVICE EVALUATION INSTRUCTIONS: Send this request AND a copy of all related letters /apphcotions and drawin0s to: The Sealed Source Safety Section, ATTN: Chief, OWFN Mail Stop 6 H3. Change the License Tracidng System milestone to 19 and eseign to reviewer code I-5.

>AOTE: Retain a copy of this request with the application and background files.

REQUESTER-REGION / LOCATION:

YA1ff)/

/ 0 9 W ) 6 !') r- l ll lll IV DV D HQ^ D LFDCB TELtPHONE NUMBER DATE TYPE OF ACTION REQUESTED (Check as appropriate)

APPUCANT'S SOURCE REVIEW hAMENDMENT OF '

M PM:) // 7 M/r? 67e( REGISTRATION SHEET L! AIL CONTROL NUMB 5R(5) V DEVICE REVIEW NUMBENS)

LE1TER/APPUCATION DATE

'7-/R- 92 UCENSE NUMBER (S) CUSTOM REVIEW M -3MT--/) /dh $

' ?[(60 c Chorks CHy Rcad Richmon d, VA 23a3i FOR SSSS USE ONLY REYlEWER MODEL NUMBERS NUMBER ASSKiNLD DATE RECENED sa /4[-o hs DATE ASSIGNED DATE TO FEES 97-79 7-/7-98 '7 o76 - 2 8

/ TYPE OF ACTION (Indk:ste the number of each type)

  • 1sfCOMMERCIAL DISTRIBUTION (FORMAL) l USE BY A SINGLE APPLICANT (CUSTOM) i SOURCE (9C) DEVICE (9A) SOURCE (9D) DEVICE (90)

NEW NEW NEW NEW .

_ AMENDMENT. gAMENDMENT AMENDMENT AMENDMENT j NO SAFETY EVALUATION REQUIRED j LICENSING ACTION REQU: RED IF KNOWN -

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,NO FEES REQUIRED NO' .

$f5 'O TOTAL NbMBER OF b

NOTES Y $Y+ - V uY REVIEW HOURG Mg dl/'?7pg d B M M f h", .**

gll/g-jyff- b jf-l-3 )]$ /~h ferhQm$

NUMBER OF DEFICtENCY LETTERS g ..

NUMBER OF M DEFICIENCY CALLS ff0f0$~e) ~/D)ln. f 0(Y C)@fehe Ehh k'pf , , . .

FOR Bit).ING PURPOSES ONLY NAME CHANGE' ADDPESS CHANGE NEW REGSMON - ] MODUCMACME k ADD TO BILLING REMOVE FROM BILLING FOR FRE USE ONLY '

WPE OF FEE FEE CATEGORY

'M) '

, [ 9A , 98

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9D AMOUNT f(ECENED p / g CHECK NUMBER ry')'7 M ) /~

MATANN UPDATEp S[ / 2h / /N (/ ~~

AS REQUIRED DATE OF CHECK LOG pg j MATSYS UPDATED WT/f Y{ 7 / 7!$ / () 79 AS REQUIRED APPROVED BY DATE SL' TURN DATE COMMEffr3 -

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I NRC FOhM 677 U.S. NUCLEAR REGULATORY COMMISSION (5-1996)

ATTN: Srndra Kimberiey, MS T-9E10 U.S. Nuclear Regulatory Commission LICENSE FEE REQUIREMENTS License Fee and Accounts Receivable Branch P. O. Box M4574 St Louis, MO 63195-4514 TYPE OF ACTION

] NEWLICENSE I

C RENEWAL OF UCENSE Ilauni Richmond,Inc y AMENDMENTTO LICENSE ATTN: Mr. Darrell Basinger 2800 Charles City Rd RbOESTE[iD TE~

Richmond,VA 23231 07/13/1998 LICENSE NUMBER NR0345 DINS

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C6STROL AUIElBER~

98-79

1. APPLICATION FEE DUE II. FEE NOT REQUIRED Your request for a licensing action is subject to the fee (s) in the Check Enclosed is your check whth category (ies) noted below in accordance with Section 170.31 of 10 CFR P:rt 170. Payment ', the fee is required prior to the issuance of the U__ _ Numver accompanied your request. The fee is not required because:

license, renewal ;, amendment.

Mb APPillC TION } REAEW L [ AMENDMENT ] mber fay $e to he ee

^9A 7 Is Ts 610.00 i

s Ts Date of The Licensing t aff has informed

$ is ,s ]. -

Request us that your request is to be considered as a continuation of f

- ls- t s the request listed.

4s, m 7

--dj8 8 g Date of Your request was combined, prior 8 s g Request to review, with the request listed.

b8 __ Control ls s s Number js s s lit. CHECK RETURNED FEE (s) DUE s 610.00 Check Enclosed is your check which was PAYMENT RECElVED s _590.00 b"7 Number retumed to us by the bank for:

AMOUNT DUE 's- 20.00' r .,

g INSUFFICIENT FUNDS

~ ~

Y ur reque'st was received without the prescribed application

] ACCOUNT CLOSED OTHER y"d We received your checik listed below. Payment ofthe additional -

77267 Check Number fee noted above is required. Mall THE REPLACEMENT CHECK TO THE ADDRESS LISTED AT THE TOP OF THIS FORM AND REFERENCE THE ABOVE CONTROL

$ 590.00 Amount NUMBER.

p Your request will increase the scope of your license program.

LJ our request is sub ect to the application fee (s) noted -- IV. LICENSE ISSUED WITHOUT THE REQUIRED FEE Therefore, above. Re fer to Section 170. i and Footnote 1(d)(2). icense The listed license was issued p._J _ __ h.umber without the re uired fee being Lq renew $slidnse e ire

11. Therefore d prioristo the receipt of youiforfee applicWa~ ku$

o ed in action I of th for .

your request subject to the application (s) -

noted above. Refer to Section 170.31 and Footnote 1(a). hsfu'ed MAKE PAYMENT OF THE FEE (S) TO THE U.S. NUCLEAR r The secpe of your licensed program was increased. Therefore, your REGULATORY COMMISSION AND Mall THE PAYMENT TO THE L.d request is sutject to the application fee (s) noted in Section 1 of this ADDRESS LISTED AT THE TOP OF THIS FORM IF WE DO NOT form. Refer to Section 170.31 and Footnote 1(d)(2).

RECElVE A REPLY FROM YOU WITHIN 30 CALENDAR DAYS FROM THE DATE LISTED BELOW, WE SHALL ASSUME THAT YOU DO NOT - - - - - - - -

WISH TO PURSUE YOUR APPLICATION AND WILL VOID THIS n Because of the urgency of your request, the license was issued- - - -

ACTION. without remitttnce of the presenbed fee noted in Section 1 of this form.

I SIGNATURE - L6 CENSE Fl E ANALYST LFDCB DATE LFDCP j '5yATk"FARB S'F Pending Cy SIndra Kimberfey, 30f-415-6096 ~~7/21 98 FpRB RF cc: TKime 07/21/1998 NRC FORM 577 (5-1998) PRINTED ON RECYCLED PAPER This form was designed using informs

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i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION'OF DEVICE j

(. amended in its entirety) l h NR-345-D-104-S DATE: May 6, 1997 PAGE 1 OF 7 1

i DEVICE TYPE: Cigarette Density Gauge

- MODEL: 2314-0-0 DS DISTRIBUTOR: Hauni-Richmond, Inc.

2800 Charles City Road j Richmond, VA 23231 l l

MANUFACTURER: Hauni Maschinenbau AG Kampchaussee 8-32 21033 Hamburg 80 Germany 1 SEAT FD SOURCE J,ODEL DESIGNATION: Amersham Model SIC.L7 ISOTOPE: MAXIMUM ACTIVITY:

Strontium-90 25 millicuries (925 MBq) e T.RAK TEST FREOUENCY: 6 Months PRINCIPAL USE1 (E) Beta Gauge r

CUSTOM DEVICE: YES X NO lcr704130!M 90

l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l SAFETY EVALUATION OF DEVICE (amended in its entirety) 1 DATE: May 6, 1997 PAGE 2 OF .1 MO.: NR-345-D-104-S DEVICE TYPE: Cigarette Density Gauge DESCRIPTION:

The Model 2314-0-0 DS density gauge is designed to measure The and control the density of tobacco rods during production.

device is mounted to a machine that manufactures cigarettes and is connected to an electronic package which controls the density of the tobacco in each cigarette rod. The device consists of an outer housing, an inner cylindrical shielding container and a moving' source holder. The outer housing has dimensions of 25.8 cm (10.16 in) x 21.0 cm (8.27 in) x 16.2 cm (6.38 in) and is constructed of cast aluminum. The inner container is constructed primarily of leaded bronze with various other mechanical parts and the source holder is constructed of stainless steel and tungsten. The. device is used in a controlled environment and the housing is sealed to minimize moisture and dust inside the device. The inner container has an inlet tube or guide tube through.which the cigarette rod passes. This tube is constructed i

I of.polyetheretherketone and has a 0.1 millimeter (0.004 in) thick window at the midptint. The cigarette rod does not directly contact the source.

Due to the small diameter of the tube, it is The not possible for the user to insert a finger in the beam.

The control housing contains two 12.5 mci (462.5 MBq) sources.

program allows the shutter mechanism to open only when the cigarette rod is running through the inlet tube at a pre-specified speed. The end of the moveable source holder functiond as a source' position indicator and located on top of the device.

If the indicator is green, then the source is in the down or shielded-position; if yellow is visible, the source is in the working or exposed position. The legend is located next to the indicator. The source housing has a safety lock which prevents any unauthorized removal cf the housing from the production equipment.

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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (amended in its entirety)

NO.: NR-345-D-104-S DATE: May 6, 1997 PAGE 3 OF 7 l

DEVICE TYPEL Cigarette Density Gauge DIAGRAM:

1 i

See attachments 1 and 2.

LABELING:

The device is labeled with the distributor's name, trefoil symbol, device model number and serial number, isotope and activity in MBq, date of assay, source model number and serial ,

number, and the words, " Caution-Radioactive Material". The labels are aluminum and riveted to the front surface of the housing.

CONDITIONS OF NORMAL USE:

The source housing is used on a cigarette process line and is located in climatically controlled facilities. The expected operational temperature range is 18 deg C (64 deg F) to 60 deg C (140 deg F).

PROTOTYPE TESTING:

A prototype device was drop tested from the mounted height of 105 cm (3.4 ft) and allowed to impact on a steel plate. Wipe ,

tests before and after the test indicated no source leakage, and there was no loss of shielding.

The device passed shutter tests performed at 18300 cycles at 20 deg C (68 deg F) and 366470 cycles at 73 deg C (163.4 deg F).

The cigarette line is maintained at approximately 50 des C (122 deg F)during operation, so the number of cycles at the endpoints of the operational temperature range should be minimal.

r REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF,DEVI'.E (amended in its entirety)

HQ 1 NR-345-D-104-S DATE: May 6, 1997 PAGE 4 OF 7 DEVICE TYPE: Cigarette Density Gauge l

l EXTERNAL RADIATION LEVRTA:

1 The dose rates around the device, measured in mrem /hr (pSv/hr) are:

$_cm 30 cm 100 cm Source in working position / rods in 10 (1) 3 (0.3) 0.3 (0.03) guide tube Source in rest position / no rods 8 (0.8) 2.5 (0.25) 0.3 (0.03) in guide tube OUALTTY ASSURANCE AND CONTROL:

The distributor will conduct periodic on-site inspections of the manufacturer to confirm that the device is manufactured according to the statements and representations contained in their application. The audits will include checks of key external / internal dimensions, labeling, radiation survey, safety features, sealed sources, documentation, and a check to confirm that no design or material changes have been implemented. ,

The user will perform a leak test upon receipt. Upon initial installation or reinstallation, the device shall be inspected to verify: that the appropriate device has been received; proper operation of the source exposure mechanism and safety warning components; that the labeling is correct; and that the radiation levels around the device are.in accordance with the information submitted in support of the application.

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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (amended in its entirety)

NO.: NR-345-D-104-S DATE: May 6, 1997 PAGE 5 OF 7 DEVICE TYPE: Cigarette Density Gauge LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE: j

  • The device shall be distributed only to persons specifically licensed by the NRC or an Agreement State.
  • The device shall be leak tested at six month intervals using techniques capable of detecting 0.005 pCi (185 Bq) of removable contamination and following the procedures in j Hauni-Richmond users manual or equivalent procedures. ,

1

  • Reviewer Note: The user may perform either a direct wipe test (of the source rod) or an indirect wipe test (of the outside surface of the measuring tube window).
  • Handling, storage, use, transfer, and disposal: To be determined by the licensing authority.
  • The device shall be initially installed (including mounting of the Optional Optical Rod System (ORIS)) or reinstalled by Hauni-Richmond, Inc., or other persons specifically licensed by the NRC or an Agreement State to perform such activities.

Initial installation or reinstallation shall include inspection of the device, in accordance with Hauni-Richmond procedures, to verify: that the approptiate device has been, received; proper operation of the bource exposure mechanism and safety warning components; correct labeling; and that the external radiation levels around the device are in accordance with the information submitted in support of the application.

  • The device shall be serviced, leak tested, and tested for correct operation of the ON/OFF mechanism only by Hauni-Richmond, Inc. or other persons specifically licensed by the NRC or an Agreement State to perform such activities.

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE l (amended in its entirety) <

NO.: NR-345-D-104-S DATE: May 6, 1997 PAGE 6 OF 7 DEVICE TYPE: Cigarette Density Gauge l

LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE (cont.)-

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  • Replacement of the measuring tube may be performed by the l user. l l
  • This registration sheet and the information contained within i the references shall not be changed without the written consent of the NRC.

SAFETY ANALYSIS SUMRRYr Based on our review of the information and test ddta cited below, we conclude that the Model 2314-0-0 DS cigarette density gauge is l

acceptable for licensing purposes. Furthermore, we conclude that l this device would be expected to maintain containment integrity  ;

of the source for normal conditions of use and accidental l' conditions which might occur during uses specified in this certificate.

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1 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l SAFETY EVALUATION'OF DEVICE (amended in its entirety)

HQ 1 NR-345-D-104-S DATE: May 6, 1997 PAGE 7 OF 7 DEVICE TYPE: Cigarette Density Gauge

REFERENCES:

The following supporting documents for the Model 2314-0-0 DS cigarette density gauge are hereby incorporated by reference and are made a part of this registry document:

  • Hauni-Richmond's letters dated July 28, 1996, December 5, 1996, February 17, 1997, and March 3, 1997, and lecter received November 26, 1996, with enclosures thereto.
  • Hauni-Richmond's facsimiles dated March 26, 1997, April 23, 1997, and April 30, 1997, with enclosures thereto.

ISSUING AGENCY:

U.S. Nuclear Regulatory Commission 7

// zr-Date: May 6. 1997 Reviewer: '/ // I

/ John Lubinski

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Date: May 6. 1997 Concurrence: .

2b'# Steven Baggett

l l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l SAFETY EVALUATION OF DEVICE NO.: NR-345-D-104-S DATE: May 6, 1997 ATTACHMENT 1 Indicator rs Scanner 1

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l h NR-345-D-104-S DATE: May 6, 1997 ATTACHMENT 2 Suction tape height adjustment motor for rear rod (not shown) Suction tape height l adjustment motor for Evaluation electronics in front rod (not shown)

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