ML20211K975
| ML20211K975 | |
| Person / Time | |
|---|---|
| Issue date: | 08/19/1997 |
| From: | Doug Broaddus, John Lubinski NRC |
| To: | |
| Shared Package | |
| ML20211K929 | List: |
| References | |
| SSD, NUDOCS 9710100080 | |
| Download: ML20211K975 (8) | |
Text
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REGISTRY U? RACIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.:
NR-8093-D-801-B DATE: August 19, 1997 PAGE 1 OF 7 DEVICE TYPE:
Electron Capture Detector MODELS:
902, 902A, 902B DISTRIBUTOR:
Chrompack, Inc.
USA 1130 Route 202 South Raritan, NJ 08869 s
MANUFACTURER:
Chrompack BV P.O. Box 519 2600 AM DELFT The Netherlands SEALED SOURCE MODEL DESIGNATION:
DuPont Merck NER-004 ISOTOPE:
MAXIMUM ACTIVITY:
Nickel-63 10 Millicuries (370 MBq)
LEAK TEST FREOUENCY:
36 months PRINCIPAL USE:
(N)
Ion Generator, Chromatography CUSTOM DEVICE:
YES X
NO 9710100000 970820 PDR RC BSD PDR w
e g
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.:
NR-8093-D-801-B DATE: August 19, 1997 PAGE 2 OF 7 DEVICE TYPE!
Electron Capture Detector DESCRIPTION:
The Models 902, 902A, and 902B electron capture detectors (ECDs) were constructed of 304 stainless steel and consisted of an outer main body into which the source holder'was crew fixed.
The ECD head and end cap was affixed to the end of the main body.
The coaxial cable protrudes-from this end cap.
Once the cell was assembled, the nickel-63 source could not be accessed or removed from-the cell without extraordinary means or the use of special tool.
Chrompack gas chromatographs were designed to allow similar use of any two detectors.
The nickel-63 source was used for its emission of beta radiation to ionize the column effluent.
The device was designed such that it would operate at teraperatures up to 400*C (752*F).
However, use is limited to temperatures up to 350*C (662'F).
The Models 902, 902A, and 902B differ only in electronics and electrical detailst differences have no effect on the radiological safety.
LABELING:
The ECDs were labeled as follows:
1.
A metal tag was affixed, with a pop rivet, to the neck of the detector.
The label included a radiation trefoil symbol, the words " CAUTION RADIOACTIVE MATERIAL," the name of the distributor, isotope, activity, model number, and the following wording:
THIS LABEL SHALL BE MAINTAINED ON THE DEVICE IN A LEGIBLE CONDITION.
REMOVAL OF THIS LABEL IS PROHIBITED.
I
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.!
NR-8093-D-801-B DATE: August 19, 1997 PAGE 3 OF 7 DEVICE TYPE Electron Capture Detector LABELING f con' t) :
See Chrompack's Users Manual for further instructions.
Wipe Test - Once Every 36 Months The receipt, possession, use, and transfer of this device-aro subject-to a general license or the equivalent and the regulations of the U.S. NRC or and Agreement State.
Abandonment cn: disposal prohibited unless transferred j
to persons specifically licensed by the U.S. Nuclear Regulatory Commission or an Agreement State.
2.
The serial number of the detector was stamped / engraved on the base of the detector.
3.
The trefoil symbol and the words " CAUTION RADIOACTIVE MATERIAL" were included on the protective-cover that shielded the electronic controller.
4.
The trefoil symbol and the words " CAUTION RADI0 ACTIVE MATERIAL" were included (black on a yellow background) on a sticker on the outside of the chromatograph.
CONDITIONS OF NOPMAL USE:
The ECDs were used in gas chromatographs under controlled, analytical laboratory conditions.
They were not a field device.
Therefore, they will not be subject to significant vibration, c
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE
~
NQ 1 NR-8093-D-801-B DATE: August 19, 1997 PAGE 4 OF 7 DEVICE TYPE!
Electron Capture Detector CONDITIONS OF NORMAL USE:
impact, puncture, compressive loads, or extreme cold under normal operat'.ng conditions.
However, they may be subject to temperatures up to 350*C (662*F).
The ECDs were specifically designed for use with Chrompack gas chromatographs and cannot be p
.2 sed as a component on any other product.
PROTOTYPE TESTING:
The model NER-004 source had been rested by the manufacturer and has achieved an ANSI N542-1977 classification of 77C32211.
Chrompack reports that prototype testing of the source included subjecting it to a. temperature of 400*C,(752*F) with no damage to the source.
In addition, Chrompack' reports that world wide there have been over 50 ECDs transferred and there have been no reported failures related to the radiological safety.of=the device.
EXTERNAL RADIATION LEVELS:
Chrompack reported.an exposure-rate of less than or equa.1 to 0.01 mR/hr (0.1.ySv/hr) un any accessible surface of the detector unit.
OUAL:..',SSURANCE AND CONTROL:
Chromoack was issued a license, by NRC Re ion I, that authorized c
distribution of the ECDs.
Any informati?n concerning Chrompack's
-quality' assurance and control program was sGbmitted to Region I as part of the license application.
1 l
l REGISTRY OF RADIOACTIVE SEALED SOURC2S AND DEVICES SAFETY EVALUATION OF DEVICE No.:
NR-8093-D-801-B DATE: August 19, 1997 PAGE 5 OF 7 1
DEVICE TYPE:
Electron Capture Detector LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
The device may be used by specific or general licensees of NRC or an Agreement State.
Handling, Storage, Use, Transfer, and Disposal:
To be tetermined by the licensing authority or as required by Section 31.5, 10 CFR Part 31 or Agreement State equivalent.
The devices may only be used in Chrompack gas chromatographe which incorporate equipment which ensures that the ECD will not be subject to temperatures which exceed 350*C (662*F).
The device shall be leak tested at intervals not to exceed 6 months using techn' ques capable of detecting 0.005 microcurie (185 Bq)of removable contamination.
The user may mount the device into gas chromotagraphs.
However, the device may not be dismantled in any way by the user unless he obtains a specific license from NRC or an Agreement State to perform such activities, This registration sheet and the information contained with the references shall not be changed without the written consent-of the NRC.
SAFETY ANALYSIS SUbMARY:
The ECDs were registered based on the following:
1.
The Cesigns were previously approved for distribution by the Illinois Department of Nuclear Safety.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES 9AFETY EVALUATION OF DEVICE NO.:
NR-8093-D-801-B DATE: August 19, 1997 PAGE 6 OF 7 DEVICE TYPE:
Electron Capture Detector SAFETY ANALYSIS
SUMMARY
(con' t ) :
2.
Upon relocation of the point of c'.ictribution of the devices to New Jersey, NRC Region I evaluoced Chrompack's application to distribute the ECDs and issued Chrompack a distribution license, 3.
Sufficient information had been submitted to provide reasonable assurance that:
The device can be safell operated by persons not having training in radiological protection.
Under ordinary conditions of handling, storage, and use of the device, the byproduct material contained in the device will not be released or inadvertently removed from the source housing, and it is unlikely that any person will receive in any period of one year a dose in excess of 10 percent of the limits specified in the table in Section 20.1201(a), 10 CFR Part 20, Under accident conditions associated with handling, storage, and use of the source housing, it is unlikely that any person would receive an external radiation dose or dose commitment in excess of *he dose to the appropriate organ as specified in the following chart:
PhRT OF BODY DOSE Whole body; head and trunk; active blood-forming organs; gonads; or lens of eye 15 rem (0.15 SV)
Hands and forearms; feet and ankles; localized areas of skin averaged over areas no larger than 1 square centimeter 200 rem (2.0 SV)
w REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE l
NO.:
NR-8093-D-801-B DATE: August 19,.1997 PAGE 7 OF 7 DEVICE TYPE:
Electron Capture Detector i
SAFETY ANALYSIS
SUMMARY
(con't):
Chrompack sold 7 units in the USA that contained ECDs.
The last unit sold was January 1993.
As of August 12, 1996, Chrompack will no longer provide service or maintenance for these products in the USA.
REFERENCES:
The following supporting documents for the electron capture detectors ~are hereby incorporated by reference and are made a part of this registry document.
Chrompack's application dated August 19, 1992.
Chrompack's letters dated April 10, 1995, January 6, 1995, and October 26, 1994, (2 letters) August 12, 1996, and April 25, 1997, with enclosures thereto.
4 ISSUING AGENCY:
U.S. Nuclear Regulatory Commission
//
/9
/
W Date:
Auaust 19, 1997 Reviewer:
d6hn~W. Lubinski j
INmh Date:
Aucust 19, 1997
- oncurrence
' Don @ A. Broaddus e
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PAGE1 NRC FORM 567 U. S. NUCLEAR REGULATORY COMMISSION C43)
REQUEST FOR A SEALED SOURCE OR DEVICE EVALUATION INSTRUCTIONS: Send this request AND a copy of at related letters /apphcotons and drawings to: The Sealed Source Safety Section, ATTN. Chief, OWFN Mail Stop 6 H1 Change the License Tracking System moestone to 19 and assign to reviewer code I-5.
NOTE: Retain a copy of this request with the appication and background fues.
REQULSILR REGION / LOCATION:
d)//2.///
Mh
]I 11 Ill IV V R HO C LFDCB TELEPHONE NUMBER DATE TYPE OF ACTION REQUESTED (Check as appropriate)
O ^ REGISTRATION SHEET AmcAurs NAME SOURCE REVIEW ut"oMc"T or ff7g,[yg I/g.
MAIL CONTHOL NUMBER $)
DEVICE REVIEW NUMBER (S)
LEYTUUAMCATION DATE LEENSE NUMBER (S)
CUSTOM REVIEW O b "" / 0 /' 8 sh1/%
ff 30 3 egg,.2c.2 eScW 7 m m 71.Cf.
o M r FOR SSSS USE ONLY REtiEWER MODEL NUMBER $
HUMBER ASSIGNE Y
I r
DATE AS$10NED
/
DATE TO FEES DATE RECEIVED 8/nh4 Wa/96 TYPE OF ACTION (Indicate the number of each type) l COMMERCIAL DISTRIBUTION (FORMAL) l USE BY A SINGLE APPLICANT (CUSTOM)
~
SOURCE (9C)
DEVICE (9A)
SOURCE (90)
DEVICE (98)
NEW NEW NEW NEW 1d1ENDMENT
~
AMENDMENT AMENDMENT g
AMENDMENT MNO SAFETY EVALUATION REQUIRED j LICENSING ACTION REQUIRED IF KNOWN NO NO FEES REQUIRED
) OTHER (Specity)
TOTAL NUMBER OF NOTES REVIEW HOURS NUMBER OF DEFICIENCY LETTERS NUMBER OF DEFICIENCY CALLS FOR BILLINO PURPOSES ONLY NAME CHANGE ADDRESS CHANGE NEW REGISMON -
] PRODUCT INACTIO ADD TO BILLING REMOVE FROM BILLING FOR FEE USE ONLY OF FEE FEE CATEGORY l 9A 98 9C 9D
/
\\
AMOUNT RECElv CHECK NUMBER
(
MATANN UPDATED AS REQUIRED gy' -
eq. A g 94 JggYgugTED L%g APPROVED BY DATE RETURN #
/
DATE COMMENTS I
I l
NRC FORM 561 (&e3) l
@MN N N
I March 20, 1997 Ms. Lori Bertrand Chrompack, Inc.
1130 Route 202 South Raritan, NJ 08869
Dear Ms. Bertrand:
This letter is in response to Carmen Gerrone's letter dated August 12,1996, requesting that registration certificate NR-0213-D 101 B be taken to inactive status and my phone call to you on February 21,1997, which requested additionalinformation to continue the inactive process.
To date, the requested information has not been received, if we do not receive the requested information within (20) days of the date of this letter, the registration will continue to be in the active status and we will have considered your request as having been abandoned by you.
This is without prejudice to the resubmission of a complete request for inactive status.
If you have any questions, please contact me at (301) 415-5787 or Mr. Steven Baggett at (301) 415-7273.
Sincerely, lb Christopher Brown, General Engineer Sea:ed Source Safety Section Medical, Academic, and Commercial Use Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards cc w/ encl: SKimberley, LFD Distribution:
SSSS r/f SSD-96-84 NE01 SSD File # NR-0213-D 101 B DOCUMENT NAME: C:\\ OFFICE \\WPWINiWPDOCS\\CHROMPAC.VOI
. Tu receive a copy of tWe document, Indcate in the box: *C' = Copy without attachment' enclosure
- E' = Copy with attachment / enclosure
- N* = No copy I OFFICE IMAB lC IMAB J, lC l
l NAME CBrowrW(&
SBaggett DATE 03f497 03/i/97 OFFICIAL RECORD COPY
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