ML20135D369
| ML20135D369 | |
| Person / Time | |
|---|---|
| Issue date: | 02/28/1997 |
| From: | Steven Baggett, John Lubinski NRC |
| To: | |
| Shared Package | |
| ML20135D326 | List: |
| References | |
| SSD, NUDOCS 9703050210 | |
| Download: ML20135D369 (8) | |
Text
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-536-D-807-B DATE: February 28, 1997 PAGE 1 OF 6 DEVICE TYPE:
Gas Chromatography Detector Cell MODEL:
330-0119 MANUFACTURER / DISTRIBUTOR:
Perkin-Elmer Company 761 Main Avenue Norwalk, CT 06859-0001 SEALED SOURCE MODEL DESIGNATION:
Du Pont Merck: NER-002 NRD: N-1001 Amersham: NBC-7020 ISOTOPE:
MAXIMUM ACTIVITY:
Nickel-63 15 millicuries (0.56 GBq)
LEAK TEST FREOUENCY:
6 Months PRINCIPAL USE:
(:N) Ion Generators, Chromatography l
CUSTOM DEVICE:
YES X
NO l
l l
4 l
9703050210 970220 PDR RC SSD PDR 1
1 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-536-D-807-B DATE: February 28, 1997 PAGE 2 OF 6 DEVICE TYPE:
Gas Chromatography Detector Cell 1
DESCRIPTION:
j The Model 330-0119 electron capture detector (ECD) consists of a i
heater, a temperature controlling mechanism, and a nickel-63 foil situated in a cylindrical cavity of the detector body.
Its construction includes a tamper proof screw to keep users from gaining access to the source.
The source foil for use in the cell assembly consist of a corrosion resistant metal foil substrate which has the radioactive material electrolytically deposited on one side.
An effluent transfer tube (anode) is located in line with the horizontally arranged source.
At the cell (cathode) the carrier gas (methane / argon or nitrogen) contacts the cylindrically formed i
foil and exits through a small tube at the other end of the detector.
When in use in the Sigma Series gas chromatograph, a double level of temperature protection against accidental over-heating of the nickel-63 foil is provided.
First, through the microprocessor temperature circuitry of the gas chromatograph.
Secondly, the ECD detector block is equipped with a curie-bar thermal trip, the operation of which disconnects power to the detector block heater if the block temperature should ever exceed 450 C (842*F).
LABELING:
For devices distributed to general licensees, a wire tether is permanently attached to the ECD cell body by looping it around and crimping it in place with metal clamps.
The other end of the tether is attached to the ECD cell label which is, in turn, attached to the body of the chromatograph.
The angled section of the label is equipped with two screw openings to enable attachment to the body of the gas chromatograph.
The label includes the radiation symbol and name of manufacturer.
It also contains the following wording:
On (date of assay) this device was determined to contain millicuries of Nickel 63, a radioactive isotope.
The receipt, possession, use and transfer of this device Model Serial No.
are subject to a general license or the equivalent and the regulations of the U.S. Nuclear Regulatory
i i
1 i
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES 4
SAFETY EVALUATION OF DEVICE i'
NO.: NR-536-D-807-B DATE: February 28, 1997 PAGE 3 OF 6 i
DEVICE TYPE:
Gas Chromatography Detector Cell l
LABELING (Cont.):
Commission or of a state with which the NRC has entered into an agreement for the exercise of regulatory 2
authority.
This label shall be maintained on the device in a legible condition.
Removal of this label is prohibited.
THE ELECTRON CAPTURE DETECTOR CELL IS NOT A CUSTOMER SERVICED PART.
This part is not to be removed, i
replaced, altered, adjusted, or tampered with by the j
user.
Please refer to ECD section of the Customer i
Service Manual supplied with your gas chromatograph.
TESTING This device must be tested at intervals of no less than six months, as required by 10 CFR 31.5 (c) (2) for leakage of radioactive material.
Please refer to ECD section of the Customer Service Manual for testing instructions.
Devices distributed to specific licensees are labeled with the model number, serial number, isotope, actiaity, radiation symbol, the words ' Danger Radioactive Material," and the name_of the manufacturer.
CONDITIONS OF NORMAL USE:
The ECD is designed to produce an ionized atmosphere for quantitative or qualitative measurement of elements in gas streams.
It is an integral component of gas chromatographs of the Perkin-Elmer Company's Sigma Series and will be used in ambient laboratory conditions.
The detector is designed for operational. temperatures of up to 450*C (842 *F).
The' foil source is fully shielded in the ECD cell and the gas chromatograph operator is not required to har31e or service either the source or the detector cell.
I
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.- NR-536-D-807-B DATE: February 28, 1997 PAGE 4 OF 6 DEVICE TYPE:
Gas Chromatography Detector Cell PROTOTYPE TESTING:
Assurance of the integrity of the design of the Model 330-0119 ECD was provided by comparison of the design to previously approved designs.
In addition to the comparison, Perkin-Elmer performed a test that consisted of simulated thermal runaway.
The test indicated that the ECD heater block, under worst-case conditions, can never achieve the melting point of the radioactive source.
EXTERNAL RADIATION LEVELS:
Since the walls of the detector cell are far in excess of the range of the maximum energy beta particles emitted from the contained source, surface readings on the cell are not expected to exceed ambient background levels.
OUALITY ASSURANCE AND CONTROL:
Perkin-Elmer submitted the quality control program followed for manufacture of the devices and the program has been deemed acceptable for licensing purposes by NRC.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
- The device may be used by persons specifically or generally licensed by the NRC or an Agreement State.
- Handling, storage, use, transfer, and disposal:
To be determined by the licensing authority or as required by 10 CFR 31.5 or Agreement State equivalent.
- The device shall be leak tested at intervals not to exceed 6 months using techniques capable of detecting 0.005 microcurie (185 Eq) of removable contamination.
This registration sheet and the information contained within the references shall not be changed without the written consent of the NRC.
I
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-536-D-807-B DATE: February 28, 1997 PAGE 5 OF 6 DEVICE TYPE:
Gas Chromatography Detector Cell SAFETY ANALYSIS
SUMMARY
Perkin-Elmer discontinued manufacture and distribution of the device in 1996 and estimates that approximately 3600 devices have been distributed.
Perkin-Elmer will not provide servicing for the ECD.
Any calls for servicing and disposal of the ECD will be referred to NRD, Inc., one of the source manufacturers.
Perkin-Elmer submitted sufficient information to provide reasonable assurance that:
- The device can be safely operated by persons not having training in radiological protection.
- Under ordinary conditions of handling, storage, and use of the device, the byproduct material corcained in the device will not be released or inadvertently removed from the source housing, and it is unlikely t'lat any person will receive in any period of one year a dose in excess of 10 percent of the limits specified f.n Section 20.1201(a),
- 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 the dose to the appropriate organ as specified in the following chart:
PART 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 cm2 (0.15 in')
200 rem (2.0 Sv)
Other organs 50 rem (0.50 Sv)
4 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l
SAFETY EVALUATION OF DEVICE i
i NO,: NR-536-D-807-B DATE: February 28, 1997 PAGE 6 OF 6 4
DEVICE TYPE:
Gas Chromatography Detector Cell SAFETY ANALYSIS
SUMMARY
(Cont. ) :
Based on review of the electron capture detector, and the information and test data' cited below, we continue to conclude that the device is acceptable for licensing purposes.
j Furthermore, we continue to conclude that the device would be expected to maintain its containment integrity 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 330-0119 are j
hereby incorporated by reference and are made a part of this registry document.
- Perkin-Elmer Company's letters dated September 20, 1996, May 7, 1996, December 20, 1995, June 5, 1995, August 6, 1991, February 13, 1987, February 18, 1986, June 16, 1981, and December 16, 1980, with enclosures thereto.
l ISSUING AGENCY:
U.S.-Nuclear Regulatory Commission l
p i
Date:
February 28, 1997 Revuewer:
/
/ohE W.
Lubinski i
1 Date:
February 28, 1997 Concurrence:
sM
- 9 '7
" Steven L. Baggett i
j i
l
PAGE1 NRC FORM 567 U. S. NUCLEAR REGULATORY COMM3SSION h
REQUEST FOR A SEALED SOURCE OR DEVICE EVALUATION i
i INSTRUCTIONS: Send ins request AND a copy of all reisted letters /apphcatens and drew 6ngs to: The Seeled Source Safety Secten, ATTN: CNef, OWFN Mail Stop 6 H3. Change the Ucense Tracidng System milestone to 19 and assign to reviewer code I-5.
NOTE: Retain a copy of this request with the appication and background files.
REQUESTER REGION / LOCATION:
M /m
/Al/cln tr7 ski D1 On Oin OIv O v O Ha O LFDCB VELEPHONE NUMBER DATE TYPE OF ACTION REQUESTED (Check as appropriate) i APPLEANTS NAME SOURCE REVIEW AMENDMENT OF g
hgg REGISTRATION SHEET MAllCONTROL NUMBER (S)
NEVICE REVIEW NUMBER (S)
/
LETTER /APPUCATIO4N 7s Az LEENSE NUMBER (S)
CUSTOM REVIEW COMMENTS h f kk' gwald, cf 6 BS FOR SSSS USE ONLY REVIEWER MODEL NUMeERS NUMeER ASelGNED
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DEVICE (9A)
SOURCE (9D)
DEVICE (90)
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j AMENDMENT
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Mff0 SAFETY EVALUATION REQUIRED j LICENSING ACTION REQUIRED IF KNOWN NO NO FEES REQUIRED j OTHER (Spect) l TOTAL NUMBER OF NOTES REVIEW HOURS NUMBER OF DEFICIENCY LETTERS NUMBER OF DEFICIENCY CALLS FOR BILLING PURPOSES ONLY j NEW REGISTRATION -
_j PRODUCT INACTIVE -
NAME CHANGE ADDRESS CHANGE ADD TO BILUNG REMOVE FROM BILLING FOR FEE USE ONLY TYPE OF FEE FEE CATEGORY
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NRC FORM $67 (843) v gg *Q
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JMW M l
761 Main Ave.
I Norwalk. CT 06859-0098 September 20,1996 1
I USNRC 475 Allendale Road
)
King of Prussia, PA 19406 RE: INR536D107BJ j
l Licensing Section:
In accordance with 10 CFR 30.36,40.42,50.82, and 70.38 the Perkin-Elmer Corporation, by this letter, notifies you that it wishes to relinquish the following 1
" Registry of Radioactive Sealed Sources and Devices" as of December 31,1996.
I NR536D107B The source described in the above registry has not been actively marketed for 9 years (discontinued in 1987). In the past five years, sales of the device has strictly been for service replacements, averaging less than 3 units per year in the US. Currently there are no sources in stock nor any plans to build new one i
- cerely, y)l.
+
i Jo Widomski I
adiation Safety Officer Cc: S. Baggett - NRC CM//7 K. Liepms R. Cardillo 2 03
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20555-0001 Attention :
S. Baggett i
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