ML20138M997

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Registry of Radioactive Sealed Sources & Devices,Safety Evaluation of Device for Model ECD-40. Certificate:NR-8081-D-801-G
ML20138M997
Person / Time
Issue date: 02/18/1997
From: Steven Baggett, John Lubinski
NRC
To:
Shared Package
ML20138M975 List:
References
SSD, NUDOCS 9702270090
Download: ML20138M997 (11)
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Text

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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE MQ1 NR-8081-D-801-G DATE: February 18, 1997 P. AGE 1 1 OP 6 nRVTOR TYPRr Gas Chromatography Detector Cell MODEL:

ECD-40 l

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3 DISTRIBUTOR:

Fisons Instruments 55 Cherry Hill Drive Beverly, MA 01915 (formerly Haake Buchler Instruments, Inc.)

MANUFACTURER:

Carlo Erba Strumentazion S.p.A.

Strada Rivoltana 20090 Rodano (Milan)

P.O. Box 20090 Rodano MI (ITALY)

SEALED SOURCE MODEL DESIGNATION:

The Radiochemical Centre Amersham Model N.B.C.

plated foil source ISOTOPE:

Nickel-63 MAXIMUM ACTIVITY:

10 mci (370 MBq)

LEAK TEST FREOUENCY:

6 months l

PRINCIPAL USE:

(N) Ion Generators, Chromatography CUSTOM DEVICE:

YES Y

NO l

9702270090 960409 PDR RC SSD PDR

i J

}

l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES j

SAFETY EVALUATION OF DEVICE j

i MD.:, NR-8081-D-801-G D&TFa. February 18, 1997 R&GE1 2 M 6 y

nevTcr TypEr Gas chromatography Detector Cell l

l DESCRIPTIOM:

As shown schematically in Figure 1, the Erba Instruments, Inc.,

j Nodel ECD-40 gas chromatograph detector cell consists of a lower main body stainless steel cylindrical' holder and a nickel-63 foil i

i source which is held in place with a stainless steel C-clip. The I

source acts as a cathode in the ionization cell. Another cylindrically shaped coaxial electrode constitutes the anode and j

is mounted above the source support chamber. The insulation of the two electrodes from the body of the detector is achieved by I

means of high temperature boron nitride insulators. A stainless 4

i steel main body top is mounted on top of the lower main body (source support) by means of standard countersunk allen screws j

with the hexagonals drilled out after mounting to prevent top removal. An outlet stainless steel tube tower is mounted on top

)

of the main body top of standard countersunk allen screws. This l

l outlet tube tower is readily removable by removing the allen j

screw. Adapter kits, available from the distributor mounted on the main body top, allow more than one ECD-40 detector call to be connected in tanden. Likewise, a flame photometric detector can be mounted directly above the ECD-40 in place of the standard outlet tube tower.

i Once the cell is assembled the nickel-63 source cannot be l

accessed or removed from the cell either deliberately or i

accidentally without the extraordinary means such as drilling out j

the modified main body top screws.

}

The ECD-40 module is approximately 4.72 in. x 4.33 in. x 1.97 in.

j (12 cm x 11 cm x 5 cm) and attaches to the column effluent i

section of Carlo Erba Gas Chronographs by use of a circular brass nut in the base. See Attachment 2.

i-l The operational temperature of the ECD-40 cell is maintained at j

temperatures up to 750 F (399 C) by two 24 volt, 25 watt heaters located within the lower main body and the temperature is j

constantly sensed by a PT100 temperature sensor fitted to the main body. The separate ECD Control Module-400 supplied with the device is necessary for the operation of the ECD-40 detector and is electronically interconnected. This temperature sensor i

switches off power to the heaters if the temperature reaches 752 F (400 C) or if the PT100 temperature sensor is open or short 4

circuited. According to the applicant even if the temperature j

contro! fails, the temperature of the ECD-40 cannot 1

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE D&. JU. February 18, 1997 RAGFul, 3 OP 6 MQ.:. NR-8081-D-801-G T

nrvTcr Typr: Gas Chromatography Detector Cell DEScDTPTION f amn et):

reach 808*F (430 C). Tests performed at 842 F (450 C) by use of an additional heat source show no release of nickel-63.

i Fisons Instruments no longer sells, distributes, or stores any of the devices.

LABELING:

The side surface of the ECD-40 is labeled with an etched aluminum

)

label in accordance with the requirements of Section 32.51(a)3, 10 CFR 32. The front surface of the detector cell is labeled with an etched aluminum label with the requirements of Sections j

20.1901 and 20.1904 of the 10 CFR 20 which identifies the 10 aci nickel-63 source, the date of measurement, and has the standard radiation symbol.

DIAGRAM:

See Attachments No. 1 and 2 CONDITTONS OF NORMAL USE:

According to the applicants, the ECD-40 is used on a gas chronograph under controlled, analytical laboratory conditions.

It is not a field device. Therefore, it will not be subject to significant vibration, impact, puncture, compressive loads, or extreme cold under normal operating conditions. Users are generally trained laboratory technicians designed for use with the ECD Model 400 control module and Carlo Erba Chromatograph.

The ECD-40 cannot be used as a component in any other product.

PROTOTYPE TESTTNGr The applicant states that this prototype ECD has been used by the manufacturer under normal conditions for 10 years without deterioration in terms of containment of the radioactive source.

The device has been held at a temperature of 842 F (450 C) for 3 days without loss of source tension or loss of containment. As used in the gas chronograph, the source can never reach a temperature of 842 F. Additionally, several hundred devices have been in use in Europe for several years without loss of containment.

i

... - _~.. - -.. -

4 i

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES I

SAFETY EVALUATION OF DEVICE 4

l MQ1 NR-8081-D-801-G DATE2. February 18, 1997 RAGE 1 & OF E navica Typr Gas Chromatography Detector Cell i

j EYTERNAL RADIATTON LEVELS:

j 4

i The applicant stated that there were no detectable radiation levels, distinguishable from background radiation, at the surface and the vent of the device.

OUALITY ASSURANCE AND CONTROLS The manufacture performed the following:

)

Each detector was checked under normal operating condition for proper operational parameters.

  • Analytical checks were made with known samples.
  • Each detector was leak tested and samples were analyzed by liquid scintillation counter methods.

i The distributor performed the following:

  • Inspected all detectors for proper labels.
  • Inspected shipment to ensure that operational instruction manuals and a copy of Section 31.5 of 10 CFR 31 are provided to each customer.

I LIMITATIONS AND OTHER CONSIDERATIONS OF USE:

  • The device may be used by general licensees of the NRC or an Agreement state.
  • The device shall be leak tested at intervals not to exceed 6 months using techniques capable of detecting 0.005 microcurie (185 Bq) of removable containment.
  • The registration sheet and the information contained within the references shall not be changed without the written consent of the NRC.

[

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE MQ1 NR-8081-D-801-G DATE: February 18, 1997 PAGE: 5 OP 6 nEVTcE TYPEr Gas Chromatography Detector Cell SAFETY ANALYSIS

SUMMARY

Based on our review of the information and test data contained in the references listed, we conclude that the Erba Model-40 gas chromatography detector cell is acceptable for general licensing purposes and can be safely used by persons not having training in radiolcgical protection. Furthermore, under ordinary conditions of use, the nickel-63 source contained in the device cannot be j

inadvertently removed for either routine or emergency conditions l

of use and it is unlikely that any person will receive an external dose or dose commitment in excmss of 10% of the limits specified in Section 20.1201(a) of 10 LAR 20. Additionally, under foreseeable accident conditions, we continue to conclude that it is unlikely that any person will receive a dose or dose commitment in excess of the dose to the appropriate organ as specified in' Column IV of the table in Section 32.51 of 10 CFR

32. Further, we continue to conclude that the Model ECD-40 device would be expected to maintain its containment integrity for normal conditions of use and accident conditions which might occur during the uses specified in this certificate.

4

'1 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE y

i 4

MQ1 NR-8081-D-801-G DATE:. February 18, 1997 P. AGE 6 or 6 2

nerTcE TYPEr Gas Chromatography Detector Cell t

l

REFERENCES:

i l

This certificate of registration is based on information and test data contained in the following supporting documents which are hereby incorporated by reference and made a part of this registry document.

i

  • Letter of application dated February 19, 1985, with enclosures thereto.

9

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  • Letter dated October 29, 1985, with enclosures thereto.
  • Amendments to the application signed by Anthony Bashall, Product Manager, Haake Buchler Instruments, Inc. And dated October 30, 1985.

1 4

  • Letter dated November 14, 1985, with enclosures thereto as amended by letter dated November 19, 1985.

4 l

  • Letter of closure intentions dated April 6, 1996, with j

enclosures thereto.

1 j

TEEUTMC ACENCYr i

U.S. Nuclear Regulatory Commission l

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DATE:

Fahvumrv 18. 1997 REVIEWER:

'St'even gett

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DATE:

Fahruary 1B_

1997 CONCURRENCE:

8" Jg6n W. Lubinski i

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j 1

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES 4

SAFETY EVALUATION OF DEVICE

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PAGE1 NRC FORM 567 U. S. NUCLEAR REGULATORY COMMISSION REQUEST FOR A SEALED SOURCE OR DEVICE EVALUATION INSTRUCTIONS: Send this request AND a copy of aR related letterthrphnahr=:s and drawings to: The Sealed Source Sefety Section, ATTN: CNef OWFN Mail Stop 6 H3. Change the Ucense Tracking System milestone to 19 and assign o reviewer code 8-5.

NOTE: Retain a copy of tNs request with the applicebon and background flies.

a outsTER REGION / LOCATION:

js)4M Mgwgd ll il ill IV V

HQ LFDCB TELEPHONE NUMBER

~DATE TYPE OF ACTION REQUESTED (Check as, 4 ^

CPPUCANTS NAME SOURCE REVIEW AMENDMENT OF REGISTRATION SHEET Mall CONTROL NUMBER (S)

DEVICE REVIEW B R(S)

LETTER /APPUCATION DATE UCENSE NUMBER (S)

CUSTOM REVIEW AI ~~

~

NI' b c "*'"'*

55 chwy MW R.

3euveIy, m A of1/7 FOR $$$$ USE ONLY REUIEWER f

MODEL NUMBERS NUMBER ASStGNED j

/h'b f W

$&~%

Tb mW

\\

DATE RECEIVED DATE ASSIONED DATE TO FEES st/nh&

'//$7 N/4

/

/

TYPE OF ACTION (Indicete the number of each type) l COMMERCIAL DISTRIBUTION (FORMAL) l USE BY A SINGLE APPLICANT (CUSTOM)

SOURCE (9C)

DEVICE (9A)

SOURCE (9D)

DEVICE (98)

NEW NEW NEW NEW

~

AMENDMENT AMENDMENT AMENDMENT AMENDMENT j NO SAFETY EVALUATION REQUIRED j LICENSING ACTION REQUIRED IF KNOWN NO FEES REQUIRED NO j OTHER (Spcsil TOTAL NUMBER OF NOTES REVIEW HOURS NUMBER OF DEFICIENCY LETTERS NUMBER OF DEFICIENCY CALLS FOR BILLING PURPOSES ONLY f

NAME CHANGE ADDRESS CHANGE REGISMON -

[RODUCMACME -

ADD TO BILLING REMOVE FROM BILLING FOR FEE USE ONLY TYPE OF FEE FEE CATEGORY l9A R 98 BC 90

~

CMCUNT RECEIVED CHECK NUMBER MATANN UPDATED AS REQUIRED DATE OF CHECK LCG j MATSYS UPDATED AS REQUIRED ACHOVED BY DATE RETURN DATE r " ENTS NRCFORM$67 (8-93)

N

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