ML20217R149
| ML20217R149 | |
| Person / Time | |
|---|---|
| Issue date: | 10/25/1995 |
| From: | John Lubinski NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Gerrone C CHROMPACK, INC. |
| Shared Package | |
| ML20216B030 | List: |
| References | |
| RTR-REGGD-10.010 SSD, NUDOCS 9805140161 | |
| Download: ML20217R149 (2) | |
Text
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NUCLEAR REGULATORY COMMISSION t
WASHINGTON, D.C. 20555M1
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October 25, 1995 hTV95 'To 60
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/A m Carmen Gerrone General Manager Chrompack, Inc. USA PE 1130 Route 202 South Raritan, NJ 08869
Dear Mr. Gerrone:
Based on the information submitted in your application dated August 19, 1992, and subsequent letters, with enclosures thereto, we are issuing the enclosed l
registration certificate (NR-213-D-101-B) for the Models 902, 902A, and 902B electron capture detectors.
~
Please be advised that you must manufacture and distribute the product in accordance with the statements and representations contained in your application, with enclosures thereto, and the information set out in your registration certificate. As a general rule, you must request and obtain an amendment to the certificate before you make changes or modifications to the information submitted to obtain the certificate.
Please read over the registration certificate in its entirety and notify us immediately of any errors or omissions.
You are obligated to notify us promptly in writing should you decide to no longer manufacture or offer service support for the product.
Please be aware that, as a holder of an NRC registration, you may be subject to the NRC's licensing and inspection fees in accordance with 10 CFR Part 170, and annual fees in accordance with 10 CFR Part 171.
If you have any questions concerning the fee requirements, please contact the License Fee and Debt Collection Branch at (301) 415-7544.
Please note that the issuance of this registration certificate does not mean that the Sealed Source Safety Section has fully completed its evaluation of the devices. We recognize that your distribution license was issued based on the registration issued by the State of Illinois, but NRC still needs to perform a complete evaluation of the device designs.
Specifically, Chrompack still needs to provide the following information or clarifications that were originally requested in my March 14, 1995, letter:
1.
Item 4 of your letter dated October 26, 1994, indicates that "The effluents processed through the ECD never come in direct contact with the Nickel-63 source..." Please explain how this is possible by describing the flow of the effluent through the ECD.
2.
Page 2 of 9 of your August 19, 1992, application indicates "Once the cell is assembled the nickel 63 source cannet be accessed or removed from the cell without extraordinary means or the use of a special tool."
E ---
C. Gerrone Please provide details of how this is accomplished.
It is not clear from the drawings submitted that the ECD is assembled using tamper resistant hardware.
It is NRC policy to have tamper resistant hardware for devices distributed to general licensees.
3.
Please provide complete details of the quality control procedures that will be followed by Chrompack, Inc. USA to ensure the devices distributed have been manufactured and labeled in accordance with information submitted in support of your application and that the ECDs are tested for removable contamination prior to distribution. The information provided in your April 10, 1995, letter did not fully address this request.
If you have any questions, please contact me at (301) 415-7868 or Mr. Steven Baggett at (301) 415-1273.
Sincerely,
/3 John W. Lubinski, Mechanical Engineer Sealed Source Safety Section Source Containment and Devices Branch-Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
Enclosure:
As stated cc w/ encl: SKimberley, LFDCB l
lI Distribution:
SCDB r/f SSD-92-51 NE01 SSD File # NR-213-D-101-B DOCUMENT NAME: C:\\ FILES \\SSDS\\NR213101. CMP Ta receive a copy of tWe document, Indicate in the boat "C" = Copy without attachment / enclosure "E" = Copy with attachment / enclosure "N" = No copy 0FFICE SCDB, M lE l
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l NAME JLubiniiki/jl DATE 10/a4/95 0FFICIAL RECORD COPY