ML20217R152
| ML20217R152 | |
| Person / Time | |
|---|---|
| Issue date: | 08/23/1994 |
| From: | John Lubinski NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Gerrone C CHROMPACK, INC. |
| Shared Package | |
| ML20216B030 | List: |
| References | |
| SSD, NUDOCS 9805140163 | |
| Download: ML20217R152 (3) | |
Text
1 a,
oc arc 4
UNITED STATES 0
Eg*)*f j
NUCLEAR REGULATORY COMMISSION
.t WASHINGTON, D.C. 20555 0001 AUG 2 31994 l
Chrompack, Inc. USA ATTN: Carmen Gerrone General Manager 1130 Route 202 South j
Raritan, NJ 08869 J
This letter is in reference to your letter dated November 2,1992, which requested registration of Chrompack's Models 902, 902A, and 902B electron capture detectors and our telephone conversation on August 19, 1994. We are in the process of performing a safety evaluation of the detectors. However, to continue the evaluation, the following information or clarifications are needed:
k b lease provide complete drawings of each model detector.
The differences between the models should be clearly identified on the drawings and the drawings should include all materials, dimensions, J
tolerances and assembly methods.
Details of some parts of the detectors F /, which do not provide shielding or contribute to the containment of the f / byproduct material, such as the electronics, may not need to be included
/j on the drawings.
2.
The following items pertain to now the detectors are labeled:
2.1 Please clearly identify which labels will be attached to the detectors when distributed to specific licensees and which labels
[o /
. g will be attached to the detectors when distributed to general
/p '
4f licensees. When distributed to specific licensees, the labels (ff should not indicate "... of this device are subject to a general license..."
.2 Please verify that the metal tag included in your submission is wrapped around the neck of detectors distributed to general licensees and that a rivet is inserted through the two holes in order to attach the label to the detectors.
If this does not describe the method of attachment, please indicate how the metal tag will be permanently attached to the detectors.
!.3 Please verify that the source identification number which is stamped 2
on the detector serves as the serial number of the detector.
2.4 Please explain the function and location of the protective cover described in the labeling section of your application.
In addition, please indicate the material from which it is made and indicate how it is attached to the detector.
/.5 Please indicate how the labels will be visible to the users of t j
2 chromatographs.
j i
9805140163 951025 PDR RC SSD PDR
Chrompack, Inc. USA 2
3.
Please clarify the following statement from your application: "The manufacturer reports in exposure rate of less than or equal to 0.0-1
/
mr/hr on any accessibie surface of the detector unit." Should the
/g(/
statement read 0.01 mr/hr (0.1 pSv)?
4.
Please describe the effluents which will be processed through the device and explain any detrimental effects the effluents may have on the
@ i-('
nickel-63 source.
5.
You indicated that the detector has been distributed since July of 1978.
Please indicate the approximate nurober of devices distributed since 1978 and provide details of any failures of the detector related to radiological safety.
In addition, please indicate the expected useful life of the detector.
6.
Please provide details and results of tests performed on a prototype of the detector which indicate that the detector will withstand temperatures cf 752*F (400*C), the design limit specified in your application.
7.
Please provide an up-to-date copy of Chrompack USA's quality assurance y
manual.
In addition, please provide details of the manufacturer's QA r
program and details of how Chrompack USA ensures the manufacturer's program is operating properly.
/8.
Chrompack BV, Netherlands, is listed as the manufacturer of the detectors.
Please indicate what type of manufacturing or assembly is performed by Chrompack USA.
9.
The previous registration certificate (IL-0529-D-105-8) indicated that the manufacturer's name is Chrompagic-Packard and is located at 2600 ANN /P.O. Box 519.
Please indicate whether this is the same manufacturer who has changed names or whether this is a different manufacturer.
If this is the same manufacturer, please verify whether the address is 2600 ANN or 2600 AM.
10.I Please provide a copy of the users manual which is supplied to each Customer.
- 11.
Odd numbered pages of the copies of regulations provided to general licensees are missing.
Please provide a copy of a complete package of I
information provided to general licensees.
12.
Please verify that the " Summary Letter to Customers" will only be sent j
to general licensees and not customers using the device under a specific license.
13.
In your " Summary Letter to Customers", you summarize the "... salient points..." of the regulations. However, the regulations governing servicing and transfer of generally licensed devices do not require that j
the devices be serviced by the distributors or manufacturers nor require 1
l
e Chrompack, Inc. USA
/ b them to be returned to the distributors or manufacturers for disposal.
If this is part of a sales contract between Chrompack and their customers, it should be stated as such and shall not be represented as part of the regulations.
We look forward to receiving the requested information.
If you have any questions, please contact me at (301) 415-7868 or Mr. Steven Baggett at (301) 415-7273.
Sincerely, OriginalSigned by John W. Lubinski, Mechanical Engineer Sealed Source Safety Section Source Containment and Devices Branch Division of Industrial and Medical Nuclear Safety, NMSS e
DISTRIBUTION:
SSSS Staff SCDB r/f IMNS Central Files NMSS r/f RBaer OFC SCDB)p C-NAME EJLubinski/tk DATE 8/20/94 C = COVER E = COVER & ENCLOSURE N = NO COPY G:\\NR213101.DEF
)
}v* "*%1 UNITED STATES yj j
NUCLEAR REGULATORY COMMISSION WASHINGTON. D.C. 20565-4001
.....+
AUG 2 31994 i
j i
Chrompack, Inc. USA
{
ATTN: Carmen Gerrone
{
General Manager I
1130 Route 202 Scuth Raritan, NJ 08869 J
L-This letter is in reference to your letter dated November 2,1992, which requested registration of Chrompack's Models 902, 902A, and 902B electron capture detectors and our telephone conversation ori August 19, 1994. We are in the process of performing a safety evaluation of the detectors. However, to continue the evaluation, the following information or clarifications are needed:
1.
Please provide complete drawings of each model detector. The differences between the models should be clearly identified on the drawings and the drawings should include all materials, dimensions,
]
tolerances and assembly methods. Details of some parts of the detectors 4
which do not provide shielding or contribute to the containment of the byproduct material,.such as the electronics, may not need to be included on the drawings.
2.
The following items pertain to how the detectors are labeled:
2.1 Please clearly identify which labels will be attached to the detectors when distributed to specific licensees and which labels will be attached to the detectors when distributed to general liccasees.. When distributed to specific licensees, the labels should not indicate "... of this device are subject to a general license..."
2.2 Please verify that the metal tag included in your submission is wrapped around the neck of detectors distributed to general licensees and that a rivet is inserted through the two holes in 4
order to attach the label to the detectors.
If this does not describe the method of attachment, please indicate how the metal tag will be permanently attached to the detectors.
2.3 Please verify that the source identification number which is stamped on the detector serves as the serial number of the detector.
2.4 Please explain the function and location of the protective cover described in the labeling section of your application.
In addition, please indicate the material from which it is made and indicate how it is attached to the detector.
2.5 Please indicate how the labels will be visible to the users of the
~
v, chromatographs.
979a&d/Q 3
4
?
Chrompack, Inc. USA 2
3.
Please clarify the following statement from your application: "The manufacturer reports an exposure rate of less than or equal to 0.0-1 mr/hr on any accessible surface of the detector unit." Should the statement read 0.01 mr/hr (0.1 pSv)?
- 4..
Please describe the effluents which will be processed through the device and explain any detrimental effects the effluents may have on the nickel-63 source.
5.
You indicated that the detector has been distributed since July of 1978.
Please indicate the approximate number of devices distributed since 1978 and provide details of any failures of the detector related to radiological safety.
In addition, please indicate the expected useful life of the detector.
6.
Please provide details and results of tests performed on a prototype of the detector which indicate that the detector will withstand temperatures of 752*F (400*C), the design limit specified in your application.
7.
Please provide an up-to-date copy of Chrompack USA's quality assurance manual.
In addition, please provide details of the manufacturer's QA j
program and details of how Chrompack USA ensurer the manufacturer's program is operating properly.
8.'
Chrompack BV, Netherlands, is listed as the manufacturer of the detectors.
Please indicate what type of manufacturing or assembly is performed by Chrompack USA.
9.
The previous registration certificate (IL-0529-D-105-B) indicated that the manufacturer's name is Chrompagic-Packard and is-located at 2600 ANN /P.O. Box 519, Please indicate whether this is the same manufacturer who has changed names or whether this is a different manufacturer.
If this is the same manufacturer, please verify whether the address is 2600 ANN or 2600 AM.
10.
Please provide a copy of the users manual which is supplied to each cetomer.
11.
Odd n abered-pages of the copies of regulations provided to general
)
licensees are missing. Please provide a copy of a complete package of informetion provided to general licensees.
12.
Please verify that the " Summary Letter to Customers" will only be sent to general licensees and not customers using the device under a specific license.
13.
In your " Summary Letter to Customers", you summarize the "... salient points..." of the regulations.
However, the regulations governing servicing and transfer of generally licensed devices do not require that j
the devices be serviced by the distributors or manufacturers nor require
Chrompack, Inc. USA 4
them to be returned to the distributors or manufacturers for disposal.
If this is part of a sales contract between Chrompack and their customers, it should be stated s such and shall not be represented as part of the regulations.
We look forward to receiving the requested information.
If you have any questions, please contact me at (301) 415-7868 or Mr. Steven Baggett at (301) 415-7273.
Sincerely, j
@lSigned by John W. Lubinski, Mechanical Engineer Sealed Source Safety Section Source Containment and Devices Branch Division of Industrial and Medical Nuclear Safety, NHSS DISTRIBUTION:
SSSS Staff SCDB r/f IMNS Central Files NMSS r/f RBaer 0FC SCDB)# d--
NAME JLubinski/tk DATE 8/20/94 1
C = COVER E = C0VER & ENCLOSURE N = NO COPY G:\\NR213101.DEF
_