ML030370528
| ML030370528 | |
| Person / Time | |
|---|---|
| Issue date: | 02/04/2003 |
| From: | NRC/NMSS/IMNS/MSIB |
| To: | Smiths Detection |
| References | |
| Download: ML030370528 (15) | |
Text
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-0163-D-101-G DATE: February 4, 2003 PAGE 1 OF 10 DEVICE TYPE:
Ion Mobility Spectrometer MODEL:
IONSCAN Models 100, 200, 250, 350, 400, Sabre 2000 MANUFACTURER:
Smiths Detection, Toronto Ltd.
(Formerly Barringer Research Ltd.)
1730 Aimco Boulevard Mississauga, ON L4W 1V1 Canada DISTRIBUTOR:
Smiths Detection, Warren (Formerly Barringer Instruments, Inc.)
30 Technology Drive Warren, NJ 07059 Smiths Detection, Edgewood 2202 Lakeside Boulevard Edgewood, MD 21040 SEALED SOURCE MODEL DESIGNATION:
Amersham Corp. Model NBC Nuclear Radiation Development (NRD) Source Model, N1001 ISOTOPE: MAXIMUM ACTIVITY:
Nickel-63 15 mCi (0.56 GBq)
LEAK TEST FREQUENCY:
6 Months PRINCIPAL USE: (N) Ion Generators, Chromatography CUSTOM DEVICE: YES X NO
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-0163-D-101-G DATE: February 4, 2003 PAGE 2 OF 10 DEVICE TYPE:
Ion Mobility Spectrometer DESCRIPTION:
The IONSCAN devices use ion mobility spectrometry (IMS) to detect and identify trace quantities of a wide variety of chemical substances. Air containing microscopic particles of various chemical substances are drawn into a sample collector. The sample is heated in order to vaporize the particulate matter.
The vapor is drawn into the detector, ionized by the Nickel-63 source and passed into a drift region. The ionized particles are focused and accelerated by an electric field along the drift-region towards a collector electrode. Ionized particles in the vapor form are accelerated at different rates and arrive at the collector electrode at different times. The amount of time the particles take to reach the collector electrode can be directly related to the ionized chemical substances present in the vapor.
Therefore, specific substances can be detected according to the time required to reach the collector.
The Ni-63 source is encapsulated in a hollow brass cylinder which is, in turn, sealed in a ceramic shield. The ceramic shield is connected to the drift region which consists of a brass tube surrounded by brass discs equally spaced along its length. These discs create the electric field which focuses and accelerates the ionized particles. The entire assembly (the drift tube assembly) is contained in a brass source housing assembly. Graphite gaskets are used to provide a seal between the flanges of the housing assembly. A Pyrex glass inlet tube is connected to the drift tube assembly. Samples are drawn into the ion chamber through this inlet. The source housing assembly, with drift tube assembly and inlet tube installed, is contained within a stainless steel housing. Void spaces between the stainless steel housing and drift tube assembly are filled with insulation in order to protect and immobilize the drift tube assembly. The entire assembly (detector cell) is mounted inside the IONSCAN device. All brass components are plated with a 1.31 X 10E-3 inch (400 microns) layer of nickel, and all internal surfaces are also plated with a 0.66 x l0E-3 inch (200 microns) layer of gold.
The Model 250 devices are identical to the Model 200 except that the Model 250 devices contain a Model 100 style keypads. The
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-0163-D-101-G DATE: February 4, 2003 PAGE 3 OF 10 DEVICE TYPE:
Ion Mobility Spectrometer Models 350 and 400 are identical to the Model 250 except that the DESCRIPTION (Contd):
Model 350 contains an alternate power/pump unit, adding a thermoelectric cooler to remove moisture from the air flow and an optional DC battery pack, and the Model 400 uses a modified keypad and an alternate, a smaller power/pump unit without mass flow controllers.
The Ionscan Sabre 2000 is a hand-held portable chemical detection device which can identify trace residues of, and vapors emitted from, a wide variety of chemicals and, therefore, will be in contact with the operator. The metals used in the construction of the detector are gold and gold plated metals, stainless steel, nickel and Hastelloy. The manufacturer has stated that these metals will not be oxidized by air under anticipated operating and storage conditions. The source is contained in a source holder constructed from gold plated Naval Brass Rod.
A maximum 15 mCi (0.56 GBq) foil source consisting of nickel metal, electroless, 99.9% pure gold plating on a backing foil of 0.006-0.008 inches (0.152-0.203 mm) in thickness (Registration Certificate No. NY-0502-S-103-U) is inserted into the holder so that it conforms to the interior radius of the brass holder. The source sits against a machined ridge on one side of the holder, and rests against a gold-plated nickel mesh (repelling mesh) on the other side of the holder. The source is physically wedged in place. Sabre 2000 device mounting of the sealed sources is such that it cannot come loose from the source holder, or be dislodged from the device under normal operating and likely accident conditions. The manufacturer stated that for shipping and transportation no additional mechanism is required for shielding the radioactive source. The source is shielded within the detector. No adhesive is used to hold the source in place.
The repelling mesh contacts the source holder on one side while a ceramic spacer contacts the source holder on the other side. The source holder, as well as other pieces of the drift tube assembly, are held together by a 10 lbs. (44.48 N) force provided by a compressed spring.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-0163-D-101-G DATE: February 4, 2003 PAGE 4 OF 10 DEVICE TYPE:
Ion Mobility Spectrometer DESCRIPTION (Contd):
Radial ceramic shielding surrounds the source holder, and the drift tube casing surrounds the ceramic shielding. The drift tube shell casing is constructed of 0.032 inches (0.813 mm) thick Hastelloy. While the Ionscan Sabre 2000 is connected to an electrical power supply and rests in a cradle on the Base Station, the battery pack, consisting of 10 Metal Hydride batteries, is continuously charged and the system offers full operational capability.
The charger checks the battery pack before charging and does not start charging a faulty pack or if the pack temperature is outside the safety range of 0°C to 40°C, (32°F to 104°F).
When the battery is fully charged, the Model Sabre 2000 can operate for one and half hours. Model Sabre 2000 may be connected to a compatible computer for data viewing and programing.
An air flow through the assembly is used to induce chemical particulate and vapor samples through the inlet and into the drift tube. A thermoelectric cooler is connected to the device to remove moisture from the air flow. The air purification cartridge removes moisture from the airflow. The tube is filled with colored and white beads of molecular sieves.
The colored beads are blue when dry and turn pink as they are used.
LABELING:
IONSCAN devices distributed prior to February 17, 1994, were erroneously labeled. Barringer (presently Smiths Detection) has committed that all devices distributed on or after February 17, 1994, will contain a label on the outer surface of the IONSCAN devices which meets the requirements of 10 CFR 32.51. In addition, Barringer has committed to sending additional labels to all users of devices distributed prior to February 17, 1994, with instructions for applying these labels. When properly applied, these past distributed devices will contain labels which meet the
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-0163-D-101-G DATE: February 4, 2003 PAGE 5 OF 10 DEVICE TYPE:
Ion Mobility Spectrometer requirements of 10 CFR 32.51. All labels are made of Mylar and are secured in place with an adhesive.
LABELING (Contd):
Model Saber 2000 drift tube assembly has two labels permanently affixed to the device. The first label is shown in Attachment No. 5. This label designates the isotope, activity level, wipe test date and has the trefoil symbol included. Additionally, the drift tube assembly carries the label shown on Attachment No. 4.
This label is to alert anyone who has removed the Ionscan cover that disassembly of the IMS detector cell is prohibited. The device outside carries Trefoil Symbol and a WARNING RADIATION HAZARD label. This label advises of the Ni-63 source, the requirements for 6 months leak testing, and the general license regulations.
DIAGRAM:
See Attachments 1 to 5.
CONDITIONS OF NORMAL USE:
IONSCAN devices will be used for detecting various chemical compounds, including drugs and explosives. Typical uses of these devices will be in controlled surroundings or in outdoor ambient conditions. The equipment is specified for operation in temperatures ranging from O°C to 500°C, (32°F to 932°F). The device is not expected to operate under any significant vibration conditions. The optional DC power pack is intended to make the IONSCAN device portable in a limited scope. It allows for movement of the device to a temporary site where AC power is not available.
Model Sabre 2000 can be used for the detection of both the trace particles and vapor. It can be used for detecting and identifying explosives and narcotics. The armed forces, law enforcement authorities, customs, correctional institutions, local police and fire departments, public and private security surveillance organizations may be the primary users of this device. The device is not expected to be used in a wet (rain,
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-0163-D-101-G DATE: February 4, 2003 PAGE 6 OF 10 DEVICE TYPE:
Ion Mobility Spectrometer snow, under water etc.) or vibrational environment.
CONDITIONS OF NORMAL USE (Contd):
The expected working life of the Model Sabre 2000 is anticipated to be 10 years or more. The Ni-63 nor radiological safety aspects limit the expected working life.
PROTOTYPE TESTING:
The manufacturer claims that the IMS detector assembly, with sealed source installed, was tested to ANSI N542-1977 and received a classification cf 77C32211 which is the minimal requirement for ion generators used as chromatograph. Following each test air was flown through the device and the drift tube assembly was tested for removable contamination. No removable contamination above 0.005 microcuries (185 Bq) was noted.
The structural integrity of the Model Sabre 2000 detecting device design was tested under the following expected extreme temperatures, pressure and impact conditions:
- Pressure test to 25 kPa, (3.63 lbs/in2)
- Drop test from 1.5 m, (59.06 inches) ten times onto a steel plate
- Temperature test -40°C to 220°C, (-40°F to 428°F)
- Impact 50 g, from 1 m, (39.37 inches)
The manufacturer reported that prototype tests were conducted on the sealed source drift tube assembly, with the sealed source installed, in accordance with the minimum classification of 77C32211 for Ion Generator of Chromatography Type (ECD), per ANSI N542-1977. The source material was not affected by the tests and there was no loss of shielding or containment integrity. No removable contamination above 0.005 microcuries (185 Bq) was noted.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-0163-D-101-G DATE: February 4, 2003 PAGE 7 OF 10 DEVICE TYPE:
Ion Mobility Spectrometer EXTERNAL RADIATION LEVELS:
Due to the shielding of the beta-radiation by the brass, ceramic and stainless steel components of the IMS detector cell, Barringer reports no detectable radiation on any accessible surface of the detector cell or the external surface of the IONSCAN device.
Since the walls of the Model Sabre 2000 detectors are far in excess of the range of the maximum energy beta particles emitted from the contained source, surface readings on the Model Sabre 2000 did not exceed ambient background levels. Furthermore, any beta radiation emitted is thermalized within a distance of 1 cm.
Leak tests are to be performed on each sealed source as a part of factory acceptance testing, and a copy of the leak test results is to be delivered to each customer along with a copy of the General License.
QUALITY ASSURANCE AND CONTROL:
Smiths Detection (formerly Barringer) performs an incoming inspection to ensure that each source assembly received is undamaged, properly labeled, that all radiation protection features are in accordance with drawings and specifications and that leak test results are provided by the manufacturer. Once the IMS is installed in the IONSCAN, an operational test will be performed on the entire unit. Each completed device, prior to installation, is tested for leakage. The quality control program involving the IMS is on file with NRC.
Smiths Detection is a certified ISO 9001 organization. Smiths Detection is committed to design, manufacture and distribute the Model Sabre 2000 and IONSCAN devices in accordance with the current ISO-9001 approved program.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-0163-D-101-G DATE: February 4, 2003 PAGE 8 OF 10 DEVICE TYPE:
Ion Mobility Spectrometer LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
The devices may be distributed to persons generally licensed pursuant to 10 CFR Part 31.5 and 32.51, and must be initially transferred in accordance with the requirements of 10 CFR Part 32.51 and 32.51a.
These devices shall be leak tested at intervals not to exceed 6 months by persons specifically or generally licensed by the NRC or an Agreement State, using techniques capable of detecting 0.005 microcuries (185 Bq) of removable contamination. Allow the units to cool down prior to taking swab samples. For Sabre 2000 model two samples, one from IMS inlet and another from the exhaust port, must be taken for leak testing.
This registration sheet and the information contained within the references shall not be changed without the written consent of the NRC.
REVIEWER NOTE: Smiths Detection distributors (formerly Barringer Instruments Inc.) understand and confirmed that the final disposal of the devices sources will be performed by Smiths Detection, Toronto Ltd. located in Ontario, Canada. In case of an emergency, USA Federal, State or Local authorities may isolate and dispose of chemically contaminated devices and sources in accordance with the applicable regulations.
SAFETY ANALYSIS
SUMMARY
Barringer Instruments, Inc. (presently Smiths Detection),
provided adequate IONSCAN units safety characteristics to ensure that individuals will not receive radiation exposures in excess of applicable regulatory limits. Unauthorized access to the source is discouraged by instructions, labeling and the fact that the source in the drift tube is buried deep within the self contained IMS detector housing providing three levels of protection1 and is itself contained inside the IONSCAN device.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-0163-D-101-G DATE: February 4, 2003 PAGE 9 OF 10 DEVICE TYPE:
Ion Mobility Spectrometer SAFETY ANALYSIS
SUMMARY
(Contd):
Barringer has 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 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 10 CFR 20.1201(a).
Under accident conditions associated with handling, storage and use, 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 rem Sv Whole body; head and trunk; active blood-forming organs; gonads; or lens of eye 15 150 Hands and forearms; feet and ankles; localized areas of skin averaged over areas no larger than 1 square centimeter 200 2000 Other organs 50 500
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-0163-D-101-G DATE: February 4, 2003 PAGE 10 OF 10 DEVICE TYPE:
Ion Mobility Spectrometer SAFETY ANALYSIS
SUMMARY
(Contd):
Based on review of the IONSCAN spectrometer design and the information and test data cited below, we continue to conclude that the devices are acceptable for licensing purposes.
Furthermore, we continue to conclude that the devices would be expected to maintain their 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 IONSCAN spectrometer devices are hereby incorporated by reference and are made a part of this registry document.
Barringer's letters dated August 31, 1995, March 30, 1995, February 17, 1994, February 15, 1994, February 2, 1994, September 8, 1993, January 17, 1992, December 3, 1991, and August 20, 1990, July 26, 1999, September 23, 1999, December 21, 1999, January 20, 2000, February 28, 2000, February 29, 2000, with enclosures thereto.
Smiths Detection letters dated November 14, 2002, December 17, 2002, and facsimile dated January 24, 2003, with enclosures thereto.
ISSUING AGENCY:
U.S. Nuclear Regulatory Commission Date: 2/4/03 Reviewer: /RA/
John P. Jankovich Date: 2/4/03 Concurrence: /RA/
Ujagar S. Bhachu
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-0163-D-101-G DATE: February 4, 2003 ATTACHMENT 1
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-0163-D-101-G DATE: February 4, 2003 ATTACHMENT 1
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-0163-D-101-G DATE: February 4, 2003 ATTACHMENT 2 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-0163-D-101-G DATE: February 4, 2003 ATTACHMENT 3
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-0163-D-101-G DATE: February 4, 2003 ATTACHMENT 3
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-0163-D-101-G DATE: February 4, 2003 ATTACHMENT 4
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-0163-D-101-G DATE: February 4, 2003 ATTACHMENT 5 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-0163-D-101-G DATE:
ATTACHMENT 5