ML20195J624
| ML20195J624 | |
| Person / Time | |
|---|---|
| Issue date: | 01/26/1988 |
| From: | NRC |
| To: | |
| Shared Package | |
| ML20195J621 | List: |
| References | |
| FOIA-88-23 NUDOCS 8801280613 | |
| Download: ML20195J624 (12) | |
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/ A REGISTRY OF RA0!0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO: NR-169-D-160-S DATE: gg ?,0 G83 PAGE 1 01 4 OEVICE TYPE: Gama Irradiator MODEL: Gami. Cell 1000, A, 8 C, or 0 MANUFACTURER / DISTRIBUTOR: Atomic Energy of Canada, Ltd.
Comercial Products Division P.O. Box 6300 Ottawa, Canada k2A3W3 MANUFACTURER / DISTRIBUTOR :
SEAL'E0 SOURCE MODEL DESIGNATION: ORNL-RAMCO-50 or 150-1000 ISOTOPE: Cesium-137 MAXIMUM ACTIVI_TY: Up to 3264 curies (see description)
LEAK TEST FREQUENCY: 6 Months PRINCIPAL USE: (J) Gama Irradiator, Category I CUSTOM DEVICE: YES X NO
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g3y33)y 8801280613 FOIA 880126 PDR PDR MALAMUDBO-23 O ' Af ~23
REGISTRY OF RADIOACTIVE SEALE0 SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (CORRECTED PAGE) 8/20/86 N01 NR-169-D-160-5 OATE: July 21, 1983 PAGE: 2 of 4 DEVICE TYPE: Gamma Irradiator DESCRIPTION:
The Gamma Cell 1000 is a fully self-contained irradiator. The irradiator chamber has a built-in turntable to provide dose uniformity when rotating.
The doubly encapsulated sources are permanently fixed and sealed off within the lead shield. The sample chamber is introduced to and removed from the radiation field by turning the rotor 180'. To obtain the dose rates needed by the user, Atomic Energy of Canada, Ltd. loads the Gamma Cell 1000 with the sources and quantities listed below:
Gamma Cell No. of Sources No. of Sources 1000 Model RANCO-50 Not to exceed 150-1000 Not to Exceed A 2---------- 828.0 curies 1 -------- 720 curies B 4----------1632.0 curies 2 --------1440 curies C 6--------- 2448.0 curies 3 --------2160 curies D 8----------3264.0 curies 4 --------2880 curies LABELING:
The Garna Cell 100 is labeled in accordance with the requirements of Section 20.203, 10 CFR Part 20 and with ANSI N433.1, 1977 requirements.
DIAGRAM:
See Attachment.
CONDITIONS OF NORMAL USE The Gamma Cell 1000 is a low dose rate irradiator designed to irradiate biological or other samples requiring low dose rate, (e.g., blood and blood components to eliminate small lymphocytes, sprout stimulation of seeds and tubers, non-sporulating bacteria and molds -- pasteurization and sterilization, viruses, polymerization, etc.). The irradiator would be located in laboratory environments and will be used by personnel trained in radiation safety.
PROTOTYPE TESTING:
The sealed sources used in the Gamma Cell 1000 have passed Special Forms Tests conducted by the manufacturer and supplier Oak Ridge National Laboratory.
Furthermore, the device has been in for more than 10 years without any significant problems being reported.
' REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICEL SAFETY EVALUATION OF DEV!CE M: NR-169-D-160-S DATE: p)L ES EGE 3 10 4
DEVICE TYPE: Gama Irradiator EXTERNAL RADI ATION LEVELS:
Atomic Energy of Canada, Ltd. reports at 5 centimeters from the surface of the radiation shield, the average dose rate will not exceed 0.5 milliroentgens per hour.
QUALITY ASSURANCE AND CONTROL:
Atomic Energy of Canada, Ltd has submitted an acceptable quality assurance and control program. A copy of this is on file with the Material Certiftcatton and Procedures Branch.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
o The device shall be distributed only to specific licensees of NRC or an Agreement State.
o Handling, storage, use, transfer, and disposal, to be determined by the licensing authortty, o The device shall be leak tested at six month intervals using techniques capable of detecttng 0.005 microcuries of removable contamination, o This registration sheet and tfie information contained within the references shall not be changed or transferred without the written consent of the NRC, SAFETY ANALYSIS
SUMMARY
The Gama Cell 1000 was deemed acceptable for licensing purposes in 1979 by the NRC, At that time, the device was manufactured by !somedix, Inc. and distributed by Atomic Energy af Canada, Ltd (AECL). AECL will now manufacture and distribute the device.
They hbve not made any significant changes to the source housing. Since the deytce was previously deemed acceptable for licensing and that the changed made do not alter the safety of the device, we continue to find the Gama Cell 1000 as acceptable for licensing purposes.
REFERENCES:
The following supporting documents for the Gansna Celi 1000 are hereby incorporated by reference and are made a part of this registry document:
o Isomedix Inc. letter dated May 9,1980 and June 11, 1980, with enclosures thereto.
o ORNL letter dated June 18, 1980, o Atomic Energy of Canada, Ltd. letter dated June 2,1983 with enclosures thereto.
REGISTRY OF RADt0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATTON OF DEVICE l
l NO: NR-169-0-160-S DATE:
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- PAGE 4 0F 4 DEVICE EPE: Gama Irradiator ISSUING AGENCY:
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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE
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'f (Amended Pages 1, 2 and 3 - June 17, 1987)M NO: CA598D103U DATE: February 28, 1980 PAGE 1 of 3 DEVICE TYPE: Gamma Irradiator MODEL: 143 Series MANUFACTURER / DISTRIBUTOR: J. L. Shepherd and Associates 1010 Arroyo Street San Fernando, California 91340 SEALED SOURCE MODEL DESIGNATION: Shepherd 6810 ORNL A-0096 ISOTOPE: Cesium 137 MAXIMUM ACTIVITY: 7000 curies LEAD. TEST FREQUENCY: Six (8) sonths PRINCIPAL USE: Gamma Irradiator, Category I CUSTOM DEVICE: YES __ __ x NO h
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REGISTRY OF RADICACTIVE SEALED SOUACES AND DEVICES SAFETY EVALUATION OF CEVICE
( Amended Page 2 - June 11,1987)
N9: CA598D103U QATE: Februaryq8, 1980 PAGE 2 0F 3 DEVICE TYPE: Ganaa Irradiator DESCRIPTION:
The Model 543 1rrediator is designed to provide a high radiation flux to small samples. It consists essentially of one or more sources of cesium-137 at fixed positions inside a lead shield, and a drawer which can be moved vertically within the shield. The middle part of the drawer consists of an {
irradiation chamber, and the ands of the drawer consist of shielding material.
The drawer moves upward to the "load" position and downward to the "irradiate" position. The drawer has positive mechanical stops welded in place to prevent it from moving in either direction beyond design limits and to prevent its renoval from the irradiator. All shielding is void free lead enclosed in welded steel containers. Following are data on sub-models of this device:
Sub-Nodel Cavity Curies Lead <
Designation Size Max Thickness I 35 3" x 5" 1155 5.0" 35A 3" x 5" 2200 5.25" l 35B 3" x 5" 3300 5.5" l 45 4" x 5" 1155 5.0" !
45A 4" x 5" 2200 5.25" I 45B 4" x 5" 3300 5.5" l 68 6" x 8" 7000 6.0" The overall dimensions of the device are 30" diameter x 50" height.
The irradiator is shipped loaded with ceslua-137 and meets DOT requirements for shipping and transport containers.
The sources are doubly encapsulated in stainless steel, sealed by hellarc welding, and certified to meet "special form" requirements, as described in 49 CFR 173.398. J. L. Shepherd and Associates designed these sources as J. L. Shepherd Model 6610 or Oak Ridge National Lab. Model A-0096.
LABELING:
The label on the irradiator includes the radioactive material caution sign, the name of the manufacturer identification and serial number, isotope, amount and date.
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l REGISTRY OF RADICACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Amended Page 3 - June 17, 1987)
HO: CA594D103U DATE: February 28, 1980 PAGE 3 0F 3 DEVICE TYPE: Gamma Irradiator EXTERNAL RADIATION LEVELS:
Each unit is designed for radiation levels at the surface not to exceed 10 ar/hr maximum and 2 ar/hr average.
The ceslua-137 sources remain in a shielded position, fixed near the center of the shield, at all times. No matter what the position of the drawer, all parts of the external surface of the irradiator are fully shielded from the sources.
stops welded Theindrawer place. cannot be removed from the irradiator because of the 1 l
It is impossible for personnel to receive overexposures unless the irradiator is partially disassembled.
A person's hand can be in the irradiation chamber only when that chamber is in the "load" position, and in that position the radiation level in the chamber is negligible.
l OVALITY ASSURANCE AND CONTROL: l i
J. L. Shepherd and Associates and their contractor will perform the integrity I and leak tests on each capsule in accordance with the standard tests for auch sources prior to shipment to the customer.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
A complete instruction and maintenance manual is supplied with each irradiator.
The supplier offers complete services for the irradiator, including a 3-month warranty.
Regular leak test intervals are recommended.
ISSUING AGENCY:
California Department of Health Services
REFERENCES:
- 1. J. L. Shepherd letter (with attachments) dated June 10, 1987.
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REGISTRY OF RADICACTIVE SEALED SOURCES AND CCVICES SAFETY EVALUATION OF DEVICE I (Amended pages 1, 3 and 4 - March 8, 1985)
$$ b NO.: CA5980104S DATE: March 21, 1980 PACE: 1 of 4 DEVICE TYPE: Irradiator MODEL: MARK I Series MANUFACTURER / DISTRIBUTOR: J.L. Shepherd and Associates 740 Salem Street Glendale, CA 91203 MANUFACTURER / DISTRIBUTOR:
SEALED SOURCE MODEL DESIGNATICN: Shepherd 6810 ISOTOPE: Cesium-137 MAXIMUM ACTIVITY: 12,000 curies LEAK TEST FREQUENC_Y Six months I l
PRINCIPAL US2: Ca:nna Irradiator, Category I
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I CUEKM DEVICE: YES X NO !
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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE l
l NO.: CA5980104U DATE: March 21, 1980 PAGE 2 0F 4 l l
OEVICE TYPE: Irradiator l l
OESCRIPTION:
The Mark i Series Irradiator consists essentially of (1) an irradiation chamber with a door on the front side; (2) a cylindrical sealed source, attached to the end of a source rod, which can be moved vertically; in its highest position, it is located at the back of the irradiation charter; in its lowest position, the irradiation chamber is shielded from it; and (3) shielding around the source and irradiation chamber, including walls and door of the irradiation chamber.
Following is data on the 15 variants of the Mark I:
Max.
Lead Shield Overall Overall Max. Radiation Max.C1 Cavity Thickness Dia. Dia. Height Radiation level at l Sub Model Cs-137 (inches) (inches) (inches) (inches) (inches) Level 3 Ft.
1 3,000 4x6 5-3/8 12 29 47-3/4 15 mr/hr .75 mr/hr 6,000 4x6 1 2 5-3/4 14 29 49-1/2 15 .75 '
3 6,000 4x6 6-7/8 16 29 51-3/4 2.5 .10 1 25-1 4,000 6x8 5-3/8 12 29 54-1/2 15 .75
-2 8,000 6x8 5-3/4 14 29 56-1/2 15 .75 ,
-3 8,000 6x8 6-7/8 16 29 59-1/4 2.5 .10 30-1 5,000 8 x 10 5-3/8 12 29 61 15 .75
-2 10,000 8 x 10 5-3/4 14 29 61-3/4 15 .75
-3 10,000 8 x 10 6-7/8 16 29 62-1/2 2.5 .10 68-1 6,000 12 x 12 5-3/8 12 32 66 15 .75 l
-2 12,000 12 x 12 5-3/4 14 32 68-1/8 15 .75
-3 12,000 12 x 12 6-7/8 16 32 70-1/4 2.5 .10 68-A-1 6,000 12 x 14 5-3/8 12 32 72 15 .75 '
-2 12,000 12 x 14 5-3/4 14 32 74-1/8 15 .75
-3 12,000 12 x 14 6-7/8 16 32 76-1/4 2.5 .10 The door to the irradiation chamber is opened and closed manually. The source is raised from the "off" position to the "irradiate" position manually, where it is held by a latch, and falls by gravity from the "irradiate" position to the "off" position by any of the following means: (1) at the end of the preset time on timer, (2) power failure, and (3) by pushing the push-button-type "off" switch which overrides the preset timer. If the source does not move from the "irradiate" position to the "off" position within ten seconds, an audible alarm sounds. The source is locked in the "off" position by means of a spring loaded
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RIGISTRY CT RADIOACTIVE SEALED SOURCES AND DEVICES SATETY EVALUATION OF DEVICE i (Amended page - March 8, 1985)
No.: CA598D104U DATE: March 21, 1980 PAGE: 3 of 4 DEVICE TYPE (CONT'D):
latch to the source rod which can be released only by passing electrical current through a solenoids in series with the soler.oid are three safety switches, two of which are closed by moving the door to its closed position and one of which is closed by a spring-loaded latch to the door only when the latch holds the door locked in its closed position. When the door is locked in its cle ed position by the latch, the latch can be released only by passing electrical current through a solenoids in series with this solenoid are two switches which are closed only when the source is latched in the "of f" position.
As of August 1984, additional safety features were implemented: (1) The wiring was changed such that no matter how the docr is opened, including mechanical failure, the source will now automatically drop into the shielded moder and (2) An interlock box now protects the door latch mechanism from tampering. A half-inch diameter stainless steel stud is welded to the plate of the interlock mechanism, and pene-trates the box cover such that a padlock secures it.
All models contain four access tubes, 2 ea. h" in diameter and 2 ea., 1" in diameter through one wall of the irradiation chamber, and a scatter shield in line with the tubes about one inch outside the wall to attenuate scattered wires, tubes containing fluids, etc., extending from the irradiation chamber to points outside the irradiator.
The irradiation chamber is fitted for the installation of one or more turntables, each of which may be continuously rotated by an electric motor outside the chamber. The turntables are connected to the electric motors bj bead chain drives which pass through tubes in a chamber wall. In line with each such tube is a scatter shield out- :
side the wall to attenuate scattered radiation emerging from the tube.
LABELING:
The label on the irradiator meets NRC requirements for a container of radioactive material.
EXTER.NAL RADIATION LEVELS:
Each unit is designed for radiation levels at one meter from the surface not to l average over 0.2 mr/hr per 1,000 curies of cesium-137. I
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATICN OF DEVICE (Amended page - >brch 8, 1985) l NO.: CA59AD104U DATE: March 21, 1980 PAGE: 4 of 4 i
DFVICE TYPE:
Irradiator CUALITY ASSURANCE AND CONTROL:
The sources are doubly encapsulated in a stainless steel, sealed by heliarc welding, and certified to meet "special form" requirements, as described L.i 49 CFR 173.398.
J.L. Shepherd and Associates designated these sources as J.L. Shepherd tiodel 6810.
J.L. Shepherd and Associates will perform the integrity and leak tests on each cap- l sule in accordance with the standard tests for such sources prior to shipment to the Customer.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
An instruction and naintenance manual is supplied with each irradiator.
The supplier offers complete services for the irradiator, ir.cluding a 12-month warranty. l l
Regular leak test intervals are recommended. Except in case c5 a major mechanical !
failure, it is impossible to open the door when the source is not in the "off" po-sition, or to put the source in the "irradiate" position while the door is not locked in the closed position. Although the probability of such nachanical failure is ex-tremly small, the manuf acturer recommends that a warning system, with an audible alarm actuated by a preset radiation level near the door of the irradiator, be installed with l the irradiator. It is unlikely, but conceivable, that an individual could be exposed in excess of the limits specified in 10 CFR 20.101 in the course of working with a normally operating irradiator. The -irradiator should be licensed only af ter appropriate review of the licensee's personnel, facilities and procedures. The licensee should be aware of serious potential. hazards which could result from tampering with the safety features of the irradiator.
As of August 1984, the changes indicated under "Description" reduce the possibility of this occurrence. Also, at the time of servicing, these modifications can be retro-fitted by the manufacturer to existing units.
ISSUING AGENCY:
California Department of Health Services
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