ML20198F211
| ML20198F211 | |
| Person / Time | |
|---|---|
| Issue date: | 04/09/1998 |
| From: | Jankovich J NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Mcgregor R NORDION INTERNATIONAL, INC. |
| Shared Package | |
| ML20138M295 | List: |
| References | |
| SSD, NUDOCS 9812280070 | |
| Download: ML20198F211 (14) | |
Text
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l April 9,1998
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FAX TRANSMITTAL FORM TO:
Ronald McGregor/Nordion PHONE:
Canada 613 592-2790 FAX:
Canada 613 591-7407 FROM:
John P. Jankovich Div. of Industrial and Medical Nuclear Safety /NMSS U.S. Nuclear Regulatory Commission Washington, DC 20555 PHONE:
301-415-7904-FAX:
301-415-5369 This is a draft of the Gammacell 40 certificate. As you requested in your April 3,1998 letter, I send it to you to screen it for technical correctness. Please mark it up where it is incorrect and fax it back to me. Thank you.
PAGES:
13 plus cover l
98 22 70 981221 SSD PDR j$121$0Cf/0
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l REGISTRY ~OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY'. EVALUATION OF' DEVICE (Amended in its Entirety)
NO,: NR-220-D-101-S.
' 'DAT E :
PAGE 1 OF 9
' Gamma Irradiator DEVICE TYPE:
l MODEL:
Gammacell 40 (Serial No.
1 through 133)
Gammacell 40. Exactor (Serial No. 134 and higher)
MANUFACTURER / DISTRIBUTOR:
MDS Nordion (formerly Atomic Energy of
. Canada, Ltd.)
447 March Road Kanata, Ontario, Canada K2K IX8 SEALED SOURCE MODEL DESIGNATION:
AECL C-161, Type 8 Nordion C-161, Type 8 Nordion C-440 i
t i
ISOTOPE:
MAXIMUM ACTIVITY:
l
' Cesium-137 4,200 curies (155.4 TBq)
LEAK TEST FREOUENCY:
6 months 1
PRINCIPAL USE: (J) Gamma Irradiator, Category I
)
CUSTOM DEVICE:
YES-x NO l
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Amended in.its Entirety)
NO.: NR-220-D-101-S DATE:
PAGE 2 OF 9 DEVICE TYPE:
Gamma Irradiator DESCRIPTION:
The Gammacell 40 is a cesium-137 irradiator designed for use in an unshielded room.
The unit provides a means for uniform gamma irradiation of small animals or biological samples while providing complete protection for operating personnel.
1 Irradiation is accomplished by moving two lead filled cylindrical drawers, each containing a single radioactive source, simultaneously by pneumatic controls from the stored to the irradiate position.
Source position is indicated by either an i
illuminated source ON (red) or source OFF (green) push-button switch located on the control pantl.
Each source directs a beam of radiation to the sample tray located in the center of the l
unit.
While in the irradiate position, the radiation beam is l
entirely enclosed by lead shielding and while in the stored position the sources are shielded on all sides by lead.
A mechanical interlock prevents the sample door from being opened while the sources are in the irradiate position.
Therefore, under normal circumstances the operator would not be exposed to a direct beam of radiation.
In the Gammacell 40 Exactor units (Serial No.
134 and higher), the head flanges incorporate grooves filled with lead to address localized radiation fields.
A Model C-161, type 8.or Model C-440, cesium-137 (in the form of cesium chloride) source is housed in each of two cylindrical sliding drawers 15 inches (38.1 cm) long by 2.5 inches (6.4 cm) in diameter.
The drawers fit into lead cylinders about 29 inches (73.7 cm) long by 16 inches (40. 6 cm) in diameter.
The cylinders lie horizontally about 12 inches (30.5 cm) apart, one above and one below the sample cavity.
A port in each cylinder wall about 10 inches (25.4 cm) from the end leaas to the sample cavity which is enclosed in a minimum of about 5 inches (12.7 cm) of lead.
The source drawers are moved from the shielded position, which is approximately 9 inches (22.9 cm) from the end opposite the port end, to the irradiate position by means of pneumatic cylinders in the Model Gammacell 40 units (Serial No. 1 through 133).
l In the Model Gammacell 40 Exactor units (Serial No. 134 and higher) the drawers are driven by a DC electric motor through a timing belt.
The electrical power source is a sealed 12 volt DC lead / acid battery.
The battery is constantly charged by a charger connected to an AC power source.
If AC power is lost while the unit is in operation, battery power is sufficient to I
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Amended in its Entirety)
NO.: NR-220-D-101-S DATE:
PAGE 3 OF 9 DEVICE TYPE:
Gamma Irradiator DESCRIPTION (cont'd):
complete the irradiation cycle-in progress with reserve power for at least three subsequent cycles.
In the Model Gammacell 40 units the sample cavity consists of an aluminum ring 13 inches (33.0 cm) inside diameter by 4.875 inches (12.4 cm) high.
The ring'is open at the top and the-bottom and has hanger slots in the top rim to allow the user to' suspend samples inside.
The ring is secured to the hinged sample cavity door such that when the door-is open, samples are easily accessible without reaching into the irradiation cavity.
Three stainless steel access tubes, 0.375 inch (0.95 cm) inside diameter, lead into the sample cavity _for ventilation and instrumentation.
The Gammacell 40 Exactor units are housed in a fiberglass cabinet which maintains a similar envelop to the sheet metal enclosure regarding the distance of the outside surface-from the source.
The distance between the source and the operator are' identical to i
I that of the sheet metal' cabinet.
l The sourcehead, pneumatic cylinders,;and controls are entirely covered by a removable sheet metal enclosure consisting of upper and lower enclosures and two back panels..The upper enclosure contains the control panel.
The entire unit is mounted on metal l
skids and stands 57.4 inches (145.9 cm) high, 36.4 inches (92.4 cm) wide and 48.3 inches (122.5 cm) deep; The unit weighs approximately 6300 pounds (2,858 kg).
The unit operates on 115 volt, single phase, 60 cycle power and may be purchased with or without an air compressor.
l
-The unit comes either with two Atomic Energy of Canada, Ltd.
(AECL) or Nordion Model C-161, type 8 sealed cources or two Nordion C-440 sealed sources.
The sources are doubly encapsulated using type 316L stainless steel.
Nominal dimensions for each source are 1.57 inches (39.9 mm) diameter by 1.70 inches (43.3 mm) length.
Nominal wall thickness for each capsule of the C-161 source is 0.020 inch (0.53 mm) and nominal thickness for each end cap is 0.085 inch (2.2 mm).
Nominal wall thickness for each capsule of the C-440 source is 0.039 inch (1.0 mm) and nominal thickness for each end cap is 0.118 inch (3.0 mm).
The capsules are sealed with active. fusion welds.
i
i lI, REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES L
SAFETY EVALUATION OF DEVICE l
(Amended in its Entirety) i NQ.,1 NR-220-D-101-S DATE:
PAGE 4 OF 9 j
i l
DEVICE TYPE:
Gamma Irradiator DESCRIPTION (cont'd)-
s Several safety features have-been incorporated into the unit for protection of operating-personnel:
~
1.
The source drawers are mechanically interlocked with the sample drawer.
A square section steel rod is mounted on the j
front of each source drawer which will only align with slots 1
in the tubular extension of the sample drawer hinge pin when the sample drawer is closed.
This assures that the source drawers cannot move into the irradiate position when the 1
sample drawer is open, or is not completely closed.
2.
A mechanical lock on the sample drawer is electrically interlocked to the source ON push-button to prevent the rawer from being opened when the sources are exposed.
3.
A spring loaded locking bar on the sample chamber door lock activates a microswitch when fully engaged, completing the electrical circuit to the source drawer control solenoids.
Disengaging the locking bar interrupts the circuit and this, in turn, returns the sources to the stored position.
4.
The Model Gammacell 40 Exactor units are equipped with electronic controls which also provides a software interlock system.
The software interlock system uses sensors and operator inputs, compares them to a stored set of inst'uctions, processes the information to determine whether r
a requested operating step can be executed safely.
The step is executed for safe conditions on?y; instruction / error messages are displayed in any other case.
MDS.Nordion reparated from AECL and became an independent entity
. October, 1981.
Prior to this date the Gammacell 40 irradiator was manufactured exclusively by AECL.
After this date AECL ceased to manufacture, distribute or service these devices and Nordion International took over these duties.
LABELING:
l
.The Gammacell 40 is labeled on the front of the device.
The label consists of the phrase " CAUTION RADIOACTIVE MATERIAL", the radioactive trefoil symbol, isotope, date of measurement and the i
~...
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Amended in its Entirety)
NO.: NR-220-D-101-S DATE:
PAGE 5 OF 9 DEVICE TYPE:
Gamma Irradiator LABELING (Cnt'd)-
curie content.
Additional labels attached to the device indicate the manufacturer (AECL or Nordion, as applicable), the model number and the serial number.
The Nordion Model C-440 sources are engraved on the upper endcap of the outer capsule with "CS-137D", source serial number, "NII" "C-440",-and the radioactive trefoil symbol.
DIAGRAM:
See Attachments 1, 2,
3 and 4.
CONDITIONS OF NORMAL USE:
The Gammacell 40 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 sterilizations, viruses,
. polymerization, small animals, etc.). Typical environments associated with the use of this device include medical facilities
-and laboratories fit for human occupancy and in an unshielded room.
Users are trained in the use of the irradiator equipment, safety interlock equipment and in radiation safety.
The Model C-440 source is to be used only in the Gammacell 40 and would therefore be subjected to these same conditions.
PROTOTYPE TESTING:
The Gammacell 40 has been in use since 1971 without any reported l
incidences.
The manufacturer claims that a full program of prototype tests sufficient to establish that the safety features n
L of the device will continue to function properly under the most adverse conditions was conducted.
The manufacturer claiv. that the C-440 sources have been tested j~
to ANSI N542-1977 and achieved a classification of E65546.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE
. Amended in'its Entirety')
(
NO.: NR-220-D-101-S DATE : -
PAGE 6 OF 9 DEVICE TYPE:
Gamma Irradiator
- EXTERNAL RADIATION LEVELS:
AECL conducted a survey of an.irradiator containing two 1800 curie (66.6 TBq), Model C-161, type 8 sources.
With the sources in the "OFF" position, no significant reading was detectable 39.4 inches (100 cm) from the center.of the sources.
The highest reading 1.97 inches (5 cm) from the surface of the irradiator was 0.3 mrem /hr (3 pSv/hr).
The sample cavity door i
was opened and the maximum reading inside the cavity was.
1 4.7 mrem /hr (47 pSv/hr).
l With the sources in the "ON" position, the highest reading 39.4 inches (100 cm) from the center of the sources was 1.3 mrem /hr (13 pSv/hr).
The highest reading 1.97 inches (5 cm) from-the unit was 11 mrem /hr (110 pSv/hr).
The manufacturer reports the calculated radiation dose rates at varying distances from the Model C-440 source as follows:
Distance Radiation Level from source R/hr iSv/hr) 5 cm/1.97 in 186,120 (1,861) 30 cm/11.8 in 5,172 (52) 100 cm/39.4 in 466 (4.7)
The manufacturer reporte that the Model Gammacell 40 Exactor units do not exceed a radiation level of 2 mrem /hr at a distance of 5-cm (1.97 inches) from any accessible surface of the device.
-OUALITY ASSURANCE AND CONTROL:
J[
Manufacture of Gammacell 40'and Gammacell 40 Exactor irradiators E[b V
~is covered under MDS Nordion's (formerly Atomic Energy of Canada, Ltd.) quality assurance and control program which has been deemed acceptable for licensing purposes by NRC.
A copy of the program is on file with the NRC.
Quality control during manufacture of the C-440 sources is maintained under Amersham International's Quality Assurance Manual for radiation sources.
The sources are manufactured by
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE
]
(Amended in its Entirety)
{
NO.: NR-220-D-101-S DATE:
PAGE 7 OF 9 LL p
DEVICE TYPE:
Gamma Irradiator,C7
/
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j OUALITY ASSURANCE AND CONTROL;(cont'd) :
)
Amersham International according to Nordion's specifications.
Upon receipt at Nordion, the sources are tested for removable contamination, dimensional conformity to design specifications, proper labeling and are measured for output.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
Containment of samples should be ensured in order to protect the integrity of the sample chamber.
The Model Gammacell 40 shall be distributed only to persons specifically licensed by the NRC or an Agreement-State.
The device shall be leak tested at' intervals not to exceed six months using techniques capable of detecting 0.005
. microcurie (185 Bq),of ~ removable ~ contamination.
c, 1
~
Maximum source activity for the Model C-440 source is 2250 curies ( 83. 3 TBq).
However,. maximum total activity allowed for the-Gammacell.40 irradiator is 4200 curies (155.4 TBq) for;two sources.
. Handling, storage use, transfer and disposal: To be determined by the licensing authority.
In view that the sealed sources exhibit high surface dose rates when unshielded, they should be handled only be experienced licensed personnel using adequate remote handling equipment and_ procedures.
The Model C-440 source is approved for use only in the Gammacell 40 irradiator.
This registration sheet and the information contained within
~
the references shall not be changed or transferred without the written consent of the NRC.
L L
t Lg REGISTRY OF RADIOACTIVE SEALEDJSOURCES AND DEVICES
[
SAFETY EVALUATION OF DEVICE L
(Amended ~in its Entirety)
NO.: NR-220-D-101-S DATE:
PAGE 8 OF 9
- Y L
DEVICE TYPE:
Gamma Irradiator-f P
SAFETY ANALYSIS
SUMMARY
l Based on our review of the information,and test data cited below, and that the irradiator design was~previously deemed acceptable by the NRC, we continue to conclude,that the Gammacell 40 L
irradiator design is acceptable for licensing purposes.
]
Furthermore, we continue to conclude from operational data since 1971, that this irradiator design-would be expected to maintain its integrity for normal and accidental conditions of use which might occur during uses specified in this. certificate.
Additionally, based on our review of the information and test data cited below as pertains to the Model C-440 source. design and the manufacturers claimed ANSI classification of E65546, we continue to conclude the Model C-440 source design is acceptable for licensing purposes when used in the Gammacell 40 irradiator.
Furthermore, we continue to conclude the Model C-440 source would be expected to maintain its integrity for normal and accidental conditions of use which might occur during uscs specified in this certificate.
I
REFERENCES:
The following supporting documents for the Gammacell 40 irradiator and C-440 source capsule designs are hereby incorporated,by reference'and are a made a part of this registry document ~:
L Atomic Energy of Canada Limited letters dated August 24, G
1970, October 21, 1970, and March 25, 1971, with enclosure thereto.
Nordion' International, Inc., letters dated Novenber 2
- 1992, December 1, 1992, and December 8, 1992, with enclosures l
thereto.
l Amersham Corporation's letter, in support of Nordion's application, dated December 16, 1992, with enclosures thereto.
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-(Amen'ded~in its Entirety)
NO.: NR-2 2 0-D-101-S '
DATE:
'PAGE 9 OF 9-DEVICE TYPE:
Gamma Irradiator' REFERENCES (cont'd):
MDS Nordion's letters dated February27, 1998, April 3, l
b 1998, with enclosures thereto.
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ISSUING AGENCY:
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U.S. NUCLEAR. REGULATORY COMMISSION' Oe/.
' DATE:
. REVIEWER:
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John'W. / Lubinski-I L
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