ML010510159
| ML010510159 | |
| Person / Time | |
|---|---|
| Issue date: | 02/27/2001 |
| From: | Jankovich J, Samson Lee NRC/NMSS/IMNS/MSIB |
| To: | MDS Nordion |
| References | |
| SSD 00-50 | |
| Download: ML010510159 (7) | |
Text
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.: NR-0220-S-120-S DATE: February 27, 2001 PAGE 1 OF 6 SEALED SOURCE TYPE: Gamma Irradiator Source MODEL:
C-198 MANUFACTURER/DISTRIBUTOR:
MDS Nordion (formerly Nordion International Inc. and Atomic Energy of Canada Ltd.)
447 March Road Kanata, Ontario Canada K2K 1X8 ISOTOPE:
MAXIMUM ACTIVITY:
Cobalt-60 5,000 curies (185 TBq)
LEAK TEST FREQUENCY:
6 Months PRINCIPAL USE:
(J) Gamma Irridiator, Category I (K) Gamma Irradiator, Category II CUSTOM SOURCE:
YES X NO
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.: NR-0220-S-120-S DATE: February 27, 2001 PAGE 2 OF 6 SEALED SOURCE TYPE: Gamma Irradiator Source DESCRIPTION:
The sealed source Model C-198 is a doubly encapsulated fusion welded source that is used either in a Self-Contained, Dry Source Storage Gamma Irradiator (Category I) or in a Panoramic, Dry Storage Gamma Irradiator (Category II). The maximum activity for each Model C-198 Cobalt-60 sealed source is 5,000 curies (185 TBq). The source capsule can contain either CO-60 slugs or Co-60 pellets.
The design specification shows that the Model C-198 is constructed of an outer stainless steel (type 316L) tube having a maximum outside diameter of 0.385" (9.78 mm), maximum overall length of 8.27" (21.96 cm) and a nominal wall thickness of 0.025" (0.64 mm).
The ends of the tube are machined out to allow the end caps to be inserted and fusion welded in order to hold the inner capsule in place and provide extra integrity of the source.
An inner stainless steel tube having a maximum outside diameter of 0.32" (8.13 mm) and maximum overall length (after weld) of 8.015" (20.36 cm) and a nominal wall thickness of 0.025" (0.64 mm) contains the Co-60 pellets or slugs. The inner tube has been machined out to allow the end caps to be inserted and fusion welded in place to hold the Co-60 material.
The active volume of all inner capsules contains Co-60, normally in the form of plated slugs, nickel-plated pellets, or nickel plated wafers (it is possible to use un-plated slugs and wafers as well). Stainless steel spacers may also be used inside the inner the inner capsules to distribute the cobalt activity.
DIAGRAM:
See Attachment 1.
LABELING:
The C-198 source is engraved on its outer in the following manner:
MDSN (an abbreviation for MDS Nordion). Sources manufactured under registration certificate number NR-169-S-151-S and NR-0220-D-107-S are marked as NII.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.: NR-0220-S-120-S DATE: February 27, 2001 PAGE 3 OF 6 SEALED SOURCE TYPE: Gamma Irradiator Source LABELING (Contd):
Co60 H (H is MDS Nordion identification for C-198 sources) xxx (A unique Serial Number)
Trefoil Symbol The C-380 inner capsule is engraved on its outer surface in the following manner:
C380 xxx (A unique Serial Number)
CONDITIONS OF NORMAL USE:
The Model C-198 sealed source is intended to be used in Self-Contained, Dry Source Storage Gamma Irradiators (Category I) for the purpose of irradiating samples. The sealed source is shielded at all times and human access to the sealed source is not physically possible due to the design configurations of the gamma irradiator. The sealed sources are contained in devices, which typically are used in areas having environments that are fit for human occupancy.
Also, the Model C-198 sealed source is intended to be used in Panoramic, Dry Storage Gamma Irradiators (Category II). The Panoramic Irradiator is installed in the shielded irradiator room. When the source is in storage mode, it is locked in the Panoramic Irradiators shielded storage container. The design and construction of the irradiator prevents human access to the source. When the source is in irradiation mode, the irradiator facility safety interlock system prevents the access of personnel to the shielded irradiator room. Environment in the irradiator room is typically controlled and fit for human occupancy.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.: NR-0220-S-120-S DATE: February 27, 2001 PAGE 4 OF 6 SEALED SOURCE TYPE: Gamma Irradiator Source PROTOTYPE TESTING:
The manufacturer has tested sealed source Model C-198 in accordance with ANSI N43.6-1997 and the prototype sources achieved an ANSI N43.6 classification of E64435 and passed the bending test as specified in 10 CFR 36.21(g).
EXTERNAL RADIATION LEVELS:
A calculation of dose was carried out using the gamma radiation constant for Co-60 of 1.32 R/hr at 1 m, per curie (39.4", per 37 GBq). The expected external radiation levels from an unshielded 5,000 Ci (185 TBq) Co-60 source are:
Distance from Radiation Level Source (cm)
R/hr Sv/hr 10 660,000 6,600 30 73,333 733 100 6,600 66 QUALITY ASSURANCE AND CONTROL:
MDS Nordion maintains an ISO 9001 compliant quality assurance and control program, which has been deemed acceptable for licensing purposes by the NRC under Quality Assurance Program No. 0703.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
The source Model C-198 shall be distributed only to persons specifically licensed by the NRC or an Agreement State.
These sources shall be leak tested at 6 month intervals using techniques capable of detecting 0.005 microcurie (185 Bq) of removable contamination.
Handling, Storage, Use, Transfer, and Disposal: To be determined by the licensing authority.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.: NR-0220-S-120-S DATE: February 27, 2001 PAGE 5 OF 6 SEALED SOURCE TYPE: Gamma Irradiator Source LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE (Contd):
This registration sheet and the information contained with the references shall not be changed without the written consent of the NRC.
REVIEWER NOTE: The Model C-198 source with a maximum activity level of 3,500 Ci (129.5 TBq) has been previously registered in NR-169-S-151-S and the registration certificate number NR-0220-D-107-S listing exclusive use for this source in the Model Gammacell 220 irradiator.
SAFETY ANALYSIS
SUMMARY
The sealed source has an ANSI N43.6-1997 classification of E64435, and have passed the bend test as specified in 10 CFR 36.21(g). This indicates that temperature, pressure, impact, vibration, and puncture stresses imposed during normal use are highly unlikely to cause breach of containment integrity of the capsules. Protection provided by the source housing (irradiator) further assures radiation material containment in the event of an accident. Design and construction of the Categories I and II irradiators prevent human access to the source, and allow the source to be shielded at all times.
The sources are not expected to be subjected to severe environments since these sources are used in environments that are fit for human occupancy.
Based on our review of the information and test data cited below, we conclude that the MDS Nordion sealed source Model C-198 is acceptable for licensing purposes.
Furthermore, we conclude that these sources would be expected to maintain their containment for normal conditions of use which might occur during the uses specified in this registration sheet.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.: NR-0220-S-120-S DATE: February 27, 2001 PAGE 6 OF 6 SEALED SOURCE TYPE: Gamma Irradiator Source
REFERENCES:
The following supporting documents for the MDS Nordion Model C-198 gamma irradiator sources are hereby incorporated by reference and are made a part of this registry document.
MDS Nordion application dated December 14, 2000, with enclosures thereto.
MDS Nordion letters dated January 4, 2001, and January 30, 2001, with enclosures thereto.
MDS Nordion letter dated February 19, 2001.
ISSUING AGENCY:
U.S. Nuclear Regulatory Commission
/RA/
Date: February 27, 2001 Reviewer:
Seung J. Lee
/RA/
Date: February 27, 2001 Concurrence:
John P. Jankovich
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE No.: NR-0220-S-120-S DATE: February 27, 2001 ATTACHMENT 1