ML20198D699
| ML20198D699 | |
| Person / Time | |
|---|---|
| Issue date: | 06/29/1993 |
| From: | Doug Broaddus, John Lubinski NRC |
| To: | |
| Shared Package | |
| ML20138M205 | List: |
| References | |
| SSD, NUDOCS 9812230183 | |
| Download: ML20198D699 (17) | |
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EN REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE F_Q,, : NR-220-S-103-S DATE: June.29, 1993 EAGE 1 OF 9 EQURCE TYPE: Gamma Irradiator Source i
MODEL: C-188 (Series) Types 1 - 12 C-306 (Series) Types 1, 2, nd 3 \
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MANUFACTURER / DISTRIBUTOR: t Nordion Internationa-1, Inc.
(formerly Atomic Energy of Canada, Ltd.)
~ P; O rBori'1500~
447 March Road Kanata, Ontario, Canada K2K 1X8 ISOTOPE: MAXIMUM ACTIVITY:
Cobalt-60 (C-188, slug material) y 17,000 curies /629 TBq s (C-188, pellet material) 14,000 curies /518 TBq (C-306) 8,500 curies /3.'.4. 5 TBq LEAK TEST FREOUENCY: 6 months PRINCIPAL USE: (M) Gamma Irradiator, Category IV l
l CUSTOM SOURCE: YES X NO
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i l D REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES ~
- SAFETY EVALUATION OF SEALED SOURCE J
1 1[Q : NR-220-S-103-S DATE: June 29, 1993 PAGE 2 OF 9 i
SOURCE TYPE: Gamma Irradiator Source i
j..
DESCRIPTION:
i The Models C-188 and C-306 are doubly encapsulated fusion welded sources consisting of one or two inner capsules and an outer capsule. The outer capsule is the same for j
1 all each source model except for the length. The inner capsules L type and activity required. The main difference according vary between the to the C-188 and C-306 is that the C-188 contains two inner capsules and the C-306 contains only one.
1 j The Model C-188 contains one or two inner capsules in various combinations according to type as shown in the table below:
N i C-188 Tyne Model Number C-188 Tyne
! Number Model Number Of Irmer(s) Number , l0f Inner (s)
{ 1 C-177/C-177 7 C-177/AC-191 j h, 2 AC-191/AC-191 8 2
y 3 ,-
C-177/AC-195 AC-195/AC-195 9/5tc C-177/AC-339 J1 4 C-246 10 AC-191/AC-195 9
4 5 ,4 AC-339/AC-339 11 y '
( 6 AC-191/AC-339 AC-345/C-348 12' r AC-195/AC-339 The inner c psules vary according to the use requirements. The g, l
Model C-188', outer capsule is the same for al ,
Fg-
! jtypesp is constructedof316Lstainlesssteel, measures 17.99t">(452mm) f,)!(#"Y.
l length , (0.'67)' (11 mm) diameter at the end daps,~Ar3305 (8 r4-am) diameteriinItha body,and has a wall thickn,ess of 0.025" (0.6 mm). A [c q The 0.025" (0.6 mm)-thick and capc of the Model C-188 puter capsule are sealed by fusion welds. g3 a
[j i The Model C-306 outer capsula is the'same u.-
or all types. - The inner capsule varies according to the user requirements. The e doubly encapsulated fusion welded source consists of either a i g C-177,cap
^"* AC-191,~or-AC-191
="1+;--The Model inner _ Type C-306, capsule-further4 caps.ul3teLin_aq 1 source contains one Model i AC-195 inner capsule; the Type 2 contains one AC-191 inner j
apsule; and the Type 3 contains one C-177 inner capsule. )
u c% ce t ,
The Model C-306l outer capsule is consTrifcted~cf 316Irstainless ~
i steel, measures)9.505" (241 mm) length,.0A37"-(11 mm) diameter at the and caps, O'.330" (8.4 mm) diameter \in the body, and has a j^ wall thickness of 0.025" (0.6 mm). The 0.025" (0.6 mm) thick and caps of the M ellC-30'6 outer capsule arej' sealed by fusion welds.
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4 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE J
EQt: NR-220-S-103-S DATE: June 29, 1993 PAGE 3 OF 9 SOURCE TYPE: Gamma Irradiator Source O U"'7
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O,31 DESCRIPTION: (Cont'd) '
/
The Models AC-191/and C-177 inner capsule assemblies are identical except that the Model AC-191 is irradiated as a complete capsule making the stainless steel radidactive. Both are constructed welded 0.025" of 316 stainless steel and are sealed by fusion 0.6 mm) assembly measur(es18.25" thick end caps. The in,ner capsule (210 mm) length and 0.317." (8.1 mm) diameter and has a wall thickness volume of the inner capsules is 8.0" of 0.025" (0.6 mm). The active jn?[-
f (6.8 mm) diameter. The active volume (203 mm) length and 0.267" -
contains either eight 1.0" (25.4 mm) long by 0.250" (6 mm) diamater cobalt slugs or 0.039" g,7j by 0.039" (1 mm by 1 mm) cylindrical pellets. Refer to the f C-177 sourceregistry appropriate capsula.document for a description of the Model j
/
The Model AC-195 inner capsule assembly is essentially the same as the Model C-177 and the AC-191 except the material of construction is Zircaloy-2. The Model AC-195 is irradiated as a complete capsule-nmaking a J < &the Zircaloy-2 radioactiveq( "
- p. 1 m " M '
TheModelC-246(innercapsu)leisconstructedof316L) stainless steel and is sealed by fusion welded [0.025" (0.6 mm) end caps.
The capsule is}16.485" (419 mm) long times 0.32" (8.1 74) outside diameter with atwall
'o m .
thickness
- <. S of 0.025" (0.6 mm).
The AC-339 model is essentially identical, both in materials and construction, to the IC-195 model with exception of the " bull nose" machine at one end. The material of this capsule is Zircaloy-2 or -4.
The wall thickness and the design of the closure end welds are identical to those of the AC-195 model.
The AC-345 model is again similar to the AC-195 model with 1
exception of the overall length.
} long whereas the AC-345 is 11.187" The (284AC-195 is 8.250" (210 mm) mm) long.
material for the AC-345 is again Zircaloy-2 or 4. The The structural wall thickness and for both models. the design of the closure end welds are identical except for the overall The length C-348 model is similar to the C-177 model of 5.312" (135 mm). The structural material, wall thicknass and the design of closure end welds are identical for both models.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES 1
SAFETY EVALUATION OF SEALED SOURCE 1 v .
) &: NR-220-S-103-S DATE: June 29, 1993 PAGE 4 OF 9
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) SOURCE TYPE: Gamma Irradiator Source
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- 1 R b)- sy P DESCRIPTION
- (Cont'd) g LP _C)
In October 1988, AECL divided a portion of its source and device production between two reparate entities, Theratronics i
i International, Ltd. and Nordion International, Inc. At that time i
AECL ceased all manufacturing, distribution, and servicing of C-188 and C-306 sources and Nordion International, Inc. assumed i the manufacturing j for these sources.,U distribution and servicing responsibilities i
f 1 LABELING:
1 c,f f Each model C-177 AC-191, AC-195, C-246, AC-339, AC-345, and "
C-348 inner capsu,le assembly is engraved on the end capsule with o a serial number. ppS $rA99 g The Model C-188 sources manufactured by 'AEdI[are . engraved on the upper and cap face of the outer capsule with tho'last three g\
i i
digits of the serial number underlined. The serial number and f)b . "g e
"C-188" are engraved on the diameter of the upper end cap. .
l diameter of the lower and cap is engraved with "AECL"-and % --The V q> 1 l "Co-60". Model C-188 scurces manufactured by}No'rdion are f engraved on the upper and cap face of the outer capsule with the ; "V ^ 'I g j serial number. The diameter of the upper and cap is engraved
with "C-188" and "Co60". The-diameter of-the Tiwer'~end cap is-
! engraved ~with'"NII"~and~the~ radiation-trafoil. ,, ,
The Model C-306 sources manufactured by ar graved on the /
j upper and cap face of the outer capsule-sith the last three digits of the serial number underlined. The serial number and
- "C-306" are engraved on the diameter of the upper end cap. The i
- diameter of the lower and cap is engraved with "AECL" and "Co60".7
' g - tu -- ~ . -
MMel C-306 souzces manufactured bygNordion are engraved on the j
upper' enp cap' fqce of' the outsi ca The diameter of itheeupp9r and cap'psule yith the seriallnumber,is engpaved' j
1co60". 'Th'e dia' met'ar ofs this lowey and cap is enh J raved with "NII" ,/
! and the radiation trefoil.
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DIAGRAM:
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE HQ&: NR-220-S-103-S DATE: June 29, 1993 PAGE 5 OF 9 SOURCE TYPE: Gamma Irradiator Source CONDITIONS OF NORMAL USE:
/,, /d b The source Models C-188 and C-306 sources are designed primarily for use inpool storage, AECL andeNordion type irradiators.InternsEional, Inc., wet source Typical environments associated with the use of these irradiators include high temperatures, thermal shock due to sources being brought out of and into the water, high pressures term contact and high/ normal pressure cycling and long with water. As of July 1, 1993, sources containing pellets and IV are not appreved irradiators. for installation into Category II, III, continue to be used. Sources installed prior to this date may The sources may be used in dry source storage irradiators and environments for these devices would typically be less harsh.
These uses would typically be medical facilities and laboratories fit for human occupancy. Therefore, the sources would be expected to be subjected to ambient temperatures and pressures. n However, high activity sources may be exposed to elevated temperatures and temperature cycling due to internally generated J c vf heat. o 6i
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PROTOTYPE TESTING:
/ p g, Model C-188 source assemblies, Types 1, 2, 3, and 4 were demonstrated to meet Requirements ANSI N5.10-1968 (superseded by 1
. ANSI N542-1977) under the Classification of E54434. In addition, an unirradiated AC-339 model passed the requirements of ANSI Classification E43424. Review of test parameters and configurations of Types 5 through 12 indicates that no change in the integrity of the C-188 assembly is expected. The main difference is between Types 1, 2, 3, 5, 7-12 and Type 6. The position of the joint between the two inner capsules in the Type 6 is moved from the-center of the assembly towards one end.
This is not expected to 'cause a significant impact on the integrity of the source ~ capsula.
An additional band test, as specified in ANSI N43.10 " Safe Design and Use of. Panoramic Wat Source Storage Gamma Irradiators," was performed on Types 2, 3, 4, and 5. The tests are described in
-~ AECL test report "C-188 Bend Test," dated September, 1984. A Model C-188, Type 1 capsule was not tested since, in terms of
- bend test parameters, it is the same as Type 2.
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/ REGISTRY 'OF.' RADIOACTIVE' SAFETY EVALUATION OF SEALED SOURCE SEALED (o q f SOUR t ec[ 4
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/ NR-220-S-103-S i
lh: DATE: June 29, 1993' l 1 y
/bC /^ft. PAGE 6 OF 9 de f %fG /kfQp SOURCE TYPE: Gamma Irradiator Source +,A/C '
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PROTOTYPE TESTING: (Cont'd) 4 /
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A Model C-188, '( 4 similar to Types 2 and 3. Type 6 capsule was not tested either jsince it -is~
The test report indicates that if the -' #$ 'd E
,LI1' force'ihPapplied in the location where the two in 4
! join, a fracture test vosort indicatesof the outer that ifcapsulethe force can,#
Vi's,occurU ,ner capsules gJ Further, the ({g hh; applied away from that / '
l location the outer capsule remainE'> intact. Vacuum Leak Bubble ,
l Tests were performed in all test specimens. In the case of the 1 g l four ussemblies where the outer capsula ruptured, tests were performed on the inner capsules. In all cases the Cobalt-60 %g ?,, c containment maintained its intecrity. Types 7-12 would be
- p.expected to perform similarly if subjected to these tests.
The manufacturer claims that the Model C-306 capsule meets the standards the Model C-188~ of ANSI classification E54434 based on comparison with capsule. ~
EXTERNAL RADIATION LEVELS:
A calculation of dose rates was done using the gamma radiation l constant per curie for cobalt-60 (39.4", per 37ofGBq).
1.32 R/hr (13.2 ESv/hr) at one meter,
! w A source containing 17,000 curies
- . ould be expected to yield the following dose rates
Distance Radiation Level from source R/hr Sv/hr pr 19 100 cm/39.4 in 22,440 .224-30 cm/11.8 in -2 4 9 , 3 3 3 ? 'I # 2,493 '2, b 5 cm/1.97 in -8,976',000
, ,,,.c , ,, 89 376,0 o c,,c, c A source containing following dose rates:14,000 curies would be expected to yield the Distance Radiation Level l from source R/hr Sv/hr o,
100 cm/39.4 in 18,480' 185 30 cm/11.8 in 205,333~ " 2 '2;053' "Ip
\
5 cm/1.97 in 7,392,000 -73,920-
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVIC ~ES
- SAFETY EVALUATION OF SEALED SOURCE l 1
1 Hb.: NR-220-S-103-S DATE: June 29, 1993 l
PAGE 7 OF 9 1
SOURCE TYPE: Gamma Irradiator Source 1
EXTERNAL RADIATION LEVRM: (Cont'd)
]-
- A source dose following containing rates
- 8,500 curies would be expected to yield the
'. Distance Radiation Level
{ from source R/hr Sv/hr j
100 cm/~19.4 in 11,220 112 30 cm/11.8 in 124,667 1,247 I
5 cm/1.97 in 4,488,000 44,680 a
j OUALITY ASSURANCE AND CONTROL: ( ,(/> r<>b > '
1 i Nordion-InternationalT~Inc.-(formerly-ABCL)r maintains a quality I j assurance for licensing and control program purposes by NRC.which has been deemed acceptable
~
A copy of the program is on file I l
with the Source-Containment _.and_ Devices _ Branch. A)(RC ,
i LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
- The sources.shall be distributed only to persons specifically licensed by the NRC or an Agreement State.
N
- REVIEWER"KOTE[ Sources cdntaini pellets de gnot-m'est the requirements in Category of \II,10III, CFR Part,36x and are not apprcved for use or IV/irradiators.
N /
N .[ \
- REVIEWER storage irradiators.
NOTE: These sources'may be used in dry source leak tes Md at intervals Sources used in these devices shall be technigve-c ot to exceed six months using removv ' capable of detecting 0.005 microcurie (185 Bq) of
- ontamination.
.* REVIEWEP. NOTE: Sources used in wet source storage irradiators Section shall be' tested for contamination according to 36.59, 10 CFR Part 36.
4 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY E'.'ALUATION OF SEALED SOURCE HQ2: NR-220-S-103-S DATE: June 29, 1993 PAGE 8 OF 9 SOURCE TYPE: Gamma Irradiator Source LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE: (Cont'd)
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 by experienced licensed personnel using adequate remote handling equipment and procedures.
This sources shall not be subjected to environmental or j other conditions Classification ofof use which would exceed an ANSI N5.10 E54434. i This registration sheet and the information contained within the references shall not be changed without the written consent of the NRC.
..f SAFETY ANALYSIS
SUMMARY
Based on our review of the information and test data cited below, including the claimed ANSI classification, we continue to conclude that the Model C-188 and C-306 source designs are acceptable for licensing purposes.
Furthermore, we continue to conclude that the Model C-188 and C-306 sources would be expected to maintain their containment integrity for normal conditions of use and accidental conditions which might occur during the uses specified in this certificate.
REFERENCES:
The following supporting documents for the Models C-188 and C-306 sources are hereby incorporated by reference and are made a part of this registry document.
Atomic Energy of Canada, Ltd. letters dated October 29, 1973, June 14, 1974, September 20, 1984, and July 18, 1985 with enclosures thereto.
~
Nordion International, Inc, letters dated June 25, 1993, March 16, 1992, December 5, 1991, and October 3, 1988, with
~' enclosures thereto, and letter received November 18, 1991, with enclosures thereto.
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l N, REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE Hb.: .NR-220-S-103-S DATE: June 29, 1993 PAGE 9 OF 9 1,URCE 0 TYPE:
Gamma Irradiator Source ISSUING AGENCY:-
U.S. Nuclear Pegulatory Commission Date: June 29, 1993 Reviewer: .
uo Doug[a's A. Broeddus Date: June 29, 1993 : b Concurrence: /FFO J 'n W. Lubinski J
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- 3. Outer espoule mendel: Type stol steniess sesel.
- 4. As capsules are sealed tar fusion welds.
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l ' REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
! SAFETY EVALUATION OF SOURCE l ,
&: NR-220-S-103-S DATE: June 29, 1993 ATTACHMENT 2 l
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! - MDS Nordion Science Advancing Heahh 1998 January 134 Mr. Steve Baggett Division of Industrial & Medical Nuclear Safety US Nuclear Regulatory Commission One White Flint North 11555'Rockville Pike Rockville MD USA 20852-2738 On September 25,1997 a number of drawings were submitted to the USNRC to the attention of Mr. John Lubinski as information relating to the Region I inspection of medical devices and source registrations. These drawings were identified as changes to the Gammacell 3000, the C-246, the_C-188 sealed source assembly and the 6160 capsule (C-3001 sealed source). A list of the drawings is as follows: - .
103203-014 Issue E -
I' '
103203-014 Issue F - h k " ' ' ' C ' '= /J 2' 9/(,v[~)
Relating to the gammacell roto, housing assembly. __ ___j . , o g.y
( C103203-114 Issue A S' " '
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- C103203-114 issue B /" '
{ ') -. t-(EC102203-114 + 'T Issue D MS -j d^ M Y3 [S fi Relating to the gammacell C-3000 Source holder assembly. I "
~
(.gh,uh(JC N,' 9 o G130102-149 issue AN r/ us 6deJ $l,$< ofrMrd /h'/ #' V
-Relating to the C-246 inactive weld.
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y A 09542 Relating to the C-246 body inactive weld.
1ssue J de"""
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A 05244 issue M Relating to the C-188 sealed source assembly. >-
y f f a a b c ,M 'r.l
, ,7 g'p s ' s e A05247 issue G yf// -/dc " " W 7
Relating to the C-188 outer body.
O F St Jityg 22 n19 D y. $1/ 0% W
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'W ;e '. GA61600 Issue A[9? ms r7 issue A o sce " - yl7g b # SA61600 .-
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Relating to the assembly of cell 6160 capsule. ~~
% l MDSL.~.Nordion requests that these drawings be used as formal submission to
.J update the registrations for the Gammacell 1000/3000, the,C-3001 'd sea Ol source being part of the Gammacell 1000/3000 registration and the C 188-
' sealed source. The drawings are a current representation of the above devices / sources, and reflect modifications that were made to the devices / sources that could have an impact on th.: safety of the devices / sou It is MDS Nordion's intention to submit to the USNRC, a full registration pa for the C-188 sealed sources by February 16,1998 describing other modifications, including those described in the above listed drawings.
I Please nate these drawings were submitted u der affidavit and we mamta o
j request for withholding the disclosure of the proprietary informatio information be insufficient to update the registrations, please do not hesitate 1
contact me for clarification or additional information.
Sincerely a
/
)
U l.' j ,
R.W. McGregor Manager, Regulatory Affairs
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