ML20203A618
| ML20203A618 | |
| Person / Time | |
|---|---|
| Site: | (NR-277-S-802-S, SSD-98-102) |
| Issue date: | 02/05/1999 |
| From: | Michele Burgess, Jankovich J NRC |
| To: | |
| Shared Package | |
| ML20203A605 | List: |
| References | |
| SSD, NUDOCS 9902100046 | |
| Download: ML20203A618 (8) | |
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REGISTRY OFr RADIOACTIVE' SEALED SOURCES 1AND DEVICES 4-SAFETY EVALUATION"OF.' SOURCE'^
,n.
- s HQ,i NR-27.7 S-$dh-S'./DATE.
FEB 051993'-
PAGE 1 OF 5 d
i-o SEAT.un ~ SOURCE ' TYPE : ; Medi' cal Neutron 1 (Brachytherapy). Source f
r F
e m
MODEL:
TALC-PC.
p.
d MANUFACTURER / DISTRIBUTOR:
U.S. Department of Energy Oak Ridge Operations.
P.O.: Box 2001 j
Oak Ridge, TN137831
' ISOTOPE:
MAXIMUM ACTIVITY:
Californium-252 540 millicuries (19.98 GBq)
(up to 1 milligram i3%)
l
' T RAK TEST FREOUENCY:
-6 Months l
1 PRINCIPAL USE: (V) General Medical Use i
CUSTOM SOURCE:
YES X
NO I
s 99d2100046 990265 PDR RC PDR
.3
- SSD
\\
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE NO.: NR-277-S-802-S DATE:
TEB 05 f339 pAGE 2 OF 5 SEALED SOURCE TYPE: Medical Neutron (Brachytherapy) Source DESCRIPTION:
The source material is a powder metallurgy (cermet) pellet that 232 contained the Cf. The pellet is composed of small particles of refractory Cf O bounded in a palladium matrix. To form the 2 3 cermet, the palladium was deposited on a finely-divided precipitate of californium oxalate. The palladium-coated particles were dried, calcined, pressed into a pellet and sintered at 1250 F (677 C). The pellet was coined to a diameter of 0,090 inch (2.29 mm) and the required length, which may had varied from 0.150 to 0.180 inch (3.81-4.57 mm). Each pellet was
'then doubly encapsulated in platinum-10% iridium capsules and sealed by fusion welds. The average length the outer capsule is 0.386 inch (9.8 mm), while the average diameter of the capsule is 0.185 inch (4.7 mm). See attachments 1 and 2, figures la, ib, and 2 for source capsule design.
The source letters TALC-PC are abbreviation for: "Toshiba After Loading Cell-Platinum Cermet." The source was designed for use in remote after loading devices for cancer brachytherapy studies and treatments. Because of the small size of the source it was to be used in special catheters and applicators for intra-cavity implantation. During use the source was protected by a stainless steel sheath which was supplied by the user. The manufacture provided a container (2R) which may had contained up to 3 sources. Color-coded inserts were contained in this container for use by medical personnel to identify individual sources. Assay results for each source were provided by the manufacturer which had an uncertainty of i3%. TALC-PC sources were loaned to users and were returned to the manufacturer when use was discontinued.
LABELING:
Because of the small size of these sources, labeling was impractical. The sources were fabricated and shipped in batches
.with the same nominal 252Cf content to i10% although the actual content of each source may had varied 13%. Attachment 3, figure 3 shows the 2R container with its color-coded inserts which had been used by medical personnel to maintain identity of the sources between treatments.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE NO.: NR-277-S-802-S DATE:
FFB 051939 PAGE 3 OF 5 SEALED SOURCE TYPE: Medical Neutron (Brachytherapy) Source DIAGRAM:
See Attachments 1, 2,
and 3.
CONDITIONS OF NORMAL USE:
The practical service life of these sources had been determined by the 2.6 year half-life of the "Cf.
For brachytherapy use, the manufacturer had determined the service life to be limited to one, or possibly two half-lives. When the sources were no longer adequate for brachytherapy, they were returned to the manufacturer.
The sources may be sterilized by any conventional procedure such as gas sterilization, or antiseptic solution.
PROTOTYPE TESTING:
The manufacturer had provided information concerning tests which had been conducted on the TALC-PC sources in accordance with the guidelines in Regulatory Guide 6.2,
" Integrity and Test Specification for Selected Brachytherapy Sources",
U.S. Atomic Energy Commission, February 1974, and Regulations for Safe Transport of Radioactive Materials - IAEA Safety Standards, Safety Series No.
6, 1973 Revised Edition, in addition to supplementary testing believed to be appropriate for intended use.
EXTERNAL RADIATION LEVELS:
TALC-PC sources will contain up to 1 milligram 2"Cf (540 mci).
2nCf emits alpha, beta, gamma,-and neutron radiations. Beta radiation is associated with the equilibrium fission products from spontaneous fission decay of the isotope. Alpha particle radiation is contained by the source capsule wall. Beta, gamma and neutron radiations are emitted from the encapsulated source.
Beta radiation intensity is very small at distances greater than
,a few centimeters from the source. Gamma emission rate is 1.3 x 10' photons /second/ microgram. Neutron emission rate is 2.3 x 10' neutrons /second/ microgram
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE FEB 051999 NO.: NR-277-S-802-S DATE:
PAGE 4 OF 5 SEALED SOURCE TYPE: Medical Neutron (Brachytherapy) Source OUALITY ASSURANCE AND CONTROL:
Each TALC-PC source had been fabricated by the same general procedure. A quality assurance program had been included as part of the manufacturing process, outlined in the Fabrication section 252 of SRL-76004 " Safety Analysis of Doubly Encapsulated Cf Medical Sources, Model TALC-PC.", August 1976.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
o These sources are no longer authorized to be distributed.
e This registration certificate and the information contained within the references shall not be changed without the written consent of the NRC.
SAFETY ANALYSIS
SUMMARY
The U.S.
Department of Energy (DOE), Oak Ridge Operations stated that a total of six (6) TALC-PC sources were fabricated at the Savannah River Laboratory: three in 1977 and three in 1982. All six have subsequently been returned to Oak Ridge and are currently in storage. DOE has withdrawn these sources from its loan pool and has designated them for disposal (recycling).
Based on the fact, that DOE has requested inactivation of this registration certificate, that these sources are no longer in use and that they are to be disposed of, we are transferring this registration certificate to inactive status. No additional safety analysis has been performed.
REGISTRY (OFRAbIOACTIVE'SEALEDSOURCESANDDEVICES SAFETY. EVALUATION OF SOURCE-st NO.: NR-277-S-802-S DATE:,fEB 05 ragg PAGE 5 OF 5 SEATRD SOURCE TYPE:, Medical-. Neutron L(Brachytherapy) Source
REFERENCES:
The following supporting documents for the TALC-PC Medical Neutron ' (Brachytherapy) source are' hereby incorporated by reference and are made a.part of this registry document.
United States Department of Energy, Oak. Ridge Operations letter dated November 25, 1998.
United States Energy and-Research Development Administration, Savannah River Operations Office letter dated October 26, 1976,-with enclosure thereto:
a)
SRL-76004 " Safety Analysis of Doubly Encapsulated Cf 2s2 Medical-Sources, Model TALC-PC.", August 1976.
ISSUING AGENCY:
U.S. Nuclear Regulatory Commission Date:
Reviewer:
h p
Michele L. Burge FEB 051999 l
f W
- Date:
Concurrence:
{/ohn P.l/Jankovich
~..
p
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE NO.: NR-277-S-802-S DATE:
FEB 051999 ATTACHMENT 1 0.03& Radius /
o t...
.~
g 0.01S" Medim
)
0.134' O.10 2'
' ' O.136' O.104=
Source Materiot is a Cf-Pd Cermet Pellet which is 0.090 inch Dio, a O.150 to 0.180 inch Length u
. -c.
sj p
O.015' 0.020",
m 0.228" O.232"
~
FIG. la Primary Capsule (Platinum 10% Iridium) of 858 Cf Neutron Source (1ALC-PC)
O.182" 0.18S" 4
O.030" Radius 7
.O.01S' nodi M k..
y 7
A O.140" O.14 3" j
(
v v.
- g u,,n,;g
.,, ; f
.s i
O.020" 0.030",
=
0 FIG. lb Secondary Capsule (Platinum 10% Iridium) of asaCf Neutron Source (TALC-PC) f I
If
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE NO NR-277-S-802-S DATE; ETACHMENT 2 R
1 0.386 in.
(9. 8m m) h
- 0. 85 in.
U-(4.7mm)
I Doubly-Encapsulated Neutron Source N
(,y<.p.qy;)
A
-:/ u
-j
)
g l
\\
g
}
-)
- -)
Pt-lO% Ir Pd. 252Cf 0 Pt-lO% Ir 2 3 End Plugs Pellet Capsules FIG. 2 Toshiba as:Cf Afterloading Source (TAl.C-PC) l
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE h NR-277-S-802-S DATE:
IIII ATTACHMENT 3 O. I l[6 ODRef d
Color Code with Point (1 -Yellow, (2)-Green, a
1/16" Dio.SS Cable 1/4 - 2 0 s 3/16" Allen Screws 4-l/2"
- - E Polyethylene -
- Inscribe on Cop insert gg, l
1/2" Sch 40 Pipe Nipple p
304 SS 1 Ref i
e--1/2" Pipe Cop of Eoch End -
4 Jl lI 304 SS,15olb p
4--
$W $,
g 1/2" Pipe Cop
- IIh one Inee el 1/4 -20 x 316" L1/2" Pipe Cop 304 SS TALC-PXC Allen Screwe 304 S (Top) S (Bottom)
Sources FIG. 3 2R Container for Toshiba ns:Cf Afterloading Source Model TALC-PC
s February 5, 1999 s
Larry W. Boyd, Coordinator Department of Energy ONRL Transuranium Element Program Oak Ridge Operations -
P.O. Box 2001 Oak Ridge, TN 37831
Dear Mr. Boyd:
Based on the information submitted in your letter dated November 25,1998 we have transferred registration certificate NR-277-S-105-S to inactive status. The registration number of the certificate has been changed to NR-277-S-802-S.
We have updated the registration certificate based on information in the background file. Please review the registration certificate (copy enclosed) in its entirety and notify us immediately if there are any errors or omissions.
If you have any questions, please contact me at (301) 415-5799 or Ms. Michele Burgess at (301) 415-5868.
Sincerely,
/s/
Eric B. Compton, Engineering Aide Materials Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety And Safeguards
Enclosure:
As stated cc w/ encl: Skimberley, LFDCB Distribution:
IMNS r/f SSD-98-102 NE01 SSD File # NR-277-S-802-S DOCUMENT NAME: H:\\ERICiCOMPLTR\\NR277802. CMP
- T* receive e cow of thle document, indcate in the bos: "C" = Copy without attachment / enclosure
'E' = Copy with attachment / enclosure
- N" = No copy I
l OFFICE MSB c
.lNAME Ecompton /t.
Mburgess /M Gf lDATE 01// 9 /99 0X03/99 OFFICIAL RECORD COPY
$79)) UW ff-
.. _ _ _ _ -.. _ _ _ _. _. ~... _ _ _ _. _ - _ _ -
-s.
- Q REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE NO.
- NR-277-S-802-S DATE:
Ff 8 051999 PAGE 1 OF 5 l.-
l
-SEALED SOURCE TYPE: Medical. Neutron (Brachytherapy) Source i
.MODEL:
. TALC-PC MANUFACTURER /DISTRIBUTOill U.S.
Department of Energy Oak Ridge Operations P.O.' Box 2001 Oak Ridge, TN 37831
' ISOTOPE:
MAXIMUM ACTIVITY:
Californium-252-540 millicuries (19.98 GBq)
(up to 1 milligram 13%)
TRAK TEST FREOUENCY:
6 Months i
PRINCIPAL USE: (V)' General Medical Use
' CUSTOM SOURCE:
YES X
NO
.F i
$..":. W: i YM 'w. f.f.
N
f.s l
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE NO.: NR-277-S-802-S DATE:
R 0 5 'H9 PAGE 2 OF ji SEALED SOURCE TYPE: Medical Neutron (Brachytherapy) Source DESCRIPTION 1 The source material is a powder metallurgy (cermet) pellet that contained the 2"Cf. The pellet is composed of small particles of refractory Cf0 bounded in a palladium matrix. To form the 2 3 cermet, the palladium was deposited on a finely-divided precipitate of californium oxalate. The palladium-coated particles were dried, calcined, pressed into a pellet and sintered at 1250 F (677 C). The pellet was coined to a diameter of 0.090 inch (2.29 mm) and the required length, which may had varied from 0.150 to 0.180 inch ( 3. 81-4. 57 mm). Each pellet was then doubly encapsulated in platinum-10% iridium capsules and sealed by fusion welds. The average length the outer capsule is 0.386 inch (9.8 mm), while the average diameter of the capsule is
- 0.185 inch (4. 7 mm). See attachments 1 and 2, figures la, ib, and 2 for source capsule design.
The source letters TALC-PC are abbreviation for: "Toshiba After Loading Cell-Platinum Cermet." The source was designed for use in remote after loading devices for cancer brachytherapy studies and treatments. Because of the small size of the source it was to be used in special catheters and applicators for intra-cavity implantation. During use the source was protected by a stainless steel sheath which was supplied by the user. The manufacture provided a container (2R) which may had contained up to 3 sources. Color-coded inserts were contained in this container for use by medical personnel to identify individual sources. Assay results for each source were provided by the manufacturer which had an uncertainty of t3%. TALC-PC sources were loaned to users and were returned to the manufacturer when use was discontinued.
LABELING:
Because of the small size of these sources, labeling was impractical. The sources were fabricated and shipped in batches with the same nominal "Cf content to 110% although the actual content of each source may had varied 13%. Attachment 3, figure 3 shows the 2R container with its color-coded inserts which had been used by medical personnel to maintain identity of the sources between treatments.
Q c
-REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE-NO.: NR-277-S-802-S DATE:
FFB 051999 E3pE 3 OF 5 SEALED SOURCE TYPE: Medical Neutron (Brachytherapy) Source DIAGRAM:
See Attachments 1, 2,
and 3.
CONDITIONS OF NORMAL USE:
The practical service life of these sources had been determined by the_2.6 year half-life of the Cf. For brachytherapy use, the 2s2 manufacturer had determined the service life to be limited to one, or possibly two half-lives. When the sources were no longer adequate for brachytherapy, they were returned to the manufacturer.
The sources may be sterilized by.any conventional procedure such as gas sterilization, or antiseptic solution.
PROTOTYPE TESTING:
The_ manufacturer had provided information concerning tests which
-had been conducted on the TALC-PC sources in accordance with the guidelines in Regulatory Guide 6.2,
" Integrity and Test Specification for Selected Brachytherapy. Sources",-U.S. Atomic
,~
Energy Commission, February 1974, and Regulations for Safe Transport of Radioactive Materials - IAEA Safety Standards,
' Safety Series No.
6, 1973 Revised Edition, in addition to supplementary testing believed to be appropriate for intended use.
s EXTERNAL RADIATION LEVELS:
2s2 TALC-PC sources will contain up to 1 milligram Cf (540 mci).
252Cf emits alpha, beta, gamma, and neutron radiations. Beta radiation is associated with the equilibrium fission products from spontaneous fission decay of the isotope. Alpha particle radiation is contained by the source capsule wall. Beta, gamma and neutron radiations are emitted from the encapsulated source.
E Beta radiation intensity is very small at distances greater than a few centimeters from the source. Gamma emission rate is 1.3 x 10'. photons /second/ microgram. Neutron emission rate is 2.3 x 10' neutrons /second/ microgram L
Lu
O h
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE FEB 051999 NO.: NR-277-S-802-S DATE:
PAGE 4 OF 5 SEALED SOURCE TYPE: Medical Neutron (Brachytherapy) Source OUALITY ASSURANCE AND CONTROL:
Each TALC-PC source had been fabricated by the same general procedure. A quality assurance program had been included as part of the manufacturing process, outlined in the Fabrication section of SRL-76004 " Safety Analysis of Doubly Encapsulated Cf Medical 2s2 Sources, Model TALC-PC.", August 1976.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
These sources are no longer authorized to be distributed.
e e
This registration certificate and the information contained within the references shall not be changed without the written consent of the NRC.
SAFETY ANALYSIS
SUMMARY
The U.S.
Department of Energy (DOE), Oak Ridge Operations stated that a total of six (6) TALC-PC sources were fabricated at the Savannah River Laboratory: three in 1977 and three in 1982. All six have subsequently been returned to Oak Ridge and are currently in storage. DOE has withdrawn these sources from its loan pool and has designated them for disposal (recycling).
Based on the fact, that DOE has requested inactivation of this registration certificate, that these sources are no longer in use and that they are to be disposed of, we are transferring this registration certificate to inactive status. No additional safety analysis has been performed.
s.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES j
SAFETY EVALUATION OF SOURCE l
NO : NR-277-S-802-S DATE:
FEB 05 rggg PAGE 5 OF 5 i
SEALED SOURCE TYPE: Medical Neutron (Brachytherapy) Source
REFERENCES:
The following supporting documents for the TALC-PC Medical Neutron (Brachytherapy) source are hereby incorporated by reference and are made a part of this registry document.
e United States Department of Energy, Oak Ridge Operations letter dated November 25, 1998.
e United States Energy and Research Development Administration, Savannah River Operations Office letter dated October 26, 1976, with enclosure thereto:
252 a)
SRL-76004 " Safety Analysis of Doubly Encapsulated Cf Medical Sources, Model TALC-PC.", August 1976.
ISSUING AGENCYL U.S.
Nuclear Regulatory Commission hsy Date:
Reviewer:
Michele L.
Burge FEB 051999
\\ su f)
P Date:
Concurrence:
@ohn P.b'Jankovich i
l
-__.__..m REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE NO. t. NR-277-S-802-S DATE:
FEB 051993 ATTACHMENT 1 0.03Cf Radiw /
n 0.015" Medius j-0.134" 0.10 2" 0.136" O.104=
. Source Material is o Cf-Pd Cermet Pellet which is 0.090 inch Dio, a e
0.150 to o.180 inch Length f
o
..w n
n v
0.015" 0.020',
0.228" 0.232" FIG. la Primary Capsule (Platinum 10% Iridium) of as:Cf Neutron Source (TALC-PC) 0.182" O.ies" A
0.030" Medius /
e
.o.015' Rodi d k i :
0.140" O.143" J
e h:
p ni,n.x, pu,gnag,4,& f
~u i
o.020" 0.030" g%
=
FIG. Ib Secondary Capsule (Platinum 10% Iridium) of
- 88Cf Neutron Source (TALC-PC) 1 i
. ~..
f REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l
SAFETY EVALUATION OF SOURCE HQ,_2 NR-2 7 7 - S - 8 0 2 - S DATE:
ATTACHMENT 2 0.386 in.
(9. 8m m)
O. 85 in.
)(4.7mm)
U --. -- __.
_J l
Doubly-Encapsulated Neutron Source
?'
l
\\
g Pt - 10%1r Pd 252Cf 0 Pt-10% Ir 2 3 End Plugs Pellet Capsules FIG. 2 Toshiba as:Cf Afterloading Source (TALC-PC)
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE i
IIII NO,: NR-277-S-802-S DATE:
ATTACHMENT 3 bi 1..OD Ret r l' int A
h Color Code with Point a
(1 -Yellow, (2) Green, 1/16" Olo.SS Cable 1/4 -20 x 3/14" Allen Screwe 4 l/2 Polyethylene -
a O b,,
Inscribe on Cop insert I/2" Sch 40 Pipe Nipple 7,
304 SS 1" Ref
- --1/2" Pipe Cop of Eoch End 4
y 304 SS,150lb o
^
1/2"Plpe Cop ineer odel 1/4 -20x 3/16" L1/2" Pipe Cop 304 SS TALC-PXC Allen Screwe 304 SS (Bottom)
Sources (Top)
FIG. 3 2R Container for Toshiba 28 Cf Afterloading Source Model TALC-PC
_ ~ _ _ _.
4 4:g February 5, 1999 Larry W. Boyd, Coordinator Department of Energy ONRL Transuranium Element Program Oak Ridge Operations P.O. Box 2001 Oak Ridge, TN 37831 Dear Mr. Boya-.
Based on the information submitted in your letter dated November 25,1998 we have transferred registration certificate NR-277-S-105-S to inactive status. The registration number of the certificate has been changed to NR-277-S-802-S.
We have updated the registration certificate based on information in the background file. Please review the registration certificate (copy enclosed) in its entirety and notify us immediately if there are any errors or omissions.
If you have any questions, please contact me at (301) 415-5799 or Ms. Michele Burgess at (301)415-5868.
Sincerely,
/s/
l l
Eric B. Compton,2;.:neering Aide Materials Safety Branch -
Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety
' And Safeguards
Enclosure:
As stated cc w/ encl: Skimberley, LFDCB Distribution:
l IMNS r/f SSD-98-102 NE0 SSD File # NR-277-S-802-S i
l DOCUMENT NAME: H:\\ERIC\\COMPLTR\\NR277802. CMP l:
74 h,..
o, v. e at, me
- t. m th. bor
- C' = Copy without attachment / enclosure
- E* = Copy with attachment / enclosure
[_
l l
NAME Ecompton /t.
Mburgess /p;M DATE 01// 9 /99 0,2/0 3/99 OFFICIAL RECORD COPY L
M P O 1~'^"t Y
6 e!>
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE NO.: NR-277-S-802-S DATE:
FFB 051999 PAGE 1 OF 5 SEALED SOURCE TYPE: Medical Neutron (Brachytherapy) Source MODEL:
TALC-PC MANUFACTURER / DISTRIBUTOR:
U.S.
Department of Energy Oak Ridge Operations P.O.
Box 2001 Oak Ridge, TN 37831 4
ISOTOPE:
MAXIMUM ACTIVITY:
Californium-252 540 millicuries (19.98 GBq)
(up to 1 milligram 13%)
LEAK TEST FREOUENCY:
6 Months i
PRINCIPAL USE: (V) General Medical Use l
CUSTOM SO'URCE:
YES X
NO i
'Gl"Tb Q t OOOW (Pf.
.. - ~ ~. - - - - ~ - - - -..
I REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE HQ21 NR-277-S-802-S DATE:
ifB 05 H9 PAGE 2 OF 5 SEALED SOURCE TYPE: Medical Neutron (Brachytherapy) Source DESCRIPTION:
The source material is a powder metallurgy (cermet) pellet that contained the 2"Cf. The pellet is composed of small particles of refractory CfCh bounded in a palladium matrix.-To form the 2
cermet, the palladium was deposited on a finely-divided precipitate of californium oxalate. The palladium-coated particles were dried, calcined, pressed into a pellet and-sintered at 1250 F. (677*C). The pellet was coined to a diameter of 0.090 inch (2.29. mm) and the required length, which may had varied from 0.150 to 0.180 inch (3.81-4.57 mm). Each pellet was then doubly encapsulated in platinum-10% iridium capsules and sealed by fusion welds. The average length the outer capsule is 0.386 inch (9.8 mm), while the average diameter of the capsule is 0.185 inch (4.7 mm). See attachments 1 and 2, figures la, 1b, and 2 for source capsule design.
The source letters TALC-PC are abbreviation for: "Toshiba After Loading. Cell-Platinum Cermet." The source was designed for use in remote after loading devices for cancer brachytherapy studies and treatments. Because of the small size of the source it was to be used'in~special catheters and applicators for intra-cavity implantation. During use the source was protected by a stainless steel sheath which was supplied by the user. The manufacture provided a container -(2R). which may had contained up to 3
- sources. Color-coded inserts were contained in this container for use by medical personnel to identify individual sources. Assay results for each source were provided by the manufacturer which had an uncertainty of 13%. TALC-PC sources were loaned to users and were returned to the manufacturer when use was discontinued.
LABELING:
Because-of the small size of these sources, labeling was impractical. The sources were fabricated and shipped in batches
. with the same nominal 2"Cf content to 110% although the actual content of each source may had varied 13%. Attachment 3, figure 3 shows the 2R container with its color-coded inserts which had been used by medical personnel to maintain identity of the sources between treatments.
?
i i
L REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE NO.: NR-277-S-802-S DATE:
FEB 051999 PAGE 3 OF S SEALED SOURCE TYPE: Medical Neutron (Brachytherapy) Source DIAGRAM:
See Attachments 1, 2,
and 3.
CONDITIONS OF NORMAL USE:
The practical service life of these sources had been determined 2n f. For brachytherapy use, the by the 2.6 year half-life of the C
manufacturer had determined the service life to be limited to one, or possibly two half-lives. When the sources were no longer
. adequate for brachytherapy, they were returned to the manufacturer.
The sources may be sterilized by any conventional procedure such as gas sterilization, or antiseptic solution.
PROTOTYPE TESTING:
The manufacturer had provided information concerning tests which had been conducted on the TALC-PC sources in accordance with the guidelines in Regulatory Guide 6.2,
" Integrity and Test Specification for Selected Brachytherapy Sources", U.S. Atomic Energy Commission, February 1974, and Regulations for Safe Transport of Radioactive Materials - IAEA Safety Standards, Safety Series No.
6, 1973 Revised Edition, in addition to supplementary testing believed to be appropriate for intended use.
EXTERNAL RADIATION LEVELS:
TALC-PC sources will contain up to 1 milligram 2n f (540 mci).
C 232Cf emits alpha, beta, gamma, and neutron radiations. Beta radiation is associated with the equilibrium fission products from spontaneous fission decay of the isotope. Alpha particle radiation is contained by the source capsule wall. Beta, gamma and neutron radiations are emitted frem the encapsulated source.
Beta radiation intensity is very small at distances greater than a few centimeters from the source. Gamma emission rate is 1.3 x 10' photons /second/ microgram. Neutron emission rate is 2.3 x 10' neutrons /second/ microgram i
I I
___m._
$h REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE FEB 051999 NO.: NR-277-S-802-S DATE:
PAGE 4 OF 5 SEALED SOURCE TYPE: Medical Neutron (Brachytherapy) Source 1
i OUALITY ASSURANCE AND CONTROL:
Eac'1 TALC-PC source'had been fabricated by the same general l
procedure. A quality assurance program had been included as part l
of the. manufacturing process, outlined in the Fabrication section 252 of SRL-76004 " Safety Analysis of Doubly Encapsulated Cf Medical Sources, Model TALC-PC.", August 1976.
' LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
i o.
These sources are no longer authorized to be distributed.
e
.This registration certificate and the information contained' within the references shall not be changed without the written consent.of the NRC.
o j;
SAFETY ANALYSIS
SUMMARY
The U.S.
Department of Energy - (DOE), Oak Ridge Operations stated that a total of six (6) TALC-PC-sources were fabricated at the.
Savannah. River Laboratory: three.in 1977 and three in 1982. All six have subsequently been returned to Oak Ridge and are currently in storage. DOE has withdrawn these sources from its
' loan pool.and has designated them for disposal (recycling).
l Based on-the fact, that DOEzhas requested inactivation of this l
. registration certificate, that these sources are no longer in use l
and that they are to be disposed of, we are transferring this registration certificate to inactive status. No additional safety L
analysis has been performed.
l:
l 1
l
s i
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE NO.: NR-277-S-802-S DATE:
FEB 05 ragg PAGE 5 OF 5 SEALED SOURCE TYPE: Medical Neutron (Brachytherapy) Source
REFERENCES:
The following supporting documents for the TALC-PC Medical Neutron (Brachytherapy) source are hereby incorporated by reference and are made a part of this registry document.
e United States Department of Energy, Oak Ridge Operations letter dated November 25, 1998.
e United States Energy and Research Development Administration, Savannah River Operations Office letter dated October 26, 1976, with enclosure thereto:
232 a)
SRL-76004 " Safety Analysis of Doubly Encapsulated Cf Medical Sources, Model TALC-PC.", August 1976.
ISSUING AGENCY:
U.S. Nuclear Regulatory Commission hsy Date:
Reviewer:
Michele L.
Burge FEB 051999
\\ gn f O'^
Date:
Concurrence:
/
@ohn P.VJankovich l
l l
l
s l1 l );
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE 1][Qd NR-277 - S - 8 0 2 - S DATE:
f EB 051999 ATTACHMENT 1 0.05Cf Medius /
o g
0.015" Redive l
l I' O.134' O.' 0 2' O.136" O.104a Source Motorial is o Cf-Pd cermet Pellet which is 0.090lach Dio. a l
O.150 to 0.180 inch Length u
p
. ej O 015*
0.020",
1 0.228" O.232" FIG. la Primary Capsule (Platinum 10% Iridium) of as:Cf Neutron Source (TALC-PC) 1 l
I O.182' l
a1e5" I
n,n3n.,,,3,, /
a
-x 0.015'Rodi c
0.140' 0.143" p
f p.
.g.g,m..t,,,.. ng,g 4 v. ;,,, ajgx y t o h 0.020" 0.030",
M 0.352 FIG. lb Secondary Capsule (Platinum 10% Iridium) of as:CfNeutronSource(TALC-PC)
L
i s
.\\
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE NO.: NR-277-S-802-S DATE:
ATTACHMENT 2 i
l l
l l
l 0.386 in.
l (9. 8m m) i
~
' O.185 in.
l (4.7mm)
}
Doubly-Eneapsulated Neutron Source i
h i.
j__
j z
l
\\
z Pt - 10%Ir Pd 252Cf 0 Pt-10% 1r 2 3 End Plugs Pellet Capsules Cf Afterloading Source (TALC-PC)
FIG. 2 Toshiba 2s:
i
s
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE FEB 051999 NO.: NR-277-S-802-S DATE:
ATTACHMENT 3 l
l 1 6'aoD Ref i
5 Color Code with Point a
(1)-Yellor, (2) Oreen, 1/16" Dia.SS Cable 1/4 -20 x 3/14" Allen Screve 4 l/~"
L-
'iE Polyethylene-p 4 '
inscribe on Cop insert g!
t 1/2, Sch 40 Pipe Nipple So4 as 1"T' Ref e--1/2" Pipe Cop of Each End v
4 d
304 SS,15olb y
"JM*
1/2 Pipe Cop Polyethylene Insert jf4 20s 3/16" L1/2" Pipe Cop 30, as TALC-PXC Allen Screwe 304 (Top)SS (Bottom) sourcoe FIG. 3 2R Container for Toshiba 85 Cf Afterloading Source Model TALC-PC
= = ' = - - - ~
~
=-
PAGE1 4
FORM 567 jyy g g U. S. NUCLEAR REGULATORY COMMISSION a
REQUEST FOR A SEALED SOURCE OR DEVICE EVALUATION DISTRUCTIONS: Send this request AND a copy of aN reisted letters /apptcetione and drawings to: The Seeled Source Safety Section, ATTN: Chief, OWFN Meu Stop 6 H3. Change the License Tracidng System milestone to 19 and seeign to reviewer code B-5.
NOTE: Retain a copy of this request with the appilcation and background files.
WEQUEMER REGION / LOCATION:
A,
]l il lil IV V
HQ U LFDCB TELEPHONENUMBER '
ItATE 8(
TYPE OF ACTION REQUESTED (Check as appropr6ste)
APPucAurs NA SOURCE REVIEW AMENOMENT OF g
REGISTRATION SHEET MAL CONTROL AUMBER(S) g
(/
DEVICE REVIEW NUMBER (S)
M-N)-h/M LETTER /APPUCATON DATE UCENSE NUMBER (S)
CUSTOM REVIEW J/-M-9 %
6AK Kidye p +iwxs bd $6X &700 /
Dah /?idye, iN 39M FOR 8888 USE ONLY v,EVIEWER MODEL NUMBERS NUMBCR33' j' &?
d DATE RECEfVED DATE ASSONED DATE TO FEES l0-Y- $
Y-Y$$
TYPE OF ACTION (Indicate the number of each type)
Vl COMMERCIAL DISTRIBUTION (FORMAL) l USE BY A SINGLE APPUCANT(CUSTOM) 1' SOURCE (9C)
DEVICE (9A)
SOURCE (90)
DEVICE (98)
NEW NEW NEW NEW AMENDMENT AMENDMENT AMENDMENT AMENDMENT NO SAFETY EVALUATION REQUIRED j LICENSING ACTION REQUIRED IF KNOWN NO 8
NO FEES REQUIRED
] OTHER (Spec #y)
TOTAL NUMBER OF NOTES 7
Lf
/M
~
U B R OF DEFICIENCY LETTERS NUMBER OF DEFICIENCY CALLS FOR BILLING PURPOSES ONLY
] NEW REGISTRATION -
J PRODUCT INACTIVE -
NAME CHANGE ADDRESS CHANGE ADD TO BILLING REMOVE FROM BILLING FOR FEE USE ONLY TYPE OF FEE FEE CATEGORY y
]9A 9B
.A 9C 9D g
AMOUNT RECEIVED h
CHECK NUMBER MATANN UPDATED gn 4qq AS REQUIRED DATE OF CHECK
.y LO 0 / A#U J MATSYS UPDATED g
0 AS REQUIRED r R VE,,,
11[),
,E RET _
ssos r4D 6r'% n4/m #
NRC FORM Se7 (s43)
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