ML20205R141
| ML20205R141 | |
| Person / Time | |
|---|---|
| Issue date: | 04/21/1999 |
| From: | Bhachu U, Samson Lee NRC |
| To: | |
| Shared Package | |
| ML20205R074 | List: |
| References | |
| SSD, NUDOCS 9904220192 | |
| Download: ML20205R141 (18) | |
Text
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE No.-
NR-569-S-801-S DATE:
APR 1 i WN PAGE 1 OF 11
)
SOURCE TYPE:
Interstitial Implant Source and Storage Container MODEL:
RSNP-Ir (Seeds), RSNP-2 (Storage Device)
MANUFACTURER / DISTRIBUTOR:
Radiation, Safety & Nuclear j
Products (RSNP) j 3589 West 500 South, Unit 2 Salt Lake City, UT 84104 ISOTOPE:
MAXIMUM ACTIVITY:
Iridium-192 15 mei (555 MBq)
LEAK TEST FREOUENCY:
6 Months l
PRINCIPAL USE-(V) General Medical Use CUSTOM SOURCE:
YES x
NO 9904220192 990421 PDR RC SSD PDR
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE No.
NR-569-S-801-S DATE:
gg g g gg PAGE 2 OF 11 SOURCE TYPE:
Interstitial Implant Source and Storage Container DESCRIPTION:
Seeds were basically right-circular cylinders (with ends slightly tapered and rounded from manufacture)
Each seed contained approximately 0.14 milligrams (0.3E-6 lb) of Iridium, in the form of Platinum 70/ Iridium 30 alloy wire.
These seeds (RSNP-Ir) were identical to seeds manufactured by Best Industries (Model 81-01) and RAD / IRID, Inc. (Model 1)
As indicated in the sketch in Attachment 1, RSNP-Au seeds were doubly encapsulated in Type 304 stainless steel.
The " core" of the seed was 2.8 mm (0.11") length of 0.1 nmi (0.004")
0.D.
The
" Outer" and " Inner" capsules were 0.020" (0.51 mm) 0.D.
x 0.011" (0.28 mm)
I.D. and 0.010" (0.25 mm) 0.D.
x 0.006" (0.15 mm)
I.D.,
respectively.
The stainless steel used in the encapsulation was medical hypodermic needle-grade Type 304 stainless steel.
The ends of the seeds were " cold welded" by crimping / shearing, and then slightly rounded to ensure closure.
The seeds were irradiated in a reactor to activate the Ir-191 to Ir-192 Upon receipt of seeds from the reactor, the seeds were assayed and separated according to activity.
Prior to shipment to customer (s) and subsequent usage, the seeds were loaded into nylon ribbons with a typical spacing of one (1) centimeter (0.37") from center to center.
Each ribbon might contain up to a maximum 12 seeds for a maximum total active length of 11.3 cm or approximately 4.5 inches.
Standard ribbons would have three (3) cm (1.18") of inactive leader and 50-100 cm (19.69 - 39.37") of inactive tail to facilitate after loading.
DIAGRAM:
See Attachments 1 through 7.
4 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE No.
NR-569-S-801-S DATE: Apg g g gg PAGE 3 OF 11 SOURCE TYPE:
Interstitial Implant Source and Storage Container LABELING:
Due to the small size of the Iridium seeds, labeling of individual seeds was impossible and impractical.
The storage / shipping container used in the DOT Type A-7A package would be labeled with the following information:
" Caution-Radioactive Material," Radiation Symbol, Isotope, Number of Seed, mci of Ir-192, and the Date of Assay.
A computer sheet detailing the above information would accompany each shipment.
(See Attachment 2) 1 1 includes a decay chart to aid the user in calculating the activity of the seeds for a 60 day period.
CONDITIONS OF NORMAL USE:
These seeds were to be used for interstitial implantation in cancerous tumors by persons authorized to possess and use therapeutic radiation sources pursuant to 10 CFR 35 or similar Agreement State licenses.
They would be used in a hospital / clinic / medical environment, by persons trained and licensed to use therapeutic radiation sources.
PROTOTYPE TESTING:
Iridium-192 seeds from RSNP were identical to sources that had been in use in the medical community since the early 1950's, with no significant health and safety problems.
They would be used in a hospital / clinic / medical environment, by persons trained and licensed to use therapeutic radiation sources.
As such, no extreme physical factors, i.e.,
high temperature, pressure, abusive use, etc., were expected which would comprise the integrity of the seeds.
I REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE
'M No.
NR-569-S-801-S DATE:
M121 NE PAGE 4 OF 11 SOURCE TYPE:
Interstitial Implant Source and Storage Container PROTOTYPE TESTING (Cont'd)
Iridium-192 seeds of this composition and design had been subjected to the following tests:
a.
Autoclaving at temperature of 250 F (121.1 C) and pressures of 350 psi (2.41 MPa) for thirty minute period with no deterioration of integrity:
b.
Exposure to concentrated antiseptic solutions "zepherin" for 6 months with no corrosion of deterioration:
c.
Six month exposure to water and 25% isotonic saline solutions without deterioration or corrosion.
EXTERNAL RADIATION LEVELS:
Sealed sources at 5 cm (1.97") and 30 cm (11.81") for typical seed:
0.8 mg Ra equivalent (1.2 mci Ir-192) = 221 mR/hr 0 5 cm and
= 6.1 mR/hr 0 30 cm OUALITY ASSURANCE AND CONTROL:
RSNP had an established quality assurance program for its laboratory analytical assay instrumentation, i.e.,
constancy checks, geometrical variation checks, NIST approved laboratory cross checks, etc.
This QA program was submitted in support of our application to manufacture and distribute Gold-198 seeds, and would be adhered to in the assay of our Iridium-192 seeds.
Below find an item-by-item breakdown of the quality assurance that went into the manufacturing of the inactive seeds:
1 1
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE No.
NR-569-S-801-S DATE: AMI 11 $6 PAGE 5 OF 11 SOURCE TYPE:
Interstitial Implant Source and Storage Container OUALITY ASSURANCE AND CONTROL (Cont'd)
(1)
During seed fabrication, representative samples (at least one in 100) will be individually inspected under a microscope or magnifying glass to assure the closure (s) at the ends of the seeds are complete.
(2)
The supplier of the stainless steel tubing will supply certification that the encapsulation is of Type 304 stainless steel (hypodermic needle-grade)
(3)
Damaged or bent seeds will be discarded.
(4)
Irradiated seeds are analyzed in a sealed ion chamber, with cross checks performed in a Nuclear Chicago Dose Calibration which has a well chamber.
The conversion units used are:
1 milligram Radium equivalent 0.85 mRh-cm
=
1.5 mci Ir-192
=
(5)
Assayed seeds will then be batched into " lots" such that the activity spread in any lot will not exceed 0.05 mg Ra equivalent.
A unique number is assigned to each lot for accountability.
(6)
Prior to irradiation, all seeds are ultrasonically cleaned to remove any cutting or shavings and other possible contaminants which may lead to radioactive contamination after irradiation.
(7)
Upon receipt of the irradiated seeds from the reactor, they will be leak tested by:
(a)
Soaking in liquid scintillation medium, with swirling and/or stirring for at least 12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br />.
(b)
The LSC medium will be analyzed for activity, with a maximum removable limit of 0.005 mci (185 Bq) l
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DrNICES SAFETY EVALUATION OF SEALED SOURCE 1
l i
l No.-
NR-569-S-801-S DATE: AM g ) 33 PAGE 6 OF 11 l
l SOURCE TYPE:
Interstitial Implant Source and Storage Container OUALITY ASSURANCE AND CONTROL (Cont'd)
(c)
A leak test certificate will accompany each shipment (See Attachment 2)
(d)
As an alternate method of leak testing, the ribbons will be smeared prior to shipment and analyzed to verify the removable contamination is less than 0.005 mci (185 Bq)
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
RSNP would only distribute to persons and/or facilitates that were specifically licensed by the US NRC or an Agreement State to possess and use these sources.
In accordance with regulations, we would require that each customer send us a copy of his/her current license to verify his/her authorization.
A separate file was established for each customer which contained that specific license.
(1)
Leak Testing Individual users were not required to perform leak tests on the Iridium seeds, unless they kept the seeds for periods of six months or longer.
As indicated in Section (7) of QA above, RSNP would leak test the l
seeds prior to shipment and would supply the user with a certificate.
(2)
Unpacking details " OPENING INTRODUCTIONS FOR " TYPE A" PACKAGE CONTAINING RADIOACTIVE MATERIALS," which would be included with
)
the packing slip for each shipment of Iridium seeds.
User (s) i l
would be instructed to sterilize the Iridium seeds and/or ribbons prior to use.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE No.-
NR-569-S-801-S DATE:
M1 I l I PAGE 7 OF 11 SOURCE TYPE:
Interstitial Implant Source and Storage Container LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE (Cont'd)-
(3)
Handling j
t The customer / user was instructed to " follow all local procedures.
State and federal Regulations for the safe handling of radioactive material to reduce personnel exposure and minimize the spread contamination will be followed."
(4)
Disposal The customer / user would be instructed that the disposal of these Iridium seed must be in compliance with State and/or federal regulations.
RSNP would include in each shipment a set of shipping papers and correct labels if the customer prefers to return the seeds for disposal (See Attachment 5).
SAFETY ANALYSIS
SUMMARY
Iridium-192 seeds in nylon ribbons had been in use in the medical community for approximately 40 years, with no significant health and safety problems.
Seeds would be used in hospital / clinical / medical environment, by persons trained and licensed to use therapeutic radiation sources.
No extreme physical factors, i.e.,
high temperatures, pressure, abusive use, etc. were expected which would compromise the integrity of the seeds.
These seeds had been subjected to tests described in PROTOTYPE TESTING Section, which tests exceeded any set of conditions to which they would reasonably be subjected during normal usage.
e REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE No.-
NR-569-S-801-S DATE: APR ! I 33 PAGE 8 OF 11 SOURCE TYPE:
Interstitial Implant Source and Storage Container STORAGE CONTAINERS:
DESCRIPTION:
RSNP, Inc. Storage Devices Model Number RSNP-2 were constructed from lead filled Schedule 40 steel pipe with an outside diameter of 3.5" (8. 89 cm) (nominal), and a wall thickness of 0.226" (5.74 mm)
They were approximately ten (10) inches (25.4 cm) long and have threaded caps on each end.
Handles were bolted onto them to facilitate carrying (Seo Attachment 6)
These containers had 24 stainless steel or copper tubes located around a two (2) inch (5.08 cm) diameter circle welded into a plate, which was welded in place at 1/2 inch (1.27 cm) from the top of the shield such that they were surrounded by a minimum of one (1) inch (2.54 cm) of lead for a length of at least four (4) inches (10.16 cm)
The bottom of the tubes would be left open for orders which required extra leader on the Iridium sed-bearing ribbons.
The nylon ribbons were held in place by means of friction and tension within the storage tubes.
The 50-100 cm (19.69 - 39.37")
long " tails" would pass through a slot in the top of pipe, and be taped to the body of the container.
With the threaded cap installed, the ribbons were held securely in place for transport to the customer.
A number of wire security seal would be connected between the two (2) caps to provide evidence that the package had not been illicitly opened.
LABELING:
RSNP-Ir (Seeds), RSNP-2 (Storage Device) Each container bears a label containing the following information:
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE No.:
NR-569-S-801-S DATE:
PAGE 9 OF 11 SOURCE TYPE:
Interstitial Implent Source and Storage Container l
LABELING (Cont'd)-
" CAUTION--RADIOACTIVE MATERIAL" RSNP, Inc.
3589 West 500 South Salt Lake City, UT 84104 Radiation Symbol Isotope and Amount Date SHIPPING:
For shipment, this container (RSNP-2) was center in a DOT Type A-7A fiberboard container described below:
a.
Outer Container (1)
Spec 12B fiberboard box, with Styrofoam inserts to maintain shield (RSNP-2) in center of box.
(2)
Fiberboard box to be 12" x 12" x 12" (30.48 cm x 30.48 cm x 30.48 cm), double-sided (2-ply) and waterproofed (See Attachment 7).
(3)
Outer container is a DOT Type A-7A container, and has met in the test conditions specified in 49 CFR 17 3. 3 9 8 ( b) ( 3 )
(4)
The majority of packages will require a " DOT-RADIOACTIVE II" label, as the Transport Index will be less than 1.0, however, those shipments whose TI > 1.0 will require a " RADIOACTIVE III."
IMPORTANT NOTE:
EVERY INDIVIDUAL PACKAGE WILL BE MONITORED TO DETERMINE TRANSPORT INDEX AND APPROPRIATE LABEL.
1
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE No.
NR-569-S-801-S DATE:
APR 2 l $$
PAGE 10 OF 11 l
SOURCE TYPE:
Interstitial Implant Source and Storage Container SHIPPING (Cont'd)-
b.
Specifications and Restrictions (1)
Authorized gross weight - 50 lb (22.68 kg)
(2)
Marking of package must be in compliance with 49 CFR 1
17 3. 24 (c) (1)
(3)
Security seals must be provided as required in 49 CFR 173.393(b)
(4)
Contamination levels, external radiation levels, and labeling must be in compliance with 49 CFR 173.393.
(5)
Maximum activity for shipping in RSNP-2 container: 250 mci (9.25 GBq) of Iridium-192 DIAGRAMS:
See Attachments 6 and 7 for diagrams of the Storage Container (RSNP-2) and the DOT Type A-7A Package for shipping.
EXTERNAL RADIATION LEVELS:
(a)
Source container loaded to maximum (250 mci [9.25 GBq)
Top - - - 100 mrem /hr (1.0 mSv/hr)
Side
- - 100 mrem /hr (1.0 mSv/hr)
Bottom -
90 mrem /hr (0.9 mSv/hr)
(b)
Shipping container loaded to maximum (250 mci [9.25 GBq]
Ir-192).
Top - - -
30 mrem /hr (0.30 mSv/hr)
Side 30 mrem /hr (0.30 mSv/hr)
Bottom -
28 mrem /hr (0.28 mSv/hr)
Transport Index (mrem /hr 0 1 m (39.37"]) - - 4.0
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE AEI I I No..
NR-569-S-801-S DATE-PAGE 11 OF 11
{
SOURCE TYPE:
Interstitial Implant Source and Storage Container EXTERNAL RADIATION LEVELS (Cont'd)
Each RSNP-2 container would be stamped with a unique serial number, and a radiation profile would be performed on each container to verify the integrity of the lead shielding prior to its use.
Records of these tests would be maintained for inspection by regulatory personnel.
SAFETY ANALYSIS
SUMMARY
The manufacturer stated that Models RSNP-Ir (Seeds) and RSNP-2 (St, age Device) are no longer manufactured and distributed and does not have any intention to produce them in the future.
Therefore, the registration certificate is being converted to an inactive registration.
REFERENCES:
Radiation Safety and Nuclear Products letter dated January 17, 1985, and April 23, 1985, with enclosures thereto.
Radiation Safety and Nuclear Products letter dated February 22, 1999, with enclosures thereto.
ISSUING AGENCY U.S.
Nuclear Regulatory Commission
,r APR 21 15E
/
d Date:
Reviewer:
-i S'eungLd'. Lee APR 21 SE
/II Date:
Concurrence.
W Ujagar S.
D
_u
REGISTRY OF RADIAOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCES 1
NO.: NR-569-S-801-S DATE:
EII E ATTACHMENT 1
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REGISTRY OF RADIAOACTIVE SEALED SOURCES AND DEVICES 1
SAFETY EVALUATION OF SEALED SOURCES 4
i NO.-
NR-569-S-801-S DATE:
APR 21 890 ATTACHMENT 2 l
IR1DIUM-192 iLD ASSAe CERIIf C f 1 I O r4
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. FOR THERAPS USE ONLt' +
. IPF06 TANT! +
T45E IRIDIUM l'2 SEEDS AND titBCuS tridiue-192 seegs 'Mosel tihe-tri ar e IR!0ttp le: SEEDS ME FCll f4RD' LSI
- E 80f i'Etit! A0 NST li STERI-licensed av the utan fareau of # asia-Jul.f. a#0 Mt K S*Lf 40*lNISTE8E3 'O Ll!ED 410R ?G USAGE. R54P a!5tPE5 tian Control +or sistrioution to ser-
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Agreve at 5 tate or a utesstie state.
CAUTIONe RADIOACTIVE MATERIAL!
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REGISTRY OF RADIAOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCES NO.
NR-569-S-801-S DATE: AM ! 1 g ATTACHMENT 3 1RIDIUN1-192 DECAY F~ A C T O R 5 4aLFLirE
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reu want to calculate the sctivit, o+ en I r t c i uni-14 2 Seed on the Cuth das +4ter calibration.
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REGISTRY OF RADIAOACTIVE SEALED SOURCES AND DEVICES 1
SAFETY EVALUATION OF SEALED SOURCES i
NO,-
NR-569-S-801-S DATE:
APR 21 999 ATTACHMENT 4 1
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REGISTRY OF RADIAOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCES NO.
NR-569-S-801-S DATEL APR Z 1 SE ATTACHMENT 5 i
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4 REGISTRY OF RADIAOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCES NO.-
NR-569-S-801-S DATE:
apt'! t W ATTACHMENT 6 9"
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l REGISTRY OF RADIAOACTIVE SEALED SOURCES AND DEVICES l
SAFETY EVALUATION OF SEALED SOURCES
{
APR 21 99 NO.
NR-569-S-801-S DATE:
ATTACHMENT 7 I
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April 21, 1999 l
l Edd Johnson Radiation Safety and Nuclear Products l
P.O. Box 70449 l
West Valley City, UT 84170 l
Dear Mr. Johnson:
Recently, the State of Utah has relinquished its Seal Source and Device registration program, transferring its authority back to the US Nuclear Regulatory Commission (NRC). With this transfer, the State of Utah had sent two registration certificates (2 sources) to NRC.
The meeting was held at Radiation, Safety & Nuclear Products (RSNP) on December 17,1998 to discuss these products' current status. At the end of the meeting, you request one registration certificate (UT-569-S-102-S) be transferred to inactive status by the fact these sources are no longer manufactured by RSNP and RSNP does not have any intention to produce them in the future.
Note that the updated registration sheets UT-569-S-101-S and UT-569-S-102-S will be reissued i
as NR-569-S-101-S and NR-569-S-801-S, respectively.
1 Please be advised that you must manufacture and distribute the product in accordance with the statements and representations contained in your application, with enclosures thereto, and the l
information set out in your registration certificate. As a general rule, you must request and obtain an amendment to the certificate before you make changes or modifications to the information submitted to obtain the certificate.
Please read over the enclosed registration certificates in its entirety and notify us immediately of any errors or omissions.
Please be aware that, as a holder of an NRC registration, you may be subject to the NRC's licensing and inspection fees in accordance with 10 CFR Part 170, and annual fees in accordance with 10 CFR Part 171. If you have any questions concerning the fee requirements, please contact the License Fee and Debt Collection Branch at (301) 415-7544.
If you have any questions, please contact me at (301) 415-5787 or Mr. Ujagar Bhachu at (301) 415-7894.
Sincerely, Se J. Lee, Mechanical Engineer Materials Safety and Inspection Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards l
Enclosure:
As stated l
Distribution:
l IMNS r/f SSD-97-80 SSD-97-81 NE01h l
DOCUMENT NAME: C:\\SJL\\nr569102. cmp Tm rec-Ivo a copy of this document, Indicate in the box: "C" = Copy without attachment / enclosure
'E" = Cecy with attachment / enclosure "N" = No copy OFFICE MSIB lE MSIB C
l l
l NAME Slee C,1M UBhachu 5/N" DATE 04/19/99
- f //f /99 OFFICIAL RECORD COPY Q y ?;2u iiG h'
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) l No.-
NR-569-S-101-S DATE: gpg g g ggg PAGE 1 OF 6 SOURCE TYPE:
Therapeutic Brachytherapy Seeds MODEL:
RSNP-Au MANUFACTURER / DISTRIBUTOR:
Radiation, Safety & Nuclear Products (RSNP) l 3589 West 500 South, Unit 2 Salt Lake City, UT 84104 i
1 i
ISOTOPE:
MAXIMUM ACTIVITY:
Gold-198 80 mci (2.96 GBq)
LEAK TEST FREOUENCY:
Not required i
l i
PRINCIPAL USE:
(V) General Medical Use CUSTOM SOURCE:
YES X
NO
,n.
me
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE j
(AMENDED IN ITS ENTIRETY)
No.-
NR-569-S-101-S DATE:
Apg g g ggg PAGE 2 OF 6 i
SOURCE TYPE:
Therapeutic Brachytherapy Seeds l
DESCRIPTION:
The "non-irradiated" gold seeds are manufactured by Engelhard Industries of Canada (Part No. 88-63-004-1).
Each seed contains 8.6 0.6 milligrams ((18.96 1.32]E-6 lb) of Gold (99.99 percent pure) which is encased in a platinum, sheath (99.99 percent pure, Iridium free).
The manufacturer certifies that the seeds are " iridium free" platinum and gold.
The seeds are cylindrical and have dimensions of 2.5 mm (0.098") in length and 0.8 mm (0.031") in diameter.
The platinum sheath is 0.15 mm (0.006") thick.
These seeds are identical to those used by Best Industries and Nuclear Sources & Services, Inc.
RSNP has the seeds irradiated in a reactor.
Upon arrival at RSNP, each seed has a maximum activity of 80 mci (2.96 GBq).
DIAGRAM:
See Attachments 1 through 5.
LABELING:
Due to the small size of the gold seeds, the seeds are not labeled.
However, the shipping / storage containers used in the USDOT Type A, 7A package will be labeled with the following:
" Caution-Radioactive Material" stickers / tape;
+
The trefoil radiation symbol;
+
Isotope contained within the package; and Total activity in the package.
+
Certificate sheet with a decay chart and instructions for handling and storage accompany each shipment of gold seed.
The shipping / storage container shall be labeled in accordance with the requirements of Section 32.74(a)(3) of 10 CFR Part 32.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)
No.-
NR-569-S-101-S DATE: gpg gj gNS PAGE 3 OF 6 SOURCE TYPE:
Therapeutic Brachytherapy Seeds CONDITIONS OF NORMAL USE:
Seeds are used in hospital / clinical / medical environment for the interstitial treatment of cancer by persons trained and licensed to use therapeutic radiation sources.
Due to the short half-life of Gold-198 (2.7 days), the useful life of the seeds is limited to about 20 days as a maximum.
PROTOTYPE TESTING:
No testing was performed on the seeds.
RSNP reports they are identical to seeds previously approved by the NRC and the States of Texas and Utah for licensing purposes.
Additionally, the seeds have been in use in the medical community for over 30 years, with no reported significant health and safety problems.
EXTERNAL RADIATION LEVELS:
The specific gamma ray constant for Gold-198 is listed as 2.327 R-cm2/hr/mC1.
Amersham, the original developer of Gold-198 seeds reports approximately 10% attenuation of the gamma ray intensity due to the platinum sheath.
Therefore, the apparent activity from a Gold-198 ceed is 90% of the contained activity.
For a 30 mci (1.11 GBq) seed, the calculated radiation levels would ber 62.80 R/hr (628.0 mSv/hr) at 1 cm (0.39")
2.51 R/hr ( 25.1 mSv/hr) at 5 cm (1.97")
0.63 R/hr (
6.3 mSv/hr) at 10 cm (3.94")
There is no beta radiation involved, as the 0.15 mm (0.006")
platinum sheath filters out the 0.96 MeV beta particle from the Gold-198.
i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE j
(AKENDED IN ITS ENTIRETY)
{
Uo.:
NR-569-S-101-S DATE:
gg g g gg PAGE 4 OF 6 SOURCE TYPE:
Therapeutic Brachytherapy Seeds OUALITY ASSURANCE AND CONTROL:
RSNP used two basic types of radiation detection systems in the assay of seed within 25% accuracy-1.
A fixed-geometry ion chamber is used for rapid counting and assay of seeds required to fill an order or to batch a shipment of irradiated seeds.
2.
A Capintec dose calibrator is used to confirm the readings of, and document the performance of the ion chamber assay systam.
To document the performance of the ion chamber, the following tests are performed:
Daily constancy check for reproducibility in measuring a Cs-137 tube source, which has been mount ed in a plastic rod to assure constant geometry.
A log of the results is maintained.
Quarterly intercomparison study to compare the measurement capabilities of the ion chamber system and the dose calibrator.
Logs of these tests are maintained.
To calibrate dose calibrators, the following tests are performed:
Constancy at least once each day prior to assay of seed strengths Linearity at installation and at least quarterly thereafter Accuracy at installation and at least annually thereafter LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
The sources shall be distributed to persons specifically licensed by the NRC pursuant to Sections 35.13, 35.14, and 35.400 of 10 CFR Part 35 or equivalent provisions of an 1
l t
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) l No.:
NR-569-S-101-S DATE:
APR 11 EE PAGE 5 OF 6 SOURCE TYPE:
Therapeutic Brachytherapy Seeds Agreement State.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE (Cont: ' d) -
Due to the short half-life of the Gold-198, these sources do not have to be leak tested.
Handling, storage, use, transfer, and disposal: To be determined by the licensing authority.
The small size of these sources will require a higher level of accountability during use to prevent source misplacement and loss.
This registration sheet and the information contained within the references shall not be changed or transferred without the written consent of the NRC.
SAFETY ANALYSIS
SUMMARY
Based on our review of information contained within the references cited below, that these seeds are identical to seeds previously deemed acceptable for licensing purposes by the NRC and the States of Texas and Utah, that the high purity gold encased in platinum is inert and the 2.7 day half-life of Gold-198, we continue to conclude that the Model RSNP-Au seeds are acceptable for licensing purposes.
Furthermore, we continue to conclude tha* this source design would be expected to maintain its containment integrity for conditions of use which might occur during uses specified in this certificate.
REFERENCES:
The following supporting documents for the Model RSNP-Au gold I
seeds are hereby incerporated by reference and are made a part of this registry document.
l i
4 i
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)
No.-
NR-569-s-101-S DATE:
PAGE 6 OF 6 gpggg g SOURCE TYPE:
Therapeutic Brachytherapy Seeds REFERENCES (Cont'd).
Radiation, Safety and Nuclear Products letters dated August
+
15, 1983, January 3, 1984, March 20, 1987, February 22, 1999, and April 7, 1999, with enclosures thereto.
ISSUING AGENCY:
U.S. Nuclear Regulatory Commission f r-Date:
APR 21 W Reviewer:
Seub(J J.
Lee APR 21 W concurrence:
AM* #
Date:
hu 4
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE
( AMENDED IN ITS l'.NTIRETY)
& NR-569-S-101-S DATE: gpg q g g ATTACHMENT 1
)
i i
i 2.5 mm
- Kenm = ===remanusum 0.8 m m 0.5 m m I
Metalic Gold Core 0.5 m m I l Platinum Metal Sheeth
.: l l
0.15 m m I
0.15 mm Note: All Dimensions are " nominal" Diagram of RSNP-Au Source
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)
NO: NR-569-S-101-S DATE:
APR 21 SW ATTACHMENT 2 Shipping Package for Gold 198 Seeds s
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)
NO: NR-569-S-101-S DATE:
APR t 1 WN ATTACHMENT 3 CAlrilON RADIOACTIVE N1 ATERI AL" tape used to identify contents of innct package components CAUil1N RADICACTIVE MATERIAL
!"Ja' e.4 DATE "Securits Seal" / tape to notil) package recipient if package has been alliatly opened IF SEAL ISBROKEN 1
CHECK CONTENTS BEFORE ACCEPTING i
R ADIOACTIVE Yellow ll and Yellow Ill lams for compliance with USDOT/l ATA regulauons RAD 10ACTlYEII JACTIVEII ACTIVITY
'flVITY.
TRANSPORT lhotr TRANSPORT INDEX
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i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) p_01 NR-569-S-101-S DATE:
AM ! 1 W ATTACHMENT 4 GOLD 198 SEED ASSAY CERTIFICATION CUSTOMER:
LICENSE:
P.O. #:
CARRIER:
INVOICE #:
AIF< BILL:
PATIENT:
SHIP DATE:
ASSAYlSHip DATA SURGERY / IMPLANT DATA Date:
Date:
Time:
Time:
Activity:
mci / seed Activity-mC6/ seed Ship Activity:
mci =
GBq Variation: +
No. of Seeds:
TotalImplant Activity:
mci Lot No.:
Cartndge Number of SNpping Number Seeds Activity l
l l
Signature:
Date.
Approved By:
ILWnQ A#tse h
M ling A@til h
Radiation, Safety & Nuclear Products. Inc Radiation Safety & Nuclear Products Inc 3589 West 500 South, Unit 2 P O Box 70449 Salt Lake City. UT 84104-4205 West Valley City UT 84170-0449 l
- IMPORTANT "
" FOR THERAPY USE ONLY'"
These brachythersey sources /
Brachytherapy seeos (Model RSNP Au)
Brachytherapy seeds (Model RSNP.Au) seeds are not stenle. and are hcensed by the Utah Divmon or are for therapy use only. aN may must be stenkzed pnor to Radiate Controd for distnbuten to usage RSNP,lnc assumes no only be admantstered to humans by persons hcensed pursuant to URC-2207tX3) physcians hcensed to dispense drugs responsstality for comphcatens and Group VI of URC-22 2CD Schedule A.
in the practice of medesne whch rnay anse from user not or under equivaWit regulations of the heeding thes woming U S Nuclear Regulatory Commission an REMINDER Sealed sources containing Agreement State or a Lcenssng State radioactive matenal with a physacal half-hfe greater than Idays must be leak tested at intervais not to exceed 6 months i
U
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l l
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES I
SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)
IS NO: NR-569-S-101-S DATE:
ATTACHMENT 5 l
l GOI.D-198 DFCAY FACTORS i
l'er NCRI' Repirt $X 2*'l dmon # 19x4 lll.nll-life ter ( rold-19X = f4 71 llours I
lit II 'RN I)I L AY F M f( >R l>AYS I)I CAY l AC [UR il l IN it NI O
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o 39xi 1
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0 9144 4
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N 0 9179 M
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16 il o lti4 17 0 8 t tn 17 0 0127 14 O M247 IM O lN NX 19 UMIS9 19 O (M)?6 2(1 O M1172 20 O (N )$9 21 Il ?9hti 21 (I r N14 $
22 070) 22 U(Mit$
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NOTE To calculate the activity of a Gold-108 seed or source on any day up to 30 days after calibration, multiply the onginal activrty by the appropnate decay factor for that day EXAMPLE _
You want to calculate the actnit) of a Gold-lW wed on the f day aner cahbrauon Onginal actnity = 10 (xp mci Decased aetnil3 = to 00 s 0 2767 = 2 767 rnCl l
,