ML20205R136
| ML20205R136 | |
| Person / Time | |
|---|---|
| Issue date: | 04/21/1999 |
| From: | Bhachu U, Samson Lee NRC |
| To: | |
| Shared Package | |
| ML20205R074 | List: |
| References | |
| SSD, NUDOCS 9904220189 | |
| Download: ML20205R136 (11) | |
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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: gpg g g gg PAGE 1 OF 6 l
SOURCE TYPE: Therapeutic Brachytherapy Seeds MODEL: RSNP-Au MANUFACTURER / DISTRIBUTOR: Radiation, Safety & Nuclear Products (RSNP) 3589 West 500 South, Unit 2 l Salt Lake City, UT 84104 I i
ISOTOPE: MAXIMUM ACTIVITY:
Gold-198 80 mci (2.96 GBq) l LEAK TEST FREOUENCY: Not required PRINCIPAL USE: (V) General Medical Use i
CUSTOM SOURCE: YES X NO 9904220189 990421 PDR RC
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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: gpg g g gg PAGE 2 OF 6 SOURCE TYPE: Therapeutic Brachytherapy Seeds DESCRIPTION:
The "non-irradiated" gold seeds are manufactured by Engelhard Industries of Canada (Part No. 88-63-004-1). Each seed contains 8.6 1 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, l 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 g g $NS 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 i 2.327 R-cma /hr/ mci. 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 l activity from a Gold-198 seed is 90% of the contained activity.
For a 30 mci (1.11 GBq) seed, the calculated radiation levels would be:
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.
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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: gg g j gg PAGE 4 OF s SOURCE TYPE: Therapeutic Brachytherapy Seeds l
OUALITY ASSURANCE AND CONTROL: i 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 system.
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 mounted in a plastic rod to I 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 l
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)
No.- NR-569-S-101-S DATE: APR ! 1 SE PAGE 5 OF 6 1
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. j j
. 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
SAFETY ANALYSIS
SUMMARY
- l Based on our review of information contained within the i 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 that 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 seeds are hereby incorporated by reference and are made a part of this registry document.
. o 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 gpg g 9 gg SOURCE TYPE: Therapeutic Brachytherapy Seeds j 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
. r Date: APR 2 1 WW Reviewer: '
Ca Seufh6 J. Lee i i
Date: APR 2198 Concurrence: 8dMa. /
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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: gpg g j gg ATTACHMENT 1
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' SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) i l NO: NR-569-S-101-S DATE: APR 21 W ATTACHMENT 2 I
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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: APg g 1 SE ATTACHMENT 3 "CAUll( W RADi(MCTI\T M AT ERI AL" tape used to identifs contents of inner package co:11ponents CAUTION RAbiOACTM ,
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)
NO: NR-569-S-101-8 DATE: APR ! 1 W ATTACHMENT 4 GOLD-198 SEED ASSAY CERTIFICATION CUSTOMER:
LICENSE:
P.O. #:
CARRIER:
INVOICE #: <
_ AIRBILL:
PATIENT:
SHIP DATE:
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ASSAY / SHIP OATA SURGERY / IMPLANT DATA Date:
Date:
Time:
Time:
Activity: mCs/ seed Activity: mCdseed Ship Activity: mci = GBq )
Variation: + %
No. of Seeds: l l
Totalimplant Activity: mci '
Lot No.:
Canndge Number of Shipping Number Seeds Activity Signature-Date:
Approved By:
sih.JppmAMpa W4naA@.tn Radiation. Safety & Nuclear Products, Inc Radiation, Safety & Nuclear Products. Inc 9 3589 West 500 South, Unit 2 P O Box 70449 Salt Lake City. UT 84104 4205 West Valley City, UT 84170-0449
" IMPORTANT "
" FOR THERAPY USE ONLY'"
j These brachytherapy sources / i Brachytherapy seeds (Model R$NP.Au) seeds are not stenie. and Erschytherapy seeds (Model RSNP Au) are hcensed by the Utah Omsion of must be stentized pnar to are for therapy use only. and may Radiation Control for distnbution to 1 usage RSNP,Inc assumes no only be administered to humans by l persons heensed pursuant to URC 2247Q3) responsstuhty for compicatens physcians hcensed to dispc.nse drugs and Group VI of URC 22-200 Schedule A. m the practme of medmine whch may anse from user fW or under equivalent regulations of the heedin0 thes warning U $ Nuciear Regulatory Commisson, an REMINDER Sealed sources containing Agreement State or a t. censing State todesctive matenal with a physcal half-hfe greater than E days must be leek tested at intervais not to exceed 6 months
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)
NO: NR-569-S-101-S DATE: I ATTACHMENT S 1
1 G()l.D-198 DfC W f M'T()RS l'er NCRl' Rqurt iM. 2*' t.Jitum # 19M 4;llalf lae og (rold IvM = f,4 ?1 llours ll( il :RS !)l l AY t All( pr( !)AY5 I)l C AY l AU l( *R fl l IP M P) If 1 (WWWf l O4891 l il 7714 l 2 II v' lim 2 fl59Mi l 1 119f iM l I is .4ti2t, 4 09%4 4 0 1477 i O4479 5 0 27t>7 f' dl 4 PX h fJ2l40 il 927M Olh$$
M 09179 M O 12MO 4 1191%) 9 O O9tM) 19 0k9xi 10 0 07h3 11 OMMM9 Il 0 tii92 12 O M71.1 12 OO45M 11 0 47tal 11 0 0134 14 O MNIX 14 0 0274 li Oxilh li 0 0212 16 OM42% 16 O ultw4 17 O MW 17 0 0127 lx OM247 IN O (N)9M 19 UMli9 19 O (N)7t>
20 OMO72 20 O t K159 21 0 79M6 21 O r niti 22 o '901 22 O0015 21 0 ?M17 21 O f M)27 24 0 77 tl 24 0 0021 m mm SQIE_
To calculate the activity of a Gold-108 seed or source on any day up to 30 days after cabbration, multiply the orlgmal actmt) by the appropnate decay factor for that day ENMiPL E You want to calculate the acuut) of a Gold-198 seed on the 5* day aller calie,ranon Ongnal actiut) = 10 00 mci Deca >cd actiuty = 10 00 s 0 2767 = 2 767 mci