ML20128N574
| ML20128N574 | |
| Person / Time | |
|---|---|
| Issue date: | 06/23/1980 |
| From: | Singer B, Wright E NRC |
| To: | |
| Shared Package | |
| ML20126D741 | List: |
| References | |
| SSD, NUDOCS 9610160437 | |
| Download: ML20128N574 (3) | |
Text
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p, UNITED STATES NUCLEAR REGULATORY COMMISSION g ;E WASHINGTON, D. C. 20555
- ,o l CERTIFICATE OF REGISTRATION l AND SAFETY ANALYSIS
SUMMARY
SEALED SOURCE l
Manufacturer and Distributor Sealed Source Model Desistnation i .
Medical Products Division Model 6711 l- 3M Company 3M Center l St. Paul, MN 55101 Isotooe Maximum Activity oer Source Iodine-125 62 Mil 11 curies (because of capsule absorption, this is-referred to as 40 millicuries compensated)
Conditions of Normal Use The 3M Company 6711 sealed source (therapeutic seed) is designed for use l in the interstitial treatment of cancerous tumors. The seeds are designed to withstand normal autoclave temperature and pressure variations from 121*C at 15 PSI to 138'C at 35 PSI. l Ability to Withstand Loss of Containment Under Accident Conditions 3M high temperature test data reveals the source retains its integrity to at least 400'C. However, the capsule does lose its integrity at temperatures of about 600 C. The capsule leaks iodine. 3M Company states that the sources should not be subjected to temperatures in excess of 138'C and 35 PSI. In addition, the sources should not be placed in concentrated acids or sterilized by dry heat methods.
Sealed Source Descriotion t
The 3M Company Model 6711 seed contains iodine-125 absorbed on a solid silver bar and encapsulated in a cylindrical titanium capsule which is sealed by tungsten-inert-gas weld at each end of the capsule. Typical capsule design is shown in the figure below.
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Radiation Levels External radiation levels from the Model 6711 was determined by the 3M Company ,
using film badges (specified accuracy + 15%). Results are:- 1 I-125 Seed Average Dose Rates (mR/hr):
Activity at 5 cms at 30 cms Model 6711 0.1 mci (comp) 2.5 0.053 Model 6711 40.0 mci (comp) 1000 21.2 Prototvoe Testina Prototypes of the Model 6711 sealed source (seeds) were subjected to tests I to demonstrate that the source will maintain their integrity under stresses !
of use and accident. The tests performed were in accordance with '
ANSI N44.1-1973, paragraphs 4.2.2 and 4.2.3 3M Company reports that the prototypes passed the specified ANSI tests for impact and percussion. High temperature tests results show that the Model 6711 sealed source retains its integrity to temperatures of at least 400*C.
Manufacturing Controls The 3M Company conducts the following quality control tests and inspection of the Model 6711 sealed source prior to distribution, visual inspection, initial leak test, second leak test, and autoclave, assay for radioactivity.
Complete details of the quality control program are included in the February 8,1980 application.
Limitations of Use and/or Other Considerations A. Licensees should observe the 3M Company instructions for handling and using the I-125 seeds. Specifically these' instructions warn that: 1
- 1. Seeds should not be exposed to concentrated acids.
- 2. Seeds should not be autoclaved in plastic tubing or other plastic containers (only autoclave compatable materials such as stainless steel, glass, nylon and teflon should be used).
3 Seeds should not be exposed to temperatures in excess of 138ec and pressures in excess of 35 PSI.
B. Labeline: Due to the small size, individual sources are not labeled. Source containers are labeled in accordance with 10 CFR Part 20, 4
441
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, ,i c. Leak Testina: Six month intervals -- The test shall be capable of detecting the presence of 0.005 microcuries of iodine-125 on the test samples.
D. Handline. Storare. Use. Transfer. and Disoosal:- To be determined by the licensing authority.
References The safety review and registration of the Model 6711 sealed source design is based on~information and test data contained in the 3M company application received February 8,1980 and letters dated April 18,1980,' May 8,1980 and June 3,1980 and enclosures thereto (see also 3M company license No. 22-00057-59MD).-
Date June 23.1980 Reviewed B N Date June 23,1980 concurrenge "! uf#/
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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE (Amended in its entirety) !
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NO. NR-460-S-167-S M 2 5- 8 6
- DATE
- PAGE: 1 of 6 l
SOURCE TYPE: Therapeutic Seed Source MODEL: 6711 MANUFACTURER / DISTRIBUTOR:
Minnesota Mining and Manufacturing 3M Center I St. Paul, MN 55101 I
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t ISOTOPE: Iodine-125 MAXIMUM ACTIVITY: 100 millicuries
-LEAK TEST FREQUENCY: 6 months PRINCIPAL USE: _(V) General Medical Use ,
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ps. CUSTOM SOURCE: YES k NO l
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c 1 0 6 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (Amended in its entirety)
NO: NR-460-S-167-S DATE: NN 2 5 1985 PAGE: 2 of 6 SOURCE TYPE: Therapeutic Seed Source DESCRIPTION:
The 3M Company Model 6711 seed contains iodine-125 absorbed on a solid silver bar and encapsulated in a cylindrical titanium capsule which is scaled by tungsten-inert-gas weld at each end of the capsule.
LABELING:
Because of the small size of I-125 Seeds, it is not possible to label each source as to its radioactive content. I-125 Seeds supplied as a group of seeds with an assay within a stated range on the assay date, are packaged in a 1 dram, screw cap glass vial, onto which is affixed a label stating radioactive content, a sample of which is attached below. This label displays the caution symbol and is printed in colors to comply with the provisions of 10 CFR 32.72 and 10 CFR 20.203.
1-125 Seetis 3M 1-125 SeetB GM Therapeutic ?!?%'C;'!!.t:1", *a:,r"~*~
3 For Interstitial __ ,.
(iodine-125) -- Brachytherapy , _ ,,- - ...,
caution: Rammtive Natw1:1 .c.
3 w m n,_ e[ a No. 6711 - . , ~ w o- ;
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Label for Lead Storage / Shipping Container - ttodel 6711
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (Amended in its entirety)
NO: NR-460-S-167-S DATE: 35 E PAGE: 3 of 6 SOURCE TYPE: Therapeutic Seed Source DIAGRAM:
1-125.edsorbed
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4.5 mm r CONDITIONS OF NORMAL USE:
I The 3M Company 6711 sealed source (therapeutic seed) is designed for use in the interstitial treatment of cancerous tumors. The placement of I-125 Seeds in tissue, which takes place in surgery, is facilitated by t.he use of one of several commercially-available implant tools. These implanters are used solely for source placement and are not designed either to store or to hold I-125 Seeds, as is the case with conventic al applicators and cesium-137 sources.
The seeds are designed to withstand normal autoclave temperture and pressure variations from 121*C at PSI to 138'C at 35 PSI.
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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES l SAFETY EVALUATION OF SEALED SOURCE l (Amended in its entirety)
NO: NR-460-S-167-S DATE: 25 @ PAGE: 4 of 6 SOURCE TYPE: Therapeutic Seed Source PROTOTYPE TESTING:
Prototype of the Model 6711 sealed source (seeds) were subjected to tests to demonstrate that the sources will maintain their integrity under stresses of use and accident. The tests performed were in accordance with ANSI N44.1-1973 paragraphs 4.2.2 and 4.2.3. 3M Company reports that the prototype passed the ANSI tests for impact and percussion. High temperature test results show that the Model 6711 sealed source retains its integrity up to temperatures of 400*C, At that temperature, the anion exchange resin breaks down and releases the iodine. However, the capsule does lose its integrity and leaks iodine at temperatures of about 600*C. 3M Company states that the sources should net be subjected to temperatures in excess of 138'C and 35 psi. In addition, the sources should not be placed in concentrated acids or sterilized by dry heat methods.
EXTERNAL RADIATION LEVELS:
External radiation levels from the Model 6711 was determined by the 3M Company using film badges (specified accuracy 15%). Results are:
I-125 Seed Average Dose Rates (mr/hr)
Activity at 5 cm At 30 cm Model 6711 0.1 mci (comp) 2.5 0.053 Model 6711 40.0 mci (comp) 1000 21.2
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_ . _ _ _ . .9-REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE l (Amended in its entirety) _
NO: NR-460-S-167-S DATE: N 25 5% PAGE: 5 of 6 SOURCE TYPE: Therapeutic Seed Source QUALITY ASSURANCE AND CONTROL:
1 2
The 3M Company conducts the following quality control tests and inspection of the Model 6711 sealed sources prior to distribution: visual inspection, initial leak test, and autoclave, x-ray inspection, ar.d assay for radioactivity.
Complete details of the quality control program are included in the February 8, 1980 application.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
o The source shall be distributed only to specific licensees of the NRC j or Agreement States. l o Handling, storage, use, transfer, and disposal: To be determined by the !
licensing authority. In view that these sealed sources exhibit high surface dose rates when unshielded, these sealed sources should be handled only by experienced licensed personnel using adequate remote handling equipment and procedures.
o The licensing authority will have to obtain details on specific holders and any operational procedures, etc. from the license applicant to make a licensing determination.
l o This registration sheet and the information contained witSin the references shall not be changed or transferred without the ,rritten consent of the NRC.
O Licensees should observe the 3M Company instructions for handling and using the I-125 seeds.
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f REGISTRY OF RADIOACTIVE SEALED SOURCES AND DE ICES FETY EVALUATION OF SOURCE (Amended in its entirety)
NO: NR-460-S-167-S DATE:
M25 $ PAGE: 6 of 6 SOURCE TYPE: Therapeutic Seed Source SAFETY ANALYSIS
SUMMARY
Based on our review of the information and test data referenced below, we conclude that the Series 6711 Therapeutic Seed 3M Sources with new design changes to be acceptable for licensing purposes. Over the past 15 years, 3M Company has distributed thousands of the sources with no incident of source damage and subsequent leakage of radioactive material during the recommended use and ,
handling procedures. We conclude, therefore, that this source series would be j
expected to maintain their containment integrity for the specified uses and the conditions of use applicable to these uses.
The manufacture concludes that the integrity of the new design surpasses the old design.
The following supporting documents for the Model 6711 therapeutic seedi sources are hereby incorporated and are made a part of this registry document:
1 o Minnesota Mining and Manufacturing Company application dated May 1, 1980 ,
i for renewal of License No. 22-00057-59MD ;
o Supersede registry document No. NR-460-S- 167-S dated June 23',; 1980.
ISSUING AGENCY:
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U. S. Nuclear Regulatory Commission !
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Date:
N 2 5 1985 Reviewer: ,
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