ML20196B694
| ML20196B694 | |
| Person / Time | |
|---|---|
| Issue date: | 06/22/1999 |
| From: | Bhachu U, Samson Lee NRC |
| To: | |
| Shared Package | |
| ML20137U384 | List: |
| References | |
| SSD, NUDOCS 9906230258 | |
| Download: ML20196B694 (18) | |
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{{#Wiki_filter:REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)
& NR-136-8-255-S DATE: M 2 2 IE90 PAGE 1 OF 7 SOURCE TYPE: Brachytherapy Source RQDEL: CDC.T1 DISTRIBUTOR: Medi-Physics, Inc.
(Previously Nycomed Amersham) 900 Durham Avenue ' South Plainfield, NJ 07080 MANUFACTURER: AEA Technology QSA GMbH < D-38110 Braunschweig Germany ISOTOPE: MAXIMUM ACTIVITY: Cesium-137 80 millicuries (2.96 GBq) LEAK TEST FREOUENCY: 6 months l (V) General Medical Use PRINCIPAL USE: I CUSTOM SOURCE: YES X NO 9906230258 990622 " PDR RC e SSD , , PDR s
l REGISTRY OF RADIOACTIVE SEnLED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN I'PS ENTIRETY) NQ1 NR-136-8-255-8 DATTji JUN 2 21999 PAGE 2 OF 7 SQURCE TYPE: Brachytherapy Source DESCRIPTION: The active material in these sources is Cs-137 as a carbonate which is incorporated by smelting into a solid borosilicate glass matrix. This matrix is formed into solid glass beads which are highly insoluble and from which the Cs-137 cannot be leached. The beads are then sized to make a good fit within the narrow bore 316L stainless steel tubing which has been previously laser welded on one end. After the glass beads are loaded into the primary capsule, the other and is plugged and laser welded. The inner capsule is then inserted into an outer capsule manufactured fram 316L stainless steel. The outer capsule is sealed by laser welding of a plug. Sources manufactured prior to April 1, 1991, contain active material in the form of cesium chloride in the form of a powder mixed with zirconium and sintered at a high temperature. Sources ! manufactured before this date also had inner capsule plugs sealed by brazing rather than welding. The loading tolerance of active material is 110% of the nominal activity, not to exceed the stated maximum activity for these sources. The-overall dimensions of these sources are as follows: Overall maximum length 20.5 mm (0.807") Length of active material 13.5 mm (0.532") Overall maximum diameter 2.67 mm (0.105") Minimum combined wall thickness 0.46 mm (0.018") For detailed drawing of the source design, including all dimensions and tolerances, see Attachment 2. Each source is individually packed in a plastic tube which is then placed in a lead container. The lead container is supported within intermediate packaging components inside an outer transport container, the design of which is tested to demonstrate conformity with the U.S. DOT requirements for a Type A package. The package is not intended for use for long term storage, i l l l
1 1 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) HQ1 NR-136-s-255-8 DATE: JUN 2 2 Iggy PAGE 3 OF 7 SOURCE TYPE: Brachytherapy Source LABELING:
- Due to small physical dimensions of these sources, the amount of legible information which can be provided on the surface of the outer capsule is extremely limited. All sources are permanently marked with the following information.
- 1. Unique serial number (engraved)
- 2. Rings (Electro Etched) which corresponds to specific product codes, model numbers and source activity.
A key to the electro etched rings is provided in Attachment 1. The lead container and the intermediate container (sealed can) in which each source is transported is labeled with the following:
- 1. The distributor's name
- 2. The Isotope (Cesium-137)
- 3. The words " Caution" " Radioactive Material"
- 4. The product code The intermediate container (sealed can) is labeled in accordance with the requirements of 10 CFR 32.74. The outer container is marked in accordance with the requirements of the U.S. DOT for Type A container.
DIAGRAM: 1 An engineering drawing (VZ-1271/4E) is included as Attachment 2. CONDITIONS OF NORMAL USE: These sources are specifically intended for medical use in conditions that are consistent with a medical environment. l
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) NO: NR-136-S-255-S DATE: J H 2 2 lpgg PAGE 4 OF 7 SOURCE TYPE: Brachytherapy Source J l I
, CONDITION OF NORMAL USE: (CONTINUED)
The sources are to be used either in applicators (e.g., Fletcher-Suit or Heyman applicators for intracavity use) or, on occasion, for direct interstitial implantation in the treatment of various forms of cancer. These sources are not expected to be subjected to excessive extremes of temperature, physical shock or to corrosive environments. These sources should also not be subjected to long term exposure to materials such as plastics which may degrado due l to radiation exposure and create corrosive agents. Sources should be removed from shipping containers designed for short j term storage to shielded stainless steel containers for long term ' storage. These sources are not to be subjected to conditions more extreme than those specified by a classification of ANSI N44.1 and ANSI N44.2, 1973, for brachytherapy sources. The manufacturer's recommended working life of these sources is 10 years. PROTOTYPE TESTING: The VZ-1271/4E design as shown in the drawing provided as Attachment 2 has been subjected to tests in accordance with ISO 2919, ANSI N542, ANSI N44.1 and ANSI N44.2 and has attained the classification of C64344. A copy of QKQ 221, the certificate of sealed source integrity, is provided in Attachment 3. Prototype testing of these sources included the impact test described under section 8.4 of ISO 2919. This test involves the striking of the source with a hammer rather than the 9 meter (30 feet) drop test specified under ANSI 44.1 for brachytherapy sources. However, there is a footnote to section 8.4 at the bottom of page 5 of ISO 2919 which states " Paragraph 748 of Advisory material for the application of the IAEA transport regulations, IAEA Safety Series No.~37, accepts impact test class 4 performed with a hammer with a mass at least greater than ten times that of the source plus contents to be equivalent to the percussion and an impact test
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE J (AMENDED IN ITS ENTIRETY) HQ1 NR-136-S-255-S DATE: JUN 2 21999 PAGE 5 OF 7 SOURCE TYPE: Brachytherapy Source PROTOTYPE TESTING: (CONTINUED) required for special form material given in IAEA Safety Series No. 6, " Regulations for the safe transport of radioactive materials." The special form impact test is a 9 meter (30 feet) drop test. EXTERNAL RADIATION LEVELS: Radiation exposure rates were measured at specific distances from a 69.1 mci (2.56 GBq) source and the following rates subsequently calculated for the maximum activity of 80 mci (2.96 GBq) as follows: DISTANCE EXPOSURE RATE 5 cm (1.97") 10.420 R/hr ( 2 . 69x10-3 Ckg4 /hr) 10 cm (3.94") 2.605 R/hr (6.72x10 Ckg4/hr) 30 cm (11.81") 255 mR/hr (6.58x104 Ckg 4/hr) 100 cm (39.37") 24 mR/hr (6.19x104 Ckg4/hr) OUALITY ASSURANCE AND CONTROL: 1 These sources are designed, manufactured and tested according to l AEA Technology QSA's QA Program under ISO 9001 described in their Quality Assurance Manual, Revision 0, dated August 1, 1998. Finished sources are leak tested by bubble and immersion testing. The distributor has established QC procedures which are conducted upon receipt of sources from the manufacturer to ensure that they are visually inspected, leak tested, and packaged with the correct labeling to ensure distribution to end users in accordance with the conditions established in the sealed source reristration. Sources are also wipe tested to ensure that removable activity is less than 0.005 pCi(185 Bq). Each shipment will be accompanied by a sealed source test report as well as unpacking and handling instructions.
r. l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMEND 1ED IN ITS ENTIRETY) l NQ1 NR-136-8-255-8 DATE- # 2 2 ISIS PAGE 6 OF 7 SOURCE TYPE: Brachytherapy Source LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
- 1. The sources shall be distributed only to persons specifically licensed by the U.S. NRC or an Agreement State.
- 2. The source shall be leak tested at six-month intervals using techniques capable of detecting 0.005 microcurie (185 Bq) of removable contamination.
l l
- 3. Handling, storage, use, transfer and disposal: To be l determined by the licensing authority.
i
- 4. The sources shall not be subjected to environment or other conditions of use which exceed the test specifications for l selected brachytherapy sources contained in ANSI N44.1 and l l
ANSI N44.2, 1973. 1
- 5. This registration sheet and the information contained within the references shal] not be changed without the written I
consent of NRC. 1. l SAFETY ANALYSIS
SUMMARY
Based on our review of the information and test data submitted by Medi-Physics Inc. (Previously Nycomed Amersham) for source design Model CDC.T1, we continue to conclude that the source should l maintain its integrity for normal use and accidental conditions which might occur.
REFERENCES:
The following documents for the Model CDC.TI are hereby incorporated by reference and are made a part of this registry i document:
- 1. Amersham Corporation's letters dated October 28, 1983 and January 8, 1992, with enclosures thereto.
i l l
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) HQ1 NR-136-8-255-S DATE: JUN 2 21999 PAGE 7 OF 7 SOURCE TYPE: Brachytherapy Source l
REFERENCES:
(CONTINUED)
- 2. Amersham Corporation's letters dated November 19, 1985, May 15, 1990, and July 17, 1990, with enclosures thereto. ;
l \
- 3. Amersham Corporation's letters dated February 27, 1991, !
August 2, 1991, and December 5, 1991, with enclosures j thereto. '
- 4. Amersham Corporation's letters dated February 8, 1999 and l March 1, 1999, with enclosuras thereto.
ISSUING AGENCY: i U.S. Nuclear Regulatory Commission l l I Date: JUN 2 21999 _ Reviewer: ' M S. Bhachu
~
l l Date: JUN 2 21999 Concurrence: M) ' l 'Seung JI Lee 1 i l l L
(. l i. l ! REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) F_Q.;. NR-136-S-255-S DATE: JUN 2 21999 ATTACHMENT 1 l Source Rina Details For Cs-137J Tubes, Each ring indicates a 5 mg radium equivalent. l Product Code CDCSJ1 O 463 MBq (12.5 mci) I Product Code CDCSJ2 0 925 mBq (25 mci) Product Code CDCSJ3 0 1.39 GBq (37.5 mci) j n V Product Code CDCSJ4 l.85 GBq (50 mci)
"' '" ' d' ' 'S "
0 2.31 GBq (62.5 mci) L_
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) HQL NR-136-S-255-S DATE: JUN 2 2 till ATTACHMENT 2 Model CDC.T1, Drawina VZ-1271/4E o z.6510.02 l [ [ weld s s l s Es-137 in form of glass
.!3
- s N
- s type activity
- Is J1 463MBa s js J2 925MBo s > J3 1388MBa s : J4 1850MBa m , y
- ' JS 2313MBq
?, M R :s wall 0.510.0 /-
' I s/ ring marked by I
{s electro-etching
- s .
s -
;y engraving s qf s \ weld ls V4%?1
-__. . _ - . _ _ _ - - . Y
..n l
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) F_Q,;_ NR-136-S-255-S DATE: M III ATTACHMENT 3 Certificate of Radioactivity Source Intecrity Renort OKO 221 l CERTIFICATE OF RADI0 ACTIVE SOURCE INTEGRITY cxo 221 iltle: Cs-137 tubes, types J1, J2 J3, J4, J5 Asses 01y drawing: VZ-1271/4E Nuclide: Caesium-137 ( Radictoxicity group: Bl. 3 Maximum activity: 3 GBq l CLASSIFICATION: c.64444 l i Test sources: 5 specisen sources, type J2 according to drawing VZ-1271/4E. No.1 5.41 MBq; No.3 4.01 MBq: No.4 4.01 MBq; No.5 3.38 MBq; No.6 4.04 MBq. Tests carried out in accordance with Reconnendation of: 85 5288: ISO 2919: ANSI N542: DIN 25 426, part 1: ( Leak test TEMP (RATUR[ PRES $URE IMPACT VIBRATION PUNCIURC method 6 4 4 Units 4 4
!seersion 41 <1 <1 <g <, g test (1 41
<1 <. g <g B4 l
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......../.{........ June 17, 1991
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) HQ1 NR-136-s-255-S DATE: JH 2 2 tils ATTACHMENT 4 WARNING Label for Lend Containerand Intermediate Container WARNING The radiation nource in thh container is for medical use only and can be EXTRE% ILLY DANGEROU5 if improper 13 used. The nource should onl3 he remosed and handled by trained, licensed persom, DO NOT USE TIIE ENCLO5ED $OURCE UNTIL TIIE PACKAGE INSERT llAS BEEN READ AND UNDERs100D BY Tile U$ER. Do not remote or destroy this label. 273514C
** Distributed by:
ph g "" \ledi Phpio,Inc. 9tMi Durham Asenue 9 e W ni houth Plainfield, NJ 070M0
- l0 F l *MM54411N Sin m$ FAmersham HEALTHCARE
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) l l F_Q;. NR-136-S-255-S DATE: JH 2 21999 ATTACHMENT 5 Source Data Label for Lead Containers ESIUM 137 BRACHYTHERAPY SOURCE 'J' TUBE , Read data sheet before opening this container. Handle this radioactive source with ! GREAT CARE. I Model Number: CDC.Tl Nuclide: Cs-137 S mrce Serial No. Product Co(le Nominal Actitity Ref. Date l
)
I l l l The U.S. Nuclear Regulatory Commission (USNRC) has approved distribution of this brachytherary source to persons licensed to use byproduct material identified in 10 CFR 35.57,35.40(), or 35.500, as appropnate, and to persons a ho hold an equivalent license issued by an Agreement State. Medi Phpics,Inc., 273576C (South Plainfield. NJ 070X0 - J J
c'- . a i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) I ' N_Q1 NR-136-S-255-S DATE: ATTACHMENT 6 Package Insert 4 0 8 4 $ J 1
o i Encapsulated Cesium-137 Sources for Interstitial and intracavitary Brachytherapy Intended Use l The Amersham encapsulated Cesium-137 sources are intended for use in interstitial and intra- i cavitary brachytherapy procedures for the treatment of malignant diseases. WARNING: These devices are intended specifically for medical use and exclusively for use in a medical radi-ological environment. lt is strongly recommended that these source types not be emr..oyed with-out extensive prior clinical experience in their use. They should be stored and locked in a restrict-ed area when not in use and handled only by trained, competent personnel. Sources should not ' be stored or packed in any plastic materials (e.g. PVC, vinyl). Storage in a stainless steel container is recommended. Introduction I Cs-137 brachytherapy sources for intracavitary treatment of certain gynecological malignant dis-eases are manufactured in several encapsulated configurations (tubes, miniature cylindrical sources and source trains). The advantages of performing brachytherapy on malignant diseases usin'g afterloading rather than the earlier pre-loading techniques have been refc 7ed to in the lit-erature."First among these advantages is a significant reduction in dose to the radiotherapist and ancillary staff rendering bedside care. A corollary advantage accrues from the fact that with afterloading greater time and care may be spent introducing and positioning the applicators ' resulting in more precise delivery of radiation to the tumor site. A. The Amersham Cs-137 capsule is designed to be afterloaded into specially designed dome , cylinders for homogeneous irradiation of selected vaginal sites. i The design of the CS-137 capsule ensures uniform isodose in the area around the dome appli-cator and approximates point-source geometry at distances such as those that exist between the source surface and the outside diameter of the dome applicator. Sources may be combined in various treatment modalities. B. Stainless steel encapsulated sources for intracavitary and interstitial therapy are offered in the form of Cs-137 tubes. 1 i t--
r Cesium Tubes Nominal content activity Nominal output Code identification (approx)* engraving Air-kerma rate ("J" tubes) (on eyelet end) I at 1 meter MBq mci pGy/h ! 463 12.5 35.8 CDCS.J1 1 l. 925 25 71.6 CDCS.J2 2 l 1388 37.5 108.5 CDCS.J3 3 1850 50 144.1 CDCS.J4 4 l; I 2313 62.5 179.8 CDCS.J5 5
*This is quoted only for licensing / transport purposes.
Dimensions I CDCS.J type Extemallength 20 mm Active length 13.5 mm Extemal diameter 2.65 mm l Wall thickness 0.5 mm . NRC Model No. CDC.T1 Precautions Before initiating any patient treatment the parties responsible for the use of the referenced rad'i-ation source (s) should ascertain the following: , 1)That there is suitable radiation detection instrumentation available to quantify the exposure j levels present in the vicinity of the source. [
- 2) That all applicable U.S. Nuclear Regulatory Commission and/or Agreement State requirements for possession and use of radioactive materials have been (or can be) met.
- 3) That the patient and/or the patient's family has been thoroughly informed of the hazards atten-dant to the use of radioactive materials in the treatment of cancer.'
Regulatory Responsibilities All institutions licensed for the possession and use of these materials are required to meet cer-tain minimum requirements of the U.S. Nuclear Regulatory Commission or the appropriate Agreement State. Persons in possession of these sources are required by law to meet all such regulatory concems.These include (but are not limited to) the necessity for conducting proper surveys for protection of personnel, for proper room monitoring and posting and for proper accountability and disposition of the radioactive sources. Among the specific requirements for possession of these sources is the need for leak tests to be performed at no less than six-month intervals (10CFR 35.59). Amersham sources are leak tested prior to shipment and the results are included in the shipping papers. , j i
T' b I L Dosage and Administration Extensive training in the application of radioactive sources to given tumor volumes is a strict pre-requisite to their use.Various methods exist for establishing the amount of radiation at a given point.These calculations should only be performed by a physicist or dosimetrist competent in such pacedures."2 Typical isodose curves for these products are illustrated in the section ttled "!sodose , Distribution". All sources should be individually measured. Specific isodose curves for each ! should be calculated after receipt and prior to first use. Cs-137 decays with a half-life of 30.17 l years. Appropriate adjustments need to be made periodically to correct for this effect."* Directions for Use l Federal law prohibits the use of those sources on human subjects without the specific orders of a licensed physician. Cs-137 sources for gynecological intracavitary brachytherapy are intended for use in appropriately designed afterloading devices.These devices are not sterile. Adverse Reactions No adverse reactions subsequent to the use of these sources have been reported to Amersham. However, users of these sources should be familiar with the various seque!ae attendant to radia-tion brachytherapy.'"'
- 1) Somatic effects:
a) Cellular damage. At the cellular level radiation damage ranges from relatively minor sub-lethel effects to complete cell death. At the macro-physiological level these effects can be expressed as a range of damage from erythema to necrosis. i b) Effects on embryonic and fetal development. Users are advised to consult U.S.N.R.C. l Regulatory Guide 8.13 for a thorough discussion of the effects of radiation on the develop-ing embryo and fetus. { c) Carcinogenesis.There exists a body of evidence which suggests that various levels of radi-ation above background may increase the risk of development of one or more forms of can-cer compared to the risk of development of the same cancer (s)in the absence of exposure to the agent. Considerable time may elapse between radiation exposure and the appearance of cancer. (Medical Radiation Biology, Pizzarello, D.J. and Witcofski, R.L, Lea & Febiger, Philadelphia,1982.) d) Cataractogenesis. it is accepted that exposure of the optic lens to a threshold level of radi-ation willinduce cataracts in man. e) Impaired fertility or sterility. Indications of impaired fertility or sterility may be present for extremely high doses of radiation. Generally these conditions are temporary. f) Lifespan shortening. There is inconclusive evidence which shows that life expectancy may be shortened as a consequence of radiation exposure. it is unclear whether the mechanisms are related to an acceleration of the aging process or to oncogenetic effects. 3 1
\
- 2) Genetic effects.There exists some evidence that extremely high radiation doses, delivered at high dose rates, may cause certain mutagenic effects.The mechanisms of this damage are complex and, at present, poorly understood.
Contraindications Irradiation is contraindicated in healthy tissue, especially tissue close to the tumor (treatment) vol-ume. In some cases (e.g., bladder, rectum) these tissues may be particularly sensitive to large doses of radiation. Packaging Cs-137 sources are supplied in containers designed to provide radiological shielding during ship-ping. Upon receipt, these sources should be transferred to a stainless steel container or safe with sufficient shielding.This shielding should be adequate to reduce the dose rates outside the con-tainer to levels within regula*ory limits. The sources are shipped with appropriate paperwork identifying the source by serial number. Any discrepancies between the source serial number, the serial numbers on, the accompanying , shipping papers and the serial numbers on the measurement certificates should be reported IMMEDIATELY to Amersham. Additional packaging information can be found in the section titled " Procedures for Unpacking,
- Transfer and Storage of Medical Brachytherapy Sources".
Lost Sources Normally, misplaced Cs-137 sources can be found easily with an operational Geiger-Mueller detector (with audible ratemeter). Should attempts fail to find a misplaced source within the first few hours after discovery of the loss, IMMEDIATELY notify the appropriate State and/or Federal authorities. Source Construction Some Cs-137 sources with stainless steel e acapsulation are designed to replace older iridio-plat- l inum encapsulated sources. ' l Active Content and Encapsulation The active component of these sources is an insoluble refractory material containing a uniform { dispersion of Cs-137. In some cases, these may be in the form of spherical ceramic beads.The active component is encapsulated in A.I.S.I. 316L type stainless steel.This type of stainless steel 1 is generally accepted as medically approved material exhibiting long-term corrosion resistance. Radionuclidic Purity l Cs-137 is a fission product and contains small quantities of Cs-134 (half life 2.06 years) pro- I duced by neutron irradiation of Cs-133, which is also a fission product. The quantity is usually . less than 0.04% by activity. ll: 4 I e
i l I Nuclear Properties h
- Cs-137 decays by emission of beta particles, with a half-life of 30.17 years, to an isomeric state ,
of Barium 137.The single penergy of 0.66 MeV is a result of the decay of Barium-137m to the I ground state. Identification Tube sources are engraved with a serial number and the appropriate catalog code. l The small size of the sources prevents the engraving of further information. l l Activity Distribution i The uniformity of distribution of radioactive material within each source is checked at an inter-mediate stage of the manufacturing process. Activity distribution is measured for some sources and found to be uniformly distributed throughout the active volume. Isodose Distribution Typical isodose curves and tables have been determined for the whole range of Cs 137 brachytherapy sources and are available on request. Rgure 1 shows the isodose distribution around a tube source of 49 pSv/h,4.90 mR/h at 1 m. Figure 1: Isodose Distribution Around a Tube Source (Scale 1.4:1. Values in rads /h in tissue) F 7 [__\ i so' 1 rad = 0.01 Gy (Gray) f f
'20
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t l { A ) - w\ / l . t L 2 Values k1 fadsM m ttssue j i
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1: 5 l
o l Figure 2:lsodose curves in water around a stainless steel encapsulated Cs 137 source of equiv-alent activity 1.85 GBq,50 mCl (From: Diffey,8.L and Klevenhagen, S.C., "An experimental and calculated dose distribution in water around CDCK-type Cesium 137 sources, Phys. Med. Biol., 1975, Vol. 20 No. 3,446-54). (c m) e 5 4 3 2 1 i M E, ,
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1 rad = 0.01 Gy l Measurement Techniques Laboratory measured sources: Sources are measured in a reentrant ionization chamber which i has been calibrated using a tertiary standard source. I Calibrated sources. The exposure rate from the sources are compared directly with that from a secondary standard source using an ionization chamber in scatter free conditions. We recom-mend that users purchase at least one calibrated Cs 137 source of each type that is ordered. This source can then be used to derive exposure rate vDes for uncalibrated sources of the same type. I Source Activity All Cs-137 medical brachytherapy sources produced by Amersham will be accompanied by a
" Radioactive Source Test Report". This report specifies output in air-kerma rate for each source.
Certification I The results of source measurement and testing are shown on the accompanying " Radioactive Source TestReport". A measurement certificate is also provided with all calibrated sources. Quality Control Quality control checks are carried out at all critical stages in the manufacturing process. 1 Manufacturing procedures are in conformance with the requirements of the Food and Drug i Administration. Source capsules have been tested and approved according to the requirements of the American National Standards Institute (USANSI Reports N44.1,1973 and N44.2,1973) for the testing of brachytherapy sources, and meet or exceed the minimum criteria for these standards. 6
r ) Leakage and Contamination Testing All sources are tested for leakage and contamination prior to dispatch. Testing details are provid-i ed on test reports supplied with the sources. The following tests are carried out on Cs-137 tubes: : Wipe test A: The source is wiped with a swab or tissue, moistened with ethanol or l j water; the activity removed is measured. Pass limit 185 Bq,0.005 Ci. Immersion test L: The source is immersed in water at 50*C for 4 hours and the activity in the water is measured. Pass limit 185 Bq,0.005 Ci. Procedures for Source Cleaning Sources may be cleaned by washing with any mild soap solution and hot water. lf surface debris is difficult to remove, sources may De soaked in a solution Of hydrogen peroxide (to remove dried blood) or in xylene (to remove mold material). Ultrasonic cleaning baths operating at frequencies within the range 25-40 kHz may be used with safety. Proprietary cleansing agents may be used 2 safely in concentrations recommended by the manufacturer. Wet steam autoclaving at 202.7 kilopascals (1.52 m Hg) total pressure and hot air sterilizing ovens may be used for heat sterilization techniques provided that a cut-out mechanism is fitted to prevent the temperature from using above 180*C. Procedures for Unpacking, Transfer and 1 Storage of Medical Brachytherapy Sources The transport containers are designed to make it easy for the user to remove sources using appropriate safety precautions. However, such source movements should only be carried out by persons who understand the precautions to be taken when working with radiation and are fully informed about the operations they are about to perform. ' The following instructions refer to the containers used to transport medical radiation sources. They explain:
-What to do on receipt of the package
- How to unpack the source
- Specific precautions to be taken
- Notes for general guidance On Receipt of Package 1 ) Check that all documentation, including label description, agrees with the acknowledgement of order. lf there are any discrepancies, please notify Medi-Physics, Inc. Amersham Healthcare or its representatives as soon as possible.
- 2) Notify the local Health Physicist or designee that the pacbge has arrived.
- 3) If the package is not to be opened immediately, a suitable and secure store must be provided.
This storage shall be reserved for radioactive materials only and must be adequately shielded and labeled. 7
1 l Unpacking Procedures The source should be unpacked in a designated area by author! zed trained personM anly. THE SECTIONS ON PRECAUTIONS AND GENERAL GUIDANCE SHOULD BE READ CAREFULLY BEFORE COMMENCING TO UNPACK THE SOURCE. Preparation for using the sour:e or transferring it to a storage facility should be made prior to unpacking the source. Radiation levels should be checked using an exposure-rate meter at each stage of the unpacking.The exposure rate on the surface of the package may be as high as 5.16 x 104 C Kg'/h,200 mR/h and levels encountered at each stage of the unpacking will get pro-gressively higher. Os-137 Tubes OUTER AND INNER CONTAINMENT i) Open the outer container and amove any intemal packing (see Agure 3). Figure 3: WC Pot /R-Can/0818 Drum Assembly e l e eEs , g_ 'N w =--u 152E25 v \ Packmg EPS Dec Packmo EPS Disc Yesow RAM Taos Potsyrene h Eneap camum Jiuo. Lua Pat Pichmo EPs one CESIUM J-TUBE LEAD POT (WC POT) DIMENSIONS Cavity (Diameter x Height)(mm) WC Pot (Width x Height)(mm) Approximate Weight (kg) Pb Shielding (mm) 20.6 x 51 95.25 x 137.4 38 11 0
- 1. Carefully unfasten the retaining ring from the 0818 dmm and remove lid.
- 2. Remove the top foam end cap and lift the R-can from the bottom foam endcap. '
- 3. Peel off tapa and lift open the R-Can tid.
- 4. Remove the internal EPS discs.
- 5. Lift out the lead pot, peel off tape and unscrew the lid.
- 6. Remove the foam discs or plastic top from the inner plastic tube using long forceps.
- 7. Carefully remove the source using long forceps.
- 8. Verify identity of source and place in proper storage area or application device.
8 i. e
)
i inspection The sources should be inspected immediately following removal from the inner containment, tak-ing care to restrict personnel (dose levels by the use of suitable shielding and viewing using mag- i
- nification. Any damage or other causes for concem should be reported to Medi-Physics, Inc.
Amersham Healthcare without delay. l Specific Precautions to be Taken ' GAMMA EMlTTING NUCUDES
- 1) Do not touch the source with tlw hand. Always use forceps. To minimize the radiation dose to operator's hands, the lower activity sources should be handled using forceps of at least 30 cm in length. Other remote manipulators should be used for the higher activity sources.
- 2) Whenever possible, the sources should be handled behind lead shields and viewed through a lead glass window or mirror system. A magnifier should be used for detailed visual inspection.
l
- 3) Although these sources are classified as sealed sources, it is prudent to make regular checks i for surface contamination in the areas where these sources are handled and on any equipment or apparatus with which they come into contact.
I
- 4) To avoid any possible corrosion, it is recommended that the source not be packed or stored in close proximity to a halogenated plastic material for a long period of time.
Notes for General Guidance 1 These sources have all been designed to prevent surface contamination and leakage of activity and they are classified as sealed sources as defined in DOT regulations. l These sources must be unpacked or transferred from their transport container to shielded stain-less steel storage containers by fully trained and authorized persons only. For all source movements outside the shielding of the transport container, the following points should be noted:
- 1) An exposure rate meter should always be readily available and used to check exposure calcu-lations. It is also essential to have one available in case of mishaps.
- 2) The source should always be handled indirectly using remote handling tools.
- 3) Reduce exposure to personnel by the use of shielding, distance and time as follows:
a) Shielding Whenever possible, percons moving radiation sources should always work behind radiation shields. In general, the best radiation shields for gamma radiation are made from dense, high atomic number materials, such as lead. The effectiveness of lead shielding for Cs 137 is shown, in terms of thickness of material required for a given treism!G n factor, in Table 1. O h 9 l
r, 1
)
Table 1 a) b) I Radionuclide Transmission Factor Transmission Factor ! 0.50.10.010.001 0.50.10.01 Thickness of Lead mm Thickness of Concrete mm Cs-137 7.5254767 155 285 460 In cases where it is not possible or convenient to work behind radiation shields, maximum dis- , tance and minimum time must be used to keep personnel exposure to a minimum but remem-ber that all materials provide some sort of radiation shielding providing they are between you and the source. Even conctete walls can provide useful additional screening as shown in Table 1b and advantage of this should be taken whenever possible. f Sources should not be permanently stored in their transport container without the use of addi- , tional shielding. Permanent storage is normally best achieved by the use of a purpose built stor-age cell or container, b) Distance l Reduction of dose using distance can be very effective and therefore should be , used to advantage whenever possible. Distance protection is based on the inverse square law. Quite simply, if the dis, , tance is halved the dose will go up by a factor of 4 and if the distance is doubled the dose will be reduced to 0.25 of its original value. Table 2 gives examples of variations of dose rate with distance from poin sources for typical activities: Toole 2
. . i . i. i.
100 m,Q F 8ee i ES 1 LS
,.:" L"', '. lL lL S i. lL E 1. lL l', i.
The values given in Table 2 indicate quite clearly why sources should never be touched by hand and why forceps of at least 30 cm in length should be used when handling them. c) Time The third factor which can help to reduce exposure to radiation is time. The total dose received during any operation involving radiation sources is directly pro-portional to the time taken to carry out the operation. Good planning always helps to reduce exposure time to a minimum. 10 L
l 1 - l References I 1 ) Fletcher, G.H., Textbook of Radiotherapy, Second Edition. Philadelphia, Lea & Febiger, (1973). !
- 2) Green, A.E., Broadwater, J.R. and Hancock, J.A., Afterloading vaginal ovoids, American Joumal l l
OfRoentgenology, 105,609-613,(1969). l
- 3) Haybittle. J.L. and Mitchell, J.S., A simple afterloading technique for the treatment of cancer of I the cervix, British Joumal of Radiology, 4B, 295-298, (1975). j
- 4) Use of small sealed sources in radiotherapy. Report of an IAEA panel. Radiology, 86, 1 154-156,(1967).
- 5) Wilson. J.F., The role of radiation therapy in endometrial cancer. JAMA, 244, 1937-1939, I (1980).
- 6) Code of practice for the protection of persons against ionizing radiations for medical and dental use,3rd edition. London, Department of Health and Social Secuity.138 pp., (1972).
- 7) AAPM Report No. 21. Specification of brachytherapy source strength, American Association of Physicists in Medicine by the American Institute.of Physics,(1987). I
- 8) Meredith, W.I., Radium dosage: the Manchester system,2nd edition, Edinburgh, E. and S. )
Uvingstone Ltd.,134 pp.,(1967). {
- 9) Paterson, R.,The treatment of malignant disease by radiotherapy,2nd edition, London, Edward l Amold (Publishers) Ltd., 556 pp., (1963).
- 10) Pierquin, B., Wilson, J.F., and Chassagne, D., Modem Brachytherapy, New York, Masson pub-lishing USA, Inc., (1987). l
- 11) Read, LR., Bums, J.E., and Liquorish, R.A.C., Exposure rate calibration of small radiatior, sou,rces of Cobalt-60, Radium-226 and Cesium-137, Intemational Joumal of Applied Radioisotopes, 29, 21-27,(1978).
- 12) Saylor, W.L and Dilland, M., Dosimetry or Cesium-137 sources with the Fletcher-Suit gyne-cological applicator, Med. Phys., 3, (1976)
- 13) Shalek, R., Stoval, M., The M.D. Anderson method for computation of isodose curves around interstitial and intracavitary radiation sources. American Joumal of Roentgenology, 102, 602-672,(1968).
- 14) Horster, A.F.C., Jones, J.C., and Stacey, A.J., Cesium-137 sources for use in intracavitary and interstitial radiotherapy, British Joumal of Radiology, 37, 385-390,(1964).
- 15) Intemational Atomic Energy Agency, Physical aspects of radioisotope brachytherapy.
Report of a panel on physical aspects of interstitial, intracavitary and surface therapy with scaled radioisotopes, held in Vienna 20-24 June 1966. Vienna, IAEA,63 pp., (1967).
- 16) International commission on Radiological Units and Measurements, Dose and volume speci-fication for reporting intracavitary therapy, ICRU, Report 38, Bethesda, MD, (1984).
- 17) Jones, J.C., and Stacey, A.J., Cesium sources for interstitial and intracavitary therapy, British Joumal of Radiology, 38, 870,(1965). Radioactivity, Recommendations of the international Commission on Padiological Units and Measurements, (ICRU) Report 10C, Washington, D.C.,
National Bureau of Standards,52 pp.,(1962).
- 18) Kjellgren, O. and Jonsson, L, Further development of the Heyman radium packing method, Acta Radiologica: Therapy, Physics, Biology, 3,143-151, (1965).
- 19) National Council on Radiation Protection and Measurement Specification of gamma-ray brachytherapy sources, Washington, (NCRP Report No. 41),24 pp.,(1974).
- 20) Pizzarello, D.J.,Witcoiski, R.L., MedicalRadiation Biology, Philadelphia, Lea & Febiger, (1982).
- 21) Results of 8056 cases of carcinoma of cervix uteri treated by irradiation, clinical use of Peking type applicator, Advances in Medical Oncology Research and Education, 6, Basis for Cancer ther-apy 2, edited by M. Moore, Pergamon Press, Oxford and N.Y., (1979).
11
r 1 i Encapsulated Cesium-137 Sources for Interstitial and intracavitary Brachytherapy i TAmersham HEALTHCARE Medi-Physics, Inc., 900 Durham Avenue South Plainfield, NJ 07080 Customer Service: 1-800-633-4123 Professional Services: 1-800-654-0118 277785C Revised February 1999
? c. i' o (), June 22, 1999 Mr. Mark A. Doruff, CHP ' l Director, Environment and Safety Regulatory Affairs Nycomed Amersham 2636 South Clearbrook Drive : - Arlington Heights, IL 60005
Dear Mr. Doruff:
i Based on your letter dated January 26,1998 and February 8,1999, we have amended in its entirety and transferred registration certificate IL-136-S-225-S from Nycomed Amersham (the l' previous owner) to Medi-Physics, Inc. Southfield, New Jersey. Please note as the new location of operations is within NRC'S jurisdiction, therefore, we have allocated a new registration certificate number. The new r9gistration certificate number is NR-136-S-225-S. Please be advised that you must manufacture and distribute the product in accordance with the statements and representations contained in the application submitted by Nycomed Amersham, with enclosures thereto, and the information set out in the enclosed 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 registration certificate. You are obligated to nctKy us promptly in writing should you decide to no longer manufacture or offer service support for the product.
I Please be aware that, as a holder of an NRC registration, you may be subject to the NRC's
. licensing 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) 415-6096.
Please read over the registration certificate in its entirety and notify us immediately of any errors ! or omissions. If you have any questions, please contact me at (301) 415-7894 or Mr. Seung Lee on (301)415-5787. Sincerely, l
/s/ 1
- Ujagar S. Bhachu, Mechanical Engineer Materials Safety and inspection Branch Division of Industrial and Medical Nuclear Safety i l
Office of Nuclear Material Safety and Safeguards
Enclosure:
- As stated cc w/ encl: SKimberley, LFDCB l Distribution: y. SSS r/f . SSD-98-96 NE01.R DOCUMENT NAME: P:\MDURUFF.COVCON NR-136-S-255-S l- T. h,. . .e vii. 4 . ina m in. b.c c - copy without .tt.cntn.nti.ncio.ur. s - copy with tt. chm.nt/.ncio.ur. n - no em OFFICE MSIB _ lC MSIB l E l ~ 11ARhanho IL V NAME SLEE (p/ l DATE- 06/ /99 06/ /99 l l
@ MOM p l
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)
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) I i M 2 2 ISOS PAGE 1 OF 7 HQ1 NR-136-8-255-S DATE: l SOURCE TYPE: Brachytherapy Source MODEL: CDC.Tl DISTRIBUTOR: Medi-Physics, Inc. (Previously Nycomed Amersham) 900 Durham Avenue South Plainfield, NJ 07080 MANUFACTURER: AEA Technology QSA GMbH D-38110 Braunschweig Germany l l ISOTOPE: MAXIMUM ACTIVITY: ' Cesium-137 80 millicuries (2.96 GBq) l LEAK TEST FREOUENCY: 6 months PRINCIPAL USE: (V) General Medical Use CUSTOM SOURCE: YES X NO t qq# 330M Y
m REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) NQ1 NR-136-8-255-8 DATE: JUN 2 21999 PAGE 2 OF 7 SOURCE TYPE: Brachytherapy Source DESCRIPTION: i The active material in these sources is Cs-137 as a carbonate which is incorporated by smelting into a solid borosilicate glass matrix. This matrix is formed into solid glass beads which are highly insoluble and from which the Cs-137 cannot be leached. The beads are then sized to make a good fit within the narrow bore 316L stainless steel tubing which has been previously laser welded on one end. After the glass beads are loaded into the primary capsule, the other.end is plugged and laser welded. The inner capsule is then inserted into an outer capsulo manufactured. from 316L stainless steel. The outer capsule is sealed by laser ' welding of a plug. l Sources manufactured prior to April 1, 1991, contain active ; material in the form of cesium chloride in the form of a powder I mixed with zirconium and sintered at a high temperature. Sources manufactured before this date also had inner capsule plugs sealed by brazing rather than welding. The loading ~ tolerance of active material is 110% of the nominal activity, not to exceed the stated maximum activity for these sources. The overall dimensions of these sources are as follows: Overall maximum length 2 0. 5 nua ( 0. 8 07 " ) Length of active 'erial 13.5 mm (0.532") Overall maximum (Em.eter 2.67 mm (0.105") Minimum combined w il thickness 0.46 nua (0.018") For detailed drawing of the source design, including all dimensions and tolerances, see Attachment 2. Each source is individually packed in a plastic tube which is then placed in a lead container. The lead container is supported within intermediate packaging components inside an outer transport container, the design of which is tested to demonstrate conformity with the U.S. DOT requirements for a Type A package.
- The package is not intended for use for long term storage.
I
. l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) l NO: NR-136-s-255-S DATE: J## 2 2 gg PAGE 3 OF 7 I SOURCE TYPE: Brachytherapy Source LABELING: -
l Due to small physical dimensions of these sources, the amount of legible information which can be provided on the surface of the outer capsule is extremely limited. All sources are permanently marked with the following information.
- 1. Unique serial number (engraved) l I
2.
^
Rings (Electro Etched) which corresponds to specific product codes, model numbers and source activity. , l A key to the electro etched rings is provided in Attachment 1. I The lead container and the intermediate container (sealed can) in which each source is transported is labeled with the following: j
- 1. The distributor's name
- 2. The Isotope (Cesium-137)
- 3. The'words " Caution" " Radioactive Material"
- 4. The product code The intermediate container (sealed can) is labeled in accordance with the requirements of 10 CFR 32.74. The outer container is marked in accordance with the requirements of the U.S. DOT for Type A container.
DIAGRAM: An engineering drawing (VZ-1271/4E) is included as Attachment 2. CONDITIONS OF NORMAL USE: These sources are specifically intended for medical use in conditions that are consistent with a medical environment.
t REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (ANENDED IN ITS ENTIRETY) HQ1 NR-136-S-255-S DATE: JUh 2 2 lggg PAGE 4 OF 7 SOURCE TYPE: Brachytherapy Source CONDITION OF NORMAL USE: (CONTINUED) The sources are to be used either in applicators (e.g., Fletcher-Suit or Heyman applicators for intracavity use) or, on occasion, for direct interstitial implantation in the treatment of various forms of cancer. These sources are not expected to be subjected to excessive extremes of temperature, physical shock or to corrosive environments. These sources should also not be' subjected to long term exposure to materials such as plastics which may degrade due to radiation exposure and create corrosive agents. Sources should be removed from shipping containers designed for short term storage to shielded stainless steel containers for long term ; storage. These sources are not to be subjected to conditions more extreme than those specified by a classification of ANSI ,
- N44.1 and ANSI N44.2, 1973, for brachytherapy sources. The manufacturer's recommended working life of these sources is 10 years.
PROTOTYPE TESTING: The VZ-1271/4E design as shown in the drawing provided as Attachment 2 has been subjected to tests in accordance with ISO 2919,' ANSI N542, ANSI N44.1 and ANSI N44.2 and has attained the classification of C64344. A copy of QKQ 221, the certificate of sealed source integrity, is provided in Attachment 3. Prototype testing of these sources included the impact test described under section 8.4 of ISO 2919. This test involves the striking of the source with a hammer rather than the 9 meter (30 feet) drop test specified under ANSI 44.1 for brachytherapy sources. However, there is a footnote to section 8.4 at the bottom of page 5 of ISO 2919 which states " Paragraph 748 of Advisory material for the application of the IAEA transport regulations, IAEA Safety Series No. 37, accepts impact test class 4 performed with a hammer with a mass at least greater than ten times that of the source plus
- contents to be equivalent to the percussion and an impact test
L l l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (ANENDED IN ITS ENTIRETY) HQ1 NR-136-S-255-S DATE: JUN 2 21999 PAGE 5 OF 7 SOURCE TYPE: Brachytherapy Source PROTOTYPE TESTING: (CONTINUED) required for special form material given in IAEA Safety Series No. 6, " Regulations for the safe transport of radioactive materials." The special form impact test is a 9 meter (30 feet) drop test. EXTERNAL RADIATION LEVELS: Radiation exposure rates were measured at specific distances from a 69.1 mci (2.56 GBq) source'and the following rates subsequently calculated for the maximum activity of 80 mci (2.96 GBq) as follows: DISTANCE EXPOSURE RATE 5 cm (1.97") 10.420 R/hr ( 2 . 69x10-3 Ckg4 /hr) 10 cm ( 3 . 94 " ) 2.605 R/hr (6.72x104 Ckg4/hr) 30 cm (11.81") 255 mR/hr (6.58x104 Ckg4/hr) 100 cm (39.37") 24 mR/hr (6.19x10-8 Ckg4/hr) OUALITY ASSURAhCE AND CONTROL: j These sources are designed, manufactured and tested according to AEA Technology QSA's QA Program under ISO 9001 described in their ; Quality Assurance Manual, Revision 0, dated August 1, 1998.
~
Finished sources are leak tested by bubble and immersion testing. The distributor has established QC procedures which are conducted upon receipt of sources from the manufacturer to ensure that they are visually inspected, leak tested, and packaged with the correct labeling to ensure distribution to end users in accordance with the conditiona established in the sealed source registration. Sources are also wipe tested to ensure that removable activity is less than 0.005 pCi(185 Bq). I ( Each shipment will be accompanied by a sealed source test report i as well as unpacking and handling instructions. i
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) NQ1 NR-136-8-255-8 DATE: 22I89I PAGE 6 OF 7 SOURCE TYPE: Brachytherapy Source LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
- 1. The sources shall be distributed only to persons specifically licensed by the U.S. NRC or an Agreement State.
- 2. The source shall be leak tested at six-month intervals using techniques capable of detecting 0.005 microcurie (185 Bq) of removable contamination.
- 3. Handling, storage, use, transfer and disposal: To be determined by the licensing authority.
- 4. The sources shall not be subjected to environment or other conditions of use which exceed the test specifications for selected brachytherapy sources contained in ANSI N44.1 and ANSI N44.2, 1973.
- 5. This registration sheet and the information contained within ;
the references shall not be changed without the written consent of NRC. SAFETY ANALYSIS
SUMMARY
Based on our review of the information and test data submitted by Medi-Physics Inc. (Previously Nycomed Amersham) for source design Model CDC.T1, we continue to conclude that the source should maintain its integrity for normal use and accidental conditions which might occur.
REFERENCES:
The following documents for the Model CDC.TI are hereby incorporated by reference and are made a part of this registry document:
- 1. Amersham Corporation's letters dated October 28, 1983 and January 8, 1992, with enclosures thereto.
l
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES , SAFETY EVALUATION OF SEALED SOURCE I (ABENDED IN ITS ENTIRETY) l l DATE: JUN 2 21999 NO: NR-136,5-255-S PAGE 7 OF 7 SOURCE TYPE: Brachytherapy Source l l
REFERENCES:
(CONTINUED)
- 2. Amersham Corporation's letters dated November 19, 1985, May l 15, 1990, and July 17, 1990, with enclosures thereto. !
- 3. Amersham Corporation's letters dated February 27, 1991, 1 August 2, 1991. and December 5, 1991, with enclosures thereto.
- 4. Amersham Corporation's letters dated February 8, 1999 and Narch 1, 1999, with one.' ares thereto.
ISSUING AGENCY: U.S. Nuclear Regulatory Commission Date:: 2 ISSI Reviewer: ME ' A g C S. Bhachu Date: JUN 2 2 ;999 Concurrence: . m <
'Seung JI Lee
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) hQi NR-136-S-255-S DATE: J H 2 2 1999 ATTACHMENT 1 Source Rina Details For Cs-137J Tubes, Each ring indicates a 5 mg radium equivalent.
"'*d" d* C '
0 463 MBq (12.5 mci) Product Code CDCSJ2 0 925 uus a5 mCo 4 Product Code CDCS13 0 1.39 GBq (37.5 mci) Product Code CDCSJ4 0 1.85 GBq (50 mci) Product Code CDCSJ5 0 2.31 GBq (62.5 mci) I i l
p l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) NO: NR-136-S-255-S DATE: Juli 2 21999 ATTACHMENT 2 Model CDC.T1, Drawina VZ-1271/4E l 02.65:0.02 I ll Weld s , Es-137 in form of glass h
- s N
- s type activity N 463MBa s J1 )
s s, , ( J2 J3 925MBo 1388MBa s :' J4 1850MBq m :' JS 2313MBq ci
+1 9
m N -
/s l
R :s wall 0 5 i').04 s/ ring marked by N {s electro-etching s . s g engravmg N ' f
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s {sN weld mr, . x,I N a I' l , ~ l $ h b
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) F_Q1 NR-136-S-255-S DATE: JUN 2 21999 ATTACHMENT 3 Certificate of Radioactivity Source Intearity Report OKO 221 CERTIFICATE OF RADI0 ACTIVE SOURCE INTEGRITY cro 221 litle: Cs-137 tubes, types J1 J2, J3, J4, J5 Assembly drawing: VZ-1271/4E Nuclide: Caesius-137 ( tadiotoxicity group: 81, 3 Maximus activity: 3 GBq CLASSIFICATION: C.64444 Test sources: 5 specisen sources, type J2 according to drawing VZ-1271/4E. No.1 5.41 NBa; No.3 4.01 M8q: No.4 4.01 NBq: No.5 3.38 MBq; No.6 4.04 N0q. Tests carried out in accordance with Recoseendation of: 83 5288:
!$0 2919:
ANSI M542: 0%N 25 426, part 1: Leak test TEMPERATURE PRES $URE IMPACT VI8tATION PUNCTURE method 6 4 4 4 4 ns lasersion 41 <1 <1 <1 <1 test <. 1 41 ,
<1 <. I <1
.m ... .....h.p/.f........
.. Jua* 17. 1991 ((
- d...II6 Pa..f.' a... * - * ...................... ..../3..#.....
v REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE 7 (AMENDED IN ITS ENTIRETY) i i N_Q_; NR-136-S-255-S DATE: M 2 2 E8 ATTACHMENT 4 WARNING Label for Lead Containerand Intermediate Container WARNING The radiation source in this container is for medical use unis and can be EXTRE\lELY DANGEROL'5 if improperly used. The source should only be remoted and handled by trained. Iicenwd persons. DO NOT U5E Tile ESCLO$ED SOURCE UNTIL Tile PACKAGE INSERT llA5 flEEN READ ASD LSDERSTOOD fly Tile L5ER. Do not remose or destro3 this label. 273514C {p *4 70 Distributed by: j \ledi-Phpio. Inc
. .3 'NN) Durham Atenue south Plainfield. NJ 070NO l MIMM54-01IN 93 ., na cs, FAmersham HEALTHCARE
e REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) NO: NR-136-S-255-S DATE: JUN 2 21999 ATTACHMENT 5 Source Data Label for Lead Containers CESIUM 137 BRACHYTHERAPY SOURCE 'J' TURE i Read data sheet before opening this container. Handle this radioactise source with GREAT CARE. Model Number: CDC.Tl Nuclide: Cs 137 1 1 Source Serial No. l Product Code Nominal Actisity I Ref. Date I 1
)
)
The U.S. Nuclear Regulatory Commission (USNRC) has approved distribution of this brachytherapy source to persons licensed to use byproduct material identified in 10 CFR 35.57,'35.400, or 35.500, as appropriate, and to persons who hold an equivalent license issued by an Agreement State. Medi Phpics,Inc., .p@i.r \ iL ' rb 273576C (South Plainfield. NJ 07080 -
, . d. . #
j 1 l 1 I
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) I ' NO: NR-136-S-255-S DATE: ATTACHMENT 6 Package Insert l
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r 3 , p June 22, 1999 Mr. Mark A. Doruff, CHP Director, Environment and Safety Regulatory Affairs Nycomed Amersham 2636 South Clearbrook Drive Arlington Heights, IL 60005 i
Dear Mr. Doruff:
J Based on your letter dated January 26,1998 anc' February 8,1999, we have amended in its entirety and transferred registration certificate IL-136-S-225-S from Nycomed Amersham (the previous owner) to Medi-Physics, Inc. Southfield, New Jersey. Please note as the new location of operations is within NRC'S jurisdiction, therefore, we have allocated a new registration certificate number. The new registration certificate number is NR-136-S-225-S. j l Please be advised that you must manufacture and distribute the product in accordance with the statements and representations contained in the application submitted by Nycomed Amersham, with enclosures thereto, and the information set out in the enclosed 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 registration certificate. You are obligated to notify us promptly in writing should you decide to no longer manufacture or offer service support for the product. Please be aware that, as a holder of an NRC registration, you may be subject to the NRC's I licensing 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) 415-6096. Please read over the registration certificate in its entirety and notify us immediately of any errors I or omissions. If you have any questions, please contact me at (301) 415-7894 or Mr. Seung Lee on (301)415-5787. Sincerely,
/s/
Ujagar S. Bhachu, Mechanical Engineer Materials Safety and inspection Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
Enclosure:
As stated cc w/ encl: SKimberley, LFDCB Distribution: p SSS r/f SSD-98-96 NEO1 DOCUMENT NAME: P:\MDURUFF.COVCON NR-136-S-255-S : To receive a copy of this document. inclicate in the bom: *C' = Copy without ettachmentlenc osure *E' = Copy with attachment / enclosure "N" = No copy
-l OFFICE MSIB lC MSIB Eli NAME i1RRhar hu IUV SLEE (, p /
DATE 06/ /99 06/ /99 CJ M b b -
c [ . REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) HQ;. NR-136-8-255-S DATE: M 2 2 ISSI PAGE 1 OF 7 SOURCE TYPE: Brachytherapy Source MODEL: CDC.T1 ! DISTRIBUTOR: Medi-Physics, Inc. (Previously Nycomed Amersham) 900 Durham Avenue South Plainfield, NJ 07080 MANUFACTURER: AEA Technology QSA GMbH D-38110 Braunschweig Germany ISOTOPE: MAXIMUM ACTIVITY: Cesium-137 80 millicuries (2.96 GBq) LEAK TEST FREOUENCY: 6 months i PRINCIPAL USE: (V) General Medical Use CUSTOM SOURCE: YES X NO J
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) HQ1 NR-136-8-255-S DATE: Jg 2 21999 PAGE 2 OF 7 SOURCE TYPE: Brachytherapy Source DESCRIPTION: l The active material in these sources is Cs-137 as a carbonate which is incorporated by smelting into a solid borosilicate glass matrix. This matrix is formed into solid glass beads which are highly insoluble and from which the Cs-137 cannot be leached. The beads are then sized to make a good fit within the narrow bore 316L stainless steel tubing which has been previously laser i welded on one end. After the glass beads are loaded into the , primary capsule, the other and is plugged and laser welded. The I inner capsule is then inserted into an outer capsule manufactured from 31CL stainless steel. The outer capsule is sealed by laser welding cf a plug. Sources manufactured prior to April 1, 1991, contain active material in the form of cesium chloride in the form of a powder mixed with zirconium and sintered at a high temperature. Sources manufactured before this date also had inner capsule plugs sealed by brazing rather than welding. The loading tolerance of active material is 110% of the nominal activity, not to exceed the stated maximum activity for these sources. The overall dimensions of these sources are as follows: Overall maximum length 20.5 nun (0.807") Length of active material 13.5 mm (0.532") Overall maximum diameter 2.67 mm (0.105") Minimum combined wall thickness 0.46 nua (0.018") For detailed drawing of the source design, including all dimensions and tolerances, see Attachment 2. Each source is individually packed in a plastic tube which is then placed in a lead container. The lead container is supported within intermediate packaging components inside an outer transport container, the design of which is tested to demonstrate conformity with the U.S. DOT requirements for a Type A package. The package is not intended for use for long term storage.
REGISTRY Oi' RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) N_Q1 NR-136-s-255-S DATE: Jgg 2 2 ggg PAGE 3 OF 7 SOURCE TYPE: Brachytherapy Source LABELING: - Due to small physical dimensions of these sources, the amount of legible information which can be provided on the surface of the outer capsule is extremely limited. All sources are permanently marked with the following information.
- 1. Unique serial number (engraved)
- 2. Rings (Electro Etched) which corresponds to specific product
, codes, model numbers and source activity. A key to the electro etched rings is provided in Attachment 1. : 1 The lead container and the intermediate container (sealed can) in l which each source is transported is labeled with the following:
- 1. The distributor's name 1
- 2. The Isotope (Cesium-137)
- 3. The words " Caution" - " Radioactive Material"
- 4. The product code The intermediate container (sealed can) is labeled in accordance with the requirements of 10 CFR 32.74. The outer container is marked in accordance with the requirements of the U.S. DOT for Type A container.
DIAGRAM: An engineering drawing (VZ-1271/4E) is included as Attachment 2. ' CONDITIONS OF NORMAL USE: These sources are specifically intended for medical use in conditions that are consistent with a medical environment.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (ANENDED IN ITS ENTIRETY) HQ1 NR-136-8-255-8 DATE: JUh 2 2 lggg PAGE 4 OF 7 SOURCE TYPE: Brachytherapy Source CONDITION OF NORMAL USE: (CONTINUED) The sources are to be used either in applicators (e.g., Fletcher-Suit or Heyman applicators for intracavity use) or, on occasion, for direct interstitial implantation in the treatment of various forms of cancer. These sources are not expected to be subjected to excessive extremes of temperature, physical shock or to corrosive environments. These sources should also not be subjected to long term exposure to materials such as plastics which may devrsde due to radiation exposure and create corrosive agents. Sources should be removed from shipping containers designed for short term storage to shielded stainless steel containers for long tema storage. These sources are not to be subjected to conditions more extreme than those specified by a classification of ANSI N44.1 and ANSI N44.2, 1973, for brachytherapy sources. The manufacturer's recommended working life of these sources is 10 years. PROTOTYPE TESTING: The VZ-1271/4E design as shown in the drawing provided as Attachment 2 has been subjected to tests in accordance with ISO 2919, ANSI N542, ANSI N44.1 and ANSI N44.2 and has attained the classification of C64344. A copy of QKQ 221, the certificate of sealed source integrity, is provided in Attachment 3. Prototype testing of these sources included the impact test described under section 8.4 of ISO 2919. This test involves the striking of the source with a hamuser rather than the 9 meter (30 feet) drop test specified under ANSI 44.1 for brachytherapy sources. However, there is a footnote to section 8.4 at the bottom of page 5 of ISO 2919 which states " Paragraph 748 of Advisory material for the application of the IAEA transport regulations, IAEA Safety Series No. 37, accepts impact test class 4 performed with a h====r with a mass at least greater than ten times that of the source plus contents to be equivalent to the percussion and an impact test
~.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (ANENDED IN ITS ENTIRETY) HQ1 NR-136-S-255-S DATE: JUN 2 21999 PAGE 5 OF 7 SOUNCE TYPE: Brachytherapy Source EEQTOTYPE TESTING: (CONTINUED) required for apscial form material given in IAEA Safety Series No. 6, " Regulations for the safe transport of radioactive materials." The special fona impact test is a 9 meter (30 feet) drop test. EXTERNAL RADIATION LEVELS: Radiation exposure rates were measured at specific distances from a 69.1 mci (2.56 GBq) source and the following rates subsequently calculated for the maximum activity of 80 mci (2.96 GBq) as follows: DISTANCE EXPOSURE RATE 5 cm (1.97") 10.420 R/hr ( 2 . 69x10-3 Ckg4/hr) 10 cm (3.94") 2.605 R/hr (6.72x104 Ckg-2 / hr) 30 cm (11.81") 255 mR/hr (6.58x104 Ckg-2/hr) 100 cm (39.37") 24 mR/hr (6.19x104 Ckg4/hr) OUALITY ASSURANCE AND CONTROI.- These sources are designed, manufactured and tested according to AEA Technology QSA's QA Program under ISO 9001 described in their Quality Assurance Manual, Revision 0, dated August 1, 1998. Finished sources are leak tested by bubble and immersion testing.
- The distributor has established QC procedures which are conducted upon receipt of sources from the manufacturer to ensure that they are visually inspected, leak tested, and packaged with the correct labeling to ensure distribution to end users in accordance with the conditions established in the sealed source registration. Sources are also wipe tested to ensure that
{ removable activity is less than 0.005 pCi(185 Bq). Each shipment will be accompanied by a sealed source test report as well as unpacking and handling instructions.
~ l ! REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES L SAFETY EVALUATION OF SEALED SOURCE l (AMENDED IN ITS ENTIRETY) LKh NR-136-8-255-8 DATE: 2 2 I898 PAGE 6 OF 7 OURCE TYPE: Brachytherapy Source LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
- 1. The sources shall be distributed only to persons specifically licensed by the U.S. NRC or an Agreement State.
- 2. The source shall be leak tested at six-month intervals using techniques capable of detecting 0.005 microcurie (185 Bq) of removable contamination.
- 3. Handling, storage, use, transfer and disposal: To be determined by the licensing authority.
- 4. The sources shall not be subjected to environment or other conditions of use which exceed the test specifications for selected brachytherapy sources contained in ANSI N44.1 and ANSI N44.2, 1973.
- 5. This registration sheet and the information contained within the references shall not be changed without the written consent of NRC.
SAFETY ANALYSIS
SUMMARY
Based on our review of the information and test data submitted by Medi-Physics Inc. (Previously Nycomed Amersham) for source design Model CDC.T1, we continue to conclude that the source should maintain its integrity for normal use and accidental conditions
'which might occur. .
1
REFERENCES:
The following documents for the Model CDC.TI are hereby incorporated by reference and are made a part of this registry document: 1
- 1. Amersham Corporation's letters dated October 28, 1983 and January 8, 1992, with enclosures thereto.
i L'
~ - - REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES j SAFETY EVALUATION OF SEALED SOURCE (AIGNDED IN ITS ENTIRETY) HQl. NR-136-S-255-8 DATE: RN 2 21999 PAGE 7 OF 7 SOURCE TYPE: Brachytherapy Source i
REFERENCES:
(CONTINUED) ;
- 2. Amersham Corporation's letters dated November 19, 1985, May 15, 1990, and July 17, 1990, with enclosures thereto. ;
- 3. Amersham Corporation's letters dated February 27, 1991, August 2, 1991, and December 5, 1991, with enclosures thereto.
- 4. Amersham Corporation's letters dated February 8, 1999 and March 1, 1999, with enclosures thereto.
4 ISSUING AGENCY: U.S. Nuclear Regulatory Commission Date: 2 IIII Reviewer: #* l M S. Bhachu Date: Concurrence: /
'Seung JI Lee
l . l~ REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) NO: NR-136-S-255-S DATE: JUN 2 21999 ATTACHMENT 1 Source Rina Details For Cs-137J Tubes, Each ring indicates a 5 mg radium equivalent. Product Code CDCSJI O 463 MBq (12.5 mci) l l Product Code CDCSJ2 0 925 uBa <25 mci) ! Product Code CDCSJ3 O 1.39 GBq (37.5 mci) Product Code CDCSJ4 0 1.85 GBq (50 mCl) Product Code CDCS15 0 2.31 GBq (62.5 mci) t I s l
l 1 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) - NO: NR-136-S-255-S DATE: JUN 2 21999 ATTACHMENT 2 Model CDC.T1, Drawina VZ-1271/4E
$ 2.65 !0.0 2 l l
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r REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) NO: NR-136-S-255-S- DATE: JUN 000 ATTACHMENT 3 Certificate of Radioactivity Source Intecrity Report OKO 221 CERTIFICATE OF RADI0 ACTIVE SOURCE INTEGRITY CK0 221 Titie: Cs-137 tubes, types J1, J2, J3 J4, J5 I Assembly drawing: VZ-1271/4E I j
'Nuclide Caesium-137
(' Radiotoxicity groups 81, 3 Maxieue activity: 3 G85 1 CLASSIFICATION: c.64444 Test sources: 5 specimen sources, type J2 according to drawing VZ-1271/4E. No.1 5.41 M84; No.3 4.01 N8q; No.4 4.01 MBq; l No.5 3.38 NC1; No.6 4.04 M8q. Tests carried out in at.4H dance with Recoseendation of: BS528s: ISO 2919: ANSI N542: DIN 25 426, part it i Leak test ICMPERATURE PRESSURE IMPACT VIBRATION PUNCIURC mothed 6' 4 4 Units 4 4
!asersion <1 <1
<1 <1 test 41 41 <1 4, t ,
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l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE , (AMENDED IN ITS ENTIRETY) l HQL NR-136-S-255-S DATE: M 2 2 IIh ATTACHMENT 4 l WARNING Label for Lead Containerand Intermediate Container ! l I i l WARNING The radiation source in ibis container is for medical use onh and can he EXTRE%1ELY DANGEROU5 if imgiroperly used. The source should only be remoted and handled by trained, licensed persons. , DO NOT L5E TIIE ENCLO5ED SOURCE UNTIL i Tile PACKAGE IN5ERT llAS BEEN READ AND ! LSDER5TOOD BY Tile L5ER. Do not remote or destroy this label. 273514C i ryf1 Dhtributed hs:
%Iedi Physics Inc.
.s WN) Durham Atenue South Plainfield NJ 07DM) 1 MMI-654411N kg, g2;, PAmersham HEALTHCARE s.
/
1
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) HQ1 NR-136-S-255-S DATE: JllN 2 21999 ATTACHMENT 5 Source Data Label for Lead Containers CESIUM 137 BRACHYTHERAPY SOURCE 'J' TURE Read data sheet before opening this container. Handle this radioactise source with GREAT CARE. Model Number: CDC.Tl Nuclide: Cs-137 Source Serial No. Product Code Nominal Activity i Ref. Date l The U.S. Nuc! car Regulatory Commission (USNRC) has approved distribution of this brachytherapy source to persons licensed to use byproduct material identified in 10 CFR 35.57,'35.4m, or 35.500, as appropriate, and to persons who hold an equivalent license issued by an Agreement State. Medi-Phpics, Inc., ..;9 C 6 i f 1' South Plainfield NJ 070x0 ; 'T w Q 1.g n 2.d E. 273576C) 1
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) R NR-136-S-255-S DATE: ATTACHMENT 6 Package Insert l
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$100017619 A 100798 910 10/07/1998 910.00 0.00 910.00 Sum Total 910.00 0.00 910.00 l
l l Payment document) ' J Datei _. . . . l Check N6J. Vendo;r No' . Payment amount 2000017553 ;10/16/1998i ?074883' 161903 ' ; " * """ *
- 910.00
- NYCOMED INC. .
Accounts Payable Dept. I 101 Camegie Center Princeton, NJ 08540-9998 Phone - (609) 514 6394 Fax - (609) 514 6568 06243}}