ML20133P476
| ML20133P476 | |
| Person / Time | |
|---|---|
| Site: | 07001342 |
| Issue date: | 05/02/1985 |
| From: | Purdy D BIOCONTROL TECHNOLOGY, INC. (FORMERLY CORATOMIC |
| To: | |
| Shared Package | |
| ML20133P439 | List: |
| References | |
| 23545, NUDOCS 8511010025 | |
| Download: ML20133P476 (24) | |
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l APPLICAT10fl FOR REf4EWAL OF LICEll5E flutlBER St#1-1319 l
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Coratomic, Inc.
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300 Indian Springs Road Indiana, Pennsylvania 15701 9'bs4 5 O
"0FFICIAL RECORD COPY" i
B511010025 850925 REG 1 LIC70
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PDR M1 18.
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l TABLE OF C0flTEllTS Page i
Item 1 - Tills IS AN APPLICATION FOR REllEWAL OF LICEllSE fluMBER SNM-1319 1
l Item 2 - NAME Afl0 MAILillG ADDRESS OF APPLICAlli 1
Item 3 - ADDRESS (ES) WilERE LICENSED MATERIAL WILL BE USED OR POSSESSED.
1,2 I tem 4 - FLAME OF PERSON TO BE C0flTACTED ABOUT Tills APPLICATION 1
Item 5 - RADI0 ACTIVE MATERIAL 3
a Item 6 - PURPOSE (S) FOR WillCil LICEllSED MATERI AL WILL BE USED.
4 l}
Item 7 - IflDIVIDUAL(S) RESP 0flSIBLE FOR RADIAT10fl SAFETY PROGRAM 5
Afl0 TilEIR TRAIN!!1G AflD EXPERIENCE.
(
Item 8 - TRAINIflG FOR INDIVIDUALS WORKING Ifl OR FREQUEllTIflG RESTRICTED 7
p' AREAS.
Item 9 - FACILITIES AtlD EQUIPMEllT.
8 Item 10 - RADIATION SAFETY PROGRN1.
11 f'
Item 11 - WASTE MAtlAGEMENT.
12 Item 12 - LICEllSE FEES 1
E Item 13 - CERTIFICATION 1
b Item 14 - VOLUNTARY ECON 0f11C DATA 1
iO
^11^ciiMe"1s c - FUEL CAPSULE ASSEMBLY PROCEDURE 14
.j - LOSS OF PLUT0NIUll-238 20
.. - PROTOCOL FOR C-100 PACEMAKERS 24
- - PROTOCOL FOR C-101 PACEMAKERS 47 - PROTOCOL FOR C-101-P PACEMAKERS 63
- - Q. A. INC0 FLING IllSPECTION OF FUEL CAPSULES 85 1
(Leak Test and Logging Procedures) i i
n 0
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U S NUCLE AR REGUL ATORv COMM8SSION NSC FORM 313 APPROVED SY OMG t1541
'0 C8 R 30. 32. 33 34 3150 0120 3* ="
APPLICATION FOR MATERIAL LICENSE E e-se 5 3ist
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INSTR UCTIONS: SFE TME APPROPal ATE UCENSE APPUCATICN GL"CE FOa DET A' LED INSTRUCTIONS FOR COVPL ETING APP (ICATION $E ND TWO COPIES OF THE ENTIRE COMPLETED APPUCATION TO THE NRC OFFfCE SPECIFIE D BELOW t
I FEDE RAL AGENCIES FILE APPUCAf TONS WITH:
IF YOU ARE LOC ATED IN U $ NUCLE AR REGULATCRV COVWisSTON IL UNOIS, INDI AN A LOW A. MICMeG A N, M6NNESOT A. MISSOURI. OMao. On DeVistON OF FUEL CYCLE AND M ATERIAL SAFETY,NV58 WISCO: stim. 5E ND AP*LICATIONS TO W ASMINGTON. OC 20555 LE AR REGULATORY COvvi5SION. REGION Its U S NUC. ALs UCENs,NG sECTIDN v&TE R ALL OTHER PERSONS FILE APPLICATIONS A$ FOLLOW $.jp VOU ARL LOCAT ED IN 799 ROOSE vf LT RO AD i
GLEN ELLvN. tk 601J7 CONNECTICUT. DELAWARE. DISTRICT OF COLUMBIA. MAINE. M ARYL AN3 MASEACHUSETTS, NEW JERSEv. NEW YORK. PE NNSVLVAN4 A. RMODE ISL AND, ARK ANSAS. COLOR ADO. IDAMO. K ANSAS. L Oues ANA MONT ANA. NEeR Asat a, J
OR VERMr /.SENO APPUCATIONS TO:
NEW ME xtCO. NORTH DAKOT A. OK LAMOM A. 5OUTH DAKOT A. T E M AS. UT AM, I
U S. NuGLE AR REGULATOR Y COMw15$ SON. REClON I NUCLEAR UATER AL $fCT*ON S U S NUCLE AR REGULATORY COVUtSS'ON REGtON 8V 631 PARE AVEUJE MATERIALRADt ATEDN PROTECTION SECTION KING OF PRUSSIA.PA 19406 611 R Y AN PL A24 0Rev t. 5d1T E 1000 ARUNGTON, T A 76011 ALABAMA. FLontDA. GEORCI A. K E NTUCK Y. MIS $ttSIP't. NORTM CAROLIN A.
d PUE RTO RICO. SOUTH CAROLINA. TENNESSE E. vlRGINIA. VIRGIN ISLAN91 OR AL ASK A. Ant 20N A. CAUFORNia MAW Aft. NEV ADA OREGON. WASMtNGTON WEST VIRGimtA, SENO APPUCATIONS TO AND U S. TERRITORrES AND POSSES $10NS IN THE PActFIC.5END APPLICATIONS TO I
U S NUCLE AR REGUL ATCR v CCwwtssiON. RE GtON is
,J U ATER' AL M ADi& TION PROTECTON SECTiON U S NUCLE AR REGUL ATORY COMUeSSiON REGICN V 101 UARIETTA STREET, SalTE 290u UATE RI AL R ADeATION PmOTECTION SECTION ATLANTA. GA 30323 145C MARIA L ANE. 5UtTE 210 W ALNut CREEK.CA 24596 FERSONS LOCATED IN AGREEMENT STATES SEND APPLICATIONS TO THE U S NUCLE AR REGULATORY COMMiSS604 ONLY IP THET WiSH TO POSSESS AND USE LICEN$fD MATERIAL IN ST ATE 5 5USJECT TO U S. NUCL EAR REGULATOR v COMul55 SON JOntEDICTION.
.I 1 TMi$ i5 AN APPUCATION FOR @ere eparapree.reai 2 NAME AND MAILING ADORE $$ OF APPUCANT #ars eele Coaed w
A. NEW UCENSE Coratonic, Inc.
. A.ENDvfNT TO UCENsE NU.ER T
SW1-1319 P. 0. Box 434 C. RENE.At op uCENsE huv.ER Indiana, Pennsylvania 15701
(additional information attached.)
b 300 Indian Springs Road Indiana, Pennsylvania 15701 j TEtEPMONE NUM.ER 4
. NAME O.,ERSON TD.E CONT ACTED A.OuT Y is APPUC ATiON John R. Klincensmith (412)349-1811
$UBulf ITEU$ 5 THROUGM 91 ON 8 + = 11 ' PAPE R THE TYPE AND SCOPF, OF INFCRUAT'ON TO ct PROVIDED I$ DESCRIBED IN TME LtCENSE APPUCAT'ON GUIDE.
- 5. RAOrOACTivE WATEmi Ag a E ea eat eae een a etwe tp r* emes'sa4 or pavs<e' 'o-m. ead e me e.ava emov t 6 PURPOSE ($1 FOR WHICM UCENSED MATEF9 AL WILL SE USED u
a nNch mai te poseenso et ea,.oceome E
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8 TRAINING FOR INDIVIQUALS WORKING IN OR FREQUEN'ING RESTRtCTED ARE AS.
RA NG A APE E
- 9. F ACluTIE5 AND EQuiputNT to RADI ATION $AFETY PROGRAW 1
13 UCENSEE FEES f$se 70 C#R f /0end Serpos f /0 Jit h@jM}Y
- 11. WASTE UANAG2 VENT gAMouNT FEE CATEGORY l ENCLO$E D $ q g jp g 13 CERTIFICATION (Must eie roma'ered Pr eos4cear/ TME APPUCANT UNDERSTAND $ TMAT ALL ST ATEMENT$ AND REPRESENT ATIONS MACE IN TMS APPUCAT'ON ARE SINDING UPON THE APPUC ANT THE APPUCANT AND ANY OFFICI AL E NE*UTING TMfS CERTIFICAf rCN ON SEMALF OF THE APPUCANT, N AWED IN JTEM 2, CERTIFY TMAT TMil APPUC ATION IS PREPARED IN CONFORWrTv WiTM TITLE 10. CDDE OF FE0ERAL REGULATIONS. PARTS 30. 33. 33. 34. 35. AND 40 AND TH AT ALL iNFORYATION CONT AINED ME REIN.
IS TRUE AND CORRECT TO THE 8EST OF THEIR KNOWLEDGE AND gEUEF WARNING 18 U S C. SECTION 1001 ACT OF JUNE 25.1948 62 STAT 749 UAufS IT A CRIUiNAL OFFENSE TC VAKE A WILLFULLY FAL$1 STATEMENT OR REPRE$tNTATION TO ANY DEPARTUENT OR A3NCY OF TME UNtTED ST ATES AS TO ANY MATTER AIT*N ITS JURISDICTION SIGNA E -CE RTI F G
- C TYPED PRINTED NAVE TITLE DATE d/8/// ///
//
David L. Purdy President May 2, 1985 d_, ~ k "
I is vopaa, eco% owc cat A a A ve a P' c f.* ? s
//
o NUMBER OF EMPLOv EE$ dTeree ror o WOULC v0U BE W'LLtNG T0 7 URN 15M COST INFORMATION 4foner ead or ererrhourst
< 5250K StW-3 SV
ee'geor'8's'n'g*e*n*t.c'e'wel'****eef or hear es-propre *ery-8 ' * '
ersqa bra <sAed to
$250K -500K
$3SM-7M th y
$50CK-750K
$ 7U-10g c NUWSER W BEQS 5750K -T M
> S10g YES NO FOR NRC USE ONLY TYPE OF FEE FEE LOG FEE r ATEGORY COMMENTS APPROvtD S Y l
AMOUNT RECElv ED CMECK N'JuSER DaIE PRIVACY ACT STATEWENT ON THE REVERSE
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l Page 2 3.
ADDRESS (ES) WHERE LICEilSED !!ATERIAL WILL BE USED OR POSSESSED.
r
[ I, The only location we are now using is:
Coratomic, Inc.
300 Indian Springs Road Indiana, Pennsylvania 15701 We were formerly located at Old Route 119 South, Indiana, Pennsylvania, 15701, and liorth Plaza, Route 119 North, Indiana, Pennsylvania, 15701.
We also had dogs with implanted pacemakers. The dogs were kept at Connie Winters Kennels, Airport Road, Indiana, Pennsylvania,15701.
We are no longer implanting pacenakers in dogs. All of the pacemakers were removed from the dogs and returned to Coratomic.
Only sealed sources were used at any of our locations. These sealed sources are capsules that are loaded and hermetically sealed by a qualified fabricator according to Coratomic Specification #1141 (see Attachment 1). Loaded capsules are delivered to Coratomic with a data sheet for each capsule that includes wipe test results, helium leak test results, quantity of fuel loaded, gama and neutron dose neasurement, capsule material certification numbers and welding parame ters.
A close-out survey was performed at our old locations, and they are I
free of nuclear material.
O One nuclear pacemaker was missing during the relocation from the old facility on Route 119 to the present fccility on Indian Springs Road.
A report on this matter is included as Attachment 2.
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Page 3 5.
RADI0 ACTIVE MATERIAL a.
Element and mass number Plutonium (Principal radionuclide Pu-238) b.
Chemical and/or physical form Sealed sources 1
c.
Maximum amount which will be possessed at any one time.
290 grams as sealed sources. Each sealed source contains 250 milligrams of Pu-238.
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PURPOSES FOR !!HICH LICEflSED f4ATERIAL !!ILL BE USED.
pC a.
As a component of Coratomic flodel C-100 pacemakers for pun oses of explantation and recovery from medical institution licensed by the fluclear Regulatory Commission or an Agreement State to implant such pacemakers in humans under the Protocol entitled
" Human Clinical Protocol for the Coratomic C-100 Series of Radioisotope Powered Cardiac Pacers" dated July 1,1975 (see ),
b.
As a component of Coratomic f4odel C-101 pacemakers to be trans-ferred to medical institutions licensed by the fluclear Regulatory Commission or an Agreement State to implant such pacenakers in humans under the Protocol entitled " Human Clinical Protocol for the Coratomic C-101 Radioisotope Powered Cardiac Pacer" dated flovember 1,1975 (see Attachment 4),
c.
As a component of Coratomic flodel C-101-P pacemakers to be transferred to medical institutions licensed by the fluclear Regulatory Commission or an Agreement State to implant such pacemakers in humans under the Protocol entitied " Human Implan-tation Protocol for the Coratomic C-101-P Radioisotope Powered Cardiac Pacemaker" dated March 2,1983 (see Attachment 5).
Coratomic shall collect and tally at six-month intervals data from all medical institutions with respect to the accountability, 3
removal, and recovery of all implanted Coratomic flodel C-100, 1
j Model C-101, and flodel C-101-P pacemakers. Copies of these reports will be sent to the United States fluclear Regulatory Commission, Division of Fuel Cycle and flaterial Safety, flaterial Licensing Branch, Washington, DC 20555.
The reports referred to in the license renewal application request are on file at Coratomic, and copies have been mailed to the above address.
These semi-annual reports will be prepared by ffr. John Klingensmith, Patient Records Specialist, and copies will be available for inspection in the Coratomic Data Center. The Coratomic Data Center also contains the patient records for each person who has a Coratomic isotopic-powered pacemaker implanted.
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IrlDIVIDUAL(S) RESP 0f4SIBLE FOR RADIATI0f1 SAFETY PROGRAM ArlD THEIR TRAINIflG AND EXPERIENCE.
d SHIPKO, FREDERICK J. - RADIATION SAFETY OFFICER, VICE PRESIDENT, CORPORATE SECRETARY Mr. Shipko received a B. A. degree in Chemistry from Syracuse University in 1950.
Experience and background summary of Mr. Shipko is as follows:
Coratomic,1972 to Present - As Manager, Research and Development, Mr. Shipko has been responsible for the chemical and mechanical component development of pacemakers, heart catheters and other implantable medical devices.
These included metal to ceramic seals, thermoelectric batteries for nuclear pacers, metal component fabrication and assembly techniques, hermetic sealing technology, development of potting and incapsulating techniques with polymers, fabrication of catheters and sterilization techniques.
Since mid-1980 he has been responsible for the mechanical components and assembly of an implantable and an external insulin dispenser. He developed i
low power solenoid-operated piston pumps for these systems which pump insulin in the range of.1 to.5 microliters per stroke.
This necessitatcd an understanding of electromagnetism and fluid dynamics.
The pumps required small precision metal components as well as injection-molded plastic parts which were fabricated at Coratomic under his direction.
He developed a unique sterilization system in which the fluid flow path in these systems could be sterilized by ethylene oxide.
NUMEC,1957 to 1972 - Staff Chemist - Af ter joining this company, which was subsequently acquired by Atlantic Richfield (ARCO), ne spent seven years in the development of processes for depositing coatings on spherical ceramic reactor fuel particles and other metal and ceramic shapes. The coatings included niobium, tungsten, vanadium, pyrolytic carbon, chromium, beryllium, beryllium oxide, molybdenum, nickel, copper, lead, aluminum, platinum, and gold. Methods for producing the deposits have included fluidized bed systems, electroplating, vaporization, and chemical immer-sion techniques. He also developed techniques for preparing high purity chemical compounds such as uranium mononitride, uraniur criiodide, and beryllium halides.
In 1965 he was assigned as Supervisor of Hot Cell Operations at itUMEC.
The work encompassed the encapsulation of gamma emitting sources such as Cobalt-60, Cesium-137, and Iridium-192, and the post-irradiation examination of plutonium-uranium oxide fuels.
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INDIVIDUAL (S) RESPONSIBLE FOR RADIATI0f1 SAFETY PROGRAM Afl0 THEIR TRAINIrlG AND EXPERIENCE.
(conti nued)
SHIPK0, FREDERICK J. (continued)
In January,1967 he transferred to the Energy Conversion Division of NUMEC and worked on developing chemical techniques and processes for nuclear-powered thermoelectric systems until November,1971, and continued
)
in this capacity when the division was acquired by ARCO Nuclear Company.
This work encompassed the development of the AEC nuclear-powered cardiac pacemaker, radioisotope-powered artificial heart sponsored by the National Heart & Lung Institute, under-sea radioisotope thermoelectric generators for the Navy, and other microwatt and milliwatt thermoelectric devices.
l KNCLLS ATOMIC POWER LABORATORY,1951 to 1957 - During his tenure at Knolls, he h
was engaged in inorganic and physical chemical research and development, where he gained substantial experience in nass spectrometry and high i
vacuum techniques, corrosion problems, and radiation chemistry.
t Publications -
"The Titanium-Hydrogen System", JACS 78, 5155 (1956)
"The Palladium-Tritium System at Low Temperatures", (KAPL-1097).
" Stability of Ferrous Hydroxide Precipitates", J. Phys. Chem 50, 1519 (2956).
" Thermal Stability of Hydrous Aluminum 0xides", (KAPL-1740).
"The Beta Paricle Radiolysis of Acetylene", JACS -77, 4723 (1955).
" Radiation Induced Exchange of Hydrogen Isotopes" J. Phys. Chem. E9, 1110 (1955).
~~
"The Oxide Decomposition Process For Coating Uranium With Zirconium",
(KAPL-876).
Co-Author " Post Examination of U0 -5 w% Pu0 Fuels", presented at the 2
2 June,1966 ANS neeting.
Patents -
1.
Co-Inventor of a technique for the preparation of a solid source of beta radiation by the polymerization of tritiated acetylene l
(Patent 2,903,383).
2.
Co-Inventor of Radio-Opaque Gloves (Patent 3,883,749).
3.
Co-Inventor of Catheter (Patent 4,142,531) which attached to the internal surface of the heart.
4.
Inventor of a Self-Sealing Set Screw for use with pacemakers (Patent 4,141,752).
5.
Co-Inventor of method of potting of the internal components of pacemakers to provide shock resistance and low weight I
(Patent 4,041,956).
6.
Co-Inventor of a Portable Insulin Infusion Pump (Patent pending).
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TRAlfilllG FOR INDIVIDUALS WORKIfiG Ill OR FREQUEllTIrlG RESTRICTED AREAS.
!, O The following is a list of persons who are qualified to handle our licensed material and assemble our pacemakers:
BABCO, JAMES BERilINI, LINDA BOARTS, GARY CARNAHAti, ROGER l
CUPP, JAllES i
KALLAS, DAVID KEISER, ROBERT KLIriGENSf1ITH, JOSEPH OSWALT, NORMAll PALAfiGIO, TI!!
PURL,7, DAVE i
RAPACH, CHARLES SEGNER, EDUARD SHIPK0, FREDERICK SPORY, DAVID J,
STILES, DARLENE STILES, UAYNE WARD, PATRICK l
WIGGIllS, BARRI I
ZIlGIERMAfl, TERRY O
All employees who handle nuclear material and/or' pacemakers will receive yearly retraining consisting of lectures on radiation and radiation safety.
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Page S 9.
FACILITIES AND EQUIPMENT.
5,,)
The following two pages show a diagram of the Coratomic facilities and a description of the rooms. These facilitias are located at 300 !adian Springs Road, Indiana, Pennsylvania 15701.
The areas through which fuel will pass are indicated with an "f".
c Storage areas are marked by an "s".
L Areas in which records are kept are labeled with an "r".
All fuel is contained in sealed sources.
In a completed pacemaker there are four hermetic seals as follows:
(a) incoming capsule (b) TA - Fuel basket weld (c) final battery closure weld (d) pacemaker case.
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9.
FACTLITIES AND EOUTPMFUT.
( cn n t i nop ri)
Page 10 Coratonic Inc. o 300 Indian Springs Road Indiana, PA 15701 IDENTIFICATION OF SPACE - CORATOMIC OFFXC'E & MANUFACTURIliG FRCILITY (see plant layout drawing) l h
ROOM NO.
DESCRIPTION 1 thru 7 OFFICE AREA 8
REPRODUCTION CENTER 9 thru 11 OFFICE AREA 12 RECEPTION AREA (VISI'IOR ENTRANCE) 13 OFFICE AREA 14 DRAFTING ROOM 15 thru 16 OFFICE AREA 17 COMMUNICATIONS ROO'i 18 thru 29 OFFICE AREA 30 EXECUTIVE CONFERENCE ROOM 31 thru 38 OFFICE AREA 39 EMPLOYEE CAFETERIA 40 thru 43 STORAGE & RESTROOMS 44 RESEARCH & DEVELOPMENT (Chemical) 45 RESEARCH & DEVELOPMENT (Electronics)... R-F Shielded
{
g 46 QUALITY CONTROL... R-F Shielded 47 PASSAGEWAY 48 ELECTRONIC CCMPONENT ASSEMBLY 49 STERILIZATION " CLEAN ROOM" 50 EMPLOYEE ENTRANCE AREA 51 SHIPPING & RECEIVING 52 PRODUCTICN OFFICE 53 PRODUCTION CONFERENCE AREA 54 thru 56 PRODUCTION OFFICES 57 CLOTHING PREPARATION ROOM l
58 MAIN ASSEMBLY ROOM 59 I.D. APPLICATION ROOM i
60 FINISHING ROOM 61 PASSAGEWAY 62 STORAGE & RECEIVING AREA 63 POWER ENGINEERING & MAINTENANCE l
64 TOOL ROOM l
l 65 GRINDING ROOM 66 MACHINE SHOP 67 LASER WELDING ROOM 68 thru 69 CHEMICAL LABORATORY
Page 11
- 10. RADIATION SAFETY PROGRAM.
- O aii n#cieer meteriei 4s coetei#ee im seeiee se rcee. oniv cePseies i
that are loaded and hermetically' sealed by a qualified fabricator i
according to Coratomic Specification #1141 are used at Coratomic (see Attachment 1).
Loaded capsules are delivered to Coratomic with a data sheet for each capsule that includes wipe test results, helium leak test results, quantity of fuel loaded, gamma and neutron dose measurement, capsule material certification numbers and welding parameters.
a-Upon receipt the capsules will be logged into the incoming capsule L
inspection log and also into the Isotopic Sources log.
I Wipe tests, neutron counts, capsule identification, and leak checks are performed on the capsules according to the procedures given in i;
All nuclear fuel capsules are stored in the safe in vials marked F
with I.D. number and radioactive tape around the vial.
e i.[
Capsules are released from the safe by Quality Assurance and a c
record is kept of the disposition of each capsule (incoming in-
[
spection log and Isotopic Sources log).
L
[
Capsules stored in the safe for longer than six months must be
?
wipe tested and information recorded in Isotopic Sources log p.
before they can be released.
I)
Capsules that are in completed batteries or pacers and kept by L
Coratomic must be checked for emissions every six months by wiping I
the outside of the battery or pacer or package it is contained i
in and by checking the battery or pacer output.
L p
Wipe tests are performed by Quality Control using the procedures l
given in Attachment 6.
Records of wipe tests are kept in areas 46 and 56 on the diagram of the Coratomic facilities (Item 9).
l Only areas that are labeled with the trefoil are holding areas y
for devices with nuclear fuel.
l D
Personnel are monitored with film badges.
Results of the monitoring
'are contained in the monthly dosimetry reports, which are kept on file in Room 34 (Item 9).
Pacemakers are shipped only to licensed hospitals.
These hospitals have agreed to follow the protocols corresponding to the models of ' pacemakers which they will receive.
Results of the accountability in the field are given in the semi-annual reports prepared by the 1
Coratomic Data Center and mailed to the U. S. Nuclear Regulatory i
Commission, Division of Fuel Cycle and Material Safety, Material J.
Licensing Branch, Washington, DC 20555.
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- 11. WASTE MANAGEllENT.
ie No waste is generated by this facility.
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LIST OF ATTACHMENTS i
h n - Fuel Capsule Assembly Procedure
!! - Loss of Plutonium-238 dll 1 - Protocol for C-100 Pacemakers a
t
] - Protocol for C-101 Pacemakers - Protocol for C-101-P Pacemakers - Q. A. Incoming Inspection of Fuel Capsules (Leak Test and Logging Procedures) 1 p
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, m Page 14 Spec.#B1-1141 Doc. #4007-1
~
(Attachment 1)
/3 FUEL CAPSULE ASSniBLY P90CEDUPE t
U l.
Prepare Inner Capsule Components for Welding Capsule parts are cleaned before shipping from Coratamic.
If parts become contaiminated through handling, etc., they musc be recleaned in boiling reagent grade trichloroethylene and then rinsed in reagent grade acetone All causule parts are to be handled with clean tweeners or clean rubber gloves and all chille, fixtures, en.,
L that come in contact with the capsule parts must also be cleaned in reagent grade trichloroethylene and acetone.
2.
Load Specified Ouantity of Fue!
Each source is to be loaded to 0.142 thermal watts (4.27 curies Pu-238,
+0, -E) using the 90% enriched Pu-238 powdered oxide specified in Coratomic Fuel Specification /IB1-2044 The Pu-238 fuel shall be pressed into pellets of.156" diameter and of such length as is necessary to obtain the specified thermal loading.
The maximum length is 0.133".
fuel pellerg shall then be loaded into a chamber. all air evacu-The ated to 1 x 10-to r ar d bach filled with oxygen-16.
The pellets shall be heated in the aresence of oxvgen-16 to 700 C at the rate of 50 C per 2 minutes.
~ When the temp'erature has reached 700"C, hold for 15 minutes, ovacuate and backfill with oxygen-16, hold for 15 8
minutes and repeat this process until the oxygen-16 atmoschere has been exchanged 8 times.
After the oxygen-16 atmosphere has been t
exchanged 3 times and the final 15 minute hold period has been ecmpleted, resume heatinc, the pellets in oxygen-16 at the rate of IOOC pt - minu te 2nterva 1..
m: il a temperature of
'000C i.e bee:
reached Hold at 14000C fr.r : hour so that cou.plet e.intering may occur.
After sintering fo: I beur, reduce temperature at the rate 0
of 50 C per 2 minutes until ronn temperature is reached.
Pellets should be stored in sealed ':et tles under desiccant.
The pellet shall then be Inaded into the fuel basket and the retaining tabs bent 900 te retain the pellet as tightly as possible.
3.
Weld Inner Capsule Welding is to be done in a hich purity argon atmosphere that has a low water vapor and oxygen content.
The argon must pass through a molecular sieve immersed in an acetone bath and which in turn is cooled by conduction through <cpper bars to a liquid nitrogen bath.
Argon supply lines must be at a positive pressure of greater than 5 psig at all times.
The molecular sieve must be reactivated each time the tank is changed.
The molecular sieve (Linde 13X) is reactivated by heating the molecular sieve tube at 250 C to 275 C and holding at this temperature for one hour with a constant purge of high purity argon through t he tube at a flow rate of about 100 cc per minute.
\\
w Page 15 Spec.#B1-1141 Doc. #4007-1 Page 2 (Attachment 1)
FUEL CAP 9ULE ASSE"Bil PROCEDURE (Con't)
Weld penetration must be 100"'
The diameterof the velded inner capsule measured in the weld bead area must be 0.310" :0.005" An example weld on an empty (unfueled) inner fuel capsule shall be done before and after each production run.
These capsules shall be sectioned and examined for 100% penetration, cracks and pores in the weld area.
These sectioned capsules shall then be crushed between hardened steel surfaces with 1000 kg load to test for embrittlement of the capsule :.atcrial.
The crushed halves should not break up or show cracks.
Before each fueled capsule weld is accomplished, an arc shall be struck on a sample of.030" thick capsule material, or weld coupon, supplied by Coratomic.
This shall be donc in the sane atmosphere and chamber and at the same time as the fueled capsule is welded.
The fuel capsule shall then be welded without changing the atmosphere.
After the capsule and sample are removed from the chamber; the sample shall be folded in half using a press to test for ductiIity.
There shall be no cracks in the sample after bending.
The weld chamber shall be capable of a vacuum of 2 x 10-6 torr before each weld. With vacuum valves closed af ter reaching 2 x 10 torr, the pressure shall not rise to greater than 1 x 10-4 torr h 3 minutes.
['j The weld chamber shall be capable of holding a pressure of 2 psig for 5 minutes.
The chamber and argon supply lines shall be purged, the chamber evacuated and then 'ackfilled to atmosphere pressure with argon before welding.
All irner capaule welds mui-is ;ingl e pass.
W re.zelding or repair work is to be atterp'eJ on the inner capsule.
The welded capsules should : at be removed from the weld chamber below 2000C.
until the capsule temperature 4.
Visually Inspect Weld Using 'eannification Greater Than 30X a.
uniform width of weld bead b.
no pores or void spaces in weld area c.
no discoloration d.
smooth surface e.
no high points 5.
Alpha Wipe Test of Inner Capsule Alpha wipe test on completed inner capsule must show less than 500 c/m of removable alpha contamination before proceeding.
l l
6.
Leak Check Inner Capsule Per Fuel Capsule Leak Check Procedure #B1-1102 l
a.
Externally pressurize the capsule in a small chamber to 100 psig with helium for one hour.
Page 16 Spec.#B1-ll41 Doc. #4007-1 Page 3
{~3 FUEL CAPSULE ASSEMBLY PROCEDURE (Con' t) (Attachment 1) x.)
b.
Remove capsule from pre.ssurization chamber and immediately place it in a small clear glass beaker containing approxi-mately 1" of distilled water at 900C and observe any bubbles of helium coming from the capsule.
No bubbles should occur in one minute.
c.
Remove capsule from water and test for leaks using a mass spectrometer lead detector such as NRC, L del 925.
Leck rate should be less than 1 x 10-8 std. cc/sec.
7.
Prepare Outer Capsule for Weld _ igg Outer capsule parts are supplied, cleaned, annealed and degassed.
The welded inner cansule must be cleaned in boiling reagent grada trichloroethylene and rinsed in reagent grade acetone before being placed in the outer capsule shell.
The weld chamber must be pumped down and checked for leaks as in the Inner Capsule Welding Procedure, Item 3 above.
The test weld on a sample c.f outer capsule materia'l is not done for the outer capsule weld.
The welded outer capsule should not be removed from the weld chamber until the capsule temperature is below 200 C.
8.
Visually Inspect Weld Usine Magnification Greater Than 30X
()
a.
uniform width of weld bead b.
no pores or void spaces in weld area c.
no discoloration d.
smooth surface e.
no high points 9.
Alpha Wipe Test of Outer Caosule Alpha wipe test on completec outer capsule must show less than 1 x 10-5 microcurie of removable alpha contamination before proceeding.
10.
Leak Check Finished Capsule Assembly Per Fuel Capsule Leak Check Procedure #B1-1102 a.
Externally pressurize the capsule in a small chamber to 100 psig with helium for one hour.
b.
Remcvc capsule from pressurization chamber and immediately place it in a small cicar " lass beaker containing approximately 1" of distilled water at 9CoC and observe any bubbles of helium coming from the capsule.
No bubbles should occur in one minute.
f c.
Remove capsule from water and test for leaks using a mass spectrometer lead detector such as NRC, Model 925.
Leak rate should be less than 1 x 10-8 std. cc/sec.
,s l
,I Page 17 i-Spec.#B1-ll41 Doc. #4007-1 e4 Pag'tachment 1) l-(At I.
FUFL CAPSULE ASSEMBLY PROCEDURE (Con't) w)
11.
Radiation Measurements Measure and record on the assembly report the neutron radiation in neutrons per second and the ;;amma radiation in milliroentgens l
per hour at 4" distance of the finished capsule.
12.
Final Dimensional Check
~
All completed fuel capsules are to be checked for dimensional acceptability by placing in the Coratomic provided go-no-go fixture.
The capsule should fit in the fixture and the two halves l_
of the fixture mate without interference.
I 13.
A final assembly report will be completed and sent with each capsule when shipped to Coratomic.
The Final Assembly Report is Form #B1-2045.
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Page 18 Spec.#B1-ll41 i
Doc. #4007-1 Page 5 (Attachment 1) g-FUEL CAPSULE ASSEMBLY PROCEDURE (Con't) e A.
A Production Run is Defined as:
L 1.
A lot not to exceed 20 capsules 2.
A lot that shall not extend over fifteen (15) calendar days.
B.
Parameters 1.
A sample shall be done prior tc the production run and examined in: mediately to assure acceptance.
2.
A sample shall be done immediately after a production run to assure current production.
F 3.
A sample at the end of a product)..- run should be used as the i
start of the next production run if the following criteria is satisfied:
a.
No change in welder set-up (including use for other job or
- f-)
associated material change).
h' /
b.
Next production run originated prior to fifteen (15) calendar day period.
4.
Allowable stoppage (will ac t terminate production run) a.
Normal day-end shutdown b.
Normal weekend or holiday shutdown 5.
Non-allowable steppages (production run to be terminated)
Change in welder set-up a.
b.
Change in associated material (include argon tank change, fixture, etc.)
c.
Capsule test failure l
CRW CR0 CRW CRW CR4 page 2/21/77 Date Date..__.
Date Cate CR0 CR4 CRR CR#
CR9 f
Date Date Date i
Date Date l
CR0 CR#
CRP CH#
CHN
[
Date Cate Dc Date l
l
, CRf a
CR8 i
Cate
~~
Page 19 Spec.#B1-2045 Doc. #5022 (Attachment 1)
FUEL CAPSULE ASSEMBLY REPORT Source No.
Date:
Puichase Order No.
Drawing No.
Material Certification No.
Part #3, 4 (Inner)
Part #1, 2 (Outer)
Part 65 (Basket)
Wel d in,; Da ta :
Welder Make llobart Model TG-201 Serial No. 8RT-4105, Inner Capsule Outer Capsule Plutonium:
Batch No.
Wt. % Isotope Powder wt.
grams Green Pellet wt.
grams Sintered wt.
grams g
Pu-233 Factor (
)
grams e;/s (17.2) curies
/
Curren.
Voltar;c Current Voltage g
Arc Gap Rotation (s/r)
Arc Gap Rotation (s/r)
Electrode Size 0.125" Electrode Size 0.060" Elee' rode Type 3% Thoria Tungsten Electrode Type 1% Thoria Tungsten Wel A r Operator Welder Operator Weldin;; Atmosphere Argon Welding Atmosphere Argon Alpha Wipe Test C/M UCi Leak Test:
Alcohol Bubbles:
yes no Alcohol Bubbles:
yes no Leak tester std.cc/sec Leak tester std.cc/sec Finished Source: Neutron Radiation Gamma Radiation at 4" Alpha wipe test uci REMARKS :
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Page 20
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(Attachment 2)
Caratomice e
P O Hox 4 34, ifJDI Af 4 A. PE Nf45YLVANI A 157nt PHONE 14121 349 1811 TfLEX 06 6650 LOSS OP PLUTOtJIUM-23H I,icense N.>.
UNM-1319 On June 27, 1978, a Coratomic, Inc. C-100 nucicar pacemaker, serial nurrber 23, was noted as missing from inventory.
Loss occurred during the relocation of Coratomic into its new facility. The following is a detailed report of p
the nuclear material burial.
6 1.
Description of the nuclear material:
Material - Pu-238 (See Attachment I)
Amount - <0.250 grams Fuel Capsule - Serial Number 24 Encapsulation (pacer form) - 5 separate encapsulations all leak checked to <lx10-8 std. cc sec-1
(
Leak Check - March 18, 1974
<1x10-8 std. cc sec-1 Wipe Test - June 2, 1978 s.0005pci 2.
Description of the circumstance which which the burial occurred (as documented from interviews with certain Coratomic personnel on June 30, 1978).
INTERVIEW - JIM CUPP (Chemist ry De; r.. Su;>e rv i so r )
Jim Cupp received the nuclear pacer on June 7th or 8th with instructions to recove the epoxy head using an epoxy stripper.
Jim labelled the beaker with a tri-foil radiation syshcl and the words " Dog Implant" using a black marking pen.
On June 16th, the Friday before the move, Jim removed the nuclear and and a few othe r lithium pacers from their respective beakers.
Upon examination he found that the nuclear pacer had not dissolved and he replaced it back into the stripper solution.
On June 19th, which was moving day, Bob Schickler asked Jim Cupp what should be done with the pacer. Jim instructed him to leave it on the j
shelf explaining that t' ay would pick it up af ter the material had all
)
been moved to the new building, f
on Wednesday, June 28, while locating a pacer Quality Assurance had requested, Jim rcmembered that the " dog pacer" had been left in the old building.
When he looked for it, the old chemistry room had been stripped bare and cleaned out.
Jim indicated that they finished packing the room before lunch on Monday, June 17.
INTERVII:W - ItOliURT SCIIICK1:!< (Precision Assembler - Chemistry Dept.)
The last time Schickler handled the pacer was Wednesday, June 14th.
On that day he put it back into the stripper because the head was dissolving
Page 21 LOSS OF PLUTONIUM-238 (Cont'd)
(Attachment 2)
/
slowly.
The last place Schickler recalls seeing the pacer was on the shelf soaking in stripper solution.
/
Schickler recalls leaving the old building about 1:30 on Monday, June 19th at about 1:00 or 1:30 p.m.
/
/
/
INTERVIEW - CLIPP HLNDERSON (Maintenance Tradenman)
/
Cliff indicated he cleaned the old chemistry room on Wednesday, June 21.
There was a log of old papers and paper towels and scrap.
Using a 3' x
2' box about 2' high, Cliff gathered all this trash and discarded it in the trash bin in back of the old building.
He speci fically remembers discarding the beaker and two others which were sitting above the sink at that time.
When asked if he had checked any of the beakers, he responded that he thought eve rything left in the room was trash to be discarded.
(The stripper solution turns a yellow-brown as it dissolves the epoxy and the contents are not visible.)
Cliff said he placed the aluminum l
foil covered beaker upright in the trash so the liquid would not spill.
The garbage bin was full Thursday, June 22 at 3:30 and had been emptied j
by the following afternoon.
(Pellegrene Sanitation Service indicated this trash was picked up late in the afternoon on Thursday.)
I i
3.
Actions taken to recover the nuclear material:
A thorough search of all Coratomic facilities, both new and old plant, including garbage of both facilities was conducted on June 28, 1978.
On June 29, 1978, the Pelligrene land fill facility was completely searched by J. Cupp and K. Munz using a Varian Survey Meter, Model No. 490, Serial No. 2341.
Assistance in moving refuse material was provided by two Pelligrene operators at the land fill.
Material wan moved five times by the operators and a complete search of the area was conducted after each movement of material.
Material was dug out approximately 18 inches each time.
No radiation was detected by the survey meter at any time when sweeping the area.
4.
Statenent of disposition and radiation exposure to individuals:
Pellegrene Sanitary Service subsequenty buried the nuclear pacemaker at a depth of~six to eight feet in their sanitary land fill.
Due to the loca-l tion and depth of the pacer and the multiple hermeticity of its design,
)
there could be no personal injury or ecological damage from this source.
1 5.
Subsequent report:
Mr. Larry Lesnak, Manager of Quality Assurance and Control, reported the burial to the regional office of the nuclear Regulatory Commission in Philadelphia within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of the burial.
He was told that the verbal reporting was sufficient since the location of the burial source was known, and it had been disposed of in a safe manner with no threat to the l
biosphere.
He was told that no formal written report was necessary.. -
Page 22 JSS OF PLUTOtJIUM-238 (Cont'd)
(Attachment 2) 6.
Procedures and measurcu adopted to prevent a recurrence of lon, of
/'
licensed material:
,/
Coratomic, Inc. will continue the current accountability system with
/
an additional safeguard to keep company personnel cognizant of regulatory
/
requirements. An audit of each department will be frequently and randomly conducted to assure proper accounting of nuclear material. The Coratomic accountability chart will be improved.
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UNITED STATES
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NUCLEAR REGULATORY COMMISSION (Attachment 2)
-l REGION I Page 23 o,
a 631 PARK AVENUE
,o#
KING OF PRUSSIA, PENNSYLVANIA 19406 s
+....
Docket No. 70-01342 1 G APR 1981 a ! il' g'(g [g hh((h
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Coratomic, Inc.
?
ATTN: Mr. David Purdy c
President L Ui.
Il i{
l APR 2(1981 P. O. Box 434
?
Indiana, Pennsylvania 15701 I
g Gentlemen:
Subject:
Loss of Source Thank you for your letter which forwarded a final report pursuant to 10 CFR 20.402 regarding the subject matter.
This matter was reviewed by our inspector during an inspection conducted on January 28, 1981.
Your cooperation with us is appreciated.
Sincerely, O
Q ohn D. Kinneman, Chief, Materials adiological Protection Section, Technical Inspection Branch i
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