ML20202E711
| ML20202E711 | |
| Person / Time | |
|---|---|
| Issue date: | 02/17/1998 |
| From: | NRC |
| To: | |
| Shared Package | |
| ML20202E702 | List: |
| References | |
| SSD, NUDOCS 9802190022 | |
| Download: ML20202E711 (7) | |
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-REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
. SAFETY EVALUATION OF-SEALED SOURCE
-h NR-8076-S-801-S D M fd.
FTB 171997 PAGE 1 OF 4 DEVICE TYPE:
Extracorporeal Blood Irradiator-Source MODEL:
B-100 MANUFACTURER / DISTRIBUTOR:
Industrial Reactor Laboratories Incorporated:
429 S. Harding _ Street Indianapolis, IN 46221 ISOTOPE:
MAXIMUM ACTIVITY:
Strontium-90 20 Ci _(740 GBq)
-LEAK TEST FREOUENCY:
6 Months PRINCIPAL USE: (J) Gamma Irradiator, Category I CUSTOM DEVICE:
YES X
NO 9002190022 980217 PDR--RC
.__SSD PDR
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE I
l HQt NR-8076-S-801-S DATE; IIB IN PAGE 2 OF 4 DEVICE TYPE:
_Extracorporeal Blood Irradiator Source DESCRIPTION:
The Industrial Reactor Laboratories (IRL) Model 1000 source is designed to be used in extracorporeal blood irradiators.
The entire capsule is made of type 304 stainless steel.
It is annular in shape with an outside wall thickness of 0.344" (8. 74 mm) and an inside wall thickness of 0.006" (0.15 mm).
The overall length of the source is 7.0" (178 mm) with an outside diameter of 1.0" (25 mm).
The inside surface of the tubing forming the inner wall is chrome-plated.
The diameter of the chrome-plated cylindrical hole (or cavity) which runs the length of the source in 0.238" (6.05 mm).
The radioactive field generated by the source forms a cylinder surrounding the central cavity through which fluid will pass during irradiation.
Both ends of the source capsule have a raised annular ridge, which is used to hold the source in position within the irradiator.
The ridge has an inside diameter of 0.750" (19.05 mm) and an outside diameter of 0.875" (22.23 mm).
The inner height of the ridge is i
0.094" (2.33 mm) and outer height up to 0.370" (9.40 mm).
During source fabrication, a mixture of " cold" and radioactive strontium silicate beads are loaded through a fill tube into the capsule cavity.
The capsule cavity outer diameter is 0.312" (7.92 mm) and inner diameter is 0.250" (6.35 mm).
The length of the capsule cavity is 6.0" (152 mm).
In the finished source, there is an inactive length of 0.5" (12.7 mm) on either end of the strontium-filled cavity.
Up to 20 Ci (740 GBq) of strontium-90 are loaded into each capsule through the fill tube.
The sources are then evacuated and heated to a temperature not exceeding 1292 F (700 C).
After the temperature has reached equilibrium, molten aluminum of the same temperature is allowed to backfill the free spaces in the cavity, which upon solidificatio:
provides a matrix in which the strontium silicate beads are imbedded.
During construction of the sources, the maximum elapsed time between alumin 2m backfilling and removal from the heat source was 3 minutes.
At no time was the outside wall exposed to the molten aluminum.
The beads were purchased from Oak Ridge National Laboratory.
After cooling, the radioactive material was sealed within the capsule by TIG welding of a stainless steel collar to the source body.
c REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE i
HQt: NR-8076-S-801-S DATE:
FEB17IN3 PAGE 3 OF 4 l
l DEVICE TYPE:-
Extracorporeal Blood Irradiator Source IABELING:
All acurces are identified by electro-etching on the source capsule.
The following is an example of the labeling on the Sources:
IRL Model B-100 20 Ci Sr-90/Y-90 8/1969.
Ser.
101 PROTOTYPE TESTING:
The manufacturer subjected a prototype source to the tests 1
specified in 173.398, 49 CFR 173, in order to qualify the source as "Special Form" material.
The tests were as follows:
1.
Heat in air to a temperature of 1475'F ( 801. 7 C) and remain at that temperature for 10 minutes.
2.
Drop a distance of 30' (9.14 m) onto a hardened 0.5" (12.7 mm) steel plate.
3.
Place the source on its side on a 0.5" lead sheet covering a hardened 0.5" steel plate and strike with a flat ended 0.5" diameter steel rod 35" (889 mm) long weighing 7.75 lbs (3.5 kg), free falling a distance of 9' (2.7 m).
4.
Immerse for one week in water at a pH 5-6, at room temperature, and at a conductivity less than 2 micromhos per centimeter.
5.
Leave at a constant temperature bath of approximately 86 F (30 C) for one week.
Following the above tests, the prototype source was leak tested following the methods prescribed in section B2.8 of " USA Standard Classification of Sealed Radioactive Sources", N5.10-1968.
The prototype was leak tested by placing it in a vacuum system and evacuating for 30 to 45 minutes.
The system was then backfilled with helium at to a pressure of 300 psi (2.1 MPa) and allowed to s
remain at that pressure for 30 minutes.
The capsule was flushed with air and subsequently evacuated in a bell jar and checked for helium leakage with a Veco MS 9 spectrometer.
No helium leakage was detected.
o i
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE HQA NR-8076-8-801-S DATE:
FFB 171998 PAGE 4 Op 4 4
DEVICE TYPEt Extracorporeal Blood Irradiator Source OUALITY ASSURANCE AND CONTROLt The sealed source capsule was checked initially using a hot water i
bubble test.
In this test, the source was immersed in a detergent-containing water bath at a temperature of approximately 200 F ( 93. 3*C) for at least 10 seconds and examined for gas leakage.
The source was then checked for encapsulation defects by immersing the source in a 5% NaOH solution and observing eny hydrogen evolution arisine from the contact of the solution with aluminum matrix material.
A third test was then performed by immersion in water or a detergent-containing water bath at a temperature of at least ISO'F ( 6 5. 6*C) for a minimum of one hour, in which time the total removable activity was not to exceed 0.005 pCi (185 Bq).
Sources were then stored for at least seven days and reimmersed as before.
For acceptability the total removable activity after storage was not to exceed 0.001 pCi (37 By).
All sources were subjected to the above leak testing as a means of quality control prior to shipment to customers.
SAFETY ANALYSIS
SUMMARY
As of the effective date of this document, the Model B-100 Extracorporeal Blood Irradiator Sonrce is no longer manufactured and distributed by Industrial Reactor Laboratories Inc.
The company has been out of business since 1991.
This source was approved for licensing purposes by the Atomic Energy Commission (AEC) on October 20, 1969.
There is insufficient information on file for this device to perform a safety evaluation.
Therefore, this certificate is being reissued without further review based on the original review and approval issued by AEC.
,.n.
PAGE1 NRC FORM t47 U. S. NUCLEAR REGULATORY COMM6SSION 0e3 REQUEST FOR A SEALED SOURCE OR DEVICE EVALUATION INSTRUCTIONSI Send tNo request AND e copy of all reisted letters /apphcottone [nd5
, t to The Seeted Source Safety SectKwi, A11N. Cheef, OWFH Mell Stop 6 H3. Change the Doonse Ttacking System rnaleetone to t9 and owagn to ' 4omt code B-5.
NOTE! Retaki e copy of this request with the application and background files.
REhWN10CATON:
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TREMKNE NVuBEH DATE TYPE OF ACTION REQUESTED (Check as appropriate)
Apesemt's NAuf SOURCE REVIEW AMENDMENT OF REGISTRATION SHEET uAE u;N1act HuuntRts)
DEVICE REVIEW NU BE 3p, trYTt suAretcATKw DATE LcENSE NUuBERm CUSTOM REVIEW couutNis FOR 8885 USE ONLY REvilWER M0(Et NUuDERS P6MBER ASSONED f
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TYPE OF ACT10N (Ind6cete the nur.ther of each type) k-} COMMERCIAL DISTRIBUTION (FORMAL)
[USE BY A SirJGLE APPLICANT (CUSTOM)
SOURCE (DC)
DEVICE (9A)
SOURCE (90)
DEVICE (9B)
NEW NEW NEW NEW f
AMENDMENT AMENDMENT AMENDMENT AMENDMENT j NO SAFETY EVALUATION REQUIRED J
NO FEES REQUIRED LICENSING ACTION REQUIRED IF KNOWN NO j OTH;.R (Specty)
TOTAL NUMBER OF NOTES REVIEW HOURS NUMBER OF DEFICIENCY LETTERS NUMBER OF DEriCIENCY CALLS FOR BILLING PURPOSES ONLY NAME CHANGE ADDRESS CHANGE j NEW REGISTRATION-y PRODUCT INACTIVE -
ADD TO BILLING REMOVE FROM DILLING FOR FEE USE ONLY tit E OF FLE FEE CATEGORY l9A 9B DC R 90
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AMOUNT REcElvf D CHECK NUuBER MATANN UPDATED AS REQUIRED DATEorcHEcx Low j MATSYS UPDATED AS REQUIRED APPRovEDBY DATE RETURN DATE couuENTs
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PAGEi NRC F ORM 667 p
U. S.NUCl3 AR REGULA10RY COMMISSION pen REQUEST FOR A SEALED SOURCE OR DEVICE EVALUATION
/
INSIRUCTKANS! Send this request AND e copy of all related letters /appicatione and drawings to: The boeled 60urte Safety Section, ATIN CNef.
OWFN Mall Stop 6 H3. Change the License Tracking System milestone to 19 end stenen to reviewer code 4-5.
NOTE: Retain a copy of this request with the opphcotton and background flies.
Rtuut sT LR REGIONtOCATION.
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]I C11 R lli CIV V
HQ R LFDCB himCNK NUMHLR I DATE TYPE OF ACTION REQUESTED (Check as appropriate)
@ SOURCE REVIEW O ^ REGISTRATION SHEET APsscANro Naut ut"out" Tor
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MAa. COM1ROL NVMMR(s)
DEVICE REVIEW LRTvtR/Aretet.AflON DAfg LICENSE NUMBER (S)
CUSTOM REVIEW coMMLNis
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I FOR 8888 USE ONLY Rty(WLR MODEL NUMBERS NUMblR ASSONLD
(' %-nov su o 9Y - 23 DATE Rf COYLD DATE ASSONLD -
DATE TQ FLEE
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7 TYPE OF A/ITION (Indicate the number of tech type)
M COMMFRCIAL DISTRIDUTION (FORMAL) l USE BY A SINGLE APPLICANT (CUSTOM)
SOURCE (9C)
DEVICE (9A)
SOURCE (9D)
DEVICE (98)
NEW NEW NEW NEW j
h AMENDMENT AMENDMENT AMENDMENT AMENDMENT j NO SAFETY EVALUATIO$ REQUIRED '
j LICENSING ACTION REQUIRED IF KNOWN NO NO F EES REQUIRED j OTHER (Spect)r)
TOTAL NUMBER OF NOTES REVIEW HOURS NUMBER OF DEFICIENCY LETTERS NUMBER OF l
DEFICIENCY CALLS FOR BILLING PURPOSES ONLY s
N W REGISMATION-J PRODUCT INACTIVE -
NAME CHANGE ADDRESS CHANGE ADD TO BILLING REMOVE FROM BILLING FOR FEE USE ONLY WPEorFEE FEE CATEGORY
~l 9A 9B DC 90 AMOUNT RECOVED CHECK NUMER MATANN UPDATED AS REQUIRED D"'E WSC" LOG J MATSYS UPDATED AS REQUIRED APPRovlO ev Dars REivn=
DAts COMMENTS NRC FORM 6ef $ 93)
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Note to Steve -The following list centains registrations that appeared on a list of " active" registrations provided to us.
Attached are documents from NUDOCS showing those related licenses that are terminated, and whatever other information I have.
Had you been provided the information relating to the re would you have considered these registrations inactive? gistrations below, NR0390S101S Industrial Reactor Labs Since 91 out of business /see attached NR0390S103S Industrial Reactsr Labs Since 91 out of business /see attached NR0469010lG MPSI OutofBusiness/seeattached/
NR0528D10lS Boeing License terminated in 1991/see attached i
NR0434010lS Machinery Electrification / No record of any license NR0434D1025 h.0275S10lS Thiokol Corp, License was terminated in 1986/see attached NR04420101U Martin Marietta All licenses for this company are inactive in Maryland Registration copied from file contains no dates at all/
see attached Thanks.
Sandy Kimberley 1
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