ML20247R516

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Registry of Radioactive Sealed Sources & Devices,Safety Evaluation of Safety Evaluation of Device for Model 3M1L. Certificate:NR-460-S-912-S
ML20247R516
Person / Time
Issue date: 01/26/1996
From: Steven Baggett, Doug Broaddus
NRC
To:
Shared Package
ML20247R521 List:
References
SSD, NUDOCS 9805290167
Download: ML20247R516 (7)


Text

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REGISTRY OF' RADIOACTIVE SEALED' SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-460-D-912-S DATE: January 26, 1996 PAGE 1 OF 6 DEVICE TYPE: ' Experimental Fluid Beta Irradiator MODEL:

3M1L MANUFACTURER / DISTRIBUTOR:

3M Health Physics Services 3M Center, Building 244-2E-06 St. Paul, MN 55144-1000 SEALED SOURCE MODEL DESIGNATION:

3M Brand Radiating Microspheres ISOTOPE:

MAXIMUM ACTIVITY:

Strontium-90 50.00 curies (1.850 TBq)

LEAK TEST FREOUENCY:

6 Months PRINCIPAL USE:

(T) Other i

CUSTOM DEVICE:

YES X

NO 9805290167 960126 PDR RC

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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO : NR-460-D-912-S DATE: January 26, 1996 PAGE 2 OF 6 DEVICE TYPE:

Experimental Fluid Beta Irradiator DESCRIPTION:

The Model 3M1L is a singly-encapsulated tube irradiator.

The irradiator body is a 7.000 in. (17.78 cm) long, 1.000 in.

l (2.540 cm) diameter stainless steel cylinder with a' shaft through its center. -Starting from one end, the first 0.500 in.- (1.270 cm) of length has a 0.250 in. (0.635 cm) shaft diameter.

'Fhe middle 6.000 in. (15.24 cm) of length has a shaft diameter of 3

0.310 in. (0.787_cm), and the final 0.500 in. (1.270 cm) of length has a shaft diameter of 0.500 in. (1.270 cm).

A 7.000 in.

(17.78 cm) long, 0.250 in. (0.635 cm) outer diameter, 0.238 in.

]

(0.605 cm) inner diameter stainless steel tube is inserted j

through the shaft.

With the tube inserted, a void 0.030 in.

(0.076 cm) wide lies between the tube and irradiator body over the middle 6.000 in. (15.24 cm) of its length.

That void widens 3

to 0.125 in. (0.318 cm) around the tube for the final 0.500 in.

(1.270 cm) of the irradiator body.

Strontium-90 (Sr-90) is absorbed into small ceramic particles.

.The isotope is then permanently fixed to the ceramic particles using a heat treatment to create 3M Brand Radiating Microspheres.

The microspheres are loaded into the void between the central

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tube and the irradiator body.

Since the void is 6.000 in.

l (15.24 cm) long, the irradiator has a 6.000 in. (15.24 cm) active length.

After the microspheres are loaded, a tubular end. plug 1.000 in. (2.540 cm) long, with a 0.500 in. (1.270 cm) outer diameter and a-0.250 in. (0.635 cm) inner diameter is inserted into the remaining void at the open end of the irradiator and brazed to both the irradiator body and the tube, sealing the j

microspheres inside.

DIAGRAM:

See Attachment i l.

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-460-D-912-S DATE: January 26, 1996 PAGE 3 OF 6 DEVICE TYPE:

Experimental Fluid Beta Irradiator LABELING:

The following information was engraved on the exterior of the source housing:

Caution - Radioactive Material XXX Curies Sr-90 3M Company Model 3M1L Serial Number XXX Date CONDITIONS OF NORMAL USE:

The Model 3M1L irradiator is intended for use in experimental irradiation studies on chemical and biological systems which are normally done in a laboratory under climate-controlled conditions.

One application of the irradiator is to insert a plastic tube through the center of the 3M1L and pump the liquid to be irradiated through the tube.

3M planned to sell the Model 3M1L to companies who would mount it in shields and then sell the Model 3M1L irradiator and shield combination as a package.

PROTOTYPE TESTING:

3M did not provide prototype data for the Model 3M1L device, but relied on the destructive prototype tests and historical use data on the 3M1B Fluid Beta Irradiator, since the devices are essentially similar.

I EXTERNAL RADIATION LEVELS *,

3M reported radiation dole rates for a Model 3M1B device loaded

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with 120.0 Ci (4.440 TBq) inside its shield at various distances

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from the surface.

Based on this data, external radiation levels j

for a Model'3M1L device, when loaded with 50 Ci (1.85 TBq) of i

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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-460-D-912-S DATE: January 26, 1996 PAGE 4 OF 6 DEVICE TYPE:

Experimental Fluid Beta Irradiator EXTERNAL RADIATION LEVELS: (continued)

Sr-90, would be expected to be approximately:

Distance From Surface Dose Rate Location inches (cm) mr/hr (usv/hri 4

Top and Bottom 0

(0) 4.2 (41.6) 12 (30.48) 0.63 (6.3)

Sides 0

(0) _

1.3 (12.5) 8.3 (83) 12 (30.48)

QUALITY ASSURANCE AND CONTROL:

The following quality control procedures were followed during production of this device:

1. The unloaded irradiator was pressurized through the fill l

hole to at least 100.0 psi (689.5 kPa).

This was done underwater and the housing was observed for leaks, which were indicated by bubbles appearing around the seals.

2. The completed irradiator was bubble leak tested by immersing it in water at 200*F (93.33*C) and watching for any bubbles j

produced.

If any bubbles were observed, the unit failed this test.

3. The completed irradiator was smear tested immediately after

-fabrication and immediately prior to shipment.

The maximur allowable amount of removable contamination for these smear tests was 0.001 C1 (37.00 Bq).

LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:

This device may be used only by persons specifically licensed by the NRC or an Agreement State.

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Handling, storage, use, transfer, and disposal:

to be determined by the licensing authority.

i l

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-460-D-912-S DATE: January 26, 1996 PAGE 5 OF 6 DEVICE TYPE:

Experimental Fluid Beta Irradiator LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE: (continued)

  • REVIEWER NOTE:

3M did not give specific radiation level information for this device and stated that it is up to the individual customer to provide shielding as well as any other required ancillary equipment needed to use the device effectively and safely.

This device shall be leak tested at intervals not to exceed 6 months using techniques capable of detecting 0.005 microcurie (185.0 Bq) of removable contamination.

This registration sheet and the information contained within

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the references shall not be changed without the written consent of the NRC.

SAFETY ANALYSIS

SUMMARY

The Model 3 MIL tube irradiator is not a current product manufactured or distributed by 3M Health Physics Services.

However, 3M Health Physics Services will continue to receive 3M1L devices for disposal.

Based on our review of the Model 3M1L tube irradiator, and the information and test data cited below, we continue to conclude that this device is acceptable for licensing purposes.

Furthermore, we continue to conclude that the Model 3M1L tube irradiator would be expected to maintain its containment integrity for normal conditions of use and accidental conditions which might occur during uses specified in this certificate.

REFERENCES:

The following supporting documents for the Model 3M1L tube irradiator are hereby incorporated by reference and are made a part of this registry document:

3M Health Physics Services' letters dated August 6,

1991, 7

October 15, 1968, and December 17, 1964, with enclosures thereto.

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-460-D-912-S DATE: January 26, 1996 PAGE 6 OF 6 DEVICE TYPE:

Experimental Fluid Beta Irradiator ISSUING AGENCY:

U.S. Nuclear Regulatory Commission

.b Date:

January 26, 1996 Reviewer:

&E6uglas A. Broaddus Date:

January 26, 1996 Concurrence:

'Stieven L. 'Biggett i

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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO : NR-460-D-912-S DATE: January 26, 1996 ATTACHMENT 1

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MINNESOTA MINING AND MANUFACTURING (3M) INACTIVE FILES FROM:

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SUBJECT:

INACTIVATION OF REGISTRATIONS BASED ON AUGUST 6, 1991, LETTER.

A number of the background files for the registration certificates requeste'd (by 3M letter dated August 6,1991) to be made inactive contain limited information on the products. A search of 3M registration, archive, and license files, and information in NUDOCS was performed to obtain additional information. Also, 3M was contacted to obtain any additional information that may have been in their files.

3M provided limited additional information concerning these products and indicated that the information provided represented all additional information in their files. Additional information obtained from these sources has been added to the applicable registration files.

At the present time, the information contained in the background registration files represents all available information for these products.

In addition, a number of these products were originally reviewed and approved by the Atomic Energy Commission (AEC).

The reviews performed for these products to make the certificates inactive were based on the information available, the previous reviews and approvals, and the historical use of the products (i.e., reports of failures or design problems, or the lack thereof).

In several instances, insufficient information was available to perform an adequate safety review.

In these instances, the certificates have been reissued based solely on the original AEC review and approval, and no additional safety review was performed.

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I February 29, 1996 Robert G. Wissink 3M Health Physics Services I

l 3M Center Bldg. 224-2E-06 St. Paul, MN 55144-1000

Dear Mr. Wissink:

This letter is in response to your request dated August 6, 1991, and subsequent letters, requesting to transfer to inactive status all registration sheets issued to 3M as listed in the first column of Enclosure 1.

We have transferred the requested certificates to inactive status. The certificate numbers have been changed as listed in Enclosure 1.

Copies of the inactive certificates are enclosed for your records.

Please read over the registration certificates and notify us immediately if there are any errors or inconsistencies.

If you have any questions, please contact me at (301) 415-5847 or Mr. Steven Baggett at (301) 415-7273.

Sincerely,

/s/

t Douglas A. Broaddus, Mechanical Engineer i

Sealed Source Safety Section Source Containment and Devices Branch Division of Industrial and Medical Nuclear Safety, NMSS

Enclosures:

As stated Distribution:

SSSS R/F NE01 SSD-91-71 Registration certificate files listed in Enclosure 1 DOCUMENT NAME: C:\\WPDOCS\\SSDS\\ INACTIVE \\NRC\\460lNACT. CMP Ta seoelve e copy of this desument,Indosee in the ben:

'C' = Copy without ettechment/encloewe

  • E* = Copy with attechment/encioews
  • N* = No copy 0FFICE SCDB lC l

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l NAME DABroaddus DATE-02/3/96 OFFICIAL ~ RECORD COPY

s-ENCLOSURE 1 REGISTRATIONS TRANSFERRED TO INACTIVE STATUS Old Certificate No.

New certificate No.

Nodel Number (s)

NR-459-S-101-S NR-8008-S-801-S 4F6Y NR-459-S-102-S NR-8008-S-802-S 3 FIG NR-460-S-101-S NR-0460-S-875-S 4F6D NR-460-S-102-S CON 8INED WITH 4F6H, 4F68 NR-0460-S-874-S NR-460-S-103-S.

NR-0460-S-876-S 4F6G l

NR-460-S-104-S CON 8INED WITH 6D6A l

NR-0460-S-865-S NR-460-S-105-S NR-0460-S-877-S 6B6F NR-460-S-106-S NR-0460-S-878-S 4F6P l

NR-460-S-107-S NR-0460-S-879-S 1C2A, IC2B NR-460-S-108-S NR-0460-S-880-S 4F3B l

NR-460-S-109-S NR-0460-S-881-S 4F3C l_

NR-460-S-110-S NR-0460-S-882-S 3MIC NR-460-S-111-S NR-0460-S-883-S 3MlB NR-460-S-ll2-S NR-0460-S-884-S 3E4G NR-460-S-113-S NR-0460-S-885-S 4D3A NR-460-S-114-S NR-0460-S-886-S 4D3B NR-460-S-Il5-S NR-0460-S-887-S 4D60 NR-460-S-Il6-S NR-0460-S-888-S 4D6F NR-460-S-117-S NR-0460-S-889-S 5FID NR-460-S-118-S CON 8INED INTO 5FIE

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NR-460-S-119-S 5FIF NR-460-S-120-S NR-0460-S-891-S 5 FIG NR-460-S-121-S NR-0460-S-892-S 3L2B r

NR-460-S-122-S NR-0460-S-893-S 3L2A NR-460-S-123-S NR-0460-S-894-S 3M1F NR-460-S-124-S NR-0460-S-895-S 3L2C i

i ENCLOSURE I REGISTRATIONS TRANSFERRED TO INACTIVE STATUS Old certificate No.

New Certificate No.

Nodel Number (s)

NR-460-S-125-S NR-0460-S-896-S lE2J NR-460-S-126-S NR-0460-S-897-S 3 FIG NR-460-S-127-S NONE - NO INFORMATION 4FIE AVAILABLE NR-460-S-128-S NR-0460-S-899-S 5F1H NR-460-S-129-S NR-0460-S-900-S 3E40 NR-460-S-130-S COMBINED INTO SFIN NR-460-S-131-S NR-0460-S-901-S 5 FIN (MODIFIED)

NR-460-S-132-S NR-0460-S-902-S 7B8L hR-460-S-133-S COMBINED INTO 6H6A NR-460-S-134-S

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6H6B NR-460-S-135-S NR-0460-S-904-S 4D6M NR-460-S-136-S NR-0460-S-905-S 3L2E NR-460-S-137-S NR-0460-S-906-S 6500, 6520 (FORM. 6D6C)

NR-460-S-138-S NR-0460-S-907-S 3L2D NR-460-S-139-S NR-0460-S-908-S 3Q10 NR-460-S-140-S NR-0460-S-909-S 3E4L, 3E4S NR-460-S-141-S NR-0460-S-910-S 3 FIR NR-460-S-142-S NR-0460-S-911-S 902, 902F, 903 NR-460-S-143-S COMBINED WITH 4P6E NR-0460-S-871-S NR-460-S-144-S COMBINED WITH 4P6M NR-0460-S-872-S NR-460-S-145-S NR-0460-S-912-S 3Mll NR-460-S-146-S NR-0460-S-913-S 3G9A NR-460-S-147-S NR-0460-S-914-S 384G NR-460-S-148-S COMBINED WITH 4F3F NR-0460-S-871-S NR-460-S-149-S NR-0460-S-915-S 4F3G

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ENCLOSURE 1 REGISTRATIONS TRANSFERRED TO INACTIVE STATUS

.01d Certificate No.

New Certificate No.

Model Number (s)

NR-460-S-150-S NR-0460-S-916-S 601A NR-460-S-151-S COMBINED WITH 6530, 6540 (FORM. 6B6G)

NR-0460-S-869-S NR-460-S-152-S NR-0460-S-917-S 6H6D NR-460-S-153-S NOT REQUIRED ALBUMIN MICR0 SPHERES NR-460-S-154-S NR-0460-S-919-S 6H6E, 8C9T NR-460-S-155-S COMBINED INTO 4D6L NR-460-S-156-S

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4D6P NR-460-S-158-S NR-0460-S-921-S 3F11, 3F1J, 3FIL NR-460-S-159-S NR-0460-S-922-S 3FIV NR-460-S-160-S COMBINED WITH 4P6T NR-0460-S-873-S NR-460-S-161-S COMBINED INTO 4F3D NR-0460-S-920-S NR-460-S-162-S NR-0460-S-923-S 4F3H NR-460-S-163-S COMBINED INTO 4F6S NR-0460-S-920-S NR-460-S-164-S COMBINED WITH 3E40 NR-0460-S-900-S NR-460-S-165-S NR-0460-S-924-S 6701 l

NR-460-S-166-S NR-0460-S-925-S 6702 NR-460-S-167-S NR-0460-S-926-S 6711 NR-460-S-168-G NR-0460-S-927-G 702, 703, 704 NR-460-S-169-S NR-0460-S-928-S 6510, 6550, 6570 l

(FORMERLY 686G)

NR-460-S-170-S NR-0460-S-929-S 4P6V j

NR-460-S-171-S NR-0460-S-930-S 4F6ST

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