ML20198F174

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Registry of Radioactive Sealed Sources & Devices,Safety Evaluation of Device for Model Gammacell 40. Certificate:NR-220-D-101-S
ML20198F174
Person / Time
Issue date: 12/17/1992
From: Doug Broaddus
NRC
To:
Shared Package
ML20138M295 List:
References
SSD, NUDOCS 9812280061
Download: ML20198F174 (17)
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE jhycuxb!Ldl..-

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NR-220-D-101-S DATE:

December 17, 1992 PAGE 1 OF 8 DEVICE TYPE:

Gamma Irradiator 5 #'f *0,t} #.

l;, e4"1 !35 MODEL: Gammacell 40 - f S'niA ND f /.[.a-1 ) $ X'CL G l vws e.. O l4 OS MANUFACTURER / DISTRIBUTOR: Nordion InternationalcInc. (formerly Atomic Energy of Canada, Ltd.) -P.Or Box-13500 447 i4 arch Road i Kanata, Ontario, Canada K2K 1X8 SEALED SOURCE.EQDEL DESIGNATION: AECL C-161, Type 8 Nordion C-161, Type 8 Nordion C-440 ISOTOPE: MAXIMUM ACTIVITyl, Cesium-137 4,200 curies (155.4 TBq) LEAK TEST FREOUENCY: 6 months PRINCIPAL USX1, (J) Gamma Irradiator, Category I CUSTOM DEVICE: YES X NO _m 9812290061 981221 P RC PDR nwnood

.-B 3 REGISTRY'OF RAD'IOACTIVE SEALED SOURCES AND DEVICES I SAFETY EVALUATION OF DEVICE q ? NO.: NR-220-D-101-S DATE: December 17, 1992 PAGE 2 OF 8 PEVICE TYPE. Gamma Irradiator DESCRIPTION: The Gammacell 40 is a casiu:2-137 irradiator designed for use in an unshielded room. The unit provides a means for uniform gamma irradiation of small animals or-biological samples while providing complete protection for operating personnel. Irradiation is accomplished by moving two lead filled cylindrical drawers, each containing a single radioactive source, simultaneously by pneumatic controls from the stored to the irradiate position. Source position is indicated by either an illuminated source ON (red) or source OFF (green) pushbutton switch located on the control paneA. Each source directs a beam r. of radiation to the sample tray located in the center-of the unit. While in the irradiate position, the. radiation beam is . entirely enclosed by lead shielding and while in the stored position the' sources are shielded on all sides by' lead. A mechanical interlock prevents the sample door from being opened while the sources are in the irradiate position. Therefore, under n.ormal circumstances the operator would not be exposed to a direct beam of radiation. %) 9 A Model C-161, type 8 or Model C-440, cesium-137 (in the form of-cesium chloride) source is housed in each of two cylindrical sliding drawers 15 inches (38.1 cm) long by 2.5 inches (6.4 cm) in diameter. The drawers fit into lead cylinders about 29 inches (73.7 cm) long by 16 inches (40.6 cm) in diameter. The cylinders lie horizontally about 12 inches (30.5 cm) apart, one above and one below the sample cavity. A port in each cylinder wall about 10 inches (25.4 cm) from the end leads to the sample cavity which is. enclosed in a minimum of about 5 inches (12.7 cm) of lead. s The source drawers are moved from the shielded position, which is approximately 9 inches (22.9 cm) from the end opposite the port end, to the irradiate position by means of pneumatic cylinders. %. The u v71e cavity consists of an aluminum ring 13 inches I (33.s s 1 inside diameter by 4.875 inches (12.4 cm) high. The ring is s, pen at the top and the bottom and has hanger slots in. the top rim to allow the user to suspend samples inside. The ring is secured to the hinged sample cavity door such that when the door is open, samples are easily accessible without reaching .\\ into the irradiation cavit7 Three stainless steel access tubes, m 0.375' inch (0.95 cm) inside diameter, lead into the sample cavity ( for-ventilation and instrumentation. 9y v) h &+'ed N o, $ th d ' .fc l 'I ,ft g) o f Ak 12 v &, (a f "-(i ( s',,-w ~c m m c u -"'" p ,-+,-<jacfn~<p' w,y'ce ded&.F,_cc fto A 48 a2< yy fj& h %f c 9 I p ( p. c; )

i ,w-REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES ~ SAFETY EVALUATION OF DEVICE u .,o - l HQ,_1, NR-220-D-101-S DATE: December 17, 1992 PAGE 3 OF 8 i t DEVICE TYPE: Gamma Irradiator ,q:,3 m, ~ DESCRIPTION: (Cont.) l .The sourcehead, pneumatic cylinders, and controls are entirely j. covered by a removable sheet metal enclosure consisting of upper l and lower enclosures and two back panels. The upper enclosure l contains the control panel. The entire unit is mounted on metal skids and stands 57.4 inches-(145.9 cm) high, 36.4 inches (92.4 cm) wide and 48.3 inches (122.5 cm) deep.. The unit weighs j g approximately-6300 pounds (2,858 kg). The unit operates on d i 115 volt, single phase, 6d cycle power and may be purchased with P' .or without an air compressor. " '9 'The unit comes either with two Atomic Energy of Canada, Ltd. (AECL).or Nordion Model C-161, type 8 sealed sources or two Nordion C-440 sealed sources. The sources.are doubly encapsulated using type 316L stainless steel. Nominal dimensions for each source are 1.57 inches (39.9 Em)/ diameter by 1.70 inches (43.3 mm) length. Nominal wall thickness for each capsule of the C-161 source.is 0.020 inch (0.53 mm) and nominal thickness for each end cap is 0.085 inch (2.2 mm). Nominal wall thickness for each capsule of the C-440 source is 0.039 inch (1.0 mm) and nominal thickness for each end cap is 0.118 inch (3.0 mm). The capsules are sealed with active fusion welds. Several safety features have been incorporated into the unit for -protection of operating personnel: L 1. The source drawers are mechanically interlocked with the sample drawer. A square section steel rod is mounted on the l front of each source drawer which will only align with slots in the tubular extension of the sample drawer hinge pin when .the sample drawer is closed. This assures that the source l drawers cannot move into the irradiate position when the l sample drawer is open, or is not completely closed. 2. -A mechanical lock on the sample drawer is electrically interlocked to the source ON pushbutton to prevent the drawer from being opened when the sources are exposed. 3. A spring loaded locking bar on the sample chamber door lock activates a microswitch when fully engaged, completing the electrical circuit to the source drawer control solenoids. ) Disengaging the locking bar interrupts the circuit and this, s in turn, returns the sources to the stored position. y' M A u n w f' '{l S'f a, M j^9 & " L' L w r( V 'lb C i c W l ' *A" ' ~ ~ ' V gn,4 Adc& % e h w. W /W'M kMO v @ _p a-

.N REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES i .w SAFETY EVALUATION OF DEVICE l e' ( HQti NR-LJ0-D-101-S DATE: December 17, 1992 PAGE 4 QE_E DEVICE TYPE: Gamma Irradiator-l DESCRIPTION: (Cont.) Nordion International,'Inc., separated from AECL and became an ' independent entity October, 1988. Prior to this date the l Gammacell 40 irradiator was manufactured exclusively by'AECL. After this date AECL ceased to manufacture, distribute or service .these devices and Nordion International took over there duties. ' LABELING: The Gammacell 40 is labeled on the front of the device. The Jabal consists of the phrase " CAUTION RADIOACTIVE MATERIAL", the radioactive trefoil symbol, isotope, date of measurement and the curie content.- Additional labels attached to the device indicate the manufacturer.(AECL or-Nordion, as applicable), the model -number and the serial number. The Nordion Model C-440 sources are engraved on the upper endcap of the outer capsule with "CS-137D", source serial number, "NII", "C-440", and the radioactive trefoil symbol. DIAGRAM: See Attachments 1, 2and'.L/ T[- CONDITIONS OF NORMAL USE: J t ~The Gammacell 40 is a low dose rate irradiator designed to ) irradiate biological or other samples requiring low dose rate, Il (e.g. blood and blood components to eliminate small lymphocytes, sprout stimulation of seeds and tubers, non-sporulating bacteria and molds, pasteurization and sterilizations, viruses, polymerization, small animals, etc.). Typical environments associated with the use of this device include medical facilities .and laboratories fit for human occupancy and in an unshielded room. Users are trained in the use of the irradiator' equipment, safety interlock _ equipment and in radiation safety. The Model C-440 source is to be used only in the Gammacell 40 and would s therefore be subjected to these same conditions. j 's l t-

4 .. ~ ' REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES L '. s SAFETY EVALUATION OF DEVICE HQ21 NR-220-D-101-S DATE: December 17, 1992 PAGE 5 OF 8 i DEVICE TYPE: Gamma Irradiator PROTOTYPE TESTING: The Gammacell 40 has been in use since 1971 without any reported incidences. The manufacturer claims.that a full. program of prototype tests sufficient to establish that the safety features of the device will continue to function properly under the most adverse conditions was conducted. The manufacturer claims that the C-440 sources have been tested to ANSI N542-1977 and achieved a classification of E65546. EXTERNAL RADIATION LEVELS: AECL conducted a survey of an irradiator containing two 1800 curie (66.6 TBq), Model C-161, type 8 sources. With the sources in the "OFF" position, no significant reading was detectable 39.4 inches (100 cm) from the center of the sources. The highest reading 1.97 inches (5 cm) from the surface of the irradiator was 0.3 mrem /hr (3 pSv/hr). The sample cavity door was opened and the maximum reading inside the cavity was 4.7 mram/hr (47 Sv/hr). With the sources in the "ON" position, the highest reading 39.4 inches (100 cm) from the center of the sources was 1.3 mrem /hr (13 pSv/hr). The highest reading 1.97 inches (5 cm) Lfrom the unit was 11 mrem /hr (110 Sv/hr). The manufacturer reports the calculated radiation dose rates at varying distances from the Model C-440 source as follows: Distance Radiation Level from source R/hr (Sv/hr) 5 cm/1.97 in 186,120 (1,861) 30 cm/11.8 in 5,172 (52) yfw a cA t u f"},9. 4 in 100 cm/3 g g [ g 466 (4.7) l f3 g f c.I ,[3 ptc b '1 y;6 4 ser~ a s,, u,n y w a t w (~

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l-NO.: NR-220-D-101-S DATE: December 17, 1992 PAGE 6 OF 8 E l ^ DEVICE TYPE! Gamma Irradiator i OUALITY ASSURANCE AND CONTROL: I . Manufacture of Gammacell 40 irradiators is covered under Nordion International's (formerly Atomic Energy of Canada, Ltd.) quality assurance and control program which has been deemed acceptable for licensing purposes by NRC. A copy of the progrfm is on file with the Source-containment--and-Devices _ Branch. TJ K C-Quality control-during manufacture of the C-440 sources is maintained under Amersham International's Quality Ass *":nce L Manual for radiation sources. The sources are manufactured by Amershcm-International acco. ding to Nordion's specifications. Upon receipt at Nordion, the sources are tested for removable . contamination,-dimensional conformity to design specifications, f proper labeling and are measured for output. l LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE: Containment of samples should be ensured in order to protect the integrity of the sample chamber. l

  • The Model Gammacell 40 shall be distributed only to persons specifically licensed by the-NRC or an Agreement State.

l The device shall be leak tested at intervals not to exceed six months using techniques capable of detecting 0.005. microcurie (185 Bq) of removable contamination.

  • Maximum source activity for the Model C-440 source is 2250 curies (83.3 TBq).

However, maximum total activity allowed for the Gammacell 40 irradiator is 4200 curies (155.4 TBq) for two sources. . Handling,. storage use, transfer and disposal: To be determined by the licensing authority. In view that the sealed sources exhibit high surface dose rates when unshielded, they should be handled only be experienced licensed personnel using adequate remote handling equipment and procedures. + The Model C-440 source is approved for use only in the j Gammacell 40 irradiator. f. ,e,. 9 e. ,g., __ 7

-~ 4 4 $.;es REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE %'d' i HQti NR-220-D-101-S DATE: December 17, 1992 PAGE 7 OF 8 1 DEVICE TYPE: Gamma Irradiator LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE: (Cont.) I

  • This registration sheet and the information contained within the references shall not be changed or transferred without the written consent of the NRC.

SAFETY ANALYSIS

SUMMARY

Based on our review of the information and test data cited below, and that the irradiator design was previously deemed acceptable by taa NRC,.we continued to conclude that the Gammacell 40 irradiator design is acceptable for licensing purposes. Furthermore, we continue to conclude from operational data since L1971, that this irradiator design would'ba expected to maintain i its integrity for normal and accidental conditions of use which might' occur during uses specified in this certificate. Additionally, based.on our review of the information and test data cited below as pertains to the Model C-440 source design and the manufacturers claimed ANSI classification of E65546, we conclude the Model C-440 source design is acceptable for licensing purposes when used in the Gammacell 40 irradiator. Furthermore, we conclude the Mcdel C-440 source would be expected to maintain its integrity for normal and accidental conditions of use which Iaight occur during uses specified in this certificate. k j-(- C^""h ut f P

REFERENCES:

-The following supporting documents for the Gammacell 40 -irradiator and C-440 source capsule designs are hereby ' incorporated by reference and are a made a part of this registry document:. Atomic Energy of Canada Limited letters dated August 24, 1970, October 21, 1970, and March 25, 1971, with enclosure thereto. Nordion International, Inc., letters dated November 2,

1992,

-December 1, 1992, and December 8, 1992, with enclosures thereto. y y ,. ~., ,~, v- ,-,-mv m .m-v- ,e.--

+* m - REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES g SAFETY EVALUATION OF DEVICE / h NR-220-D-101-S DATE: December 17, 1992 PAGE 8 OF 8 DEVICE TYPE: Gamma Irradiator REFEilENCES: (Cont.) Amersham Corporation's letter, in_ support of Nordion's application, dated December 16, 1992, with enclosures thereto. ,, /~ [ ISSUING AGENCY: f ,U.S. NUCLEAR REGULATORY COMMISSION l' I. b a m b ia_ DATE: December 17. 1992 REVIEWER: \\ DATE: December 17, 1992 CONCURRENCE: // / .(c (n.cCccic ) * '* < g, s u \\~ ldh [t_pO O yvo cf 6&r* \\ L l l-Y

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Mr. Jol n Jankovich

/ Senior Engineer ~ Sealed Source Safety Section Medical, Academic & Comml. Use Safety Br. 3 Division of Industri J & Medical Nuclear Safety ~ United States Nuclear Regulatory Commission ~ I White flint North 11555 Rockville Pike

Rockville Maryland USA 20852

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.m.. CONVERSATION RECORD TYPE: Outgoing Telephone x Incoming Telephone Meeting NAME OF PERSON CONTACTED: ORGANIZATION: TIME: DATE: Joseph Sterling MDS Nordion 1:30 pm 07/17/98 1

SUBJECT:

Nordion'u amendment request,'re. C-188, to add Co-60 in pellet i form with a diameter of 1 mm as authorized source. GUMMARY: .I called R. McGregor/Nordion to inform him about IMNS's l meeting with RES regarding the interpretation of the requirements in 10 CFR 36.21 for nondispersibility and j insolubility. Mr. McGregor is on vacation until 8/5/98. I l was connected to Joe Sterling in his place. I informed him that NRC will consider the Co-60 pellets.as meeting the requirements and that we proceed with the review of Nordion's 1 application. 1 i l ACTION REQUIRED: ) NRC to proceed with the review. PLACE THIS RECORD IN: Registration File NR-220-S-103-S QA File Incident File 98-31' General File PERSON DOCUMENTING THE SIGNATURE: g DATE: CONVERSATION: .g John Jankovich 07/17/98 l i i i i-}}

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