ML20198F152
| ML20198F152 | |
| Person / Time | |
|---|---|
| Issue date: | 12/21/1998 |
| From: | Steven Baggett, John Lubinski NRC |
| To: | |
| Shared Package | |
| ML20138M295 | List: |
| References | |
| SSD, NUDOCS 9812280057 | |
| Download: ML20198F152 (13) | |
Text
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY' EVALUATION OF DEVICE (Amended in its Entirety)
NQ. NR-220-D-101-S DATE: December 21, 1998 PAGE 1 OF 9 DEVICE TYPFa Gamma Irradiator MODEL: Gammacell 40 (Serial No. I through 133)
Gamunacell 40 Exactor (Serial No. 134 and higher)
MANUFACTURER / DISTRIBUTOR: MDS Nordion, Inc.
(formerly Atomic Energy of Canada, Ltd., and Nordion International, Inc.)
447 March Road Kanata, Ontario K2K IX8 Canada SEALED SOURCE MODEL DESIGNATION: AECL C-161, Type 8 MDS Nordion C-161, Type 8 MDS Nordion C-440 ISOTOPE: MAXIMUM ACTIVITY:
Cesium-137 4,200 curies (155.4 TBq)
LEAK TEST FREOUENCY: 6 months PRINCIPAL USE: (J) Gamma Irradiator, Category I l
CUSTOM DEVICE: YES x NO 9812280057 981221 PDR RC
- SSD PDR O() (2 21 ducl}
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Amended in its Entirety)
NO,. NR-220-D-101-S DATE: Decenter 21, 1998 PAGE 2 OF 9 l DEVICE TYPE: Gamma Irradiator DESCRIPTION:
The Gammacell 40 is a cesium-137 irradiator designed for use in an unshielded room. The unit provides a means for uniform gamma irradiation of samples while providing complete protection for i operating personnel. Irradiation is accomplished by moving two lead filled cylindrical drawers, each containing a single radioactive source, simultaneously by actuators from the stored to the irradiate position. Source position is indicated by either an illuminated source ON (red) or source OFF (green) push-button switch located on the control panel or by text messages on the display. Each source directs a beam 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 not in the storage position. Therefore, under normal circumstances the operator would not be exposed to a direct beam of radiation. In the Gammacell 40 Exactor units (Serial No. 134 and higher), the head flanges incorporate grooves filled with lead to address localized radiation fields.
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 approximately 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 26 inches (71 cm) conter to center, one above and one below the sample cavity. A port in each cylinder wall about 11 inches (29 cm) from the end I leads to the sample cavity which is enclosed in a minimum of I about 5 inches (12.7 cm) of lead. 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 i position by means of pneumatic cylinders in the Model Gammacell 40 units (Serial No. 1 through 133).
l 1
l 1
I
. .- . . . . . - . - - . _ _ . . . . .. -_ ~- - ~ . - . - _ - - - .
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Amended in its Entirety) l NO.: NR-220-D-101-S DATE :necenimr 21, 1998 PAGE 3 OF 9 i 1
DEVICE TYPE: Gamma Irradiator DESCRIPTION (cont'd):
In the Model Gammacell 40 Exactor units (Serial No. 134 and higher) the drawers are driven by a DC electric motor through a timing belt. The electrical power source is a sealed 12 volt DC lead / acid battery. The battery is constantly charged by a charger connected to an AC power source. If AC power is lost while the unit is in operation, battery power is sufficient to complete the irradiation cycle in progress with reserve power for at least three subsequent cycles.
In the Model Gammacell 40 units the sample cavity is sized to process small laboratory samples. The ring is open at the top and the bottom and has hanger slots in the top rim to allow the t
user to suspend samples inside. The ring is secured to the hinged sample cavity door such that when the door is open, I samples are easily accessible without reaching into the i irradiation cavity. Three stainless steel access tubes lead into the sample cavity for ventilation and instrumentation.
The Gammacell 40 and Gammacell 40 Exactor are housed in an outer enclosure. The maximum dimensions are approximately 59 inches l (150 cm) high, 37 inches long (94 cm) wide, and 49 inches (124 cm) deep. The maximum weight is approximately 7000 lbs (3180 kg).
l The unit comes either with two Model C-161, Type 8 sealed sources )
l or two Nordion C-440 sealed sources. The sources are doubly encapsulated using type 316L stainless steel. Nominal dimensions l for each source are 1.57 inches (39.9 mm) 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 i each end cap is 0.085 inch (2.2 mm). Nominal wall thickness for
- j. each capsule of the C-440 source is 0.039 inch (1.0 mm) and l nominal thickness for each end cap is 0.059 inch (1.5 mm). The capsules are sealed with active fusion welds. .
l Several safety features have been incorporated into the unit for protection of operating personnel.
l l
1 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE 1 (Amended in its Entirety)
NO,: NR-220-D-101-S DATE :IMcenter 21, 1998 PAGE 4 OF 9 DEVICE TYPE: Gamma Irradiator )
DESCRIPTION (cont'd)-
l
- 1. The source drawers are mechanically interlocked with the ;
sample drawer. A square section steel rod is mounted on the j front of each source drawer which will only align with slots ;
in the tubular extension of the sample drawer hinge pin when j the sample drawer is closed. This assures that the source drawers cannot move into the irradiate position when the sample drawer is open, or is not completely closed. At the same time it prevents the sample drawer from opening unless both sources are in the safe position.
- 2. A mechanical lock on the sample drawer is electrically interlocked to the source ON push-button to prevent the rawer 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, in turn, returns the sources to the stored position.
- 4. The Model Gammacell 40 Exactor units are equipped with electronic controls which also provide a software interlock system. The software interlock system uses sensors and compares them to a stored set of instructions, and processes the information to determine whether a requested operating step can be executed safely.
LABELING:
l The Gammacell 40 is labeled on the front of the defice. The l label' consists of the phrase " CAUTION RADIOACTIVE MATERIAL", the
- radioactive trefoil symbol, isotope, date of measurement and the i curie content. Additional labels attached to the device indicate the manufacturer (AECL or Nordion, or MDS Nordion e as l
applicable), the model number and the serial number.
. . . - -.. __ -. ... - . .~ -~
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Amended in its Entirety)
NQ, NR-220-D-101-S DATE: Decelber 21, 1998 PAGE 5 OF 9 DEVICE TYPE: Gamma Irradiator LABELING (cont'd)-
The Model C-440 sources are engraved on the upper endcap of the outer capsule with "CS-137D", source serial number, "NII" or "MDS , "C-440", and the radioactive trefoil symbol. The Model C-161 sources are engraved on the upper end cap of the outer capsule with "CS-137A," source serial number, and the letters "AECL," "NII," or "MDSN."
DIAGRAM:
See Attachments 1, 2, 3 and 4.
CONDITIONS OF NORMAL USE:
l The Gammacell 40 is a low dose rate irradiator designed to_ l irradiate biological or other samples requiring low dose rate. I 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 interlocx equipment and I in radiation safety. ,
l PROTOTYPE TESTING:
The Gammacell 40 nas been in use since 1971 without any reported incidences. The manufacturer claims that a full program of 1 prototype tests sufficient to establish that the safety features L
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 l to ANSI N542-1977 and achieved a classification of E65546.
l l
l l
I REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES i SAFETY EVALUATION OF DEVICE l (Amended in its Entirety) !
NO.: NR-220-D-101-S DATE : Decanter 21, 1998 PAGE 6 OF 9 j
DEVICE TYPE: Gamma Irradiator I I
EXTERNAL' RADIATION LEVELS: )
AECL conducted a survey of an irradiator containing two l 1800 curie (66.6 TBq), Model C-161, type 8 sources. With the :
sources in the "OFF" position, no significant reading was l detectable 39.4 inches (100 cm) from the center of the sources. I The highest reading 1.97 inches (5 cm) from the surface of the I
irradiator was 0.3 mrem /hr (3 pSv/hr). The sample cavity door 1 was opened and the' maximum reading inside the cavity was 14.7 mrem /hr (47 pSv/hr). 1 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) from the unit was 11 mrem /hr (110 pSv/hr).
l The manufacturer reports the calculated radiation dose rates at i varying distances from the Model C-440 source as follows:
Distance Radiation Level from source R/hr (Sv/hr) )
1 5 cm/1.97 in 186,120 (1,861) 30 cm/11.8 in S,172 (52) 100 cm/39.4 in 466 (4.7)
The manufacturer reports that the Model Gammacell 40 Exactor units have a maximum external radiation field of approximately 2 mrom/hr at a distance of 5 cm (1.97 inches) from any accessible surface of the device.
OUALITY ASSURANCE AND CONTROL 1 i Manufacture of Gammacell 40 and Gammacell 40 Exactor irradiators is covered under MDS Nordion'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 program is on file with the NRC.
i
! l l
.,, . . . . . . - . . . ~ - . . ~ - . - - - . . - - ..-. -. - .. - ~ .. -... ~ -.-
REGISTRY-OF RADIOACTIVE SEALED SOURCES'AND DEVICES SAFETY EVALUATION OF DEVICE L (Amended 1in its Entirety)
NO,: NR-220-D-101-S DATE: Decaiber 21, 1998 PAGE 7 OF 9 DEVICE TYPE: ' Gamma Irradiator l
!' OUALITY' ASSURANCE AND CONTROL (cont'd)-
Quality control during manufacture of the C-440 sources is ;
maintained under Amersham International's Quality Assurance Manual- i for radiation sources. The sources are manufactured by
' Amersham International according to Nordion's specifications. Upon receipt at-Nordion, the sources are tested for removable L l contamination, dimensional conformity to design specifications, ,
L proper labeling and are measured for output. .
LIMITA12 r AND/OR JTHER~ CONSIDERATIONS OF USE:
i
'a- LContainment of samples should be ensured in order to protect '
I the integrity of the sample chamber. ,
t The Model Gammacell 40 and Gananacell 40 Exactor shall be !
distributed only to persons specifically licensed by the NRC j or an Agreement State. :
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. l l
l
, -* Maximum source activity for the Model C-440 source is 2250 curies (83.3 TBq). However, maximum total activity allowed l for the Gammacell 40 irradiator is 4200 curies (155.4 TBq) for l two sources.
- Handling, storage use, transfer and disposal: To be determined y .by the licensing authority. In view that the sealed sources l exhibit high surface dose rates when unshielded, they should 1
be handled only be experienced licensed personnel using adequate remote handling equipment and procedures.
L'
- The.Model C-440 source is approved for use only in the i
t Gammacell'40 irradiator.
- This. registration sheet and the information contained within the. references shall not be changed or transferred without the l written consent'of the NRC.
1
_ _. . . . _ . - ..._m _. . . _ . . .. _ . - __ _. _ . . . _ _ . _ _ _ . . .
I L .<
REGISTRY'OF.-RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE '
, (Amended in its Entirety)
NO.: NR-220-D-101-S DATE: Decanimr 21, 1998 .PAGE 8 OF 9 DEVICE TYPE: ' Gamma'Irradiator
. SAFETY ANALYSIS GUMMARY:
E Based on our review of the information and test data cited below, and that the irradiator design.was previously deemed acceptable by.the-NRC,.we continue to conclude'that the Gammacell 40 irradiator design is acceptable for licensing purposes.
Furthermore,' we continue to conclude from operational data since c1971, that-this irradiator design would be expected-to maintain l
- its-integrity for normal and accidental conditions of use which
'might occur during uses specified in this certificate.
Additionally, based onfour review of the information and test-p data. cited below:as pertains to the Mode'. C-440' source design and b the manufacturers claimed ANSI classification of E65546, we continue to conclude the Model C-440 source design is acceptable for licensing purposes.when used in the Gammacell 4011rradiator.
l Furthermore, we' continue to conclude the Model C-440 source would i be expected to maintain its integrity for normal and' accidental l conditions of use which might occur during uses specified in this certificate.
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.
i l-
6 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Amended in its Entirety)
NO.- NR-220-D-101-S DATE: December 21, 1998 PAGE 9 OF 9 DEVICE TYPE: Gamma Irradiator REFERENCES (cont'd):
I Amersham Corporation's letter, in support of Nordion's "
application, dated December 16, 1992, with enclosures thereto.
- MDS Nordion's letter dated February 27, 1998, two letters ,
dated April 3, 1998, and telefax dated May 26, 1998, with I enclosures thereto. l ISSUING AGENCY:
U.S. NUCLEAR REGULATORY COMMISSION /
DATE: December 21, 1998 REVIEWER: 7/N
'o,hn W.
Lubinski DATE: Nr =hm- 91 1998 CONCURRENCE: )
it$Iven L. Baggett 4
l I
i l
I l
l REGISTRY-OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Amended in its Entirety)
NO.: NR-220-D-101-S DATE : December 21, 1998 ATTACHMENT 1 1
1 l
1 1
4 3
'/ 2'O'.""
[
&-.- 8 e
- v. .,
~ /
'n e- ,
$1 1 2 ') !
,, om
~~~ --- -
g yf Q S$$$ S J..
I J//e
- P Q' s
=
Q:-M/
IM E3 if ff: 1
~--
~t
,a l
j ~_-,-.--.-.-- . . - . - - . -
l l .a .- .
~.
.-__ 1
- ==._._. ::: _ -
l- f i .
- ==- - ' "
- =:=
l
-=
JIa ."...'L. ._
-.=u..====
1 I
l l
l l
Model Gammacell 40 Irradiator I (Serial No.1 through 133) with pneumatic drive system l I
l l
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES i SAFETY EVALUATION OF DEVICE (Amended in its Entirety)
N_12. NR-220-D-101-S DATE: December 21, 1998 ATTACHMENT 2 l
yRcTAnNo mNo PLUG (URANIUM ALLOY) 4.Hott$ h *2O U.N.C. SOURCt r0R ORA *cR 0.surm0 WCCHANISM.
/
. irs mRASS cNCASc0 SOURCE SLEEVE LEAD k th DIA. TRANSFtR U>CATING MOLE I m
$.rf**
f
-6 MN.C.
Rt.og TRANSFCR PUSH R00 2.HOLESI6*'8
, LtKC. TH'O. FOR RIDE R RING A$ S'Y
_ 2 4 7$ " DI A.S. *sMIN AL '
6 29 CM.
z SOURCE NO Cl46 & CISI =
h
( Ot A.* C 5,0 75. 3 0,125,1 S,1 75 y p j 3 2 0. 2 25.2 S CW. ) / / / /
/ / / / Y
.t!QIL l
s' /
/ / s
///
' //
h j
I SOURCE SLEEvt AS ILLUSTRATED, USIO WITN SOURCCS OF / / / #
p p j , g['j // /'j 0.S CE TO 2 2S CM. DIA. INCLUS3VE f / / = = - -
- /
2 SOURCE SMCER ( NOT SHOWN) USED FOR 2 $ CM. SOURCE / / / /
S M00CLS 6 ANO 40- N0hdNAL CAPACITY - TS LM.M. ScuRCE # / / // f 'ca
/ /e, // / / .
4 M00tLS 6 AND 40 - NOMINAL CApihCITY -ISO fLM.M. SOURCE /'f ' "---
p 'f a
S. M00CLS E70 AND 7700-NOMINALCANOTY-200 R.M.M. SOURCE ' a< g
- 4. MODELS E76 AND T765-NOMINALCAMCITY-115 RAI.M.50UftCE
( ,
7 MAXIMuu CAmQTY WILL WRV SIGN 6FICANTLY WITN EACH W NIT. CONFIRM AVAILASLE UNITS wtTN EQUIPMENT PR00vCTK>as. CROSS SECTION OF ORAWER AT SOURCE futt sizz
. . . . . . - - - . . - . . . - . . - . - - ~ .
1 l
l 1
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
. SAFETY EVALUATION OF DEVICE
-(Amended inilts Entirety) l
" I
-NO'. : ~- NR-22 0-D'-101-S DATE: December 21, 1998 -
ATTACHMENT 3-4 l
l 1
l OCS.137 XYMM C 2AD Aceve t sion welds a '
- ...............:\
ir
..;i t i s 1 ss ssss sssssst
!,:5.9'#. . . .. .
{i!V..!!!cE:?26( F
- .i K
.-:....':...........i...........:......,
a, :.. .
2
- . .' . , : . *... . ,' .. . - ls?;?
- Radioactive meterlat cessum.137 5
'l - l::l. ::.., .
. . ~ . '.?:- --
n '.- - -
e
- :2:. :;.:
- . : :B.
- '.: .::..::.:::? . . '.::<:...
_ ::a.m : # ... , . c_ _ .. ,
g _
1.670 h (30.85) Die.
Notes
- 1. Corderms to I AE.A. 3pecial Form requiremente under UnRed Nnedom Cort Geek No. G8/388/5 84
- 2. Fatwketed to Amershem Dwg. 3A82547 cepeuts X2101
- 3. Motoriet: stabless ste4\ Type 310L
- 4. Wed Ncimese:0.030 h(1.0 mm)
- 5. Engraving on upper end ces
- 8. Dimensions h trocasts are (vpened h m3 meters l
a i
p
3 l
l i
i I
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l
SAFETY EVALUATION OF DEVICE (Amended in its Entirety) l h NR-220-D-101-S- DATE: December 21, 1998 ATTACHMENT 4 SOL *RCE *sRRADtATE' POSmON MECHANICAL NTERLOCK (UPPER) SOURCE *OFF* POSITION UPPER HEAD I
KEYPAD
~ ~
A I ' ' ~- q g SOUR R SAMPLE CHAMBER DOOR -
~_ , ,
} l'
'( J ELECTRIC DRIVE MOTOR MECHANICAL
()
INTERLOCK i l (LOWER) i
{ )
ELECTRICAL j OCK j SU R or (LOWER)
- *f N
h \
__ p BATT c s-J LOWER HEAD FLKEO SHIELD Gammacell 40 Exactor Irradiator (Serial No. 134 and higher) with electric motor drive system l
1 l
- . .- _= .. - . . - - . . - . . . .
k>* I December 21, 1998 1
Mr. Ronald McGregor Manager, Regufatory Affairs MDS Nordion, Inc.
447 March Road Kanata, Ontario, Canada K2K 1X8
Dear Mr. McGregor:
Based on the information and test data submitted in your application dated February 27,1997, and subsequent correspondance, we conclude that the Model Gammacell 40 irradiator is acceptable for licensing purposes in accordance with the conditions of the enclosed registration certificate (NR-220-D-101-S).
Please be advised that you must manufacture and distribute the product in accordance with the statements and representations containeo in your application, with enclosures thereto, and the information set out in your 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 certificate.
Please read over tne registration certificate in its entirety and notify us immediately of any errors or omissions.
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 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.
If you have any questions, please contact me at (301) 415-7904 or Mr. Steven Baggett at (301) 415-7273.
Sincerely, John bJankovich, Ph.D., Sr. Engineer Materials Safety Branch ,
Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
Enclosure:
As stated cc w/ encl: SKimberley, LFDCB Distribution: j IMNS r/f SSD-98-35 NE0 0 SSD File # NR-220-D-101-S DOCUMENT NAME: H:\SSDFILES\ LETTERS \NR220101.COM Tn receive a copy of this document. Indicate in the box: "C" - Cop /without attachment / enclosure "E" = Copy With attachment / enclosure "N"
= No copy , ff l OFFICE IMNS ,glC IMQS ,.(/ IMNS l
[
NAME JJankovich/j/f 1 J/] JLubVi SBaggett DATi:i 05/Jy98 V" 06/ //9( @fy/98 l p1CIAL RECOR) COPY 4jhMov0fML IP.
REGISTRY OF RADIOACTIVE' SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Amended in its Entirety)
NO.- NR-220-D-101-S DATE: December 21, 1998 PAGE 1 OF 9 DEVICE TYPE: Gamma Irradiator MODEL: Gammacell 40 (Serial No. 1 through 133)
Gannmacell 40 Exactor (Serial No. 134 and higher)
M_MlQFACTURER/ DISTRIBUTOR: MDS Nordion, Inc.
(formerly Atomic Energy of Canada, Ltd., and Nordion International, Inc.)
447 March Road Kanata, Ontario K2K IX8 Canada SEALED SOURCE MODEL DESIGNATION: AECL C-161, Type 8 MDS Nordion C-161, Type 8 MDS Nordion C-440 ISOTOPE: MMUM ACTIVITY _;.,
~
Cesium-137 4,200 curies (155.4 TBq)
LEAK TEST FREOUENCY:
I 6 months PRINCIPAL USE: (J) Gamma Irradiator, Category I CJ2STOM DEVICE: YES _x NO
~
b k' - _ _ _ - _ _ _ _ _ _ _ _
m.-. . . . .a . . _ _ . . . . . _ ,
l-l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Amended in its Entirety)
NO.:. NR-220-D-101-S DATE: Deceiber 21, 1998 PAGE 2 OF 9 DEVICE TYPE: Gamma Irradiator i
DESCRIPTION:
The Gammacell-40 is a cesium-137 irradiator designed for use in l an unshielded room. The unit provides a means for uniform gamma I irradiation of 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 actuators from the stored
- o the irradiate position. Source position is indicated by either an illuminated source ON (red) or source OFF (green) push- l button switch located on the control panel or by text messages on '
the display. Each source directs a beam 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 positicn the sources are shielded on all sides by lead. A mechanical interlock prevents the sample door from being opened while the sources are not in the storage position. Therefore, under normal circumstances the operator would not be exposed to a direct beam of radiation. In the Gammacell 40 Exactor units (Serial No. 134 and higher), the head flanges incorporate grooves filled with lead to address localized radiation fields.
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 approximately 15 inches (38.1 cm) long by 2.5 I 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 26 inches (71 cm) center to center, one above and one below the sample cavity. A port in each cylinder wall about 11 inches (29 cm) from the end leads to the sample cerity which is enclosed in a minimum of about 5 inches (12.7 m) of lead. The source drawers are moved
- 'from the shielded po-.. tion, which is approximately 9 inches l (22.9 cm) from the end opposite the port end, to the irradiate position by means of pneumatic cylinders in the Model Gammacell 40 units (Serial No. 1 through 133).
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE j (Amended in its Entirety) l l
NO.: NR-220-D-101-S DATE : neester 21, 1998 PAGE 3 OF 9 DEVICE TYPE: Gamma Irradiator DESCRIPTION (cont'd):
In the Model Gammacell 40 Exactor units (Serial No. 134 and higher) the drawers are driven by a DC electric motor through a thaing belt. The electrical power source is a sealed 12 volt DC lead / acid battery. The battery is constantly charged by a charger connected to an AC power source. If AC power is lost while the unit is in operation, battery power is sufficient to complete the irradiation cycle in progress with reserve power for at least three subsequent cycles.
In the Model Gammacell 40 units the sample cavity is sized to process small laboratory samples. The ring is open 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 cavity. Three stainless steel access tubes lead into the sample cavity for ventilation and instrumentation.
The Gammacell 40 and Gammacell 40 Exactor are housed in an outer enclosure. The maximum dimensions are approximately 59 inches (150 cm) high, 37 inches long (94 cm) wide, and 49 inches (124 cm) deep. The maximum weight is approximately 7000 lbs (3180 kg). I The unit comes either with two 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 mm) diameter by 1.70 inches (43.3 mm) length. Nominal wall thickness Fcr 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 0.059 inch (1.5 mm). The capsules are sealed with active fusion welds.
l Several safety features have been incorporated into the unit for protection of operating personnel:
l
~ .- . . . - . . .- . . - _ .. - - ~ -. . . - . - -
l'.
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
! ' SAFETY EVALUATION OF DEVICE (Amended in its Entirety)
NO,; NR-220-D-101-S DATE: December 21, 1998 PAGE 4 OF 9 DEVICE TYPE: Gamma Irradiator DESCRIPTION (cont'd)-
, ' 1. The source drawers are mechanically interlocked with the l sample drawer. A square section steel rod is mounted on the 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 drawers cannot move into the irradiate position when the sample drawer is open, or is not completely closed. At the same time it prevents the sampin drawer from opening unless both sources are in the safe position.
- 2. A mechanical lock on the sample drawer is electrically interlocked to the source ON push-button to prevent the rawer 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, in turn, returns the sources to the stored position.
- 4. The Model Gammacell 40 Exactor units are equipped with electronic controls which also provide a software interlock system. The software interlock system uses sensors and compares them to a stored set of instructions, and processes the information to determine whether a requested operating step can be executed safely.
LABELING:
The Gammacell 40 is labeled on the front of the device. The label' consists of the phrase " CAUTION RADIOACTIVE MATERIAL", the l radioactive trefoil symbol, isotope, date of measurement and the l
curie content. Additional labels attached to the device indicate
- the manufacturer (AECL or Nordion, or MDS Nordion, as applicable), the model number and the serial number.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES' SAFETY EVALUATION OF DEVICE (Amended in its Entirety)
NO.: NR-220-D-101-S p2EE1 December 21, 1998 PAGE 5 OF 9 DEVICE TYPE: Gamma Irradiator LABELING'(cont'd)-
The Model C-440 sources are engraved on the upper endcap of the outer capsule with "CS-137D", source serial number, "NII" or "MDs," "C-440", and the radioactive trefoil symbol. The Model C-161 sources are engraved on the upper and cap of the outer capsule with "CS-137A," source serial number, and the letters "AECL," "NII," or "MDSN."
DIAGRAM:
See Attachments 1, 2,.3 and 4.
CONDITIONS OF NORMAL USE:
The Gammacell 40 is a low dose rate irradiator designed to irradiate biological or other samples requiring low dose rate.
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.
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 l of the device will continue to function properly under the most i l adverse conditions was conducted. !
i The manufacturer claims that the C-440 sources have been tested !
to ANSI N542-1977 and achieved a classification of E65546.
i l
l a
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE l (Amended in its Entirety)
NO.: NR-220-D-101-S DATE : Decanber 21, 1998 PAGE 6 OF 9 DEVICE TYPE: Gamma Irradiator 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 mrem /hr (47 pSv/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) from the unit was 11 mrem /hr (110 pSv/hr).
The manufacturer reports the calculated radiation dose rates at varying distances from the Model C-440 source as follows:
Distance Radiation Level j from source R/hr (Sv/hr) 5 cm/1.97 in 186,120 (1,861) 30 cm/11.8 in 5,172 (52) I 100 cm/39.4 in 466 (4.7)
The manufacturer reports that the Model Gammacell 40 Exactor units have a maximum external radiation field of approximately 2 mrom/hr at a distance of 5 cm (1.97 inches) from any accessible '
surface of the device.
OUALITY ASSURANCE AND CONTROL:
Manufacture of Gammacell 40 and Gammacell 40 Exactor irradiators i is covered under MDS Nordion'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 program is on file with the NRC.
--.--.. .=. - --
REGISTRY OF-RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Amended in its Entirety)
NO,;. NR-220-D-101-S DATE : December 21, 1998 PAGE 7 OF 9 DEVICE TYPE: Gamma Irradiator OUALITY ASSURANCE AND CONTROL (cont'd)* '
Quality control during manufacture of the C-440 sources is maintained under Amersham International's Quality Assurance Manual for radiation sources. The scurces are manufactured by Amersham International according to Nordion's specifications. Upon receipt at Nordion, the sources are tested for removable contamination, dimensional conformity to design specifications, proper labeling and are measured for output.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
- Containment of samples should be ensured in order to protect the integrity of the sample chamber.
- The Model Gammacell 40 and Gammacell 40 Exactor shall be distributed only to persons specifically licensed by the NRC or an Agreement State.
- 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 Gammacell 40 irradiator.
- This registration sheet and the information contained within the references sball not be changed or transferred without the written consent of the NRC.
c
- r )
+
h REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
~ SAFETY EVALUATION OF DEVICE I
(Amended in its Entirety)
HQ 1 NR-220-D-101-S DATE: Decenter 21, 1998 PAGE 8 OF 9 DEVICE TYPE: Gamma Irradiator SAFETY ANALYSIS
SUMMARY
Based on our review of the information and test data cited below, andithat.the irradiator design was previously deemed acceptable by the NRC, we continue to conclude that the Gammacell 40 i irradiator design is acceptable for licensing purposes.
Furthermore, we continue to conclude from operational data since 1971, that this irradiator design world be expected to maintain its integrity for normal and accidental conditions of use which .
might occur during uses specified in this certificate. I 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 continue to conclude the Model C-440 source design is acceptable for licensing purposes when used in the Gammacell 40 irradiator.
Furthermore, we continue to conclude the Model C-440 source would i be expected to maintain its integrity for normal and accidental l conditions of use which might occur during uses specified in this ;
certificate. )
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:
- Atonic Energy of Canada Limited letters dated August 24, ;
1970, October 21, 1970, and March 25, 1971, with enclosure 1 thereto.
- Nordion. International, Inc., letters dated November 2, 1992, ;
December 1, 1992, and December 8, 1992, with enclosures thereto.
a
- o REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Amended in its Entirety)
NO.: NR-220-D-101-S DATE: December 21, 1998 PAGE 9 OF 9 DEVICE TYPE: Gamma Irradiator REFERENCES (cont'd):
l
- Amersham Corporation's letter, in support of Nordion's application, dated December 16, 1992, with enclosures thereto.
MD5 Nordion's letter dated February 27, 1998, two letters date' April 3, 1998, and telefax dated May 26, 1998, with enclosures thereto.
I S S U I N G A G E N Q,Y_;.,
U.S. NUCLEAR REGULATORY COMMISSION f' ' )
DATE: December 21, 1998 REVIEWER:
/y'fV[ ~
l 6hn W. Lubinski DATE: nornmhnr 91 1998 CONCURRENCE:
"It$Iven L. Baggett i
1 t
I 5
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Amended in its Entirety)
NO.: NR-220-D-101-S DATE: December 21, 1998 ATTACHMENT 1 l
- ,.e,., -
/
W ,
s
...~.
/
/
F b i I W /
~
(
g9 %'
gf g
$y
,y. S/
j.,
^
i=
p .
%g,.... . . . . .
P . -
IM E5 'l .
li i.# ( : . - _ _ . . _ _
1 f :- r __ . .. . _ : = .__ _ - -
!l .../ . _ _ o, !_br
_.......m..........
..==__
- =_.r_.._.
- g. . . ,4 -.
7 ___
i
- =--
- =.r I m- q- ,
Ji' :=. : :=- _
i.
I l
l Model Gammacell 40 Irradiator (Serial No. 1 through 133) with pneumatic drive system
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Amended in its Entirety)
NO.: NR-220-D-101-S DATE: December 21, 1998 ATTACHMENT 2 RCTAIMNQ RING PLUG (URAN!UM ALLOY) 4 HOLES4' 20 U.N.C. $0uRCC FOR ORA *ER 0*ERATING utCMANISM.
ITS' SRA$$ (NCA$ED SOURCE SLEEVE LCAO
~
~ ~.
, k' IP32 Cla, TRANSFER LDCATING MOLE f N '
.p C
e6 U.N.C.
" Lug TRANs!tR PU$M ROC
- 2. MOLES %6*'8 uMC. TH'O. FOR R10t R RIN G A S S'y
__ 2 4TS " OlA.NOMIN AL 6 29 CM.
z SOURCE NO. Cl46 & CISI =
h
, ( Ol A = C S ,0 FS,1 0, 8 2 3,1. S ,1 T S , y p f j 2 0. 2 25,2 S CM. ) / / /,/ p l '
/ /// h
.!$IL, / / s l / /
j I $0uRCE $LEEVE AS ILLUSTRATED. USED wtTH SOURCES OF ,/ j /j /, g f 'j '/j 05CE TO 2 2S CE OLA. INCLUSsVE f f / <--"
- /
2 $0uRCE SPACER I NOT SHowN) U$E0 F04 2 5 CM. SOURCE / /
S WOOCLS 4 AND 60- NOMINAL CAPACITv - TS ARM. $0uRCE / / / // / 'ce
/ / / / / a h 4 u00tLs e AND 00 - NoumAL CApRCITv -ISO Auu. $0uRCE /,e: ,/ f a
S. M00(LS E Te AND T700-NOMINALCAPAQTY=200 RM.KSOURCE 'f(,"--- m ejg' a_' g
- a. M00tts tr6 AND 776S=NOMINALCAl% CITY-ISS RM.M. SOURCE yp 7 uAximuu CAsmoty wou. wir securiCANTLv wiTH EACH '- '
U W T. CO*lFIRM AVAILABLE UMTS WITH EQulPMENT Pe009CT60N. CROSS SECTION OF ORAWER AT SOURCE FULL SIZE
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Amended in its Entirety)
NO , .: NR-220-D-101-S DATE: December 21, 1998 ATTACHMENT 3 OCS.13 XXXX Nil C 440 Active RJelon wekfe d '
- - ,,,,,,,,,,,,,,ll
?ss sssssss sssAsC i
- :?;;
- ln.
- : :.G;*.,'jv: ::...)Y:::ifp:
- s. :,,t .' .. '.;.. :.s R ,
.a ..'..'..T y .
- .* : . . %. . :i.
.,....* N Ji ,' . *.*.
...*..g..i.,
a Redloactko meterialcesium 137 p .
,~
a v.
.. .. .. .. .. .u.... ',:..M :,.
i i
ri.:l.,'.:
. .. :f : 7,*.. f.f
- l. ,.*.:.*..
f $n.,s.*.::i.: c.
p b'_: _ _ -.9.'_ _ - _*:_ *l - _.__
1.570 in (39.65) 06e.
Notes
- 1. Cerdsmo to IAE A Specani Form requiremente mder Unted IGngde'n Cetuscete No. 08/308446
- 2. Fetwtosted to Amersham Dwg. 3Ag2547 cepaulo X2181
- 3. Metectet: stainiese steel, Tne 31 St.
4.
Ws3 lhicknese:0.030 in (1.0 rnm)
- 5. Engreq en upper end up
- 8. Dirnensione in tracitete are expreened in mametere
l
,o e
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE I
(Amended in its Entirety)
NO.: NR-220-D-101-S DATE: December 21, 1998 ATTACHMENT 4 i
SOURCE *1RRADIATE" POSITION MECHANICAL INTERtOCK (UPPER) SOURCE 'OFF* POSITION UPPER HEAD
_A KEYPAD y -
4/ .
CE gy R
/(UPPER) j SAMPLE CHAMBER DOOR 7' * '\ .
iN i
. t i
1 s lP..*
l j f ELECTRIC DRIVE MOTOR
/ %
Jy- /
< / \ ,.; f MECHANK:AL
- d. '
O I/ B%j i
/g' E"OAlP* (/ 8 s
CTRICAL I < -
( j ,,
'" " ock a
<,L/ Sguy,EggWER y
1 (LOWER)
.i ..
r-- _ p BATTERY
- W LOWER HEAD FIXED SHIELD Gammacell 40 Exactor Irradiator (Serial No. 134 and higher) with electric motor drive system
i e
l December 21, 1998 Mr. Ronald McGregor Manager, Regulatory Affairs MDS Nordion, Inc. ,
l 447 March Road l Kanata, Ontario, Canada K2K 1X8
Dear Mr. McGregor:
Based on the information and test data submitted in your application dated February 27,1997, and subsequent correspondance, we conclude that the Model Gammacell 40 irradiator is acceptable for licensing purposes in accordance with the conditions of the enclosed registration certificate (NR-220-D-101-S).
Please be advised that you must manufacture and distribute the product in accordance with the statements and representations contained in your application, with enclosures thereto, and the information set out in your 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 certificate.
Please read over the registration certificate in its entirety and notify us immediately of any errors or omissions.
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 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.
If you have any questions, please contact me at (301) 415-7904 or Mr. Steven Baggett at (30s) 415-7273.
Sincerely, John bJankovich, Ph.D., Sr. Engineer Materials Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
Enclosure:
As stated cc w/ encl: SKimberley, LFDCB Distribution: gi IMNS r/f SSD-98-35 NE0Q SSD File # NR-220-D-101-S DOCUMENT NAME: H:\S S DFI LE S\LETTE R S\N R220101.C O M Te r. .w. . copy of thi. docum.ni, indic.t. in in. bon: c - copy /witnout .it.cnm.nt/.nc.iosur. s - copy with att. chm.nt/ enclosure *N*
= No copy 1 / /'
OFFICE IMN) g C 1%S f/ IMNS l l NAME JJankovich/jjf M JLubgeki SBaggett DATE 05/.27798 V" 06/ //9( @tt\ /98 Op1CIAL RECORJ COPY GWrCO P
t REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Amended in its Entirety) h NR-220-D-101-S DATE: December 21, 1998 PAGE 1 OF 9_
DEVICE TYPE: Gamma Irradiator MODEL: Gammacell 40 (Serial No. 1 through 133)
Gammacell 40 Exactor (Serial No. 134 and higher) f MANUFACTURER / DISTRIBUTOR: MDS Nordion, Inc.
(formerly Atomic Energy of Canada, Ltd., and Nordion International, Inc.)
447 March Road Kanata, Ontario K2K IX8 Canada SEALED SOURCE MODEL DESIGNATION: AECL C-161, Type 8 MDS Nordion C-161, Type 8
'MDS Nordion C-440 ISOTOPE: MAXIMUM ACTIVITY, Cesium-137 4,200 curies (155.4 TBq)
LEAK TEST FREOUENCY: 6 months PRINCIPAL USE: (J) Gamma Irradiator, Category I l CUSTOM DEVICE: YES x NO i
b Gh_'
~
)
[ REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l
SAFETY EVALUATION OF DEVICE (Amended in its Entirety) l l NO,: NR-220-D-101-S DATE: Decater 21, 1998 PAGE 2 OF 9 I- {
DEVICE TYPE: Gamma Irradiator t
l DESCRIPTION:
l The Gammacell 40 is a cesium-137 irradiator designed for use in
.an unshielded room. The unit provides a means for uniform gamma Jrradiation of 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 actuators from the stored to the irradiate position. Source position is indicated by either an illuminated source ON (red) or source OFF (green) push-button switch located on the control panel or by text messages on the display. Each source directs a beam 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 not in the storage position. Therefore, under normal circumstances the l
operator would not be exposed to a direct beam of radiation. In the Gm==mcell 40 Exactor units (Serial No. 134 and higher), the head flanges incorporate grooves filled with lead to address localized radiation fields.
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 approximately 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 cylinderc lie horizontally about 26 inches (71 cm) center to center, one above and one below the sample cavity. A L port in each cylinder wall about 11 inches (29 cm) from the end leads to the sample cavity which is enclosed in a minimum of about 5 inches (12.7 cm) of lead. 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 in the Model Gammacell 40 units (Serial No. 1 through 133).
l
l a
Y l
! l l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l l
SAFETY EVALUATION OF DEVICE (Amended in its Entirety)
NO.: NR-220-D-101-S DATE :Ncanber 21, 1998 PAGE 3 OF 9 j l
l l
! DEVICE TYPE: Gamma Irradiator
! DESCRIPTION (cont'd):
In the Model Gammacell 40 Exactor units (Serial No. 134 and higher) the drawers are driven by a DC electric motor through a I
timing belt. The electrical power source is a sealed 12 volt DC l lead / acid battery. The buttery is constantly charged by a l charger connected to an AC power source. If AC power is lost
'while the unit is in operation, battery power is sufficient to complete the irradiation cycle in progress with reserve power for l at least three subsequent cycles.
In the Model Gammacell 40 units the sample cavity is sized to process small laboratory samples. The ring is open at t'ho top and the bottom and has hanger slots in the top rim to atlow 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 cavity. Three stainless steel access tubes lead into the sample cavity for ventilation and instrumentation.
i The Gammacell 40 and Gammacell 40 Exactor are housed in an outer enclosure. The maximum dimensions are approximately 59 inches (150 cm) high, 37 inches long (94 cm) wide, and 49 inches (124 cm) deep. The maximum weight is approximately 7000 lbs (3180 kg).
The unit comes either with two 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 mm) 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 w 11 thickness for each capsule of the C-440 source is 0.039 inch (1.0 mm) and
! nominal thickness for each end cap is 0.059 inch (1.5 mm). The capsules are sealed with active fusion welds.
Several safety features have been incorporated into the unit for protectlon of operating personnel:
l
\ .
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Amended in its Entirety)
NO : NR-220-D-101-S DATE :IMcenter 21, 1998 PAGE 4 OF 9 DEVICE TYPE: Gamma Irradiator DESCRIPTION (cont'd)*
- 1. The source drawers are mechanically interlocked with the sample drawer. A square section steel rod is mounted on the 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 drawers cannot move into the irradiate position when the sample drawer is open, or is not completely closed. At the same time it prevents the sample drawer from opening unless both sources are in the safe position.
- 2. A mechanical lock on the sample drawer is electrically interlocked to the source ON push-button to prevent the rawer 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 i electrical circuit to the source drawer control solenoids. 1 Disengaging the locking bar interrupts the circuit and this, I in turn, returns the sources to the stored position.
- 4. The Model Gammacell 40 Exactor units are equipped with electronic controls which also provide a software interlock system. The software interlock system uses sensors and compares them to a stored set of instructions, and processes the information to determine whether a requested operating step can be executed safely.
LABELING:
The Gammacell 40 is labeled on the front of the device. The label 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, or MDS Nordion, as j applicable), the model number and the serial number.
w r - -
- _ , . _ .- - . - . ~ _ . . . . . . .
.- l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE-(Amended in its Entirety)
NO,: NR-220-D-101-S DATE: Decanimr 21, 1998 PAGE 5 OF 9 DEVICE TYPE: Gamme Irradiator LABELING (cont'd)-
The Model C-440 sources are engraved on the upper endcap of the
' outer capsule with "CS-137D", source serial number, "NII" or "MDS," "C-440", and the radioactive trefoil symbol. The Model C-161 sources are engraved on the upper and cap of the outer capsule with "CS-137A," source serial number, and the letters "AECL," "NII," or "MDSN."
DIAGRAM:
See Attachments 1, 2, 3 and 4.
CONDITIONS OF NORMAL USE:
The Gammacell 40 is a low dose rate irradiator designed to irradiate biological or other samples requiring low dose rate.
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.
-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.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Amended in its Entirety)
NO.: NR-220-D-101-S DATE : Decanber 21, 1998 PAGE 6 OF 9 l DEVICE TYPE: Gamma Irradiator 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 mrem /hr (47 pSv/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) from the unit was 11 mrem /hr (110 pSv/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) 100 cm/39.4 in 466 (4.7) l The manufacturer reports that the Model Gammacell 40 Exactor units have a maximum external radiation field of approximately 2 mram/hr at a distance of 5 cm (1.97 inches) from any accessible surface of the device.
OUALITY ASSURANCE AND CONTROL:
Manufacture of Gammacell 40 and Gammacell 40 Exactor irradiators is covered under MDS Nordion'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 program is on file with the NRC.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Amended in its Entirety)
NO. NR-220-D-101-S DATE : December 21, 1998 PAGE 7 OF 9 DEVICE TYPE: Gamma Irradiator OUALITY ASSURANCE AND CONTROL (cont'd)-
Quality control during manufacture of the C-440 sources is maintained under Amersham International's Quality Assurance Manual for radiation sources. The sources are manufactured by Amersham International according to Nordion's specifications. Upon receipt at Nordion, the sources are tested for removable contamination, dimensional conformity to design specifications, proper labeling and are measured for output.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
Containment of samples should be ensured in order to protect the integrity of the sample chamber.
The Model Gammacell 40 and Gammacell 40 Exactor shall be distributed only to persons specifically licensed by the NRC or an Agreement State.
The device shall be leak tested at intervals not to exceed six months using techniques capable of detecting O.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 Gammacell 40 irradiator.
This registration sheet and the information contained within the references shall not be changed or transferred without the written consent of the NRC.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Amended in its Entirety)
NO : NR-220-D-101-S DATE: Decemter 21, 1998 PAGE 8 OF 9 DEVICE TYPE: Gamma Irradiator 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 the NRC, we continue to conclude that the Gammacell 40 irradiator design is acceptable for licensing purposes.
Furthermore, we continue to conclude from operational data since 1971, that this irradiator design would be expected to maintain 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 continue to conclude the Model C-440 source design is acceptable for licensing purposes when used in the Gammacell 40 irradiator.
Furthermore, we continue to conclude the Model C-440 source would be expected to maintain its integrity for normal and accidental conditions of-use which might occur during uces specified in this certificate.
EEFERENCES:
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.
e REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Amended in its Entirety) i u
NO.: NR-220-D-101-S PAGE 9 OF 9 l
- . DATE
- December 21, 1998
' DEVICE' TYPE 1 Gamma Irradiator REFERENCES (cont'd):
'
- Amersham Corporation's letter, in support of Nordion's application, dated December 16, 1992, with enclosures thereto.
- MDB Nordion's letter dated February 27, 1998, two letters
. dated April 3, 1998, and telefax dated May 26, 1998, with enclosures thereto.
ISSUING AGENCY: ;
l U.S. NUCLEAR REGULATORY COMMISSION DATE: December 21, 1998 REVIEWER: /- b[/) .
6hn W. Lubinski DATE: nornmhne 91 1998 CONCURRENCE:
dt$Iven L. Baggett
1 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Amended in its Entirrty)
NO.: NR-220-D-101-S DATE: December 21, 1998 ATTACHMENT 1 b-4 4
4 N
' "."O.'.T" 4 .a e*
, , s
.- / /
- @--- \; ., l j 0-- -
6
'. d ,
Ib ,/
, 4 ,
. ,g
.7
.x _L o
[F lD L. (IO
{ p v * * * =
,' ' s =%.**./
l
.e l' : EH .]. --
S II b f1 ,... .., ; -;- _
' '~~ - - - - - - - - - -
. . . . . ........... l- ~-
- -*- '.~.
l
- 7 ~
. [ E3'.D
- l. .- ._
i i
- =-
- . =:... ;-* _._ _. :-- 1 l
e- .'"!L 3*7 .. l0 ~ :: :;-_
Model Gammacell 40 Irradiator (Serial No. 1 through 133) with pneumatic drive system
l r
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Amended in its Entirety)
NO, NR-220-D-101-S DATE: December 21, 1998 ATTACHMENT 2 RETANNG RtNG PLUG (URANIUM ALLOY)
A Mott$ h-20 U.N.C. SOURCC FOR ORAwtm OMRAT6NG W(CHAN#5M.
/
475' 8AASS ENCASED LEAD [
N ~ 'N k ]i ih DA. TRANSTER
.. LOCATING HOLE N. i US47'
' ' CM, h,-a6 uN C.
- Lug TRANSFER PUSH #00 2 HOLT $Ig IS uxC. TH'O. FOR RIDE R RING AS$'y
, _ 2 4TS
- 01A.NOMIN AL
! 6 29 Ce z
SOURCE NO Cl46 & CISI =
h
( OL A. = C S . 0 7 5. l 0 l 2 5.1 S .1 7 5, j p j 3 e
2 0. 2 2S.2 S CM. ) / / p /, g
.!!$IL
'//
/ / /
'// /
' / / Q.
I SOURCE SLEtyt AS ILLUSTRAtto. USCO wtTH SoulCES OF QwS CE TO 2 2S CE WA. INCLU$avt
,/j //,
j f / .--"
g///f l ' '
2 Sou2CE SfECER ( NOT SHOWN) USCO POR 2 S C& SOUACE j 'y [ g 3 MODELS 4 AND 40- N088NAL CAPACITv - 73 fLhu SOURCE / / / / f ag
/ /, // / / . .
a 4 vootLS e ANO 90 - NOW*4AL CAPac TY -ISO fluu SoumCE S M00(LS Ett AND T790=NOMINALCAPAGTY-200 R.MX$0VRCE
///
p 'f
/"""--- a' g
'y t
~ '
r uimi uu CAnaiv wu mar S.cwiCANTtv wiTN cACs uself. CONFIRM AVAILAOLE U8elTS W1TH E0VIPW(NT
[ wt:0N. CROSS SECTION OF ORAWER AT SOURCE mL..sizt l
l , -
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Amended in its Entirety)
NO.: NR-220-D-101-S DATE: December 21, 1998 ATTACHMENT 3 0031370 XXXX Nil C 440 Aceve AmenvreWe th "
1....,,,,,,,,,,'l
- 7xs xxxxx xx xxxAx2
- ,
.Wp '- .
- ggy. .;* iv. . :..:.y;;;id'c
- .. ;' '. l . ' ;., :*s v ,,
g \?.. .
. :, . <M:
g .
- :. . ........:....: . , n.. . ,,
3 '
- a -
Radiceaks metertelcessum 137 k '
l
.* * * * * * '. *,'. *; *.., *. .,%',Ij
.(.l:,,, . . .
t';.,'f
. . rl .... .-~
t . :l.::.' : ' . * ,: : .': ' . ,,. . '
n
' s
- h ';.*..*.::f:..::. .:::.. "'
k..:.::,*:-
- - -.. '<.. t.M r,. *n.g:s_ ,
- -? --
g, .___
1.570 In (39.85) Die.
Notes 1
Cordonne to IAEA Special Form requkemente under Unted Kagdom Cordicate No. 05/386/S.44 1 Fetuttsted to Amorehem Ows. 3A42547 cepeute X2101 1 Meteriet stamismo stool, Type 319L 4 Wel Becknese:0.030 in (1.0 mm)
- 5. Engrevery on upper end cap
& Dimensions in trockete ere emproceed in mismetere
O, P
1 i
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES i SAFETY EVALUATION OF DEVICE l (Amended in its Entirety) !
h NR-220-D-101-S DATE: December 21, 1998 ATTACHMENT _1 SOURCC '4RRADIATE' POSmON I
MECHANICAL INTERLOCK (UPPER) SOURCE 'OFF' POSITK)N
/ UPPER HEAD I
KEYPAD
! m\ %
r H . I % gy I
v
~-
' -W f* t:, SOURCE DRAWER g WORr4 SYSTEM l ih, / (UPPER)
S WPLE CHAMBER DOOR '
l[
f-
- i
~ .
p
' 1 .
% 'wl lf j LECTRIC DRIVE MOTOR MECHANICAL -
f l
l INTERLOCK (LOWER)
(
h ,
/ l l 3
ELECTROL l
4* I U
{ j j LOCK
\j yu CE WER
- s. i (LOWER) l N k~ f O \
p BATTERY I
l J i LOWER HEAD FIXED SHIELD Gammacell 40 Exactor Irradiator (Serial No. 134 and higher) with electric motor drive system-k
,