"71-'!

31

ZBe le~t413 March Road

Ottawa, Ontario
Canada K2K 0E4
Theratronics Tel: 613-591-2100

June 8, 2015

Licensing Section
Spent Fuel Project Office
Office of Nuclear Material Safety and Safeguards
U.S. Nuclear Regulatory Commission
Washington, DC 20555-0001

Re: Amendment for transport package F431, certificate USA/9310/B(U)-96

Dear Sir/Madam,

On behalf of Best Theratronics Ltd., I am requesting an amendment to the F431 transport

package, certificate number USA/9310/B(U)-96. The amendment request is to add a new Cs137
sealed source model, the C3100, as authorized radioactive contents.

Best Theratronics Ltd has recently developed the C3100, Cs137 sealed source model. The C3100
source model has been certified as Special Form Material by the CNSC, certificate CDN/0035/S-
96 (see attached).

The C3100 source model is made as a direct replacement to the C3001 source model currently
used in the Gammacell (GC) 1000 and 3000 blood irradiators. The device certificate for the
GC1000 and GC3000 (NR-1307-D-102-S) has been recently revised to include this new source
model (see attached). The C3100 is identical to the C3001 in both outer dimensions and
allowable activity contents.

There are absolutely no changes to the designs of the GC1000 or GC3000 to incorporate the
C3100 source model. The C3001 can be replaced directly with the C3100. The GC construction,
dimensions, and weight remain unchanged and as such, there is no change to the F431 safety
analysis report.

Payment for the amendment will be provided by credit card. Please contact Gwen McCaffrey
613-591-2100 ext: 2595 for details.

Thank you for your consideration of this matter. I believe the above information will prove
satisfactory. However, if you have any questions or require further information please feel free
to contact me.

Page 1 of 2 1 j 'SD(
Sincerely,

Richard Wassenaar, PhD, MCCPM

Director of Compliance and RSO

Page 2 of 2
 Canada's Nuclear Regulator
1 L'organisme de rdglementation Canadian Certificate No.: CDN/0035/S -96 (Rev. 0)
nuclaire du Canada
Issue Date: Nov-19-2014
Expiry Date: Nov-30-2019
CNSC File: 30-B5-1-2

Certificate
CDN/0035/ S -96 (Rev. 0)

Special Form

The special form radioactive material identified below is certified by the Canadian Nuclear Safety
Commission pursuant to paragraph 21 (1)(h) of the Nuclear Safety and ControlAct and Section 7 of the
Packagingand Transport of Nuclear Substances Regulations, and to the 1996 Edition (Revised) of the
IAEA Regulationsfor the Safe Transportof Radioactive Material.

CAPSULE IDENTIFICATION

Designer: Best Theratronics

Make/Model: C3100

CAPSULE DESCRIPTION

The C3100 capsule, as shown on Best Theratronics Drawing No. G 143101-001 (Issue 5), consists of two
sealed stainless steel inner capsules further encapsulated in a stainless steel capsule.
An illustration of the capsule is shown on attached Drawing No. C3100 (Issue A).
The configuration of the capsule is as follows:
Shape: Cylinder Shielding: n/a
Mass: 0.3 kg Outer Casing: Stainless Steel
Length: 271.5 mm Height: n/a
Width: n/a Diameter: 17.58 mm

AUTHORIZED RADIOACTIVE CONTENTS

This capsule is authorized to contain not more than 56.25 TBq of Cs-137 in the form of pressed or tamped
Cs-137 chloride powder within two inner encapsulations.

Page 1 of 2

fl*E Safety Commission

Canadian Nuclear
Commission canadienne
de sOret6 nucl6aire Cinada"
 Canada's Nuclear Regulator
L'organisme de r6glementation Canadian Certificate No.: CDN/0035/ S -96 (Rev. 0) A
nucldaire du Canada
Issue Date: Nov-19-2014
I
Expiry Date: Nov-30-2019
CNSC File: 30-B5-1-2
QUALITY ASSURANCE

Quality assurance for the design, manufacture, testing, documentation, use, maintenance and inspection of
the capsule shall be in accordance with:

* Best Theratronics Document No. 5.05-QA-02 (2)*, "Sealed Source Quality Plan"
" Best Theratronics Document No. IN/TS 2578 COOO (C), "Technical Specification for Sealed
Sources"
" Best Theratronics Document No. IN/TS 2714 COOO (C), "Technical Specification for Sealed Sources
Containing Cs- 137"
" Packaging and Transport of Nuclear Substances Regulations
" IAEA Regulations
* * or latest current revision

S. Faille
Designated Officer pursuant to paragraph 37(2)(a) of
the Nuclear Safety and Control Act

Page 2 of 2

Canadian Nuclear
Safety Commission
Commission canadienne
de sOmrt6 nucl6aire Canadil
 Canada's Nuclear Regulator
L'organisme de rdglementation
nucIdaire du Canada

NOTES

Revision 0: November 19, 2014. New Certificate.

* ~fl Safety Commission

Canadian Nuclear
Commission canadienne
de sOret6 nucl6aire Cmanad~
 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
SAFETY EVALUATION OF A DEVICE
(AMENDED IN ITS ENTIRETY)

NO.: NR-1307-D-102-S DATE: May 15, 2015 PAGE: 1 of 16

DEVICE TYPE: Gamma Irradiator

MODEL: Gammacell 1000-A, B, C, or D and

Gammacell 1000 Elite-A, B, C, D, Type I or Type I and
Gammacell 3000 Elan-A, B, C, Type I or Type II

DISTRIBUTOR: Best Theratronics Ltd.

7643 Fullerton Road
Springfield, VA 22153

MANUFACTURER: Best Theratronics Ltd.

413 March Road
Ottawa, Ontario
Canada K2K 0E4

SEALED SOURCE MODEL Isomedix RAMCO-50 or ISO-1000

DESIGNATION: MDS Nordion C-1000, C-3000
Best Theratronics C-1001, C-3001,
Best Theratronics C-378
Best Theratronics C3100

ISOTOPE: MAXIMUM ACTIVITY:

Cesium-137 3,264 curies (120.8 TBq)

LEAK TEST FREQUENCY: 6 months

PRINCIPAL USE: (J) Gamma Irradiator, Category I:

CUSTOM DEVICE: YES X NO

 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
SAFETY EVALUATION OF A DEVICE
(AMENDED IN ITS ENTIRETY)
NO.: NR-1307-D-102-S DATE: May 15, 2015 PAGE: 2 of 16

DEVICE TYPE: Gamma Irradiator

DESCRIPTION:

The Gammacell 1000, 1000 Elite, and 3000 Elan are fully self-
contained irradiators. The weight range for the Gammacell 1000
and 1000 Elite is 2500 to 2800 lbs (1134 to 1270.1 kg). The
weight range for the Gammacell 3000 Elan is 3000 to 3300 lbs
(1360.8 to 1496.9 kg). Each unit contains a sample chamber with
a built-in turntable which provides dose uniformity for the
sample when rotating. The A, B, C, D, Type I, and Type II
designations refer to the various configurations of sources
which can be provided with each unit. Doubly encapsulated
sources are fixed in a source holder designed specifically
according to the unit and source selected. The source holder,
with sources installed, is inserted into the source cavity of
the unit and a cover is either bolted or fully welded in place
to prevent access. The various source configurations allowed
are described later in this document.

The Gammacell 1000 measures 24 inches wide by 24 inches in

length by 65 inches in height (60.96 cm wide by 60.96 cm length
and 165.1 cm in height). The sample chamber accepts beakers up
to 8 inches (20.3 cm) in height and 3 inches (7.6 cm) in
diameter (0.25 gallon (0.96 liter) capacity). The sample
chamber is introduced into the radiation field by manually
turning the rotor 1800 by means of a lever. Irradiation of the
sample will continue until the sample chamber is returned to the
'loads-'unload' position.

In October of 1988, AECL divided a portion of its source and

device production between two separate entities (Theratronics
International Limited and Nordion International, Inc.). At that
time only the Gammacell 1000 was being manufactured. AECL ceased
all manufacture, distribution and servicing of the Gammacell
1000 irradiators and Nordion International, Inc., took over the
manufacturing and servicing responsibilities-for these devices.
The Gammacell 1000 is no longer supplied as a new unit.

The Gammacell 1000 Elite is an updated version of the Gammacell

1000. Operation of the unit has been mechanized in order to
simplify operation and provide more precise irradiation. The
 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
SAFETY EVALUATION OF A DEVICE
(AMENDED IN ITS ENTIRETY)
NO.: NR-1307-D-102-S DATE: May 15, 2015 PAGE: 3 of 16

DEVICE TYPE: Gamma Irradiator

DESCRIPTION (Cont.):

unit is housed in a fire resistant cabinet which measures 30

inches to 33 inches wide by 26 inches to 32 inches length by 56
inches to 63 inches in height (76.2 to 83.82 cm wide by 66 cm to
81.3 cm in length and 142.2 to 160 cm in height). Access to the
sample chamber is gained by opening a door in the cabinet. An
interlock system prevents operation of the unit when the door is
open. The manual lever which was used to introduce the sample
chamber to and from the radiation field has been replaced by a
DC motor. This motor is controlled by digital DC components
which are programmed from a control panel on the cabinet face.
From this control panel the unit can be programmed to rotate a
sample into the radiation field for a prescribed time and
automatically return it to the 'load'-'unload' position. A DC
battery backup has been added which, when input power is lost,
will complete the current programmed cycle; however no
additional cycles will be initiated until power is restored.
The backup battery is continuously recharged while input power
is available.

The Gammacell 3000 Elan is essentially similar to the Gammacell

1000 Elite. Only differences between the two will be discussed.
The sample chamber of the Gammacell 3000 Elan has been enlarged
to accommodate sample beakers of up to 0.69 gallon (2.6 liter)
capacity. As a consequence of this, radiation shielding was
slightly reduced. In order to compensate for the reduced
shielding, secondary shielding constructed of lead is bolted
onto the rear and side of the existing radiation shield at the
time of installation.

The C-1000 and C-3000 sources are manufactured by Westinghouse

Hanford Co., USA for the exclusive use in the Gammacell 1000
Elite and Gammacell 3000 Elan research irradiators. The sources
are not registered by the NRC under any other name or
manufacturer. These sources are similar in design and
construction. Both are doubly encapsulated using 316L stainless
steel capsules with fusion welded end caps and contain cesium-
137 pellets in the form of pressed cesium chloride powder.
 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
SAFETY EVALUATION OF A DEVICE
(AMENDED IN ITS ENTIRETY)
NO.: NR-1307-D-102-S DATE: May 15, 2015 PAGE: 4 of 16

DEVICE TYPE: Gamma Irradiator

DESCRIPTION (Cont.):

Nominal activity for the C-1000 is 600 Ci (22.2 TBq) +20%, -10%,
and for the C-3000 is 1,270 Ci (47.0 TBq) +20%, -10%. Nominal
capsule wall thickness for both sources is 0.035 inches (0.89
mm).

The C-1001 and C-30Q1 sources are manufactured by Reviss

Services Ltd. (formerly AEA Technology QSA, Inc., Amersham
Corporation) for the exclusive use in the Gammacell 1000 Elite
and Gammacell 3000 Elan research irradiators. The sources are
not registered by the NRC under any other name or manufacturer.
These sources are similar in design and construction to the C-
1000 and C-3000. The only significant differences between the
C-1001 and the C-000 sources and the C-3001 and C-3000 sources
is that the C-1001 and C-3001 contain cesium-137 encapsulated in
three inner capsules instead of a single capsule and the nominal
wall thickness of the C-l001 and C-3001 sources is 0.039 inches
(1.0 mm) as compared to 0.035 inches (0.89 mm). All sources are
doubly encapsulated using 316L stainless steel with fusion
welded end caps and contain cesium-137 in the form of cesium
chloride powder. Nominal activity for the C-1001 is 590 Ci
(21.9 TBq) with a maximum activity of 810 Ci (30.0 TBq) and for
the C-3001 nominal activity is 1,270 Ci (47.0 TBq) with a
maximum activity of 1,620 Ci (60.0 TBq).

The inner capsule of the Model C-1000 measures 9.840 inches in

length by 0.375 inches in diameter (25.0 cm by 0.953 cm) and is
sealed by fusion weld at each end by 0.250 inches thick by 0.317
inches in diameter (0.635 cm by 0.805 cm) end caps. The outer
capsule measures 10.690 inches in length by 0.500 inches in
diameter (27.15 cm by 1.27 cm) and is sealed by fusion weld at
each end by 0.375 inches thick by 0.442 inches in diameter
(0.953 cm by 1.12 cm) end caps.

Each of the inner capsules of the Model C-1001 measures maximum

3.47 inches in length by 0.406 inches in diameter (8.805 cm by
1.03 cm) and is sealed by fusion weld at each end by 0.075
inches thick by 0.328 inches in diameter (0.19 cm by 0.834 cm)
end caps. The outer capsule measures 10.690 inches in length by
 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
SAFETY EVALUATION OF A DEVICE
(AMENDED IN ITS ENTIRETY)

NO.: NR-1307-D-102-S DATE: May 15, 2015 PAGE: 5 of 16

DEVICE TYPE: Gamma Irradiator

DESCRIPTION (Cont.):

0.50 inches in diameter (27.15 cm by 1.28 cm) and is sealed by

fusion weld at each end by 0.114 inches thick by 0.427 inches in
diameter (0.290 cm by 1.084 cm) end caps.

The inner capsule of the Model C-3000 measures 9.840 inches in

length by 0.562 inches in diameter (24.9 cm by 1.43 cm) and is
sealed by fusion weld at each end by 0.250 inches thick by 0.50
inches in diameter end caps (0.64 cm by 1.28 cm). The outer
capsule measures 10.690 inches in length by 0.687 inches in
diameter (27.15 cm by 1.75 cm) and is sealed by fusion weld at
each end by 0.375 inches thick by 0.630 inches in diameter end
caps (0.95 cm by 1.60 cm).

Each of the inner capsules of the Model C-3001 measures maximum

3.467 inches in length by 0.593 inches in diameter (8.8065 cm by
1.5065 cm) and is sealed by fusion weld at each end by 0.075
inches thick by 0.513 inches in diameter end caps (0.19 cm by
1.31 cm). The outer capsule measures 10.690 inches in length by
0.687 inches in diameter (27.15 cm by 1.74 cm) and is sealed by
fusion weld at each end by 0.114 inches thick by 0.618 inches in
diameter end caps (0.29 cm by 1.56 cm).

RAMCO-50 source is constructed of 316L stainless steel and

contains cesium-137. ISO-1000 source is constructed of 304L
stainless steel and contains cesium-137. The ISO-1000 or the
RAMCO-50 sealed sources for GC-1000 or GC-3000 models are no
longer manufactured.

The Model C-378 sealed source is manufactured for exclusive use

in the Gammacell 1000 Elite and Gammacell 3000 Elan research
irradiators. The sources are not registered by the NRC under
any other name or manufacture. The Model C-378 sealed source is
an over-encapsulation of the ISO-1000 approved sealed source
with an additional outer shell of 316L stainless steel. The
maximum activity for each Model C-378 cesium-137, source is 550
curies (20.4 TBq).
 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
SAFETY EVALUATION OF A DEVICE
(AMENDED IN ITS ENTIRETY)

NO.: NR-1307-D-102-S DATE: May 15, 2015 PAGE: 6 of 16

DEVICE TYPE: Gamma Irradiator

DESCRIPTION (Cont.):

The outer capsule has a maximum length of 10.993 inches (279.22

mm), a maximum diameter of 0.632 inches (16.05 mm) with a 0.025
inches (0.64 mm) wall thickness. The C-378 is produced by
inserting an active used leak tested ISO-1000 capsule into the
C-378 body with one end cap already welded into place. The
final end cap is then inserted and fusion welded. The
manufacturer provides a one year warranty for the C-378 source.
However, the manufacturer expects the physical and working life
of the source to be unlimited.

The Model C3100 sealed source is manufactured for exclusive use

in the Gammacell 1000 Elite and Gammacell 3000 Elan research
irradiators. Sealed source model C3100 is a direct replacement
for the C3001 source model. Model C3100 sources contain cesium-
137 in the form of cesium chloride. The maximum activity for
each C3001 source capsule is 1520.3 Ci (56.25 TBq) of cesium-
137.

The C3100 source capsule consists of two sealed 316L stainless

steel inner capsules further encapsulated in a 316L outer
stainless steel capsule. Each inner capsule has a length of
4.667 inches (118.55 mm) and a diameter of 0.506 inches (12.85
mm), with an inner wall thickness of 0.041 inches (1.05 mm).
The outer capsule has a maximum length of 10.689 inches (271.5
mm), a maximum diameter of 0.692 inches (17.58 mm), with a wall
thickness of 0.039 inches (1 mm). The thickness of the end caps
is 0.375 inches (9.525 mm). Caps are press fit into position
and fusion welded. Model C3100 sealed sources have a
recommended working life of 15 years. However, the recommended
working life may be extended by Best Theratronics based on
inspection and technical assessment.

The sources are installed into source holders designed

specifically for each source type. The source holder, with
sources installed, is then inserted into the source cavity of
the unit and a cover plate is welded over the cavity to prevent
access to the sources. The sources are installed according to
the activity requested by the customer. Table 1 shows the
 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
SAFETY EVALUATION OF A DEVICE
(AMENDED IN ITS ENTIRETY)

NO. : NR-1307-D-102--S DATE: May 15, 2015 PAGE: 7 of 16

DEVICE TYPE: Gamma Irradiator

DESCRIPTION (Cont.):

allowable configurations for the sources loaded with maximum

activity for each model.

Table 1

Gammacell Number of sources Max. Activity (Ci)

2, 4, 6, or 8 RAMCO-50 sources 3264.0

1000
1, 2, 3, or 4 ISO-1000 sources 2880.0

1, 2, 3, or 4 ISO-1000 sources 2880.0

1000 Elite
Any combination of CI000/CI001,
C3000/C3001/C3100, or C378 3048.0
sources, up to 3 sources

Any combination of CI000/C1001,

3000 Elan C3000/C3001/C3100, or C378 3048.0
sources, up to 3 sources
 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
SAFETY EVALUATION OF A DEVICE
(AMENDED IN ITS ENTIRETY)
NO.: NR-1307-D-102-S DATE: May 15, 2015 PAGE: 8 of 16

DEVICE TYPE: Gamma Irradiator

LABELING:

The devices are labeled in accordance with the requirements of

Section 20.1901, 10 CFR Part 20 and with the requirements of
ANSI N433.1-1977, "Safe Design and Use of Self Contained, Dry
Source Storage Gamma Irradiators (Category I)." The labels are
affixed to the exterior of the unit by screws and contain the
radiation symbol, isotope, activity, model number, serial
number, name of manufacturer, and the words "CAUTION-RADIOACTIVE
MATERIAL".

The following information is engraved on the C-1000, C-3000, C-

1001, and C-3001 sources:

For the C-1000 For the C-3000

NII NII
CsI37B Cs137C
XXXX (Serial Number) XXXX (Serial Number)
Radiation Symbol Radiation Symbol
or or
Radioactive Radioactive

For the C-1001 For the C-3001

NII or MDSN or BTL NII or MDSN or BTL
Cs137E CsI37F
Clool C3001
XXXX (Serial Number) XXXX (Serial Number)
Radioactive Radioactive

For the C3100

BTL
C3100
XXXX (Serial Number)
Cs137
Radiation Symbol
or
Radioactive
 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
SAFETY EVALUATION OF A DEVICE
(AMENDED IN ITS ENTIRETY)

NO.: NR-1307-D-102-S DATE: May 15, 2015 PAGE: 9 of 16

DEVICE TYPE: Gamma Irradiator

LABELING (Cont.):

The following is engraved on the outer surface of the C-378

sources:
MDSN or BTL
Cs137G
C378
XXXX (Serial Number)
RADIOACTIVE

DIAGRAMS:

Attachments 1 through 6.

CONDITIONS OF NORMAL USE:

The Gammacell 1000, Gammacell 1000 Elite, and the Gammacell 3000
Elan are low dose rate irradiators designed to irradiate
biological or other samples requiring low dose rate, (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, etc.). The irradiators would be located in
laboratory environments and will be used only by personnel
trained in radiation safety.

PROTOTYPE TESTING:

The manufacturer claims that the devices comply with ANSI

N433.1-1977. The Gammacell 1000 has been in use for over 15
years without any reported problems. The Gammacell 1000 Elite
and 3000 Elan are essentially similar to the Gammacell 1000 and
for this reason the manufacturer claims they are expected to
perform with comparable reliability.

The RAMCO-50 and ISO-1000 sealed sources have passed special

form tests conducted by the manufacturer, Oak Ridge National
Laboratory. The C-1000 and C-3000 sealed sources have passed
special form tests conducted by the manufacturer and have been
tested to and received a rating of 77E65546 as per ANSI N542-
 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
SAFETY EVALUATION OF A DEVICE
(AMENDED IN ITS ENTIRETY)
NO.: NR-1307-D-102-S DATE: May 15, 2015 PAGE: 10 of 16

DEVICE TYPE: Gamma Irradiator

PROTOTYPE TESTING (Cont.):

1977. The C-1001 and C-3001 sealed sources have passed special
form tests conducted by Amersham Corporation.

The C-378 sealed sources have passed special form tests

performed by MDS Nordion and have achieved a rating of
96E64334(5)as per ANSI N43.6-1997. MDS Nordion subjected this
sealed source model to a bend test to satisfy ISO 2919.1999(E)
requirements.

The Model C3100 sealed sources were tested to IAEA special form
requirements by Best Theratronics and have achieved an ISO
2919:2012 E65646 classification.

EXTERNAL RADIATION LEVELS:

MDS Nordion reported that the Gammacell 1000 has an average dose
rate less than 0.5 mrem/hr (5 pSv/hr) at 1.97 inches (5 cm) from
its surface when loaded with maximum activity.

The Gammacell 1000 Elite is self-shielded and can be safely

operated in an existing lab environment. The manufacturer
claims that with the secondary shielding installed the Gammacell
3000 Elan can be safely operated in an existing lab environment
as well. When loaded with maximum activity the external
radiation levels for these devices in the transient condition
have been calculated by Nordion to be no greater than 5.0
mrem/hr (50 pSv/hr) at 1.97 inches (5.0 cm) from the accessible
surface of the unit and 0.5 mrem/hr (5 pSv/hr) at 39.4 inches
(100 cm) from the accessible surface of the unit.

With the devices in the "in use" or "not in use" condition the
external radiation levels have been calculated by Nordion to be
no greater than 1.0 mrem/hr (10 pSv/hr) at 1.97 inches (5 cm)
from the accessible surface of the unit and 0.05 mrem/hr (0.5
pSv/hr) at 39.4 inches (100 cm) from the accessible surface of
the unit.
 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
SAFETY EVALUATION OF A DEVICE
(AMENDED IN ITS ENTIRETY)
NO.: NR-1307-D-102-S DATE: May 15, 2015 PAGE: 11 of 16

DEVICE TYPE: Gamma Irradiator

QUALITY ASSURANCE AND CONTROL:

Best Theratronics maintains a quality assurance and control

program (QA/QC) which has been deemed acceptable for licensing
purposes by NRC and is ISO 9001:2008 certified. The manufacture
of Model C3100 sealed source is covered by Best Theratronics'
QA/QC program. A copy of the program is on file with the NRC.

LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:

" The irradiators and sources shall be distributed only to

persons specifically licensed by the NRC or an Agreement
State.

• Handling, Storage, Use, Transfer, and Disposal: To be

determined by the licensing authority.

" The irradiators shall be leak tested at intervals not to

exceed 6 months using techniques capable of detecting 0.005
microcurie (185 Bq) of removable contamination.

* REVIEWER NOTE: The secondary shielding for the Gammacell

3000 Elan must be installed at the time of delivery to the
user's facility and prior to the initial use of the device.
This installation must be performed by Best Theratronics or
persons specifically licensed by the NRC or an Agreement
State to perform service on this device.

* The Model C-1000, C-1001, C-3000, C-3001, C-378, and C3100

sealed sources are approved by the NRC for use in the
Gammacell 1000 and Gammacell 3000 Series irradiators.
These sources are not registered on a separate certificate.

* This registration sheet and the information contained

within the references shall not be changed without the
written consent of the NRC.
 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
SAFETY EVALUATION OF A DEVICE
(AMENDED IN ITS ENTIRETY)

NO.: NR-1307-D-102-S DATE: May 15, 2015 PAGE: 12 of 16

DEVICE TYPE: Gamma Irradiator

SAFETY ANALYSIS SUMMARY:

This certificate supersedes NR-0220-D-102-S. MDS Nordion has

transferred the manufacture and distribution of these devices to
Best Theratronics. The quality control programs remain the same
and the technical capability to administer these programs has
not been changed. The transfer is limited to the name change,
no changes were made in the design, fabrication, or operating
procedures.

The Gammacell 1000 was deemed acceptable for licensing purposes

in 1979. At that time, the device was manufactured by Isomedix,
Inc. and distributed by AECL.

The Gammacell 1000 Elite was deemed acceptable for licensing

purposes in 1990. The unit has a simplified operation from that
of the Gammacell 1000. The cavity door has been equipped with
an interlock to prevent the sample chamber from rotating when
the door is open. This reduces the risk of hand injuries and
radiation exposure. The unit is more stable due to a lower
center of gravity and larger base. No significant changes were
made to the source housing as compared to the Gammacell 1000.

The Gammacell 3000 Elan is identical to the Gammacell 1000 Elite

in operation and essentially similar in design. Slight changes
in the sample chamber, source cavity, rotor and exterior
appearance were made for the Gammacell 3000 Elan. These changes
do not affect the safety of the device and do not significantly
change the radiation profile of the unit. Since the Gammacell
1000 and Gammacell 1000 Elite were deemed acceptable for
licensing and that the changes made do not affect the safety of
the device, the Gammacell 3000 Elan is deemed acceptable for
specific licensing purposes.

The C-000 source is essentially similar to the ISO-1000 source.

The C-3000 source is identical in construction to the C-000
source, but with a slightly larger diameter and a higher
activity. The C-1000 source has been subjected to tests
sufficient to receive an ANSI N542-1977 rating of 77E65546 and
by comparison the C-3000 source has received the same rating.
 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
SAFETY EVALUATION OF A DEVICE
(AMENDED IN ITS ENTIRETY)
NO.: NR-1307-D-102-S DATE: May 15, 2015 PAGE: 13 of 16

DEVICE TYPE: Gamma Irradiator

SAFETY ANALYSIS SUMMARY(Cont.):

For these reasons the C-1000 and C-3000 sources are deemed
acceptable for use in the Gammacell 1000 Elite and Gammacell
3000 Elan.

The C-1001 source is essentially similar to the C-1000 source

and the C-3001 source is essentially similar to the C-1001
source. The C-1001 and C-3001 sources are expected to be able
to withstand similar conditions to the C-1000 and C-3000
sources.

The C-378 has an additional encapsulation of ISO-1000 approved

source with a leak tested single outer shell. The C-378 sealed
source has passed special form tests performed by MDS Nordion
and have been tested to and achieved a rating of 96E64334(5) as
per ANSI N43.6-1997.

The Model C3100 sealed source is a direct replacement of the

Model C-3001 sealed source. The C3100 sealed source has passed
special forms test performed by Best Theratronics and has been
tested to and achieved an ISO 2919 classification of E65646.
Based on our review of the information and test results provided
by Best Theratronics we conclude that the Model C3100 sealed
source is acceptable for licensing purposes when used in the
Gammacell 1000 and Gammacell 3000 Series irradiators.
Furthermore, we conclude that the Model C3100 source would be
expected to maintain its integrity for normal and accidental
conditions of use which might occur during uses specified in
this certificate.

We continue to conclude that these devices and sources would be

expected to maintain their containment integrity for normal
conditions of use specified in this certificate.
 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
SAFETY EVALUATION OF A DEVICE
(AMENDED IN ITS ENTIRETY)
NO.: NR-1307-D-102-S DATE: May 15, 2015 PAGE: 14 of 16

DEVICE TYPE: Gamma Irradiator

REFERENCES:

The following supporting documents for the Gammacell 1000

research irradiator are hereby incorporated by reference and are
made a part of this registry document.

* Isomedix, Inc. letters dated May 9, 1980 and June 11, 1980
with enclosures thereto.

* ORNL letter dated June 18, 1980. Atomic Energy of Canada,

Ltd. letter dated June 2, 1983 with enclosures thereto.

The following supporting documents for the Gammacell 1000 Elite

research irradiator are hereby incorporated by reference and are
made a part of this registry document.

* Atomic Energy of Canada, Ltd. letter dated August 20, 1986

with enclosures thereto.

* Nordion International, Inc. letters dated December, 8, 1988

and April 11, 1990 with enclosures thereto.

The following supporting documents for the Gammacell 3000 Elan

research irradiator, C-1000, and C-3000 sources are hereby
incorporated by reference and are made a part of this registry
document.

" Nordion International, Inc. letters dated September 5,

1991, September 24, 1991, November 4, 1991, December 17,
1991 and December, 20, 1991 with enclosures thereto.

" Nordion International, Inc. facsimile received November 22,

1991. MDS Nordion, Inc., letters dated September 25, 1997,
and January 13, 1998, with enclosures thereto.
 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
SAFETY EVALUATION OF A DEVICE
(AMENDED IN ITS ENTIRETY)

NO.: NR-1307-D-102-S DATE: May 15, 2015 PAGE: 15 of 16

DEVICE TYPE: Gamma Irradiator

REFERENCES (Cont.):

The following supporting documents for the C-1001 and C-3001

sources are hereby incorporated by reference and are made a part
of this registry document.

* Nordion International, Inc. letters dated June 4, 1993, and

March 18, 1993, with enclosures thereto.

* Amersham Corporation's letter, in support of Nordion's

application, dated December 16, 1992, with enclosures
thereto.

* MDS Nordion, Inc., letters dated September 25, 1997, and

January 13, 1998, with enclosures thereto.

" MDS Nordion letter dated December 14, 2001, requesting name
and address change.MDS Nordion letter dated September 18,
2003, and electronic mail dated November 24, 2003, with
enclosures thereto.

The following supporting documents for the C-378 sources are

hereby incorporated by reference and are made a part of this
registry document.

* MDS Nordion letters dated May 23, 2002, and September 16,
2002, with enclosures thereto.

" Best Theratronics letter dated March 20, 2008, with

enclosures thereto.

* Best Theratronics letter and e-mail dated September 9,

2010, with enclosures thereto.

" Best Theratronics letters dated June 28, 2011, with

enclosures thereto.
 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
SAFETY EVALUATION OF A DEVICE
(AMENDED IN ITS ENTIRETY)
NO.: NR-1307-D-102-S DATE: May 15, 2015 PAGE: 16 of 16

DEVICE TYPE: Gamma Irradiator

REFERENCES (Cont.):

" Best Theratronics letters dated November 17, 2011, and

April 27, 2012, with enclosures thereto.

* Best Theratonics emails dated April 27, 2012, with

enclosures thereto.

The following supporting documents for the C3100 sources are

hereby incorporated by reference and are made a part of this
registry document.

Best Theratonics letters dated December 3, 2014

(ML15005A339), March 26, 2015 (ML15090A673), April 24, 2015
(ML15117A055), and May 1, 2015 (ML15124A003), with
enclosures thereto.

ISSUING AGENCY:

U.S. Nuclear Regulatory Commission

Date: May 15, 2015 Reviewer:

Tomas Herrera

Date: May 15, 2015 Concurrence: 2

Cymari S4pulveda
 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
SAFETY EVALUATION OF A DEVICE
(AMENDED IN ITS ENTIRETY)
NO.: NR-1307-D-102-S DATE: May 15, 2015 ATTACHMENT: 1 of 6
DEVICE TYPE: Gamma Irradiator

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Model Gammacell 1000 Elite