ML24004A125

Certificate of Compliance No. 9338, Revision No. 5

ML24004A125
Person / Time
Site:	07109338
Issue date:	01/12/2024
From:	Yoira Diaz-Sanabria Storage and Transportation Licensing Branch
To:	Croft Associates Limited
Shared Package
ML24004A123	List: ML24004A124 ML24004A125
References
EPID L-2024-RNW-0003
Download: ML24004A125 (1)

Text

NRC FORM 618 U.S. NUCLEAR REGULATORY COMMISSION (8-2000) 10 CFR 71 CERTIFICATE OF COMPLIANCE FOR RADIOACTIVE MATERIAL PACKAGES

1. a. CERTIFICATE NUMBER b. REVISION NUMBER c. DOCKET NUMBER d. PACKAGE IDENTIFICATION NUMBER PAGE PAGES 9338 5 71 - 933 8 USA/933 8/B(U) - 9 6 1 OF 8

2. PREAMBLE

a. This certificate is issued to certify that the package (packaging and contents) described in Item 5 below meets the applicabl e safety standards set forth in Title 10, Code of Federal Regulations, Part 71, Packaging and Transportation of Radioactive Material.

b. This certificate does not relieve the consignor from compliance with any requirement of the regulations of the U.S. Department of Transportation or other applicable regulatory agencies, including the gove rnment of any country through or into which the package will be transported.

3. THIS CERTIFICATE IS ISSUED ON THE BASIS OF A SAFETY ANALYSIS REPORT OF THE PACKAGE DESIGN OR APPLICATION.

a. ISSUED TO (Name and Address) b. TITLE AND IDENTIFICATION OF REPORT OR APPLICATION Croft Associates L td Croft Associates Limited application dat ed F4 Culham Science Centre September 29, 2012, as supplemented.

Culham, Abingdon Oxon, OX14 3DB, United Kingdom

4. CONDITIONS This certificate i s conditional upo n fulfilling the requirements of 10 CFR Part 71, as applicable, and the conditions specified below.

5.

(a) Packaging

(1) Model No.: 3977A

(2) Description

The M odel No. 3977A is a package for the transport of radioisotopes used in a wide range of therapeutic and diagnostic applications and research. The packaging consists of an outer stainless-steel keg and an inner containment vessel surrounded by insulating cork packing. There are f ive specific inserts, designated as Shielding Insert Design Nos. 3982, 3985, 3987, 4081 and 4109,

authorized for use in the Model No. 3977A. The outer keg provides impact and thermal protection.

Containment is provided by the containment vessel. Shielding is provided by the containment vessel and shielding ins erts.

The k eg has a stainless - steel outer shell and a stainless - steel liner, between which insulating cork is fitted. The keg lid is attached to the body by eight stainless steel studs and nuts, with a single O - ring weather seal. An inner cork liner is fitte d between the keg liner and the top and sides of the containment vessel, consisting of a cork body and cork top, with no cork between the bottom of the containment vessel and the keg liner.

The c ontainment vessel consists of a body and lid. The body has a stainless - steel outer wall, base, and flange/cavity wall. The flange/cavity wall is welded to the outer wall to form a cavity into which DU shielding is placed. The DU shielding thickness is approximately 46 mm at the base of the CV and 47.6 mm along the side of the CV except at the top where the lid seats. The DU shielding thickness at the top is 22.5 mm thick. After the DU shielding is installed, the base is then welded to the outer wall.

NRC FORM 618 U.S. NUCLEAR REGULATORY COMMISSION (8-2000) 10 CFR 71 CERTIFICATE OF COMPLIANCE

FOR RADIOACTIVE MATERIAL PACKAGES

1. a. CERTIFICATE NUMBER b. REVISION NUMBER c. DOCKET NUMBER d. PACKAGE IDENTIFICATION NUMBER PAGE PAGES 9338 5 71 - 933 8 USA/933 8/B(U) - 9 6 2 OF 8

5.(a) (2) Description (Continued)

There are two CV lid configurations: a standard configuration and a split lid configuration. For the standard CV lid, the stainless-steel lid shielding casing, with 45.9 mm of DU inside, is welded to the stainless-steel CV lid top. For the split CV lid, a shiel ding plug, composed of 45.9 mm of DU enclosed within a stainless -steel body and a stainless -steel top, sits within the CV and a stainless steel CV lid is installed. A ll CV lid configurations are secured by eight, M-10x1.5x20, alloy steel recessed hexagon socket head cap screws. The containment vessel is sealed by two concentric fluoroelastomer O-rings, and the lid is equipped with a leak test port.

There are five shielding inserts designed for use in the Model No. 3977A packaging: Design Nos. 3982, 3985, 3987, 4081 and 4109. Design No. 3982, HS-12x95-Tu, is a tungsten insert with inner cavity size of 12 mm diameter by 95 mm height. The approximate mass of the insert is 9.2 kg. Design No. 3985, HS-31x114-Tu, is a tungsten insert with inner cavity size of 31 mm diameter by 114 mm in height. The approximate mass of the insert is 7.9 kg. Design No. 3987, H S-55x128-SS, is a stainless -steel insert with inner cavity size of 55 mm diameter by 128 mm height. A titanium liner shall be employed with the HS-55x128-SS insert. The approximate mass of the insert is 1.8 kg with a liner installed. Shielding insert Design Nos. 3982, 3985 and 3987 are only used with the standard CV lid arrangement. Design No. 4081, HS-50x85-SS, is a stainless-steel insert with inner cavity size of 50 mm diameter by 85 mm height. Design No. 4081 is used in conjunction with a snap ring, which attaches the shielding insert to the shielding plug associated with the split CV lid design, and a tungsten liner which provides additional shielding from the radioactive material transported. The approximate mass of the insert is 3.3 kg.

Design No. 4109, HS-50x113-SS, is a stainless-steel insert with inner cavity size of 50 mm diameter by 113 mm height. The approximate mass of the insert is 1.2 kg. Design No. 4081 and 4109 are only used with the split CV lid arrangement.

The radioactive material shall be enclosed in a convenient plastic, metal or quartz product container (e.g., vial, capsule or bottle) or wrapping to minimize the contamination of the insert.

The approximate dimensions and mass of the package are:

Overall package outer diameter 424 mm Overall package height 585 mm Containment vessel outer diameter 200 mm Containment vessel height 302.5 mm Containment vessel cavity inner diameter 65.8 mm Containment vessel cavity inner height 157.1 mm Maximum package mass 163 kg

NRC FORM 618 U.S. NUCLEAR REGULATORY COMMISSION (8-2000) 10 CFR 71 CERTIFICATE OF COMPLIANCE FOR RADIOACTIVE MATERIAL PACKAGES

1. a. CERTIFICATE NUMBER b. REVISION NUMBER c. DOCKET NUMBER d. PACKAGE IDENTIFICATION NUMBER PAGE PAGES 9338 5 71 - 933 8 USA/933 8/B(U) - 9 6 3 OF 8

( 3) Drawings

Packaging employ ing a standard lid for the transport of Insert Design Nos. 3982, 3985 and 3987 is constructed and assembled in accordance with Croft Associates Limited Drawing Nos:

1C-5940, Rev. H Cover Sheet for Safkeg HS Design No. 3977A (Licensing Drawing) 0C - 5941, Rev. E Safkeg HS Design No. 3977A (Licensing Drawing) 0C - 5942, Rev. C Keg Design No. 3977 (Licensing Drawing) 0C - 5943, Rev. B Cork Set for Safkeg HS (Licensing Drawing) 1C-5944, Rev. C Containment Vessel Design No. 3978 (Licensing Drawing) 1C-5945, Rev. D Containment Vessel Lid (Licensing Drawing) 1C-5946, Rev. E Containment Vessel Body (Licensing Drawing) 2C - 6920, Rev. A Silicone Sp onge Rubber Disc (Licensing Drawing)

Packaging employ ing a split lid for the transport of Insert Design No. 4081 is constructed and assembled in accordance with Croft Associates Limited Drawing Nos:

1C-7500, Rev. C Cover Sheet for Safkeg HS Design No. 3977A - Mallinckrodt Version (Licensing Drawing) 0C - 7501, Rev. C Safkeg HS Design No. 3977A - Mallinckrodt Version (Licensing Drawing) 0C - 7502, Rev. A Keg Design No. 3977 - Mallinckrodt Version (Licensing Drawing) 0C - 7503, Rev. A Cork S et for Safkeg HS - Ma llinckrodt Version (Licensing Drawing) 1C-7504, Rev. A Containment Vessel Design No. 3978 - Mallinckrodt Version (Licensing Drawing) 1C-7505, Rev. A Containment Vessel Lid - Mallinckrodt Version (Licensing Drawing) 1C-7506, Rev. A Cont ainment Vessel Body - Mallinckrodt Version (Licensing Drawing) 1C-7507, Rev. A Containment Vessel Plug - Mallinckrodt Version (Licensing Drawing)

Packaging employing a split lid for the transport of Insert Design No. 4109 is constructed and assembled in accordance with Croft Associates Limited Drawing Nos:

1C-7940, Rev. C Cover Sheet for Safkeg HS Design No. 3977A - #4109 Insert 0C - 7941, Rev. C Safkeg HS Design No. 3977A - 4109 Insert 0C - 7942, Rev. B Keg Design No. 3977 - 4109 Insert 0C - 7943, Rev. B Cork Set for Safkeg HS - 4109 Insert 1C-7944, Rev. C Containment Vessel Design No. 3978 - 4109 Insert 1C-7945, Rev. B Containment Vessel Lid - 4109 Ins ert 1C-7946, Rev. C Containment Vessel Body - 4109 Insert 1C-7947, Rev. B Containment Vessel Plug - 4109 Inse rt 1C-7975, Rev. D Pac king for Thorium Target i n Design No. 3978 - #4109 Insert 2C - 6920, Rev. A Silicone Sponge Rubber Disc (Licensing Drawing)

NRC FORM 618 U.S. NUCLEAR REGULATORY COMMISSION (8-2000) 10 CFR 71 CERTIFICATE OF COMPLIANCE FOR RADIOACTIVE MATERIAL PACKAGES

1. a. CERTIFICATE NUMBER b. REVISION NUMBER c. DOCKET NUMBER d. PACKAGE IDENTIFICATION NUMBER PAGE PAGES 9338 5 71 - 933 8 USA/933 8/B(U) - 9 6 4 OF 8

5.(a) (3) Drawings (Continued)

Th e shielding inserts, and packaging components associated with their use, are constructed and assembled in accordance with Croft Associates Limited Drawing Nos:

2C - 6173, Rev. D HS - 12 x 95 - Tu Insert Design No. 3982 (Licensing Drawing) 2C - 6174, Rev. D HS - 31 x 114 - Tu Insert Design No. 3985 (Licensing Drawing) 2C - 6176, Rev. F HS - 55X1 28-SS Insert Design No. 3987 (Licensing Drawing) 2C - 7508, Rev. C HS - 50 x 85 - SS Insert Design No. 4081 (Licensing Drawing) 2C - 7509, Rev. B Snap Ring 2C - 7510, Rev. A Tungsten Liner 2C-8094, Rev. B HS - 55x113-SS Insert Design No. 4109 ( Licensing Drawing)

5. (b ) Contents

( 1) Type and form of material

Solid material must have a melting point greater than 250 o C and must not be volatile below 250 o C.

(i ). Solids, normal or special form ma terial, as limited in Table 1, within insert Design No.

3982. All contents may be shipped as individual elements or compounds except for Cs, Hg, I, Na, and P. Cs, Hg, I, Na, and P contents must be shipped as compounds.

( ii). Solids, normal or special form mat erial, as limited in Table 2, within insert Design No.

3985. All contents m ay be shipped as individual elements or compounds except for Cs, Hg, I, Na, and P. Cs, Hg, I, Na, and P contents must be shipped as compounds.

( iii). Gases, normal form material, as lim ited in Table 3, within insert Design No. 3985 as individual elements. The product container shall be a quartz vial sealed by fusing or aluminum capsules.

(i v). Liquids, normal form, as limited in Table 4, within insert Design No. 4081 as natrium molyd enate in a matrix solution of NaNO 3 1M and NaOH 0.2M ( Na 2 MoO 4 [NaNO 3 1M/NaOH 0.2M ]). The product container shall be stainless steel.

( v). Liquids, normal form, as limited in Table 5, within insert Design No. 3987 as either alkali or acidic salt solutions. For acidic salt solutions, only HC l, H 2 SO4 and HNO 3 solutions of 0.1 N are allowed. The product container shall be a quartz vial or aluminum capsule wrapped in LDPE or similar material with equivalent radiation resistance.

(v i). Normal form proton irradiated thorium metal pieces, as limited in Table 6, tran sported in a meta l or plastic product container.

NRC FORM 618 U.S. NUCLEAR REGULATORY COMMISSION (8-2000) 10 CFR 71 CERTIFICATE OF COMPLIANCE FOR RADIOACTIVE MATERIAL PACKAGES

1. a. CERTIFICATE NUMBER b. REVISION NUMBER c. DOCKET NUMBER d. PACKAGE IDENTIFICATION NUMBER PAGE PAGES 9338 5 71 - 933 8 USA/933 8/B(U) - 9 6 5 OF 8

( 2) Maximum quantity of material per package

Decay heat not to exceed 30 watts per package for both solid and gaseous contents. Decay heat not to exceed 5 watts per package for liquid contents. Mixtu res of nuclides are allow ed pr oviding the sum of the pr oportionate amounts of each nuclide with respect to the quantities shown in the respective table does not exceed unity. T he contents in clude the progeny of the radionuclides listed in Tables 1 through 4 ; however, t he quantities in the tables are for the liste d r adionuclides without progeny present (i.e., at the time of loading, only the radionuclides explicitly listed in the table may be present up to the quantities shown in the tables).

( i) For the cont ents described in 5(b)(1)(i):

Tot al mass of contents and insert not to exceed 9.3 kg. Maximum mass of radioactive material is 45 g.

TABLE 1 Radionuclide Maximum TBq Radionuc lide Maximum TBq Radionuclide Maximum TBq Ac - 225 2.51E+ 00 I-131 3.2 6E+02 Re - 186 1.56E+02 Ac - 227 7.24E - 01 In - 111 4.2 5 E+02 Re - 188 7.25E - 01 Ac - 228 4.28E - 01 Ir-192 1.81E+02 Rh - 105 8.12E+02 Am - 241 3.51E - 01 Ir-194 2.05E+00 Se - 75 4.61E+02 As - 77 7.90E+02 Lu - 177 1.03E+03 Sm - 153 6.12E - 01 Au - 198 2.56E+02 Mo - 99 5.27E +01 Sr-89 1.22E+01 Ba - 131 1.88E+02 Na - 24 2.63E - 02 Sr-90 1.73 E+00 C-14 7.20E+0 0 Np - 237 1.17E - 03 Tb - 161 1.61E+01 Co - 60 2.38E - 01 P-32 5.58E+00 Th - 227 1.01E+01 Cs - 131 6.71E+03 P-33 2.44E+03 Th - 228 6.7 9E - 02 Cs - 134 7.05E+00 Pb - 203 5.20E+02 Tl-201 1.45E+03 Cs - 137 1.44E+02 Pb - 210 8.04E+00 W - 187 2.24E+01 Cu - 67 6.91E+0 2 Pd - 109 2.96E+02 W - 188 6.43E - 01 Hg - 203 3.57E+01 Ra - 223 6.83 E+0 0 Y-90 1.73E+00 Ho - 166 2.04E+00 Ra - 224 8.86E- 02 Yb - 169 4.42E+02 I-125 3.19E+03 Ra - 226 9.91E - 02 Yb - 175 1.11E+03 I-129 2.93E - 04 Note: Boron and bery llium shall not be loaded with the contents in Table 1.

NRC FORM 618 U.S. NUCLEAR REGULATORY COMMISSION (8-2000) 10 CFR 71 CERTIFICATE OF COMPLIANCE

FOR RADIOACTIVE MATERIAL PACKAGES

1. a. CERTIFICATE NUMBER b. REVISION NUMBER c. DOCKET NUMBER d. PACKAGE IDENTIFICATION NUMBER PAGE PAGES 9338 5 71 -933 8 USA/933 8/B(U) - 9 6 6 OF 8

5.(b) (2) (continued)

(ii) For the contents described in 5(b)(1)(ii):

Total mass of contents and insert not to exceed 8.6 kg. Maximum mass of radioactive material is 345 g.

TABLE 2 Radionuclide Maximum TBq Radionuclide Maximum TBq Radionuclide Maximum TBq Ac-225 5.47E-01 I-131 3.26E+02 Re-186 2.66E+01 Ac-227 1.63E-01 In-111 4.25E+02 Re-188 2.61E-01 Ac-228 9.30E-02 Ir-192 1.81E+02 Rh-105 8.12E+02 Am-241 7.92E-01 Ir-194 4.83E-01 Se-75 4.61E+02 As-77 7.90E+02 Lu-177 1.03E+03 Sm-153 5.71E+02 Au-198 5.69E+01 Mo-99 9.56E+00 Sr-89 2.59E+00 Ba-131 3.06E+01 Na-24 6.38E-03 Sr-90 4.15E-01 C-14 5.52E+01 Np-237 8.97E-03 Tb-161 3.70E+00 Co-60 4.68E-02 P-32 1.25E+00 Th-227 2.09E+00 Cs-131 6.71E+03 P-33 2.44E+03 Th-228 1.67E-02 Cs-134 1.32E+00 Pb-203 5.20E+02 Tl-201 1.45E+03 Cs-137 1.58E+02 Pb-210 1.66E+00 W-187 4.28E+00 Cu-67 6.91E+02 Pd-109 4.81E+01 W-188 2.19E-01 Hg-203 5.58E+02 Ra-223 2.07E+00 Y-90 4.15E-01 Ho-166 4.60E-01 Ra-224 2.19E-02 Yb-169 4.42E+02 I-125 3.19E+03 Ra-226 2.34E-02 Yb-175 1.11E+03 I-129 2.24E-03 Note: Boron and beryllium shall not be loaded with the contents in Table 2.

(iii) For the contents described in 5(b)(1)(iii):

Total mass of contents and insert not to exceed 8.6 kg. M aximum mass of radioactive material is less than one g ram. Maximum volume of contents, including the product container material and packing, is less than 10 cc.

TABLE 3 Radionuclide Maximum TBq Radionuclide Maximum TBq Kr-79 1.15E+01 Xe-133 1.04E+03

NRC FORM 618 U.S. NUCLEAR REGULATORY COMMISSION (8-2000) 10 CFR 71 CERTIFICATE OF COMPLIANCE FOR RADIOACTIVE MATERIAL PACKAGES

1. a. CERTIFICATE NUMBER b. REVISION NUMBER c. DOCKET NUMBER d. PACKAGE IDENTIFICATION NUMBER PAGE PAGES 9338 5 71 - 933 8 USA/933 8/B(U) - 9 6 7 OF 8

5.(b) (2) (continued)

( iv) For the contents described in 5(b)(1)(iv ):

Tot al mass of contents and insert not to exceed 4.9 kg. Maximum mass of radioactive material is 0.8 kg. Ma ximum specific activity shall be less than 60 Ci/ml and th e m aximum volume shall be 75 ml.

TABLE 4 Radionuclide Maxi mum TBq Mo - 99 3.7 E+0 1

( v) For the contents described in 5(b)(1)(v ):

Tot al mass of contents and insert not to exceed 3.6 kg. Maximum mass of radioactive material is 0.9 kg.

TABLE 5 Radionuclide Maximum TBq I-131 7.4E +00

( vi) For the contents described in 5(b)(1)(vi):

Tot a l mass of contents, spacers and product containers not to exceed 3.3 kg. Maximu m m ass of radioactive material is 2.1 kg.

TABLE 6 Energy Bands (Upper Energy Limit Shown) 3 0 keV 50 keV 100 keV 200 keV 300 keV 500 keV 700 keV Limit 11E 89E10 39E 15E 34E 44E

( /

EnerUppern Limithow 1 M 5 M 2 M 5 M 3 M 4 M 5 M L 98E 09E 36E9 18E9 95E6 32E5

(/

For ttentscribb)(1) (, tpmentiod begin tontnmentss cled and mt beits.

7. For ttentscribb)(1)(vi t lidhght r themet or plasticrttnerhl be eater6.1 millims.

NRC FORM 618 U.S. NUCLEAR REGULATORY COMMISSION (8-2000) 10 CFR 71 CERTIFICATE OF COMPLIANCE FOR RADIOACTIVE MATERIAL PACKAGES

1. a. CERTIFICATE NUMBER b. REVISION NUMBER c. DOCKET NUMBER d. PACKAGE IDENTIFICATION NUMBER PAGE PAGES 9338 5 71 - 933 8 USA/933 8/B(U) - 9 6 8 OF 8

8. In addition to the requirements of Subpart G of 10 CFR Part 71:

( a) New O - ring seals must be installed in insert Design No. 4081 and insert Design No. 3987 prior to each shipment of the contents described in 5(b)(1)(iv) and 5(b)(1)(v).

( b) The package shall be prepared for shipment and operated in accordance with the Pack age Operations in Section 7.0 of the application, as supplemented.

(c ) The pac kage must meet the Acceptance Tests and Maintenance Program in Section 8.0 of t he appl ication, as supplemented.

9. The package authorized by this certificate is hereby approved for use under the general licens e pr ovisions of 10 CFR 71.17.

10. Revision No. 4 of this c ertificate may be used until March 31, 2024.

11. Expiration date: March 31, 2029.

REFERENCES

Cr oft Associates Li mited application dated September. 29, 2012

Supplements dated: December 20, 2012 ; April 23, September 20, November 21, and 28, December 13, 16,

and 17, 2013; January 6, 10, 27, and 31, and February 11, 2014; De cember 14, 2015 ;

and Mar ch 21, May 23, July, 6, September 9, and October 27, 2016; January 26, March 22, and May 12, 2017 ; March 31, and July 31, 2018; October 2, December 9, 2019 ;

January 3, 2024.

FOR THE U.S. NUCLEAR REGULATORY C OMMISSION

Yoira K. Diaz - Sanabria, Chief Stor age and Trans portation Licensing Branch Division of Fuel Management Office of Nuclear Material Safety and Safeguards

Date: January 12, 2024