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r REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES r
                                -SAFETY EVALUATION OF DEVICE t                             -
-SAFETY EVALUATION OF DEVICE t
NO.: NR-440-D-805-S           DATE:                       PAGE 1 OF 9 MAR 2 01998 DEVICE TYPE:     Technetium-99m Pertechnetate Generator MODEL:           5540, 5541, 5542 DISTRIBUTOR / MANUFACTURER:         Mallinckrodt Medical, Inc.
NO.: NR-440-D-805-S DATE:
MAR 2 01998 PAGE 1 OF 9 DEVICE TYPE:
Technetium-99m Pertechnetate Generator MODEL:
5540, 5541, 5542 DISTRIBUTOR / MANUFACTURER:
Mallinckrodt Medical, Inc.
2703 Wagner Place Maryland Height, MO 63043
2703 Wagner Place Maryland Height, MO 63043
        - SEAT.Rn SOURCE MODEL DESIGNATION:         Not Applicable ISOTOPE:                             MAXIMUM ACTIVITY:
- SEAT.Rn SOURCE MODEL DESIGNATION:
Molybdenum-99                       135 mci (5.0 GBq) in Model 5540 Molybdenum-99                       270 mci (10 GBq)   in Model 5541
Not Applicable ISOTOPE:
        - Molybdenum-99                       540 mci (20 GBq)   in Model 5542 t
MAXIMUM ACTIVITY:
T.RAK TEST FREOUENCY:         Not Required PRINCIPAL USE:                 (V) General Medical Use CUSTOM DEVICE:                   YES       X     NO I
Molybdenum-99 135 mci (5.0 GBq) in Model 5540 Molybdenum-99 270 mci (10 GBq) in Model 5541
9804060347 980320 PDR RC
- Molybdenum-99 540 mci (20 GBq) in Model 5542 t
* SSD             PDit     m
T.RAK TEST FREOUENCY:
Not Required PRINCIPAL USE:
(V) General Medical Use CUSTOM DEVICE:
YES X
NO I
9804060347 980320 PDR RC SSD PDit m


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f                       ,
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Ly                                   o REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-440-D-805-S       DATE:   MAR 2 01998     PAGE 2 OF 9 DEVICE TYPEr   Technetium-99m Pertechnetate Generator DESCRIPTION:
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-440-D-805-S DATE:
The Mo-99 is absorbed on alumina which is packed in a glass column over a glass frit filter. The column is approximately 3.5" (8.89 cm) long and 1" (2.54 cm) in diameter. The ends of the column are sealed with pierceable rubber septa. The glass
MAR 2 01998 PAGE 2 OF 9 DEVICE TYPEr Technetium-99m Pertechnetate Generator DESCRIPTION:
: column is encased in a lead shield and a metal can. The can is 3 625" (9.21 cm) in diameter and 5.7" (4.48 cm) long. Two metal screw caps and two threaded lead plugs provide access to the rubber septa.
The Mo-99 is absorbed on alumina which is packed in a glass column over a glass frit filter.
i The initial generator shipment includes a lead shielding base, an external lead shield, two slotted lead plugs (all described below), and a suspension hook. These items are retained for use with subsequently delivered generators. Each generator shipment includes the' following accessories: a 15.3 in5 (250 cc) sodium   .
The column is approximately 3.5" (8.89 cm) long and 1" (2.54 cm) in diameter.
chloride reservoir sealed with a rubber septum; a plastic reservoir tube which.has, at one end, a plastic spike, a drip     ;
The ends of the column are sealed with pierceable rubber septa.
chamber, and a breather tube containing a bacterial filter and, at the other end, a 10-gauge needle; a plastic elution tube with an 18-gauge needle at one end and a luer connector at the other end; 12 needles with luer connectors; two clamps; 12 evacuated elute receiving bottles sealed with rubber septa; and a lead cup, with a lead cover, to hold the elute receiving bottles.
The glass
The cylindrical lead shield in the metal can containing the generator column is 1-1/8" (2.86 cm) thick. The cylindrical lead   ]
: column is encased in a lead shield and a metal can.
shielding base on which the can is placed has 0.2" (0.51 cm)       l L   . walls and a 1/2" (1.27 cm) thick base. The plug for the top of     j
The can is 3 625" (9.21 cm) in diameter and 5.7" (4.48 cm) long.
      'the column is 5/8" (1.59 cm) thick lead with a slot for the elution tubing. Over the can, and resting on the lead base, is i     placed an external cylindrical lead shield 3/4" (1.91 cm) thick I     on the side and 1" (2.54 cm) thick on top.                           I L
Two metal screw caps and two threaded lead plugs provide access to the rubber septa.
                                                                          )
i The initial generator shipment includes a lead shielding base, an external lead shield, two slotted lead plugs (all described below), and a suspension hook.
These items are retained for use with subsequently delivered generators.
Each generator shipment includes the' following accessories: a 15.3 in5 (250 cc) sodium chloride reservoir sealed with a rubber septum; a plastic reservoir tube which.has, at one end, a plastic spike, a drip chamber, and a breather tube containing a bacterial filter and, at the other end, a 10-gauge needle; a plastic elution tube with an 18-gauge needle at one end and a luer connector at the other end; 12 needles with luer connectors; two clamps; 12 evacuated elute receiving bottles sealed with rubber septa; and a lead cup, with a lead cover, to hold the elute receiving bottles.
The cylindrical lead shield in the metal can containing the generator column is 1-1/8" (2.86 cm) thick.
The cylindrical lead
]
shielding base on which the can is placed has 0.2" (0.51 cm)
L walls and a 1/2" (1.27 cm) thick base.
The plug for the top of j
'the column is 5/8" (1.59 cm) thick lead with a slot for the elution tubing.
Over the can, and resting on the lead base, is i
placed an external cylindrical lead shield 3/4" (1.91 cm) thick I
on the side and 1" (2.54 cm) thick on top.
L
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: f.             REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES f                         SAFETY EVALUATION OF DEVICE i
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES f
l NO.: NR-440-D-805-S         DATE:   NAR 2 01998     PAGE 3 OF 9 l   DEVICE TYPS1     Technetium-99m Pertechnetate Generator DESCRIPTION (Cont'd):
SAFETY EVALUATION OF DEVICE i
This shield has a bail handle and a 2-7/8" (7.30 cm) diameter plug in the center of the shield with a slot for the elution tubing.                                                           i The generator are shipped five days before the calibration date.
l NO.: NR-440-D-805-S DATE:
NAR 2 01998 PAGE 3 OF 9 l
DEVICE TYPS1 Technetium-99m Pertechnetate Generator DESCRIPTION (Cont'd):
This shield has a bail handle and a 2-7/8" (7.30 cm) diameter plug in the center of the shield with a slot for the elution tubing.
i The generator are shipped five days before the calibration date.
The licensee may receive the generators four days before calibration, thus receiving an amount of activity as given below.
The licensee may receive the generators four days before calibration, thus receiving an amount of activity as given below.
The manufacturer has submitted information sufficient to ensure that, provided the recommended e3ution and assay procedures are followed, the eluted Tc-99m pertechnetate can be expected to meet the Commission's criteria,
The manufacturer has submitted information sufficient to ensure that, provided the recommended e3ution and assay procedures are followed, the eluted Tc-99m pertechnetate can be expected to meet the Commission's criteria, 1.
: 1. Mo-99 Contamination:
Mo-99 Contamination:
The manufacturer recommends two methods. The first method is a chemical test using potassium ethyl xanthate and hydrochloric acid. The chemicals are not routinely supplied by the manufacturer. A negative result indicates that there is less than 0.2 pCi (7.4 kBq) of Mo-99 per mci of Tc-99m.
The manufacturer recommends two methods.
If the chemical test is positive, the user is instructed to check the elute radiometrically to determine if the Mo-99 contamination exceeds the Commission's specifications. The manufacturer does not test any generators during production for Mo-99 breakthrough.
The first method is a chemical test using potassium ethyl xanthate and hydrochloric acid.
The second and alternate method is a radiometric test using a Cs-137 calibrated standard, a two-piece lucite stand, a j         lead shield, and two 0.025" (0.0635 cm) lead absorbers.
The chemicals are not routinely supplied by the manufacturer.
A negative result indicates that there is less than 0.2 pCi (7.4 kBq) of Mo-99 per mci of Tc-99m.
If the chemical test is positive, the user is instructed to check the elute radiometrically to determine if the Mo-99 contamination exceeds the Commission's specifications.
The manufacturer does not test any generators during production for Mo-99 breakthrough.
The second and alternate method is a radiometric test using a Cs-137 calibrated standard, a two-piece lucite stand, a j
lead shield, and two 0.025" (0.0635 cm) lead absorbers.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-440-D-805-S       DATE:                     PAGE 4 OF 9 MMi 2 01998 DEVICE TYPE:   Technetium-99m Pertechnetate Generator DESCRIPTION (Cont'd):
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-440-D-805-S DATE:
The calibrated standard is a solution of approximately 15 pCi (0.56 MBq) of Cs-137 in a 1.8 in) (30 ml) volume in an elution vial. The manufacturer hac submitted information which substantiates their use of a calculated conversion factor of 5.1 for the ratio of the pCi of Mo-99 to pCi of Cs-137. The Cs-137 standard is supplied at the request of the licensee. The lucite stand (designed for obtaining constant geometry), lead shield and filter discs, and an instrument check source (approximately 1 yCi [37 kBq) of Co-57 and less than 1 pCi [37 MBq] of Cs-137) are supplied on a one-time basis. The procedure is adequate to detect 0.5 pCi (18.5 kBq) of Mo-99 per mci of Tc-99m. The procedure may be performed with either a well-type scintillation detector or a scintillation probe.
MMi 2 01998 PAGE 4 OF 9 DEVICE TYPE:
: 2. Ruthenium-103. Tellurium. and Iodine-131 contamination:
Technetium-99m Pertechnetate Generator DESCRIPTION (Cont'd):
The calibrated standard is a solution of approximately 15 pCi (0.56 MBq) of Cs-137 in a 1.8 in) (30 ml) volume in an elution vial.
The manufacturer hac submitted information which substantiates their use of a calculated conversion factor of 5.1 for the ratio of the pCi of Mo-99 to pCi of Cs-137.
The Cs-137 standard is supplied at the request of the licensee.
The lucite stand (designed for obtaining constant geometry), lead shield and filter discs, and an instrument check source (approximately 1 yCi [37 kBq) of Co-57 and less than 1 pCi [37 MBq] of Cs-137) are supplied on a one-time basis.
The procedure is adequate to detect 0.5 pCi (18.5 kBq) of Mo-99 per mci of Tc-99m.
The procedure may be performed with either a well-type scintillation detector or a scintillation probe.
2.
Ruthenium-103. Tellurium. and Iodine-131 contamination:
The Mo-99 is obtained by irradiation of stable Mo rather than by separation of fission products, so these contaminants will not be present.
The Mo-99 is obtained by irradiation of stable Mo rather than by separation of fission products, so these contaminants will not be present.
: 3. Aluminum Breakthrough:
3.
The manufacturer's specifications indicate that aluminum contamination will not exceed 0.018 oz (0.5 mg) of elemental l aluminum per 10 mci (0.37 GBq) of eluted Tc-99m. For each production run, at least one generator is eluted on Monday and Friday, and the aluminum contamination in the elute is determined. The package insert includes a chemical test for )
Aluminum Breakthrough:
aluminum.                                                   l
The manufacturer's specifications indicate that aluminum contamination will not exceed 0.018 oz (0.5 mg) of elemental aluminum per 10 mci (0.37 GBq) of eluted Tc-99m.
For each production run, at least one generator is eluted on Monday and Friday, and the aluminum contamination in the elute is determined.
The package insert includes a chemical test for
)
aluminum.


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I i-REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l
I i-REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l
SAFETY EVALUATION OF DEVIC 8 L
SAFETY EVALUATION OF DEVIC 8 L
NO.: NR-440-D-805-S       DATE:
NO.: NR-440-D-805-S DATE:
WAR 2 01998       PAGE 5 OF 9 l     DEVICE TYPE:     Technetium-99m Pertechnetate Generator DESCRIPTION (Cont'd):
WAR 2 01998 PAGE 5 OF 9 l
l
DEVICE TYPE:
: 4. Radioassay:
Technetium-99m Pertechnetate Generator DESCRIPTION (Cont'd):
The package insert includes two radioassay procedures.       One method involves dilution of a small sample of the eluted Tc-99m and comparison with a Co-57 calibrated standard, 98%
l 4.
accurate. The procedure requires use of a well-type scintillation counter with a multi-channel analyzer,     a single channel analyzer, or a scaler with a low level discriminator.
Radioassay:
l         A second and alternate method consists of:
The package insert includes two radioassay procedures.
l l         a. Establishing optimum instrument settings by means of a 1 pCi (37 kBq) Co-57 reference source and the constant geometry equipment described previously.
One method involves dilution of a small sample of the eluted Tc-99m and comparison with a Co-57 calibrated standard, 98%
: b. Establishing an efficiency factor for Tc-99m by means of a 15 pCi (0.56 MBq) Tc-99m calibrated standard and the constant geometry equipment.
accurate.
!          c. Determining the activity of the eluted Tc-99m by multiplying the count rate of the eluted material by the efficiency factor obtained in (b) above. The entire elution vial of Tc-99m is counted, using the l
The procedure requires use of a well-type scintillation counter with a multi-channel analyzer, a
constant geometry equipment.
single channel analyzer, or a scaler with a low level discriminator.
l A second and alternate method consists of:
l l
a.
Establishing optimum instrument settings by means of a 1 pCi (37 kBq) Co-57 reference source and the constant geometry equipment described previously.
b.
Establishing an efficiency factor for Tc-99m by means of a 15 pCi (0.56 MBq) Tc-99m calibrated standard and the constant geometry equipment.
c.
Determining the activity of the eluted Tc-99m by multiplying the count rate of the eluted material by the efficiency factor obtained in (b) above.
The entire elution vial of Tc-99m is counted, using the constant geometry equipment.
On subsequent days following the initial calibration of the counting equipment, the Co-57 reference source is used to assure proper operation of the equipment.
On subsequent days following the initial calibration of the counting equipment, the Co-57 reference source is used to assure proper operation of the equipment.
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i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES 1 SAFETY, EVALUATION OF DEVICE l-NO.: NR-440-D-805-SL DATE!
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES 1 SAFETY, EVALUATION OF DEVICE l-NO.: NR-440-D-805-SL       DATE!   WMR'2 01998         PAGE 6 OF 9
WMR'2 01998 PAGE 6 OF 9 DEVICE TYPE
;    DEVICE TYPE     -Technetium-99m' Pertechnetate Generator l
-Technetium-99m' Pertechnetate Generator l
I-   DESCRIPTION (Cont'd):
I-DESCRIPTION (Cont'd):
The manufacturer specifically states that if the count rate
The manufacturer specifically states that if the count rate for the.Co-57 source cannot-be reproduced with a 95% or i
,          for the.Co-57 source cannot-be reproduced with a 95% or i         greater accuracy, the user should recalibrate the instrument l           (which may involve establishment of a new efficiency factor)
greater accuracy, the user should recalibrate the instrument l
!          using a new Tc-99m calibrated standard. This method-l         requires the use of a scintillation crystal and either a l         single or multi-channel analyzer.
(which may involve establishment of a new efficiency factor) using a new Tc-99m calibrated standard.
This method-l requires the use of a scintillation crystal and either a l
single or multi-channel analyzer.
Both methods of radioassay are adequate to measure the Tc-99m activity to a 90% or greater accuracy if proper care
Both methods of radioassay are adequate to measure the Tc-99m activity to a 90% or greater accuracy if proper care
          ;and equipment are employed.
;and equipment are employed.
: 5. Sterility and Pyrocenicity:
5.
The generator is a sealed, sterile system, autoclaved during     ,
Sterility and Pyrocenicity:
production. If an individual follows the manufacturer's       1 instructions, using routine aseptic techniques, the system L         can be expected to produce a sterile, pyrogen-free elute.
The generator is a sealed, sterile system, autoclaved during production.
Quality Control procedures include   sterility and-pyrogenicity tests on at least 10%   of the generators in each autoclave load, up to a maximum of   ten generators per load.
If an individual follows the manufacturer's 1
At least two generators.are tested   for autoclave loads less than twenty generators.
instructions, using routine aseptic techniques, the system L
can be expected to produce a sterile, pyrogen-free elute.
Quality Control procedures include sterility and-pyrogenicity tests on at least 10% of the generators in each autoclave load, up to a maximum of ten generators per load.
At least two generators.are tested for autoclave loads less than twenty generators.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-440-D-805-S       DATE:
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-440-D-805-S DATE:
MAR 2 01998     PAGE 7 OF 9 DEVICE TYPE:   Technetium-99m Pertechnetate Generator EXTERNAL RADIATION LEVELS:
MAR 2 01998 PAGE 7 OF 9 DEVICE TYPE:
Technetium-99m Pertechnetate Generator EXTERNAL RADIATION LEVELS:
The manufacturer submitted the following radiation profile data for a generator containing 143 mci (5.29 GBq) of Tc-99m.
The manufacturer submitted the following radiation profile data for a generator containing 143 mci (5.29 GBq) of Tc-99m.
DOSE         DISTANCE   WITH EXT. SHIELD     W/O EXT. SHIELD POSITION       in,   cm   mrem /hr   mSv/hr. mrem /hr mSv/hr Side             0     0   24         0.24     150       1.5 6   15   8         0.08     18       0.18 12   30   1         0 01       4       0.04 Top Port         0     0   60         0.60     500       5.0 6   15   10         0.10     150       1.5 12   30   4         0.04     25       0.25 Bottom Port     0     0   500         5.0     500       5.0 6   15   60         0.6       60       0.6 12   30   15         0.15     15       0.15 LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
DOSE DISTANCE WITH EXT. SHIELD W/O EXT.
SHIELD POSITION in, cm mrem /hr mSv/hr.
mrem /hr mSv/hr Side 0
0 24 0.24 150 1.5 6
15 8
0.08 18 0.18 12 30 1
0 01 4
0.04 Top Port 0
0 60 0.60 500 5.0 6
15 10 0.10 150 1.5 12 30 4
0.04 25 0.25 Bottom Port 0
0 500 5.0 500 5.0 6
15 60 0.6 60 0.6 12 30 15 0.15 15 0.15 LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
The devices may be used by persons specifically licensed by the NRC or an Agreement State.
The devices may be used by persons specifically licensed by the NRC or an Agreement State.
* Handling, storage, use, transfer and disposal are to be determined by the licensing authority.
Handling, storage, use, transfer and disposal are to be determined by the licensing authority.
* Leak test for this device is not required.
Leak test for this device is not required.
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l              REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE l
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE l
NO.: NR-440-D-805-S         DATE: MAR 2 01998       PAGE 8 OF 9 i
NO.: NR-440-D-805-S DATE:
DEVICE TYPE:     Technetium-99m Pertechnetate Generator LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE ( Cont ' d) . :.
MAR 2 01998 PAGE 8 OF 9 i
DEVICE TYPE:
Technetium-99m Pertechnetate Generator LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE ( Cont ' d). :.
This registration sheet and the information ceptained within the references shall not be changed without tiie written consent of the NRC.
This registration sheet and the information ceptained within the references shall not be changed without tiie written consent of the NRC.
SAFETY ANALYSIS  
SAFETY ANALYSIS  


==SUMMARY==
==SUMMARY==
The Model 5540, 5541, and 5542 devices are not current products manufactured by Mallinckrodt Medical Inc. Although there may be physical pieces of these generators in the field, there is no radioactivity left in the columns. The half life of Mo-99 is 2.75 days, and the half life of Tc-99m is 6.02 hours. Since September 1971 when the last generators were produced, enough half lives have elapsed to effectively eliminate any radioactivity originally present in the generator.
The Model 5540, 5541, and 5542 devices are not current products manufactured by Mallinckrodt Medical Inc.
Although there may be physical pieces of these generators in the field, there is no radioactivity left in the columns.
The half life of Mo-99 is 2.75 days, and the half life of Tc-99m is 6.02 hours.
Since September 1971 when the last generators were produced, enough half lives have elapsed to effectively eliminate any radioactivity originally present in the generator.
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==REFERENCES:==
==REFERENCES:==
 
The following supporting documents for the Models 5540, 5541, and l
;      The following supporting documents for the Models 5540, 5541, and l     5542 devices are hereby incorporated by reference and are made a part of this registry document.                                   ,
5542 devices are hereby incorporated by reference and are made a part of this registry document.
a  Mallinckrodt letter of September 24, 1992, requesting that this registry be made inactive.
Mallinckrodt letter of September 24, 1992, requesting that a
this registry be made inactive.
I
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e REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-440-D-805-S       DATE:   MAR 2 01998           PAGE 9 OF 9 DEVICE TYPE:   Technetium-99m Pertechnetate Generator REFERENCES (Cont'd)-
e REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-440-D-805-S DATE:
NRC Registry NR-440-D-101-U dated December 8,           1969, describing these devices.
MAR 2 01998 PAGE 9 OF 9 DEVICE TYPE:
Technetium-99m Pertechnetate Generator REFERENCES (Cont'd)-
NRC Registry NR-440-D-101-U dated December 8,
: 1969, describing these devices.
ISSUING AGENCY:
ISSUING AGENCY:
U.S. Nuclear Regulatory Commission                   /
U.S. Nuclear Regulatory Commission
                                                              /
/
                                                                    '/ _ -
/
Date:                           Reviewer:       /''                     _
'/ _ -
                                                    /Y ohn W.       Lubinski I         7 Date:                           Concurrence:                   #
Date:
Reviewer:
/''
/Y ohn W.
Lubinski I
7 Date:
Concurrence:
bteven L. Baggett l
bteven L. Baggett l
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==Dear Ms. James:==
==Dear Ms. James:==
 
]
                                                                                                                                                                  ]
This letter is in reference to your {{letter dated|date=September 24, 1992|text=letter dated September 24,1992}}, requesting to transfer the registration certificates NR-440-D-101-U, NR-440-D-103-U, NR-440-D-104-U, and MO-440-S.
This letter is in reference to your {{letter dated|date=September 24, 1992|text=letter dated September 24,1992}}, requesting to transfer the registration certificates NR-440-D-101-U, NR-440-D-103-U, NR-440-D-104-U, and MO-440-S.                                                       I 105-S to inactive status. These certificates have been transferred to inactive status as you have requested. The registration numbers for the certificates have been changed. The new registration numbers are NR-440-D-805-S, NR-440-D-806-S, NR-440-D-807-S, and MO-440-S-808-S, respectively,                                                                                                                         j i
I 105-S to inactive status. These certificates have been transferred to inactive status as you have requested. The registration numbers for the certificates have been changed. The new registration numbers are NR-440-D-805-S, NR-440-D-806-S, NR-440-D-807-S, and MO-440-S-808-S, respectively, j
Please review the registration certificates (copies enclosed) in their entirety and notify us immediately if there are any errors or omissions.
i Please review the registration certificates (copies enclosed) in their entirety and notify us immediately if there are any errors or omissions.
If you have any questions call me at (301) 415-5787 or Mr. Steven Baggett at (301) 415-7273.
If you have any questions call me at (301) 415-5787 or Mr. Steven Baggett at (301) 415-7273.
i Sincerely,                                                     i l$
i Sincerely, l$
1 Seung J. Lee, Mechanical Engineer                             i Medical Safety Branch Division of Industrial and Medical Nuclear Safety, NMSS
Seung J. Lee, Mechanical Engineer i
Medical Safety Branch Division of Industrial and Medical Nuclear Safety, NMSS


==Enclosure:==
==Enclosure:==
As stated                                                                                                                           l cc w/ encl: SKimberley, LFDCB Distribution:                                                                                                                             /)
As stated cc w/ encl: SKimberley, LFDCB
SSSS Staff                         IMSB r/f                         SSD-98-06                         NE01 SSD File # NR-440-D-805-S, NR-440-D-806-S, NR-440-D-807-S, NR-440-D-808-S DOCUMENT NAME: H:\SSDFILES\ LETTERS \MALLINC. CMP T r receive a cop't of this document, Indicate in the box: "C" = Copy without attachment / enclosure "E" = Copf with attachment / enclosure "N" = No copy OFFICE           IMSB                         lE IMSB (/                     l NAME             Slee         Uf                   SBaggett DATE             03/16/98                           03//i198
/)
;                                                                          OFFICIAL RECORD COPY
Distribution:
                                  >30033                                                                                                                     .
SSSS Staff IMSB r/f SSD-98-06 NE01 SSD File # NR-440-D-805-S, NR-440-D-806-S, NR-440-D-807-S, NR-440-D-808-S DOCUMENT NAME: H:\\SSDFILES\\ LETTERS \\MALLINC. CMP T r receive a cop't of this document, Indicate in the box: "C" = Copy without attachment / enclosure "E" = Copf with attachment / enclosure "N" = No copy OFFICE IMSB lE IMSB (/
9gotcy;oc 1.                  9}}
l NAME Slee Uf SBaggett DATE 03/16/98 03//i198 OFFICIAL RECORD COPY
>30033 1.
9gotcy;oc 9}}

Latest revision as of 06:03, 4 December 2024

Registry of Radioactive Sealed Sources & Devices,Safety Evaluation of Device for Models 5540,5541 & 5542. Certificate:NR-440-D-805-S
ML20212H281
Person / Time
Issue date: 03/20/1998
From: Steven Baggett, John Lubinski
NRC
To:
References
SSD, NUDOCS 9804060347
Download: ML20212H281 (9)
v • d • e


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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES r

-SAFETY EVALUATION OF DEVICE t

NO.: NR-440-D-805-S DATE:

MAR 2 01998 PAGE 1 OF 9 DEVICE TYPE:

Technetium-99m Pertechnetate Generator MODEL:

5540, 5541, 5542 DISTRIBUTOR / MANUFACTURER:

Mallinckrodt Medical, Inc.

2703 Wagner Place Maryland Height, MO 63043

- SEAT.Rn SOURCE MODEL DESIGNATION:

Not Applicable ISOTOPE:

MAXIMUM ACTIVITY:

Molybdenum-99 135 mci (5.0 GBq) in Model 5540 Molybdenum-99 270 mci (10 GBq) in Model 5541

- Molybdenum-99 540 mci (20 GBq) in Model 5542 t

T.RAK TEST FREOUENCY:

Not Required PRINCIPAL USE:

(V) General Medical Use CUSTOM DEVICE:

YES X

NO I

9804060347 980320 PDR RC SSD PDit m

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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-440-D-805-S DATE:

MAR 2 01998 PAGE 2 OF 9 DEVICE TYPEr Technetium-99m Pertechnetate Generator DESCRIPTION:

The Mo-99 is absorbed on alumina which is packed in a glass column over a glass frit filter.

The column is approximately 3.5" (8.89 cm) long and 1" (2.54 cm) in diameter.

The ends of the column are sealed with pierceable rubber septa.

The glass

column is encased in a lead shield and a metal can.

The can is 3 625" (9.21 cm) in diameter and 5.7" (4.48 cm) long.

Two metal screw caps and two threaded lead plugs provide access to the rubber septa.

i The initial generator shipment includes a lead shielding base, an external lead shield, two slotted lead plugs (all described below), and a suspension hook.

These items are retained for use with subsequently delivered generators.

Each generator shipment includes the' following accessories: a 15.3 in5 (250 cc) sodium chloride reservoir sealed with a rubber septum; a plastic reservoir tube which.has, at one end, a plastic spike, a drip chamber, and a breather tube containing a bacterial filter and, at the other end, a 10-gauge needle; a plastic elution tube with an 18-gauge needle at one end and a luer connector at the other end; 12 needles with luer connectors; two clamps; 12 evacuated elute receiving bottles sealed with rubber septa; and a lead cup, with a lead cover, to hold the elute receiving bottles.

The cylindrical lead shield in the metal can containing the generator column is 1-1/8" (2.86 cm) thick.

The cylindrical lead

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shielding base on which the can is placed has 0.2" (0.51 cm)

L walls and a 1/2" (1.27 cm) thick base.

The plug for the top of j

'the column is 5/8" (1.59 cm) thick lead with a slot for the elution tubing.

Over the can, and resting on the lead base, is i

placed an external cylindrical lead shield 3/4" (1.91 cm) thick I

on the side and 1" (2.54 cm) thick on top.

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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES f

SAFETY EVALUATION OF DEVICE i

l NO.: NR-440-D-805-S DATE:

NAR 2 01998 PAGE 3 OF 9 l

DEVICE TYPS1 Technetium-99m Pertechnetate Generator DESCRIPTION (Cont'd):

This shield has a bail handle and a 2-7/8" (7.30 cm) diameter plug in the center of the shield with a slot for the elution tubing.

i The generator are shipped five days before the calibration date.

The licensee may receive the generators four days before calibration, thus receiving an amount of activity as given below.

The manufacturer has submitted information sufficient to ensure that, provided the recommended e3ution and assay procedures are followed, the eluted Tc-99m pertechnetate can be expected to meet the Commission's criteria, 1.

Mo-99 Contamination:

The manufacturer recommends two methods.

The first method is a chemical test using potassium ethyl xanthate and hydrochloric acid.

The chemicals are not routinely supplied by the manufacturer.

A negative result indicates that there is less than 0.2 pCi (7.4 kBq) of Mo-99 per mci of Tc-99m.

If the chemical test is positive, the user is instructed to check the elute radiometrically to determine if the Mo-99 contamination exceeds the Commission's specifications.

The manufacturer does not test any generators during production for Mo-99 breakthrough.

The second and alternate method is a radiometric test using a Cs-137 calibrated standard, a two-piece lucite stand, a j

lead shield, and two 0.025" (0.0635 cm) lead absorbers.

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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-440-D-805-S DATE:

MMi 2 01998 PAGE 4 OF 9 DEVICE TYPE:

Technetium-99m Pertechnetate Generator DESCRIPTION (Cont'd):

The calibrated standard is a solution of approximately 15 pCi (0.56 MBq) of Cs-137 in a 1.8 in) (30 ml) volume in an elution vial.

The manufacturer hac submitted information which substantiates their use of a calculated conversion factor of 5.1 for the ratio of the pCi of Mo-99 to pCi of Cs-137.

The Cs-137 standard is supplied at the request of the licensee.

The lucite stand (designed for obtaining constant geometry), lead shield and filter discs, and an instrument check source (approximately 1 yCi [37 kBq) of Co-57 and less than 1 pCi [37 MBq] of Cs-137) are supplied on a one-time basis.

The procedure is adequate to detect 0.5 pCi (18.5 kBq) of Mo-99 per mci of Tc-99m.

The procedure may be performed with either a well-type scintillation detector or a scintillation probe.

2.

Ruthenium-103. Tellurium. and Iodine-131 contamination:

The Mo-99 is obtained by irradiation of stable Mo rather than by separation of fission products, so these contaminants will not be present.

3.

Aluminum Breakthrough:

The manufacturer's specifications indicate that aluminum contamination will not exceed 0.018 oz (0.5 mg) of elemental aluminum per 10 mci (0.37 GBq) of eluted Tc-99m.

For each production run, at least one generator is eluted on Monday and Friday, and the aluminum contamination in the elute is determined.

The package insert includes a chemical test for

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aluminum.

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I i-REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l

SAFETY EVALUATION OF DEVIC 8 L

NO.: NR-440-D-805-S DATE:

WAR 2 01998 PAGE 5 OF 9 l

DEVICE TYPE:

Technetium-99m Pertechnetate Generator DESCRIPTION (Cont'd):

l 4.

Radioassay:

The package insert includes two radioassay procedures.

One method involves dilution of a small sample of the eluted Tc-99m and comparison with a Co-57 calibrated standard, 98%

accurate.

The procedure requires use of a well-type scintillation counter with a multi-channel analyzer, a

single channel analyzer, or a scaler with a low level discriminator.

l A second and alternate method consists of:

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a.

Establishing optimum instrument settings by means of a 1 pCi (37 kBq) Co-57 reference source and the constant geometry equipment described previously.

b.

Establishing an efficiency factor for Tc-99m by means of a 15 pCi (0.56 MBq) Tc-99m calibrated standard and the constant geometry equipment.

c.

Determining the activity of the eluted Tc-99m by multiplying the count rate of the eluted material by the efficiency factor obtained in (b) above.

The entire elution vial of Tc-99m is counted, using the constant geometry equipment.

On subsequent days following the initial calibration of the counting equipment, the Co-57 reference source is used to assure proper operation of the equipment.

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i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES 1 SAFETY, EVALUATION OF DEVICE l-NO.: NR-440-D-805-SL DATE!

WMR'2 01998 PAGE 6 OF 9 DEVICE TYPE

-Technetium-99m' Pertechnetate Generator l

I-DESCRIPTION (Cont'd):

The manufacturer specifically states that if the count rate for the.Co-57 source cannot-be reproduced with a 95% or i

greater accuracy, the user should recalibrate the instrument l

(which may involve establishment of a new efficiency factor) using a new Tc-99m calibrated standard.

This method-l requires the use of a scintillation crystal and either a l

single or multi-channel analyzer.

Both methods of radioassay are adequate to measure the Tc-99m activity to a 90% or greater accuracy if proper care

and equipment are employed.

5.

Sterility and Pyrocenicity:

The generator is a sealed, sterile system, autoclaved during production.

If an individual follows the manufacturer's 1

instructions, using routine aseptic techniques, the system L

can be expected to produce a sterile, pyrogen-free elute.

Quality Control procedures include sterility and-pyrogenicity tests on at least 10% of the generators in each autoclave load, up to a maximum of ten generators per load.

At least two generators.are tested for autoclave loads less than twenty generators.

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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-440-D-805-S DATE:

MAR 2 01998 PAGE 7 OF 9 DEVICE TYPE:

Technetium-99m Pertechnetate Generator EXTERNAL RADIATION LEVELS:

The manufacturer submitted the following radiation profile data for a generator containing 143 mci (5.29 GBq) of Tc-99m.

DOSE DISTANCE WITH EXT. SHIELD W/O EXT.

SHIELD POSITION in, cm mrem /hr mSv/hr.

mrem /hr mSv/hr Side 0

0 24 0.24 150 1.5 6

15 8

0.08 18 0.18 12 30 1

0 01 4

0.04 Top Port 0

0 60 0.60 500 5.0 6

15 10 0.10 150 1.5 12 30 4

0.04 25 0.25 Bottom Port 0

0 500 5.0 500 5.0 6

15 60 0.6 60 0.6 12 30 15 0.15 15 0.15 LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:

The devices may be used by persons specifically licensed by the NRC or an Agreement State.

Handling, storage, use, transfer and disposal are to be determined by the licensing authority.

Leak test for this device is not required.

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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE l

NO.: NR-440-D-805-S DATE:

MAR 2 01998 PAGE 8 OF 9 i

DEVICE TYPE:

Technetium-99m Pertechnetate Generator LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE ( Cont ' d). :.

This registration sheet and the information ceptained within the references shall not be changed without tiie written consent of the NRC.

SAFETY ANALYSIS

SUMMARY

The Model 5540, 5541, and 5542 devices are not current products manufactured by Mallinckrodt Medical Inc.

Although there may be physical pieces of these generators in the field, there is no radioactivity left in the columns.

The half life of Mo-99 is 2.75 days, and the half life of Tc-99m is 6.02 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br />.

Since September 1971 when the last generators were produced, enough half lives have elapsed to effectively eliminate any radioactivity originally present in the generator.

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REFERENCES:

The following supporting documents for the Models 5540, 5541, and l

5542 devices are hereby incorporated by reference and are made a part of this registry document.

Mallinckrodt letter of September 24, 1992, requesting that a

this registry be made inactive.

I

e REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-440-D-805-S DATE:

MAR 2 01998 PAGE 9 OF 9 DEVICE TYPE:

Technetium-99m Pertechnetate Generator REFERENCES (Cont'd)-

NRC Registry NR-440-D-101-U dated December 8,

1969, describing these devices.

ISSUING AGENCY:

U.S. Nuclear Regulatory Commission

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Date:

Reviewer:

/

/Y ohn W.

Lubinski I

7 Date:

Concurrence:

bteven L. Baggett l

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March 20, 1998 Maillinckrodt Medical, Inc.

ATTN: Kathryn A. James 2703 Wagner Place Maryland Heights, MO 63043

Dear Ms. James:

]

This letter is in reference to your letter dated September 24,1992, requesting to transfer the registration certificates NR-440-D-101-U, NR-440-D-103-U, NR-440-D-104-U, and MO-440-S.

I 105-S to inactive status. These certificates have been transferred to inactive status as you have requested. The registration numbers for the certificates have been changed. The new registration numbers are NR-440-D-805-S, NR-440-D-806-S, NR-440-D-807-S, and MO-440-S-808-S, respectively, j

i Please review the registration certificates (copies enclosed) in their entirety and notify us immediately if there are any errors or omissions.

If you have any questions call me at (301) 415-5787 or Mr. Steven Baggett at (301) 415-7273.

i Sincerely, l$

Seung J. Lee, Mechanical Engineer i

Medical Safety Branch Division of Industrial and Medical Nuclear Safety, NMSS

Enclosure:

As stated cc w/ encl: SKimberley, LFDCB

/)

Distribution:

SSSS Staff IMSB r/f SSD-98-06 NE01 SSD File # NR-440-D-805-S, NR-440-D-806-S, NR-440-D-807-S, NR-440-D-808-S DOCUMENT NAME: H:\\SSDFILES\\ LETTERS \\MALLINC. CMP T r receive a cop't of this document, Indicate in the box: "C" = Copy without attachment / enclosure "E" = Copf with attachment / enclosure "N" = No copy OFFICE IMSB lE IMSB (/

l NAME Slee Uf SBaggett DATE 03/16/98 03//i198 OFFICIAL RECORD COPY

>30033 1.

9gotcy;oc 9

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