Event Notification Report for March 29, 2024
U.S. Nuclear Regulatory Commission
Operations Center
EVENT REPORTS FOR
03/28/2024 - 03/29/2024
EVENT NUMBERS
57651
57651
Non-Agreement State
Event Number: 57651
Rep Org: Novartis Pharmaceutical Corp
Licensee: Novartis Manufacturing LLC
Region: 3
City: Indianapolis State: IN
County:
License #: 13-35658-01
Agreement: N
Docket:
NRC Notified By: C.J. Eastman
HQ OPS Officer: Josue Ramirez
Licensee: Novartis Manufacturing LLC
Region: 3
City: Indianapolis State: IN
County:
License #: 13-35658-01
Agreement: N
Docket:
NRC Notified By: C.J. Eastman
HQ OPS Officer: Josue Ramirez
Notification Date: 04/07/2025
Notification Time: 16:35 [ET]
Event Date: 03/29/2024
Event Time: 18:00 [EDT]
Last Update Date: 04/07/2025
Notification Time: 16:35 [ET]
Event Date: 03/29/2024
Event Time: 18:00 [EDT]
Last Update Date: 04/07/2025
Emergency Class: Non Emergency
10 CFR Section:
30.50(b)(1) - Unplanned Contamination
10 CFR Section:
30.50(b)(1) - Unplanned Contamination
Person (Organization):
Hills, David (R3DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
Hills, David (R3DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
UNPLANNED CONTAMINATION EVENT
The following is a summary of the information provided by the licensee via phone and email:
During an ongoing inspection, the licensee determined that the following event had not been previously reported.
On March 29, 2024, at approximately 1800 EDT, a rejected batch of individual lead pots containing glass vials of Pluvicto (Lu-177) solution was being logged into the waste room. Each dose of Pluvicto was 5ml with an activity between 7 to 12 GBq.
An individual handling the lead pots accidentally lifted a lead pot by the lid instead of the bottom. The lead pot was taped shut but the tape failed, and the vial was dropped, breaking on the floor of the waste room. The individual's clothes were contaminated but no skin contamination occurred. Based on dosimetry records the individual has a current lifetime exposure of 1 mrem of deep-dose equivalent, 2 mrem of lens dose equivalent, 2 mrem of shallow-dose equivalent, and 11 mrem to the extremity.
The spread of contamination was limited to the radioactive waste room and the individual's clothing. The radiation safety officer secured access to the radioactive waste room for approximately 48 hours while room decontamination efforts were in progress.
The following is a summary of the information provided by the licensee via phone and email:
During an ongoing inspection, the licensee determined that the following event had not been previously reported.
On March 29, 2024, at approximately 1800 EDT, a rejected batch of individual lead pots containing glass vials of Pluvicto (Lu-177) solution was being logged into the waste room. Each dose of Pluvicto was 5ml with an activity between 7 to 12 GBq.
An individual handling the lead pots accidentally lifted a lead pot by the lid instead of the bottom. The lead pot was taped shut but the tape failed, and the vial was dropped, breaking on the floor of the waste room. The individual's clothes were contaminated but no skin contamination occurred. Based on dosimetry records the individual has a current lifetime exposure of 1 mrem of deep-dose equivalent, 2 mrem of lens dose equivalent, 2 mrem of shallow-dose equivalent, and 11 mrem to the extremity.
The spread of contamination was limited to the radioactive waste room and the individual's clothing. The radiation safety officer secured access to the radioactive waste room for approximately 48 hours while room decontamination efforts were in progress.