ENS Event | |
|---|---|
22:00 Mar 29, 2024 | |
| Title | Unplanned Contamination Event |
| Event Description | 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 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> while room decontamination efforts were in progress. |
| Where | |
|---|---|
| Novartis Manufacturing Llc Indianapolis, Indiana (NRC Region 3) | |
| License number: | 13-35658-01 |
| Organization: | Novartis Pharmaceutical Corp |
| Reporting | |
| 10 CFR 30.50(b)(1) | |
| Time - Person (Reporting Time:+8970.58 h373.774 days <br />53.396 weeks <br />12.288 months <br />) | |
| Opened: | C.J. Eastman 16:35 Apr 7, 2025 |
| NRC Officer: | Josue Ramirez |
| Last Updated: | Apr 7, 2025 |
| 57651 - NRC Website | |
Novartis Manufacturing Llc with 10 CFR 30.50(b)(1) | |
WEEKMONTHYEARENS 576512024-03-29T22:00:00029 March 2024 22:00:00
[Table view]10 CFR 30.50(b)(1) Unplanned Contamination Event 2024-03-29T22:00:00 | |