Radiopharmaceutical Production FDG Production Problems Troubleshooting STOP
Table of Contents • No Fluorine-18 transferred to synthesizer • Partial transfer of F-18 • Fluorine-18 not released from the resin column • No trapping of tetraacetate on C-18 column • Final product not delivered into vial • Product purity is low due to unhydrolyzedtetraacetate • Mechanical problems • Software problems • Human errors • Sterile filtration failure and recovery • Pyrogen test failure • Ionization chamber failure STOP
No FDG Delivery STOP
No FDG Delivery STOP
Sterile Filtration Failure Syringe Filter Integrity Test • Conduct the integrity test for the filter used to filter the final product into the MIV. If the test fails, indicating that filter is not intact at the time of testing, the product can be re-filtered into a new set sterile MIV, and delivered to the PET. Additional Sterile MIV • If there is another identical sterile setup available from a later run, this may be used after changing the label to indicate the correct delivery number. • Otherwise, a new sterile setup must be prepared using the standard sterile setup technique. The product must be drawn up from the original MIV using a sterile needle and syringe, and filtered as usual into the new MIV. • The new filter must be integrity tested before delivery can be made.
Pyrogen test failure Positive Pyrogen Tests • If the sample showed positive results for pyrogen on the 20 minute PTS test at maximum allowable dilution, this is a serious matter and NO deliveries can be made for humans until the problem is resolved. • If a radiotracer has failed to pass the two consecutive tests, then a sample must be sent to AppTec (Commercial Testing Company) for pyrogen testing. Responsible Physician Notification • In all cases, the responsible physician should be informed, so appropriate notations can be made in the subject’s file.
Capintec Failure High Background • If background activity exceeds normal background limits, then check for radioactivity in the hood and remove or shield appropriately. Re-check background. Contaminated Capintec • If no radioactivity is found in the area then check for contamination of the chamber liners and/or dipper. Replace if contaminated and re-check background. Capintec Problems • If normal background cannot be established with either procedure above then the chamber must be re-calibrated, repaired or replaced. Noisy response • A noisy response is defined as abnormal fluctuations in displayed numbers with or without radioactivity. Check that the proper isotope selection button is depressed. Depress the button then release and repeat several times to confirm position. Check cable connections from chamber to display. Repeat daily check if noise is eliminated to assure proper operation.
Capintec Failure • No Capintec response • If no numbers are displayed then check power connections, circuit breaker and main power switch on display unit. A circuit breaker may be reset only one time to restore power. If numbers appear, but do not change after a known change in radiation levels, then confirm radioactivity levels with another device (e.g. frisker) and re-check cables and isotope selection button. • Malfunction during Synthesis • Most often the problems above will be detected during the daily performance check when there is time to carry out corrective actions and re-check instrument performance. If there is a malfunction during synthesis and the corrective actions listed above are not possible then: • Alternate Ion Chamber- If the final product assay chamber malfunctions then the radioactivity of the product may be measured in another calibrated chamber in the laboratory. Confirm that the chamber has been properly calibrated before use and document in the batch record.
Summary There are several problems which can occur during the production and delivery of the fluoride There are other problems that may occur during the production Some of these problems can be anticipated and corrective actions taken if the corrective actions are planned and documented in advance.