Security Mechanisms for Radiopharmaceutical Elution System and Elution Process

An 82Sr/8Rb elution system comprising a radioisotope generator containing a parent radioisotope that decays into a daughter radioisotope, a patient line for infusing a patient with a daughter radioisotope eluate generated by the generator, a pump for pumping an eluant from an eluant reservoir into the generator, a controller, and a user interface, a dose calibrator, wherein the system has at least mechanism for identifying whether the eluant is a saline solution or not, said mechanism comprises:

• a liquid parameter detector, wherein the liquid parameter detector is adapted to detect in the eluant at least one of the following parameters:
• i. pH,
• ii. quantity of divalent ions or trivalent ions,
• iii. piezoelectricity,
• iv. light absorbance detected by atomic absorption spectroscopy, based on absorption of light of free metallic ions,
• v. photoelectricity detected by flame photometry, atomic emission detected by atomic emission spectroscopy (AES),
• vi. optical emission detected by inductively coupled plasma atomic emission spectroscopy (ICP-AES) also referred to as inductively coupled plasma optical emission spectrometry (ICP-OES),
• vii. atomic mass detected by inductively coupled plasma mass spectrometry (ICP-MS),
• viii. EDTA complexing ability,
• ix. fluorescence detected by X-ray fluorescence (XRF), and
• x. element content detected by a particle-induced X-Ray Emission (PIXE), wherein the dose calibrator detects the parent radioisotope content in a sample of eluate and a controller for controlling the pump, wherein:
• the controller is configured for automatically performing a daily quality control test at a pre-determined time of the day that was configured by a user, and
• the daily quality control test comprises the detection of a parent radioisotope content in said sample of the radioisotope eluate.

An 82Sr/82Rb elution system comprising a radioisotope generator containing a parent radioisotope that decays into a daughter radioisotope, a patient line for infusing a patient with a daughter radioisotope eluate generated by the generator, a pump for pumping an eluant from an eluant reservoir into the generator, a controller, a user interface, and a dose calibrator, wherein the system has at least mechanism for identifying whether the eluant is a saline solution or not, said mechanism comprises:

• a liquid parameter detector, wherein the liquid parameter detector is adapted to detect in the eluant or the eluate at least one of the following parameters:
• i. pH,
• ii. quantity of divalent ions or trivalent ions,
• iii. piezoelectricity,
• iv. light absorbance detected by atomic absorption spectroscopy, based on absorption of light of free metallic ions,
• v. photoelectricity detected by flame photometry, atomic emission detected by atomic emission spectroscopy (AES),
• vi. optical emission detected by inductively coupled plasma atomic emission spectroscopy (ICP-AES) also referred to as inductively coupled plasma optical emission spectrometry (ICP-OES),
• vii. atomic mass detected by inductively coupled plasma mass spectrometry (ICP-MS),
• viii. EDTA complexing ability,
• ix. fluorescence detected by X-ray fluorescence (XRF), and
• x. element content detected by a particle-induced X-Ray Emission (PIXE),
• wherein the dose calibrator detects the parent radioisotope content in a sample of eluate and a controller for controlling the pump, wherein:
• the controller is configured for automatically performing a daily quality control test at a pre-determined time of the day that was configured by a user, and
• the daily quality control test comprises the detection of a parent radioisotope content in said sample of the radioisotope eluate, and
• wherein said pre-determined time of the day is outside the user working hours.

An 82Sr/82Rb elution system comprising a radioisotope generator containing a parent radioisotope that decays into a daughter radioisotope, a patient line for infusing a patient with a daughter radioisotope eluate generated by the generator, a pump for pumping an eluant from an eluant reservoir into the generator, a controller, a user interface, and a dose calibrator, wherein the system has at least mechanism for identifying whether the eluant is a saline solution or not, said mechanism comprises:

• a liquid parameter detector, wherein the liquid parameter detector is adapted to detect in the eluant or the eluate at least one of the following parameters:
• i. pH,
• ii. quantity of divalent ions or trivalent ions,
• iii. piezoelectricity,
• iv. light absorbance detected by atomic absorption spectroscopy, based on absorption of light of free metallic ions,
• v. photoelectricity detected by flame photometry, atomic emission detected by atomic emission spectroscopy (AES),
• vi. optical emission detected by inductively coupled plasma atomic emission spectroscopy (ICP-AES) also referred to as inductively coupled plasma optical emission spectrometry (ICP-OES),
• vii. atomic mass detected by inductively coupled plasma mass spectrometry (ICP-MS),
• viii. EDTA complexing ability,
• ix. fluorescence detected by X-ray fluorescence (XRF), and
• x. element content detected by a particle-induced X-Ray Emission (PIXE),
• wherein the dose calibrator detects the parent radioisotope content in a sample of eluate and a controller for controlling the pump, wherein:
• the controller is configured for automatically performing a daily quality control test at a pre-determined time of the day that was configured by a user, and
• the daily quality control test comprises the detection of a parent radioisotope content in said sample of the radioisotope eluate, and
• wherein said pre-determined time of the day is outside the user working hours, and wherein the system is stopped after a quality control test, or when the controller stops the pump upon detecting an error in the system.