Investigation of Staff Finger Doses During Quality Control of FDG Production

Ferguson, Dorota; McGrath, Sonia; O'Hara, Gary; Marshall, Christopher

doi:10.1097/hp.0b013e3181f1e9b5

Cited by 3 publications

(3 citation statements)

References 16 publications

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“…Conventional QC tests require an array of expensive analytical instrumentation, all of which requires space, maintenance, training, calibration, and documentation, making such testing a time-consuming, expensive procedure 49 , 62 . Furthermore, some of the tests require manual handling of the radioactive batches resulting in high radiation exposure to the operator 63 and higher margin for human error or subjective interpretation. Moreover, pairing a compact microfluidic reactor system with a large analytical laboratory facility undermines the economic and practical advantages offered by microfluidic technology.…”

Section: Discussionmentioning

confidence: 99%

Economical droplet-based microfluidic production of [18F]FET and [18F]Florbetaben suitable for human use

Lisova

Wang

Hajagos

et al. 2021

Sci Rep

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Current equipment and methods for preparation of radiopharmaceuticals for positron emission tomography (PET) are expensive and best suited for large-scale multi-doses batches. Microfluidic radiosynthesizers have been shown to provide an economic approach to synthesize these compounds in smaller quantities, but can also be scaled to clinically-relevant levels. Batch microfluidic approaches, in particular, offer significant reduction in system size and reagent consumption. Here we show a simple and rapid technique to concentrate the radioisotope, prior to synthesis in a droplet-based radiosynthesizer, enabling production of clinically-relevant batches of [18F]FET and [18F]FBB. The synthesis was carried out with an automated synthesizer platform based on a disposable Teflon-silicon surface-tension trap chip. Up to 0.1 mL (4 GBq) of radioactivity was used per synthesis by drying cyclotron-produced aqueous [18F]fluoride in small increments directly inside the reaction site. Precursor solution (10 µL) was added to the dried [18F]fluoride, the reaction chip was heated for 5 min to perform radiofluorination, and then a deprotection step was performed with addition of acid solution and heating. The product was recovered in 80 µL volume and transferred to analytical HPLC for purification. Purified product was formulated via evaporation and resuspension or a micro-SPE formulation system. Quality control testing was performed on 3 sequential batches of each tracer. The method afforded production of up to 0.8 GBq of [18F]FET and [18F]FBB. Each production was completed within an hour. All batches passed quality control testing, confirming suitability for human use. In summary, we present a simple and efficient synthesis of clinically-relevant batches of [18F]FET and [18F]FBB using a microfluidic radiosynthesizer. This work demonstrates that the droplet-based micro-radiosynthesizer has a potential for batch-on-demand synthesis of 18F-labeled radiopharmaceuticals for human use.

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Section: Discussionmentioning

confidence: 99%

Economical droplet-based microfluidic production of [18F]FET and [18F]Florbetaben suitable for human use

Lisova

Wang

Hajagos

et al. 2021

Sci Rep

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show abstract

“…If the bubble point exceeds a threshold pressure, then it can be assured that the membrane is intact and pores do not exceed the specified size. A drawback of this test is that the operator has to manually handle the filter membrane and it has been reported that this test results in the largest radiation dose to QC personnel [ 18 ].…”

Section: Miniaturization Of Quality Control Testsmentioning

confidence: 99%

“…In addition, for most tests, manual handling, loading, and/or visual assessment of samples leads to significant radiation exposure to personnel and operator-induced variability in the results. In particular Ferguson et al found that QC personnel received significant radiation exposure, especially due to performing sterility (filter integrity), pH, and chemical/radiochemical purity and identity testing [ 18 ]. Furthermore, in contrast to ordinary pharmaceuticals, each batch of short-lived PET radiopharmaceuticals has to be manufactured and tested within a short period of time to prevent significant losses due to radioactive decay [ 17 ].…”

Section: Introductionmentioning

confidence: 99%

Recent Progress toward Microfluidic Quality Control Testing of Radiopharmaceuticals

Sadeghi

Dam

2017

Micromachines

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Radiopharmaceuticals labeled with short-lived positron-emitting or gamma-emitting isotopes are injected into patients just prior to performing positron emission tomography (PET) or single photon emission tomography (SPECT) scans, respectively. These imaging modalities are widely used in clinical care, as well as in the development and evaluation of new therapies in clinical research. Prior to injection, these radiopharmaceuticals (tracers) must undergo quality control (QC) testing to ensure product purity, identity, and safety for human use. Quality tests can be broadly categorized as (i) pharmaceutical tests, needed to ensure molecular identity, physiological compatibility and that no microbiological, pyrogenic, chemical, or particulate contamination is present in the final preparation; and (ii) radioactive tests, needed to ensure proper dosing and that there are no radiochemical and radionuclidic impurities that could interfere with the biodistribution or imaging. Performing the required QC tests is cumbersome and time-consuming, and requires an array of expensive analytical chemistry equipment and significant dedicated lab space. Calibrations, day of use tests, and documentation create an additional burden. Furthermore, in contrast to ordinary pharmaceuticals, each batch of short-lived radiopharmaceuticals must be manufactured and tested within a short period of time to avoid significant losses due to radioactive decay. To meet these challenges, several efforts are underway to develop integrated QC testing instruments that automatically perform and document all of the required tests. More recently, microfluidic quality control systems have been gaining increasing attention due to vastly reduced sample and reagent consumption, shorter analysis times, higher detection sensitivity, increased multiplexing, and reduced instrumentation size. In this review, we describe each of the required QC tests and conventional testing methods, followed by a discussion of efforts to directly miniaturize the test or examples in the literature that could be implemented for miniaturized QC testing.

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Automation of PET Radiopharmaceutical Quality Control

Elizarov

2020

Handbook of Radiopharmaceuticals

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Investigation of Staff Finger Doses During Quality Control of FDG Production

Cited by 3 publications

References 16 publications

Economical droplet-based microfluidic production of [18F]FET and [18F]Florbetaben suitable for human use

Economical droplet-based microfluidic production of [18F]FET and [18F]Florbetaben suitable for human use

Recent Progress toward Microfluidic Quality Control Testing of Radiopharmaceuticals

Automation of PET Radiopharmaceutical Quality Control

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