Eclipse hp

¹⁸F-GE-180 was produced in a GMP-compliant synthesis using a single use disposable cassette (FASTlab PET GE-180 cassette, GE Healthcare, UK) on an automated synthesizer system (FASTlab™, GE Healthcare, UK) and the corresponding S-enatiomeric pure mesylate precursor (3.5 mg, GMP grade) [39 (link)]. [¹⁸F]fluoride was obtained from a 11-MeV cyclotron (Eclipse HP, Siemens, Knoxville, USA) using the ¹⁸O(p,n)¹⁸F nuclear reaction on enriched (97–98%) [¹⁸O]water, and directly transferred to the radiosynthesizer. After 45 min automated synthesis, the product ¹⁸F-GE-180 was obtained as the pure S-enatiomer (S)-N,N-diethyl-9-(2-[¹⁸F]fluoroethyl)-5-methoxy-2,3,4,9-tetrahydro-1H-carbazole-4-carboxamide [40 (link)] in a sterile buffer solution (35–37 ml). The radiochemical yield was 42% ± 5% with radiochemical purity of ≥ 97% and specific activity of 517 ± 54 GBq/μmol. Quality control tests were performed according to GMP and the EU pharmacopoeia. All batches met the required acceptance criteria and were released for human administration.

[¹⁸F]fluoride was produced via the ¹⁸O (p, n) ¹⁸F nuclear reaction by a 11 MeV cyclotron (Eclipse HP, Siemens, USA). A tantalum target containing 2.6 mL O-18 enriched water was irradiated with a proton beam (Target current: 50 μA). At the end of bombardment, [¹⁸F]fluoride was delivered into a V-vial in CFN-MPS200 Module (Sumitomo Heavy Industries, Ltd., Tokyo, Japan), and then trapped on a QMA exchange solid phase extraction (SPE) cartridge (Waters Corporation, USA), which was pre-activated by 1 mL of 7.4% NaHCO₃ (aq.) and 10 mL of sterile water.

[¹⁸F]fluoride is produced using a Siemens Eclipse HP (11 MeV, 2 x 80 µA) cyclotron using 2-3 mL ¹⁸O-enriched water (>98%) contained in a tantalum target with a 50 µm thick Havar window. Typically, irradiation is performed with 60 µA 11 MeV protons for 20 min, yielding 30-40 GBq of [¹⁸F]fluoride at the end of bombardment (EOB). Transport of [¹⁸F]fluoride in [¹⁸O]H₂O from the cyclotron target to the designated hot cell, through 35-40 m long 1/16” OD PTFE tubing from Bohlender GmbH (Grüsfeld, Germany), is effectuated using argon and helium gas (Argon Scientific 6.0, Helium Scientific 6.0, both from Linde Gas, Schiedam, Netherlands) in a two-stage delivery system. To ensure high A_m and RCYs, transfer lines towards the designated hot cell are rinsed with ¹⁸O-enriched water using an in-house rinsing system on the day of the production (preferably shortly before irradiation).