This 3rd production line for injectable medicines, which has been operational for a few weeks now, will enable Arronax’s In-House Hospital Radiopharmacy to take part in new clinical trials with its industrial partners.
Arronax’s new clean room, named GMPS3 and located in the restricted area of Arronax, meets all the criteria of good practice required for the manufacture of injectable radiopharmaceuticals for clinical trials. It is equipped with a class B preparation hot cell for cold preparation operations, a class A hot cell adapted for the synthesis and distribution of radiopharmaceuticals and a class C hot cell dedicated to automated preparations. “We designed this area with a view to starting a new clinical trial with one of our industrial partners,” explains Aurélien Vidal, radiochemical engineer at the In-House Hospital Radiopharmacy. However, the line can be used for any clinical trial. Dose calibrators, automatic synthesis and distribution systems, particle counters and appropriate environmental monitoring equipment complete the facility. “Access to this work area is only possible with special clothing and footwear, to guarantee and maintain the cleanliness of the site, and only by qualified staff,” adds Laurane Léost, engineer.
The project, which began in 2018, has been delayed by the covid-19 pandemic. Work to fit out the facility and create a floor area of 40 m2 began in June 2020 and lasted 15 months. “We had to cut back on the adjacent laboratories,” explains Julien Orsonneau, Operations Manager at Arronax, which carried out the construction work. The challenge of this project was to fit out, in such a small area, all the airlocks and laboratories required for the work in compliance with GMP rules, in an ergonomic manner and integrating the hot cells”. It took more than two years to install these hot cells. It was necessary to open the outer wall of the restricted zone, as well as bypass the entire building to transport the various parts of the enclosures, some of which weigh more than a tonne. “This project would not have been possible without the collaboration of the various departments within Arronax,” emphasises Aurélien Vidal. The room and the Arronax’s In-House Hospital Radiopharmacy staff are now ready to host the first clinical trial.
This installation was co-funded by the Région Pays de la Loire and Nantes Métropole.
Contact : Arronax’s In-House Hospital Radiopharmacy team