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Cyclowest partners with Tema Sinergie and Cyclomedica, for an hot cell line for FDG production at the new nuclear medicine center in Western Australia

31 August 2023

Perth, Australia, welcomes the new Cyclowest center, installed by our team, featuring a custom hot cell line for FDG production, from synthesis to dispensing.

 

Cyclowest becomes the second production hub equipped with a cyclotron in West Australia and the newly installed custom hot cell line for FDG production, engineered by Tema Sinergie enables Cyclowest to achieve complete management of radiopharmaceuticals synthesis, manipulation, and dispensing processes. This development is of significant importance for the region as it gains access to greater production resources, allowing the expansion of the range of PET and SPECT diagnostics.

At the new center, the personnel supervised all phases of installation and training, conducted on-site by Cyclomedica and our Product Specialists.

According to Jacquie Cawthray – Cyclowest’s Head of Production:

 

We have recently established a cyclotron and radiopharmaceutical manufacturing facility in Perth, Australia equipped with Tema Sinergie synthesises and dispensing hot cells, semi-automated aseptic dispensing equipment, HYPER and radiation monitoring systems. Our collaboration with the team at Cyclomedica/Tema Sinergie has been extremely positive from start through to finish. The installation, qualification, training and support provided is excellent.

 

We designed a solution that perfectly adapts to the client’s demands and needs within the workflow.
This project led to the creation of a mirrored configuration line that allows two operators to work simultaneously, maximizing both time and space utilization efficiently.

1. Synthesis

The line features two synthesis module hot cells – SYNT2 model – positioned on its outer sides. These hot cells are designed to host automatic synthesis modules, offering a controlled and safe environment in compliance with the latest GMP guidelines, as well as operator radiation protection. Its inflatable seals are granting an ISO 10648:2 air tightness, while the ventilation system provides a GMP class B clean air environment.

2. Cold materials introduction

The insertion of vials and kits into FLEX happens through a SASLAF model pre-chamber, positioned between the dispensing hot cells.

3. Decontamination

The sterility of both the FLEX and SASLAF hot cells and the material placed inside them is ensured by the integration of our HYPER system, a vapor-phase hydrogen peroxide (VPHP) generator.

4. Dispensing – phase 1

Once the synthesis is completed, the radiopharmaceutical is transferred through capillary ducts to the two FLEX model dispensing hot cells. These are units designed for class C laboratories and comply with GMP standards. They enable radiopharmaceutical dispensing operations, automated extraction of vials and aseptic environment decontamination, in compliance with the strictest pharmaceutical standards.

5. Dispensing – phase 2

In each FLEX, an automatic vial dispenser model CRP Compact has been installed. This automatic vial filling unit, for both open and closed, allows safe and fast dispensing, drastically reducing any kind of operator intervention.

6. Reporting

The custom line provides with comprehensive reporting of all process-related data, meeting the highest standards of data integrity and incorruptibility. This can be done through DataWall, a software developed by Tema Sinergie. DataWall can collect reports, audits, events, alarms, and trends from both the hot cells and HYPER.

 

As a new center, we provided Cyclowest not only with a production line but also with practical solutions to include even those stages not directly involved to mere production, such as disposal and monitoring. In this way, we delivered a comprehensive turnkey system to our customer.

In relation to radioactive waste gas management, we have installed a WGHS system that is connected to the synthesis hot cells. Regarding monitoring, we have established a network comprising 7 of our ENVIRO to monitor specific areas of the facility. The resulting system provides an overlay between the installed devices and the layout of the structure so that any radiation in individual rooms can be monitored.

 

Are you planning to set up a new line for radiopharmaceutical production?

Prodotti correlati

GMP flexible Vials and Syringe dispensing system
FLEX
Synthesis modules hot cell
SYNT
Automatic radiopharmaceutical dispensing unit for open and closed vials
CRP Compact
Environmental Monitoring Net
Enviro

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