New radiopharmaceutical production line for SWAN Isotopen signed by Tema Sinergie

21 March 2022

In the SWAN Isotopen’s laboratories, at Bern University Hospital, there is a new production line coming into operation. This line is dedicated both to the development of new formulas requested by medical prescription and to the synthesis-and-dispensing process of radiopharmaceutical based on [18F] e [177Lu].


 

The new line realized by Tema Sinergie for SWAN Isotopen, swiss company leader and specialized in the production of radiopharmaceuticals for Nuclear Medicine, has been designed and developed to reach a complete and avantgarde management in the production, handling, and dispensing process of various radiopharmaceuticals, designated both to diagnosis and therapy.

The whole workflow, from the entrance in line of the radioisotopes, to the bio-decontamination cycles, automatic dispensing and data processing, has been meticulously designed and developed in compliance with SWAN’s production needs and the current GMP guidelines.

The result is a maximized and compact line made by three main segments, that allow to manage the different phases of the production process following specific requests, as underlined by Dr. Konrade von Bremen CEO and Riccardo Bosi Head of Infrastructure & Operation at SWAN Isotopen AG.

 

“The professionalism of its personnel and the possibility to completely customize the equipment are just some of the strengths, for which we consider Tema Sinergie as our choice. For us it is the best solution for the implementation of new production lines.

The long-standing cooperation between SWAN Isotopen and Tema Sinergie has resulted in an efficient and optimized production process in compliance with current guidelines, ISO and general cGMP regulations.

SWAN Isotopen’s production site is fully equipped with Tema equipment and environmental control systems, which have been developed and produced by Tema Sinergie over the years. After 10 years of continuous production activity, we are happy to equip our latest Production line with TEMA Sinergie’s newest hot cells.

We hope to have the pleasure of working with TEMA Sinergie on other promising future projects.”

Are you planning to realize a new
radiopharmaceutical production line?

 

Workflow

1. Synthesis

The first part of the line is made by two hot cells for synthesis modules, side by side, model SYNT2L, where the radiopharmaceutical is synthesized.

These are hot cells designed to house an automatic synthesis modules, ensuring a safe and controlled environment in accordance with the latest GMP guidelines and the radioprotection of the operators.
The inflatable gaskets guarantee and air quality ISO 10648:2, while the ventilation and H14 filtration offer a Class B GMP environment.

 

2. Disposable insertion and decontamination

Vials insertion into DTC takes place through a pre-chamber, located between the dispensing cells, model SASLAF. It’s a Class B + Class A pre-chamber that allows material insertion and it’s equipped with VHP decontamination cycle run by our HYPER system.

3. Dispensing phase 1

As the synthesis is completed, the radiopharmaceutical is transferred, through capillary channels, to the two dispensing hot cells, model DTC.
These units are designed for Class C laboratories and completely conformed to GMP regulations.
The hot cells are key to the radiopharmaceutical dispensing operations, the vials automatic extraction and aseptic environment sterilization, as set out by the most rigorous pharmaceutical standards.

 

4. Dispensing phase 2

Inside every DTC an automatic vial dispensing device (model CRP Compact) has been installed. This device drastically reduces every kind of intervention by the operator: thanks to its automatic vial filling feature, the CRP Compact ensures a quick, safe and accurate dispensing.

Even if the CRP Compact can manage both opened and closed vials, in this case it was chosen to dedicate each system to just one dispensing mode.
This choice cuts the production time and, on the other hand, it allows to manage both kinds of vials simultaneously.

 

5. Data Processing

The line provides a data managing and processing complete with every production process data, aligned with the highest integrity and incorruptibility standards of the data themselves.

Are you planning to realize a new
radiopharmaceutical production line?

 

For details

Posted in Medicina Nucleare
© 2022 TEMA SINERGIE S.p.A
Fiscal Code n. 00970310397
Business Register of Ravenna n. 00970310397  |  R.E.A. 111877
Capital Stock € 2.000.000,00 paid-up