News

RLT: A Complete GMP Line for the Safe and Efficient Production of Radiopharmaceuticals – The Case of IRST IRCCS in Meldola

Tema Sinergie — Tue, 29 Sep 2026 11:28:10 GMT

In the ever-evolving field of Radioligand Therapy (RLT), the ability to produce radiopharmaceuticals safely, in compliance with regulations, and tailored to the diverse needs of each client is a critical factor for centers of excellence.

It is against this backdrop that the recent renovation of the radiopharmacy at the IRST “Dino Amadori” IRCCS in Meldola took place, where a Tema Sinergie RLT Production Line was installed, designed to ensure high standards of quality, safety, and operational performance.

This configuration represents a customized solution, tailored to the center’s specific production and operational needs, within a product line that can also include even more advanced levels of integration and automation.

An integrated approach in accordance with GMP guidelines

The entire production workflow is developed in accordance with EU cGMP and GAMP5 guidelines, with particular attention to operator safety, process sterility, and product integrity.

GammaPod has obtained the CE mark

Tema Sinergie — Thu, 17 Sep 2026 08:00:55 GMT

The certification of this innovative system for stereotactic breast radiation therapy paves the way for the first European installation and opens the door to installations at other centers.

GammaPodTM: unlocking a new era in breast cancer stereotactic radiotherapy

Tema Sinergie — Tue, 18 Aug 2026 09:06:28 GMT

Three clinical trials: presentation and analysis of the results obtained throughout the months by Dr. Marco Trovò – Director of Radiation Oncology Department at University Hospital in Udine.

First European patient to undergo stereotactic radiotherapy breast treatment with GammaPod™

Tema Sinergie — Tue, 18 Aug 2026 08:50:20 GMT

Santa Maria della Misericordia hospital in Udine adopted GammaPod™, a groundbreaking technology specifically designed for breast cancer radiation treatments, for clinical use.

The press conference held on December 23rd 2021 by Azienda sanitaria universitaria Friuli Centrale (ASU FC) made the clinical use of GammaPod™ official. Actually, the first three patients in Europe underwent the radiation treatment with this brand new technology days prior to the official news release.

AseptiFill, the new automatic vial filling and capping system in aseptic conditions

Tema Sinergie — Tue, 18 Aug 2026 08:26:34 GMT

Specifically designed for Pharma & Biotech companies, perfect for the production of small batches of injectable products.

New radiopharmaceutical production line for SWAN Isotopen signed by Tema Sinergie

Tema Sinergie — Tue, 18 Aug 2026 07:55:18 GMT

In the SWAN Isotopen’s laboratories, at Bern University Hospital, there is a new radiopharmaceutical 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].

Hundred treatments carried out and completed with GammaPodTM in Udine, Italy

Tema Sinergie — Tue, 18 Aug 2026 07:44:38 GMT

Azienda Sanitaria Universitaria Friuli Centrale (ASUFC) in Udine, Italy crosses the line of a hundred treatments carried out with GammaPod^TM, the brand new stereotactic radiotherapy system specifically designed for breast cancer, and approaches the publication of the first structured study gathering the data for this first phase of the trial.

Sterility Isolators: a complete range of solutions for microbiological quality control in the pharmaceutical field

Tema Sinergie — Tue, 18 Aug 2026 07:28:18 GMT

ST-IS Series by Tema Sinergie offers a complete range of Sterility Isolators, fully compliant with the most stringent cGMP regulations and international laws, specifically designed for carrying out sterility tests and quality control activities in the pharmaceutical field.

AGLTS 2: beyond glove leak testing

Tema Sinergie — Tue, 18 Aug 2026 06:58:35 GMT

Tema Sinergie presents the new automatic glove test system developed in response to the requirements of the new Annex 1, EU Guidelines

The name is AGLTS 2, and it’s the brand new automatic glove leak testing system designed for the pharmaceutical industry. The official launch was on April 25th at Interphex 2023, one of the most relevant trade shows for the pharmaceutical market in America.

CRP Compact Plus, the answer to different GMP dispensing needs of radiopharmaceuticals

Tema Sinergie — Mon, 17 Aug 2026 14:56:41 GMT

Tema Sinergie introduces CRP Compact Plus, the new version of the well-known and consolidated radiopharmaceutical dispenser specific for vials with Push-Fit caps.