Access quality tracers via our global network

The availability of our radiopharmaceuticals is essential in supporting earlier diagnoses, assessing the effectiveness of treatments, and guiding clinical decisions for hundreds of thousands of patients each year.
Above all, the reliability and quality of production at our sites is crucial, as it directly influences the accuracy and effectiveness of diagnostic imaging, thus solidifying our role as a leading provider of modern medical diagnostics.

What are radiopharmaceuticals?

Radiopharmaceuticals are substances that are attracted to specific organs, bones, or tissues. A scanner (PET, SPECT or gamma camera) is then used to detect the radiopharmaceutical and acquire images of the body. The amount of radiopharmaceutical used is carefully selected to provide the least amount of radiation exposure to the patient but a high quality result.

Our 7 step manufacturing process

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Nuclide production

In our in-house cyclotron, [F18] fluoride is produced several times a day for the synthesis of our radiopharmaceuticals by bombarding [O18] water with accelerated protons.

Synthesis

To synthesise the [F18]-labelled products, the required amount of activity is transferred to one of the lead-shielded modules located in the clean room. A fixed, pre-programmed, optimised synthesis process takes place here.

Dispensing

The finished radiopharmaceutical is dispensed aseptically in a hot-cell under class A clean room conditions.

Packaging

The product vials are discharged directly into special, sealable lead containers which are then packed in special, sealable transport containers in accordance with ADR regulations.

Quality control

Immediate and detailed analyses of the precisely timed tracers guarantee a safe product at all times.

Dispatch

Parallel to quality control, the product is transported to the customer by specially trained, professional carriers using the fastest route.

Release for use

In order to release the radiopharmaceutical for use, both production and quality control are meticulously checked again by the Qualified Person (QP).  The release for use is then sent directly to the doctor using the product.

All processes, from production and quality control through to dispatch and release, are subject to the applicable GMP standards. This guarantees uncompromisingly high quality for the patient.
Alliance Medical is a Contract Manufacturing Organisation (CMO) specialising in contract manufacturing of 18F-labeled radiopharmaceuticals: human medicinal products, human investigational medicinal products and auxiliary products. Contract manufacturing medicinal products is carried out in GMP manufacturing facilities in Germany, Poland and the UK.
  • Professional CMC service during the implementation and maintenances manufacturing processes
  • Grade A, B, C clean room
  • Aseptic filling
  • Packaging and labelling
  • In-house quality control laboratory
  • Trained and experienced staff  

Nuclide production

In our in-house cyclotron, [F18] fluoride is produced several times a day for the synthesis of our radiopharmaceuticals by bombarding [O18] water with accelerated protons.

Synthesis

To synthesize the [F18]-labelled products, the required amount of activity is transferred to one of the lead-shielded modules located in the clean room. A fixed, pre-programmed, optimized synthesis process takes place here.

Dispensing

The finished radiopharmaceutical is dispensed aseptically in a hot-cell under class A clean room conditions.

Packaging

The product vials are discharged directly into special, sealable lead containers which are then packed in special, sealable transport containers in accordance with ADR regulations.

Quality control

Immediate and detailed analyses of the precisely timed tracers guarantee a safe product at all times.

Dispatch

Parallel to quality control, the product is transported to the customer by specially trained, professional carriers using the fastest route.

Release for use

In order to release the radiopharmaceutical for use, both production and quality control are meticulously checked again by the Qualified Person (QP).  The release for use is then sent directly to the doctor using the product.

All processes, from production and quality control through to dispatch and release, are subject to the applicable GMP standards. This guarantees uncompromisingly high quality for the patient.

Distribution locations

Alliance Medical BSM GmbH (Distribution)

Alser Straße 25
A-1080 Wien
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Alliance Medical f-con GmbH
(Distribution)

Nic.-Aug.-Otto-Straße 7a
56357 Holzhausen
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