Radiopharmaceutical Production

Integrated solutions for the production of radiopharmaceuticals for diagnostic and theranostic applications, designed to ensure full compliance with the most stringent GMP requirements (Annex 1) and the highest standards of quality and safety.

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NEEDS AND SOLUTIONS

The requirements for radiopharmaceutical production are undergoing an unprecedented evolution. The industry is gradually shifting from an on-demand production model to an industrial approach, in which sterility, process scalability, traceability, and data integrity play a role just as crucial as radiation protection.

This transformation requires a rethinking of production processes to address new market challenges and growing regulatory and operational requirements. The solutions and systems for radiopharmaceutical production developed by Tema Sinergie enable this new complexity to be managed safely, efficiently, and scalably, supporting the transition to production models that comply with GMP requirements for radiopharmaceuticals.

From handling in radiopharmaceutical hot cells and shielded isolators to aseptic dispensing, all the way to the design of automated lines for managing automated synthesis modules, automatic fractionation, sterile filtration of radiopharmaceuticals, and quality control, our radiopharmaceutical production systems support every stage of the process, ensuring efficiency, product sterility, traceability, and operator safety.

Infertility and Radiation Protection

The integration of Grade A/B environments with laminar flow and VHP systems, along with negative-pressure hot cells equipped with dual HEPA and activated carbon filtration, ensures high standards of sterility, containment, and operator protection.
The seamless integration of HVAC and VHP ensures effective management of controlled environments and compliance with the requirements of Annex 1.

Scalability

The modular architecture of the systems allows production capacity to be adapted to operational needs, supporting parallel production and the gradual expansion of the plant through integrable modules.

Data Management

Data management is integrated into the production process, enabling complete control over the workflow and traceability of every operational step.
The software, which complies with the requirements of 21 CFR Part 11, ensures data integrity, security, and full regulatory compliance.

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Method

How We Meet the Needs of Modern Industrial Radiopharmaceutical Manufacturing

With over 40 years of experience, combined with ongoing research and development, Tema Sinergie has developed an integrated approach that combines specialized expertise, advanced technologies, and dedicated support, guiding the evolution of radiopharmaceutical manufacturing toward increasingly efficient, scalable, and compliant industrial workflows.

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Proven experience

Internationally recognized expertise in the development of systems for the handling, synthesis, and fractionation of radiopharmaceuticals, gained in complex manufacturing and regulatory environments.

Modular Architecture

Solutions designed for parallel production and to reduce installation, qualification, and startup times.

Integrated Solutions

A turnkey system that includes hardware, software, and qualification and validation documentation to support the entire project lifecycle.

Native integration

Direct connection to HVAC systems and Grade A/B cleanroom infrastructure, in compliance with GMP and Annex 1 requirements.

Support During the Start-up Phase

Technical support during the installation, qualification, and operational commissioning phases of the system.

Specialized Training

Structured training programs for operational and technical staff, designed to ensure the proper use of systems and the maintenance of quality and safety standards.

Services

Project Support Services

Maintenance Service

We offer a comprehensive maintenance service that includes annual preventive maintenance.

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Installation and Validation

Commissioning and controlled startup to integrate the system into the workflow and stabilize operations.

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Training

Operational and procedural training for operators and maintenance personnel, focused on safety and consistency.

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Meet Tema Sinergie at upcoming trade shows and conferences. Discover our technologies, talk with our experts, and learn more about the solutions tailored to your needs.

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