GAMP5
21 CFR Part 11 compliant
Tailor-made solutions designed around your needs.
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Tailor-made solutions designed around your needs.
Start a custom project
Tailor-made solutions designed around your needs.
Start a custom project
Tailor-made solutions designed around your needs.
Start a custom project
Tailor-made solutions designed around your needs.
Start a custom project
Tailor-made solutions designed around your needs.
Start a custom project
Tailor-made solutions designed around your needs.
Start a custom project
Comprehensive support throughout the entire project lifecycle.
Discover our services
Comprehensive support throughout the entire project lifecycle.
Discover our services
Comprehensive support throughout the entire project lifecycle.
Discover our services
Insights, Events and Technical Content from Tema Sinergie
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Insights, Events and Technical Content from Tema Sinergie
Explore Our Resources
Insights, Events and Technical Content from Tema Sinergie
Explore Our Resources
Discover more about the Tema Sinergie Group and its international presence.
Learn more about the Company
Discover more about the Tema Sinergie Group and its international presence.
Learn more about the CompanyDiscover more about the Tema Sinergie Group and its international presence.
Learn more about the Company
Discover more about the Tema Sinergie Group and its international presence.
Learn more about the Company
Discover more about the Tema Sinergie Group and its international presence.
Learn more about the CompanyEnviro
ENVIRO is a comprehensive and versatile environmental monitoring system designed for the continuous and simultaneous detection of environmental radioactivity , air contamination , temperature,humidity, and pressure.
It is the ideal solution for all types of laboratories that work with radioactive sources, thanks toits wide range of configuration options, which allow the system to be adapted to the specific needs of the workspace.
Designed and Manufactured by Tema Sinergie
21 CFR Part 11 compliant
OVERVIEW
ENVIRO allows for continuous and simultaneous measurements of environmental radioactivity , air contamination, temperature, and humidity, with no gaps between readings.
ENVIRO can be used either as a standalone monitoring station or as part of a modular environmental monitoring system capable of integrating all individual units and various types of sensors to monitor different areas of the laboratory or plant.
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ENVIRO can simultaneously acquire, save, and store data from two different Geiger-Müller detectors and numerous other environmental sensors.
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ENVIRO’s central unit allows you to modify and check all parameters via the touch screen.
A 3.5-inch display shows the system status, alarms, and data.
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Its design, specifically engineered for cleanrooms, perfectly meets the cleanliness and decontamination requirements of the environment.
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ENVIRO ensures comprehensive and continuous monitoring of laboratories and any other environments at risk of contamination. A PC for remote monitoring is also available.
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ENVIRO is a system that stands out for its ease of installation. It does not require any dedicated or additional wiring, as it is connected via an Ethernet network.
details that matter
CRP Compact is designed to streamline a critical phase: the dispensing and capping of vials under sterile conditions, reducing manual intervention and batch-to-batch variability. Its value lies not only in automation, but in its ability to adapt to real production needs: handling of open/closed vials, various capping strategies, and customizable workflows.
In regulated environments, this operational consistency results in a process that is more controllable and easier to transfer between shifts and production lines.
Method
A clinical-first approach: reduced surgical risk, consistent procedures, and support until the patient is stabilized.
Step 01
Solutions designed to accommodate shifts, schedules, and departmental constraints.
Step 02
Radiation protection and procedures: an integral part of the project, not an afterthought.
Step 03
Quality becomes apparent after delivery: commissioning and training reduce variability.
Step 04
Reduce downtime and manage the department's evolution with clear support.
CRP Compact is highly customizable to meet specific production needs, vial types, and capping strategies.
It can be used to process a very wide range of radiopharmaceuticals in vials, while fully complying with the latest GMP specifications.
It can be used to process a very wide range of radiopharmaceuticals in vials, always in full compliance with the latest GMP specifications.
It automates the entire radiopharmaceutical dispensing process, minimizing the need for manual intervention by the operator.
Thanks to its compact size, it can be installed in any type of laminar-flow shielded chamber equipped with a well for a calibrator and a remote gripper.
The refilling station is equipped with a 0.22 µm filter that sterilizes the radiopharmaceutical at the end of the dispensing line.
The Plus version of the CRP Compact features a vial closure system with push-fit caps.
Removable anodized aluminum plate, equipped with a dedicated mounting slot for quick, secure, and error-proof installation of the single-use kit.
High-precision external scale for weighing the stock solution.
High-precision scale integrated into the filling station for weight-controlled dispensing.
PRODUCT OPTIONS
Add the ability to seal vials with a push-fit cap for greater versatility and flexibility in the process.
Add the ability to seal vials with a push-fit cap for greater versatility and flexibility in the process.
Add the ability to seal vials with a push-fit cap for greater versatility and flexibility in the process.
Additional Features
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Additional Features
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Additional Features
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Vial Sealing Modules
Workflow Adaptability
Process Integration
| Feature | Value |
|---|---|
| Volumetric Accuracy (Weight) | <1% (deviation) |
| Vial Compatibility | Open / Closed (with piercing module) |
| Type of closure | Crimp (stopper + ring), Push-fit |
| Dispensing Speed | Up to X ml/min (depending on the vial) |
| Volumetric Accuracy (Weight) | <1% (deviation) |
CRP Compact is highly customizable to meet specific production needs, vial types, and capping strategies.
A probe for detecting environmental radioactivity through direct irradiation.
It is equipped with an energy-compensated Geiger-Müller tube, specifically designed to measure the environmental dose equivalent H*(10) (installed “outside” the central unit). It is also equipped with audible and visual alarms.
A probe for monitoring environmental radioactivity, designed to ensure reliable measurements in environments characterized by high dose rates.
Less sensitive but more resistant to high levels of radiation, it is used to measure environmental radioactivity levels inside facilities such as bunkers while the cyclotron is in the acceleration phase.
Additional Features
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Case Studies
From the Clinic to Production: Case Studies Demonstrating Integration, Compliance, and Continuity.
Share your operating environment and key requirements: we’ll guide you toward the configuration that best suits your production process.
Quality and compliance are an integral part of how we work.
OTHER related products
Explore other solutions in the Radiopharma Production category.
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