Class A
EU GMP
PET
Production Line
A modular production line designed for the manufacture of PET radiopharmaceuticals, developed to meet the needs of centers specializing in nuclear medicine and the production of diagnostic radiopharmaceuticals.
It integrates the main stages of the production process—from synthesis to the final dispensing of the radiopharmaceutical—into a single solution, ensuring controlled operating conditions and operator safety.
Used in contexts of:
Designed and Manufactured by Tema Sinergie
overview
Flexibility and Safety in the Dispensing of PET Radiopharmaceuticals and Radiopharmaceuticals for Nuclear Medicine
The modular architecture allows the workflow to be configured according to the facility’s production process, defining the layout of the modules, the interfaces between stages, and the material transfer routes. Shielded cells and controlled environments combine radiation containment and product protection, supporting radiation protection for operators and process management in accordance with GMP requirements.
Flexibility of Use
FLEX allows for the dispensing of radiopharmaceuticals both in vials—with various closure types—and in shielded syringes.
Manual Dispensing
The standard configuration of FLEX allows you to perform manual dispensing operations.
Automatic Dispensing
Automatic dispensing can be achieved by integrating μDDS-A and CRP Compact dispensers.
Compact Size
FLEX combines a compact design, a spacious processing chamber with laminar flow throughout the entire area, and full compliance with EU GMP.
Safety
Asepsis
OVERVIEW
An integrated solution for the production of PET radiopharmaceuticals
CONFIGURATION FLEXIBILITY
The line's configuration can be customized based on the radiopharmaceuticals produced, production volumes, and the customer's operational needs.
INTEGRATED PROCESS
This configuration allows for the management of the synthesis, material transfer, and radiopharmaceutical dispensing stages within a single production line, thereby optimizing the organization of the production process.
AUTOMATION
The line incorporates synthesis modules and automated dispensing systems, helping to optimize the workflow and reduce the need for manual intervention.
RADIATION PROTECTION
The cells are specifically designed to accommodate the workflow and the isotopes used, in order to limit operators' exposure to radiation during the various stages of the process.
SAFETY
Monitoring systems and operator interfaces allow users to monitor the cells' key operating parameters and support operations management.
ASEPSIS
Ventilation and filtration systems ensure controlled work environments, with cleanliness classes appropriate for the various operations and applicable GMP requirements.
Features
Flex
Shielded Dispensing Chamber
The dispensing cell is used for the final stage of the production process, during which the synthesized radiopharmaceutical is divided into containers for subsequent use.
The shielded chamber provides a Class A work environment, with laminar flow ventilation and HEPA filtration systems, to enable operations under controlled environmental conditions.
The cell can accommodate automated dispensing systems and equipment for measuring radioactivity, helping to reduce the need for manual intervention and operator exposure.
The shielded chamber provides a Class A work environment, with laminar flow ventilation and HEPA filtration systems, to enable operations under controlled environmental conditions.
The cell can accommodate automated dispensing systems and equipment for measuring radioactivity, helping to reduce the need for manual intervention and operator exposure.
Details
Pre-chamber for material transfer
The antechamber is designed for the controlled introduction and transfer of materials destined for the dispensing chamber. It serves as a transition area between the external environment and the main chamber, allowing for the introduction of vials, consumables, and other components necessary for dispensing operations.
The laminar flow ventilation system and containment solutions help maintain the required environmental conditions, minimizing the risk of contamination during transfer.
The antechamber can also be integrated with decontamination systems, depending on the needs of the production process.
Details
Synthesis Cells
The synthesis cell is designed to house modules for the production of PET radiopharmaceuticals, and the presence of multiple cells allows for the organization of different synthesis processes based on the center’s production needs.
Each cell features a shielded and controlled environment, with ventilation and containment systems that help protect operators and maintain the required cleanliness standards.
The stainless steel interior structure, the fully removable tray, and the sealed passages for fluids, gases, and cables facilitate the integration of synthesis modules and maintenance operations.
configuration
Work Area: Configuration
CRP Compact
The integration of CRP Compact enables the automatic dispensing of radiopharmaceuticals into sealed vials—by piercing the septum—and into open vials with push-fit or crimp closures.
CRP Compact
CRP Compact is a unit for the automatic dispensing of radiopharmaceuticals and the automated sealing of open and closed vials under sterile conditions, in compliance with EU GMP Annex 1.
Safe, compact, and extremely precise, the system allows for the dispensing of a wide range of radiopharmaceuticals, with no limits on concentration or volume, while minimizing operator intervention. It can work with both open and closed vials and handles both crimped and push-fit caps.
CRP External Scale
Dose Calibrator
Vial Extraction System
Waste Material Removal System
CRP Compact
The integration of CRP Compact enables the automatic dispensing of radiopharmaceuticals into sealed vials—by piercing the septum—and into open vials with push-fit or crimp closures.
CRP Compact
CRP Compact is a unit for the automatic dispensing of radiopharmaceuticals and the automated sealing of open and closed vials under sterile conditions, in compliance with EU GMP Annex 1.
Safe, compact, and extremely precise, the system allows for the dispensing of a wide range of radiopharmaceuticals, with no limits on concentration or volume, while minimizing operator intervention. It can work with both open and closed vials and handles both crimped and push-fit caps.
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Technical Details
Technical Specifications and Dimensions
-
Width: 1,270 mm
-
Depth: 1,220 mm
-
Height: 2,680 mm
-
Width: 1,070 mm
-
Depth: 980 mm
-
Height: 670 mm
Between 10,500 and 12,000 kg
-
Shielded port: 80–90 mm
-
Other parts: 75–80 mm
overview
Flexibility and Safety in the Dispensing of PET Radiopharmaceuticals and Radiopharmaceuticals for Nuclear Medicine
Flexibility and Safety in the Dispensing of PET Radiopharmaceuticals and Radiopharmaceuticals for Nuclear Medicine
Flexibility of Use
FLEX allows for the dispensing of radiopharmaceuticals both in vials—with various closure types—and in shielded syringes.
Manual Dispensing
The standard configuration of FLEX allows you to perform manual dispensing operations.
Automatic Dispensing
Automatic dispensing can be achieved by integrating μDDS-A and CRP Compact dispensers.
Compact Size
FLEX combines a compact design, a spacious processing chamber with laminar flow throughout the entire area, and full compliance with EU GMP.
Safety
Asepsis
Technical Details
Technical Specifications and Dimensions
-
Width: 1,270 mm
-
Depth: 1,220 mm
-
Height: 2,680 mm
-
Width: 1,070 mm
-
Depth: 980 mm
-
Height: 670 mm
Between 10,500 and 12,000 kg
-
Shielded port: 80–90 mm
-
Other parts: 75–80 mm
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