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radioligand production line

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Radioligand Production Line

A modular production line for radioligands, designed for centers that produce therapeutic radiopharmaceuticals and radiopharmaceuticals for theranostic applications.

It integrates the radiopharmaceutical synthesis, controlled material transfer, and final dispensing stages into a single line.

Used in contexts of:

Radiopharma Production

Designed and Manufactured by Tema Sinergie

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Class A

EU GMP

Class II

Air Tightness ISO 10648:2

GAMP5

FDA 21 CFR Part 11

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.

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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.

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Compact Size

FLEX combines a compact design, a spacious processing chamber with laminar flow throughout the entire area, and full compliance with EU GMP.

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Safety

Asepsis

configuration

Work Area: Configuration

CRP Compact

The integration of CRP Compact into FLEX 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 handle both crimped and push-fit caps.

CRP Compact

The integration of CRP Compact into FLEX enables the automatic dispensing of radiopharmaceuticals into sealed vials—by piercing the septum—and into open vials with push-fit or crimp closures.