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FLEXA

The Flexa-Flexall cell is an innovative system consisting of a GMP Grade B shielded isolator for synthesis and a GMP Grade A isolator for dispensing, all housed in a single cell.

 

 

Used in contexts of:
Nuclear Medicine · Radiopharma Production

Designed and Manufactured by Tema Sinergie

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GMP-compliant

Class II

Air Tightness ISO 10648:2

GAMP5

FDA 21 CFR Part 11

OVERVIEW

Key Features of the System

Flexa is designed for the preparation—both manual and automatic—of injectable doses of radiopharmaceuticals for PET and nuclear medicine.

Manual dispensing can be performed using the standard FLEXA configuration, while automatic dispensing can be performed using the CRP automatic dispenser.

Flexa cells are equipped with inflatable seals to ensure Class II airtightness (ISO 10648:2)

Settings and Customization

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Features & Benefits

Why Choose FLEXA

Flexibility

It is equipped with a vial extraction system, featuring an automatic lead pot retrieval system (at the front, back, or sides).

Operator Safety

The touchscreen interface allows for a remote connection so that remote support services can be provided.

Compact size

It is the smallest GMP-compliant shielded dispensing isolator on the market, featuring a built-in Class B synthesis chamber.

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Case Studies

Results in Real-World Settings

From the Clinic to Production: Case Studies Demonstrating Integration, Compliance, and Continuity.

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