Class A
EU GMP
FLEX
A multifunctional shielded isolator designed for the dispensing of injectable doses of radiopharmaceuticals into syringes or vials, using both manual and automated processes.
FLEX features a large GMP Grade Awork area with vertical laminar flow which, together with dedicated equipment, makes this shielded isolator a flexible solution suitable for a wide range of dispensing processes in PET and nuclear medicine applications .
Used in contexts of:
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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
Key Features of the Insulator
Anteroom
A watertight, shielded, and ventilated pre-chamber (GMP Class B), equipped with a double door and a drawer-style opening system.
It allows for the insertion and removal of disposable materials, as well as the insertion and removal of syringes or vials, without compromising the aseptic integrity of the work environment.
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Flex
Pre-chamber for bottle extraction
A watertight, shielded, and ventilated antechamber (GMP Class B) for the automatic removal of vials and the retrieval of the lead-shielded container.
System Features
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GMP-compliant pressure cascade.
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Interlocked inner and outer doors to ensure the system functions as an airlock (pressure equalization chamber).
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Controlled descent of the vial from the main work area into the lead-shielded container.
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Automatic positioning and closing system for the lid of the lead-shielded container.
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Flex
Main Door
FLEX is equipped with a double main door:
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Shielded door: 80 mm thick lead shielding (90 mm optional), equipped with openings for handling gloves and a leaded glass window measuring 200 (W) × 200 (H) mm, with a shielding equivalence of 80 mm of lead (Pb).
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Polycarbonate door: equipped with gloves and designed to ensure isolation of the interior environment.
The airtight seal of the polycarbonate door is ensured by inflatable gaskets that provide a Class II airtightness rating, in accordance with ISO 10648-2.
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Technical Details
Technical Specifications and Dimensions
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Width: 1,270 mm
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Depth: 1,220 mm
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Height: 2,680 mm
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Width: 1,070 mm
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Depth: 980 mm
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Height: 670 mm
Between 10,500 and 12,000 kg
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Shielded port: 80–90 mm
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Other parts: 75–80 mm
configuration
Work Area: Configuration and Customization
FLEX offers a spacious work area designed to be configured and customized through the integration of specific process equipment, such as dispensers, dose calibrators, and autoclaves.
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.
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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.
µ DDS-A
The integration of the µ DDS-A system into FLEX enables the automatic dispensing of radiopharmaceuticals into sealed vials (by perforating the septum), open vials (sealed using a crimping station), and shielded syringes.
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This approach makes it possible to adapt the system to different clinical scenarios while maintaining process continuity, safety, and accuracy throughout the various operational phases.
Automatic Lift for Dose Calibrator
The integration of the automatic lifting system into FLEX allows syringes and vials to be automatically transferred to the dose calibrator for the necessary measurements and then returned to the work chamber.
The elevator can be operated in three modes:
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Floor pedal (footswitch).
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Manually, via the control panel.
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Via PC commands, when the elevator is in use and connected to the μDDS-A dispenser.
Autoclave
A single main unit can dispense multiple doses, which can be administered simultaneously to patients via two or more Rad-Inject units, resulting in significant savings in terms of time and cost.
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.
OTHER Shielded Isolators
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