VI will be officially presented in Barcelona, during the next EANM (European Association of Nuclear Medicine) edition where it will be possible to see it live at our booth #24.
Lorenzo Pompignoli, Product Specialist manager at Tema Sinergie, gives us a preview of the functionality and features of Tema Sinergie’s new automatic visual inspection and labelling system.
Visual inspection is one of the essential checks to ensure the quality and safety of parental pharmaceutical products. The aim is to determine whether there are any visible particles within the drug. In Nuclear Medicine, it is usually performed with the naked eye, by a specially trained operator and using specific techniques.
In most cases, it is therefore an immediate check, which is rather simple to carry out.
In the presence of radiopharmaceuticals, however, the visual inspection process is much more complex. The need to protect the operator from radiation by means of shielding, leaded glass and the use of tele-pliers, makes the visual check of radioactive drugs much more complicated; to the point of sometimes compromising the final result of the check itself.
VI was created to respond to these critical issues and enable steady and well-characterised visual inspection processes to be performed on radiopharmaceuticals contained in vials, without compromising operators safety.
It is in fact a system consisting of an indoor unit, positioned inside the hotcell, and a high-resolution monitor that allows the operator to view the vial in complete safety.
The indoor unit is specially designed to be placed and used within the work area of hotcell. It mounts components suitable for exposure to VPHP decontamination cycles, while the small size of the unit as a whole is perfectly compatible with GMP-compliant work areas with flow.
The inspection area, located in the indoor unit, is equipped with a high-resolution shielded camera, as well as a set of instruments that can complete the visual check cycle in less than 60 seconds.
Based on a system of LED lights installed in various positions, to ensure accurate inspection in different modes.
There are also two interchangeable backgrounds, one white and one black, to enable an optimal inspection process thanks to the colour contrast.
The housing system rotates the vial and is designed to ensure correct positioning even at high speeds.
Outside the hotcell, there is a high-resolution monitor that completes the system, allowing the operator to check the visual inspection of the vial in complete safety.
All inspection parameters can be managed during validation to create cycles consistent with the inspection procedure.
Rotation speed and time, light source origin and background can be customised to define a personalised inspection cycle according to needs and inner quality protocols.
The visual inspection unit can be complemented by an automatic vial labelling system that allows you to further customise VI to create the most suitable configuration for your process.
There is a choice of 3 configurations, from the inspection unit alone, to the version with an integrated labeller, to the model with a printing and labelling system, which is separate from the inspection system and can be integrated into the technical compartment of the hotcell.
VI is the basic version, consisting only of the visual inspection system that can be installed directly in the work area.
VI+ is the version that enables visual inspection of closed vials and automatic application of pre-printed labels in a Class A environment in a single work cycle.
It consists of the visual inspection unit and the labelling system, which can be installed stand-alone within the main work area.
VI++ is the version that integrates the inspection system with an additional unit consisting of a printer, for printing the labels with the real production information, and a labeler, for applying them to the vials.
In this configuration, the visual check system is positioned in the work area, while the printer and labeler are installed in the technical compartments of the cell. This version is only available on Tema Sinergie cells, subject to evaluation by the technical department.
