HEUFT spotter II PHS: simply complete!29 May 2019
The new HEUFT spotter II PHS not only has sophisticated optical detection technologies. It is also equipped with unique X-ray strobes. Therefore tiny glass splinters and other high-density foreign objects can even be identified in lyophilised products reliably and safely.
Fully equipped for an unprecedented functionality and detection reliability: the HEUFT spotter II PHS identifies foreign matter such as fibres or hair in vials, containing between 2 ml and 100 ml, filled with emulsions, suspensions, powders, granules and lyophilised products with high-performance cameras and targeted container alignment.
Deviations to the filling quantity and product colour, contamination due to product splashing as well as minute cosmetic defects in the glass are detected just as reliably by it. The innovative inspection system also identifies faulty, possibly leaking crimp caps as well as defective or non-brand flip off caps based on camera technology – with the powerful HEUFT FinalView II CAP module for a continuous 360° closure inspection.
In addition the compact straight-through system, which manages without container specific change parts, has the pulsed X-ray technology available exclusively from HEUFT as the only device of its kind. On the one hand it can be used for a redundant fill level detection. But above all it makes solid foreign objects such as glass and metal particles visible even when hidden in medicinal powder, granules or lyophilisates. And that with such a low level of radiation that vials with active pharmaceutical ingredients (APIs) can often also be examined without impairing their active properties.
In contrast to conventional X-ray scanners which emit radiation continuously this is only the case with pulsed X-ray technology in the brief moment when an object to be examined is in the inspection area. Only one X-ray flash lasting no longer than a millisecond is emitted instead of a continuous beam. Very clear X-ray images, without distortions or motion blurs, in which solid foreign objects are made distinctly visible are produced together with optimised receiver and image converter technology and the HEUFT reflexx² real-time image processing system with learning ability.
The intensity of an average X-ray flash of 0.000015 Gray is 7,000 times lower than the limit value of the World Health Organization regarding the marking obligation of irradiated pharmaceutical products. The radiation energy of a pulse amounts to just 70 kilo electron volts instead of the permissible 10,000. And the radiation dose at only 10 microsieverts per measurement is over 100 times below the permitted limit value for the irradiation of medicinal products.
Whether optically or with this unique pulsed X-ray technology: all the vials which the HEUFT spotter II PHS has detected as faulty are removed reliably by the HEUFT e-mono for a fault rejection without compressed air in clean room class B.
The highly automated system of the HEUFT SPECTRUM II generation with the self-explanatory, tamper-proof HEUFT NaVi user guidance is designed for optimum hygiene and is extremely space-saving and efficient as a linear machine. An online connection enables real-time transmission, the preparation and complete archiving of batch and production data, test container and Knapp test logs, a reliable audit trail documentation and targeted remote maintenance with the HEUFT TeleService. The fully equipped HEUFT spotter II PHS fulfils fundamental FDA, GMP, GAMP5 and 21 CFR Part 11 requirements reliably.
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