Full vial inspection: simply complete!
Now with Head Space Analysis (HSA): the fully equipped HEUFT spotter II PHS not only carries out the optical and radiometric complete inspection of up to 800 full vials per minute but now also the volumetric determination of the O2 content in the headspace along a gentle and efficient linear system.
The HSA module uses laser technology to identify leaking vials where the o2 content is too high and which can cause oxidation and impair the effectiveness of the medicinal product. This new integrated container closure integrity testing complements the camera-based 360° closure inspection.
The tried and tested HEUFT spotter II PHS also detects foreign matter optically such as fibres in vials as well as deviations in filling quantity and product colour, contamination, product splashing and glass defects. And even glass splinters hidden in lyophilisate are made visible carefully and precisely by means of pulsed HEUFT X-ray technology. The HEUFT reflexx² image processing system differentiates between real faults and supposed faults and therefore ensures complete detection and rejection reliability.
The compact linear machine is suitable for clean room class B and has an online connection for, among other things, real-time transmission, the preparation and complete archiving of batch and production data and Knapp test logs as well as audit trail documentation. It meets fundamental FDA, GMP, GAMP5 and 21 CFR Part 11 requirements reliably.
And the modular system based on the highly automated HEUFT SPECTRUM II now achieves full functionality for a really comprehensive full vial inspection with the new laser technology for headspace analysis which can be integrated as an option: only faultless, safely sealed vials with perfect contents reach the patient.