Now with Head Space Analysis (HSA), the fully equipped Heuft spotterII PHS carries out the optical and radiometric complete inspection of up to 800 full vials per min, as well as 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, which can cause oxidation and impair the effectiveness of the medicinal product. This new integrated container closure integrity testing complements the camera-based 360-deg closure inspection.
The tried and tested Heuft spotterII PHS also detects foreign matter optically, such as fibers in vials, as well as deviations in filling quantity and product color, contamination, product splashing, and glass defects. Even glass splinters hidden in lyophilisate are made visible carefully and precisely by means of pulsed Heuft X-ray technology. The Heuft reflexxA.I. 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 cleanroom 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.
The modular system based on the highly automated Heuft SpectrumII now achieves full functionality for 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.