Annex 1 compliance and visual inspection
Radiopharmaceuticals must meet the strict requirements outlined in Annex 1 for sterility, inspection, validation, risk control, and quality assurance. Visual inspection is a crucial step in this process. In collaboration with LUO, Von Gahlen offers the advantages of fully automated visual inspection derived from regular GMP processes to the challenging environments of radiopharmaceuticals.
Fully integrated hot cell production lines
With decades of expertise in radiation protection and GMP compliance, we design and build hot cells for both research and production. Our integrated solutions combine proven technology with innovation to meet the highest international standards.
Dispensing Hot Cell
Our Dispensing Hot Cell (DPB) provides a GMP class A environment for aseptic filling. Designed for seamless integration of dose dividers, it ensures safe, accurate, and efficient workflows.
Automatic dispensing system
Our OVDD and CVDD dose dividers precisely and quickly fill patient-specific vials. The software calculates optimal doses, scans vial labels, and generates customized identification to ensure safety and traceability. This makes the entire dispensing process smoother, more efficient, and optimized.
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Visual inspection system
The compact automated visual inspection unit for radiopharmaceuticals, developed by Luo Automation (the VI-Assist R), operates directly inside the dispensing hot cell. By rotating vials under different light settings, it fully automatically detects contaminations, cap integrity issues, and cosmetic defects. The VI-Assist R combines Luo’s patented inspection methods from regular GMP productions with Von Gahlens' hot-cell manufacturing expertise.
From filling to transport
The integration of dispensing, inspection, and automated handling ensures that every vial is safely prepared, controlled, and securely packed in Type A packaging – ready for transport.
Visual inspection
Each final product must undergo 100% visual inspection for particles and defects.
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