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. The automatic visual inspection radio assist (VIRA) performs reliable visual inspection of small and medium-sized batches in 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.
Visual inspection system
The Visual Inspection Radio Assist (VIRA) is a compact, fully automated visual inspection system for radiopharmaceuticals,designed for seamless integration into our hot cells. It performs reliable visual inspection of small and medium-sized batches, independent of vial type or liquid.
The compact VIRA for radiopharmaceuticals Powered by LUO combines Von Gahlen’s expertise in hot cell manufacturing, radiation shielding and GMP-compliant radiopharmaceutical production with LUO’s patented visual inspection technology, a proven platform implemented and validated in GMP-regulated environments. Using controlled vial rotation under multiple lightning conditions, the system automatically performs the entire visual inspection process, including visible particles, cosmetic defects, cap integrity issues and fill level checkes, ensuring consistent and reproductible inspection results.
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.
-1920x1080px.jpg?sfvrsn=87d3a9f2_0 "Open Vial Dose Divider (OVDD) & Closed Vial Dose Divider (CVDD)")
