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Bonfiglioli Engineering, a provider of advanced leak detection and packaging integrity solutions for the pharmaceutical industry, today announced the launch of two new inspection systems designed specifically for IV bag applications. The IVB Flex and LDB-Pro expand Bonfiglioli Engineering’s container closure integrity testing (CCIT) portfolio, delivering innovative, non-destructive solutions that safeguard patient safety and support compliance with the most stringent regulatory standards.
“We are proud to introduce inspection technologies that address the unique challenges of IV bag testing,” said Serena Santi, Global Commercial Director of Bonfiglioli Engineering. “Both the IVB Flex and LDB-Pro demonstrate our commitment to innovation, precision, and patient safety by helping pharmaceutical manufacturers achieve reliable CCIT while maximizing production efficiency.”
The IVB Flex: Scalable High-Performance Leak Detection for IV Bags
The IVB Flex sets a new benchmark for IV bag CCIT, combining vacuum decay testing with a magnetic levitation transport system to ensure unmatched sensitivity and reliability. Designed for filled IV bags ranging from 50 mL to 1 L, including saline, plasma, viscous, and oily-based solutions, the IVB Flex delivers leak detection speeds of up to 2,880 containers per hour.
Key features include:
- High-sensitivity leak detection that ensures sterility and safety
- Non-contact magnetic transport to reduce contamination risk and mechanical wear
- Modular, scalable design with removable test plates for fast changeovers and cleaning
- Optional modules, such as an automated drying station for enhanced reliability
- Compliance with USP <1207>, FDA cGMP, EU GMP Annex I, and 21 CFR Part 11
Bonfiglioli Engineering's LDB-ProBonfiglioli Engineering
The LDB-Pro: Compact, Mobile, Non-Destructive Testing
For environments where space and convenience are critical, the LDB-Pro offers a compact, mobile solution for IV bag integrity testing. Providing a non-destructive, non-invasive alternative to traditional blue dye ingress methods, the LDB-Pro is designed for IV bags from 50 mL to 1 L and is fully compatible with a variety of bag sizes thanks to its toolless design.
Key features include:
- Non-invasive CCIT based on force decay technology
- Smart HMI for real-time test review
- Compact, mobile footprint with easy cleaning and maintenance
- 21 CFR Part 11-compliant reporting and full IQ/OQ validation support
Santi added, “By introducing both the IVB Flex and LDB-Pro, we now provide pharmaceutical manufacturers with scalable solutions for both high-volume production and smaller-scale or space-limited operations. This dual launch emphasizes our mission to deliver reliable, regulatory-ready technologies that improve quality assurance and protect patients worldwide.”
