Product Description
The IVB Flex sets a new benchmark in container closure integrity testing (CCIT) for IV bags, combining advanced vacuum decay technology with a frictionless magnetic transport system to deliver unparalleled accuracy and efficiency. Specifically designed for filled IV bags from 50 ml up to 1 L, the IVB Flex provides high-sensitivity leak detection that safeguards product sterility and patient safety across a wide range of pharmaceutical solutions, including saline, plasma, viscous, and oily-based contents.
Its innovative design minimizes mechanical wear and contamination risks through non-contact handling, while maintaining speeds of up to 2,880 containers per hour. The system is fully scalable to production needs, featuring modular components for easy format changeovers, removable test plates for quick cleaning, and optional modules like an automated drying station for enhanced reliability.
Main Features and Benefits
- Container Application: Filled IV bags from 50 ml to 1 L
- Products: Saline, Plasma, Viscous, and Oily-based content
- Testing Speed: Up to 2,880 cph
- Technology: Vacuum Decay Method (USP <1207> compliant)
- Transport System: Magnetic “floating mover” system with electromagnetic tile bed for frictionless, precise bag handling
- Smart HMI: Easy-to-use and review tests in real time
- Cleanability: Removable and cleanable test plates, spill containment design and automatic drying system to grant high reliability
- Easy Maintenance and Cleaning minimize downtime
- Format Changeover: Simple via modular lower test chamber plates with keyed alignment; no mover adjustments required
- Scalable tile-based system can be configured to production requirements
- Container Closure Integrity Testing: Vacuum decay test method combined with an innovative magnetic floating mover system provides accuracy and reliability, reducing false rejects
- Reliable and repeatable validation approach (ASTM F2338), deterministic and non-destructive method
- MES/LIMS OPC UA connectivity available
- Automatic loading system available
- Data Management: 21 CFR Part 11 compliant software with audit trail and electronic records
- Validation Support: Built-in capability for auto test verification (ASTM F2338); full support for qualification
- Regulatory Compliance: Designed to meet USP <1207>, FDA cGMP, EU GMP Annex I, and 21 CFR Part 11 standards
