IVB Flex Leak Detection System for IV Bags

Pharmaceuticals

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.

IV Bags

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Highlights

  • Innovative Vacuum Decay test method applied to flexible IV bags providing accuracy and reliability, reducing the false rejection rate and combined with a magnetic floating mover that together provides a CCIT turnkey solution 
  • High Sensitivity Leak Detection ensures product sterility and safety for bags from 50 ml to 1 L 
  • Non-Contact Magnetic Transport reduces mechanical wear and contamination risk 
  • Testing speeds up to 2,880 containers per hour 
  • MES connectivity and 21 CFR Part 11-compliant data management 
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Technical Features

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  • 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
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Additional Benefits

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  • 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 
  • Optional modules available including automated drying station (speak with rep for more options)
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Technology

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  • 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.
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Quality Assurance

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  • 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 

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