Container Closure Integrity Testing of IV Bags
IV bags present unique challenges for CCIT, particularly due to their flexible construction and fusion-sealed design. Under EU GMP Annex 1, manufacturers are expected to implement a contamination control strategy that includes deterministic methods for verifying the integrity of containers closed by fusion.
The Sepha Multi-Q is a benchtop solution for deterministic, non-destructive container closure integrity testing of IV bags. Using vacuum decay and flexible membrane technologies, it enables repeatable, quantitative detection of leaks and defects in accordance with ASTM F2338-24. Suitable for both small- and large-volume parenteral bags, Multi-Q enables deterministic leak testing, helping manufacturers control critical process risks in line with Annex 1 requirements.
Looking to develop a robust, compliant sampling plan for IV bags? Get in touch to learn how Multi-Q can support your contamination control strategy.
Our Products
Multi-Q Vacuum Decay
