Large Volume Parenteral (LVP) Bottle CCIT

For more than a half century, Nikka Densok has been tackling the challenge of CCIT for LVP bottles.

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LVP Bottle CCIT

High-sensitivity Leak Inspection for LVP Bottles

In accordance with EU GMP Annex 1, pharmaceutical manufacturers are mandated to perform 100% CCIT on containers closed by fusion, including LVP bottles. At Nikka Densok, we offer top-of-the-line non-destructive CCIT solutions for LVP containers that reliably detect microleaks in critical container areas. Due to their large size, IV bottles present handling challenges; however, with over 50+ years of experience, Nikka Densok continues to provide a wide range of customized CCIT solutions.

Optional Manual Visual Inspection Station

Dedicated black/white background station for manual visual inspection can be added
as an option before the HVLD inspection.

Four clear plastic bottles with different colored accents at the base and top, showcasing variations in design.
  • 100% CCIT
  • 21 CFR Part 11 compliance
  • USP <1207> recommended
  • 0.1μm hole size detection capability
  • WFI (Water for Injection) detection
  • Up to 100 pcs/min processing speed