The Leader
of Pharmaceutical CCIT
As the original inventor of High Voltage Leak Detection (HVLD),
Nikka Densok offers a comprehensive lineup of leak inspection
machines tailored to the specific characteristics of each container
type, including BFS strips, vials, ampoules, and more.
CCIT
Container Closure Integrity Testing: Critical Requirement for Sterile Product Assurance under EU and PIC/s GMP Annex 1.
HVLD
High Voltage Leak Detection: USP <1207> Recommended Non-Destructive Method for Sterile Product Integrity Testing.
NIKKA HISTORY
With over 70 years of R&D in high-voltage applications, Nikka Densok has mastered HVLD technology for precise and reliable inspection of sterile containers.
Applications
Nikka Densok offers a wide range of CCIT solutions optimized for both fused-sealed and assembled pharmaceutical containers, ensuring comprehensive leak inspection across diverse packaging formats.
World’s Most advanced BFS leak inspection machine
BFS STRIPS Inspection Flagship
Our leak inspection system for BFS (Blow-Fill-Seal) strips is engineered to detect ultra-fine defects as small as 0.1 micrometers, particularly in vulnerable areas such as twist-off sections and joint mold lines. It ensures precise, non-destructive testing even for low-conductivity products like WFI (Water for Injection), making it ideal for sterile pharmaceutical applications. With high-speed performance and advanced sensitivity, the system provides reliable protection against contamination while maintaining production efficiency and compliance with regulatory standards.
Totally
Customizable
Nikka Densok is the only company that offers 100% customizable CCIT solutions for IV bags
IV bags are among the most vulnerable pharmaceutical packages when it comes to leakage and are also some of the most challenging to inspect. Due to their nature as fused-seal containers, Annex 1 of the EU GMP guidelines recommends that they undergo 100% Container Closure Integrity Testing (CCIT)—meaning that every single unit must be individually inspected. Ensuring leak-free IV bags is critical for maintaining sterility and patient safety.
NIKKA DENSOK
Glass Ampoule HDB Series
As the company that pioneered the fundamental principles of ampoule Container Closure Integrity Testing (CCIT) in the 1970s, Nikka Densok has continued to evolve its technology through the HDB series—a high-performance solution for glass ampoules and vials. With continuous improvements in inspection speed and detection sensitivity, the HDB series remains a core offering in the Nikka lineup, trusted by pharmaceutical manufacturers worldwide.
Cartridges CCIT,
Cartridges are becoming an increasingly popular drug delivery format, especially for diabetes treatments. As their use expands, the demand for reliable Container Closure Integrity Testing (CCIT) has grown significantly. Nikka Densok offers specialized leak inspection machines designed specifically for cartridges sealed with aluminum caps and rubber stoppers, ensuring product integrity and compliance with regulatory standards.
— Nikka Densok
Posts and Articles
