CS Analytical Extends High Voltage Leak Testing Capabilities with Addition of Nikka Densok HDL-1 HVLD Test System

The addition of this Nikka Densok HDL-1 Instrument will enable the CS Team to better meet client demand for the development of validated test methos for USP 1207 CCI testing programs across a variety of liquid-filled packages

CLIFTON, N.J., March 25, 2025 /PRNewswire/ -- CS Analytical Laboratory, the world's only cGMP, FDA-registered and inspected contract laboratory exclusively designed and dedicated to container testing for the pharmaceutical, biotechnology, and medical device industries, is excited to announce that it has acquired, installed and qualified a Nikka Densok HDL-1 High Voltage Leak Detection Instrument to improve our capabilities for USP 1207 Container Closure Integrity Testing. As referenced in USP 1207, High Voltage Leak Detection, is a sensitive and non-destructive technology applicable to a variety of liquid-filled pharmaceutical and medical containers including glass vials and ampoules, IV-bags, Blow Fill Seal (BFS) bottles and pre-filled syringes. HVLD can be used to conduct USP 1207 CCIT on any liquid-filled product as long as the container is made of electrically insulated material and it contains an electrically conductive solution.

"Nikka Densok has a long and well-documented history in the development and use of high voltage electrical currents being used for drug container and package system integrity testing," noted CS Analytical CEO Brian Mulhall. "The addition of this Nikka Densok, HDL-1 Instrument will enable the CS Team to better meet client demand for the development of validated test methods for USP 1207 CCI testing programs across a variety of liquid-filled packages."

High Voltage Leak Detection (HVLD) exploits the electrical conductivity of liquid drug products that are packaged in containers made of non-conductive materials. A high-frequency voltage potential is applied to the container by means of suitable electrodes and the discharge current is measured by the system. To be tested, the product or container typically needs to be approximately 30% full of liquid. The current seeks path of least resistance to the container. If a container is defective, the resulting resistance differential and change in current flow through the liquid in the container will indicate the presence of container seal defects, pinholes, leaks or cracks. The Nikka Densok's HDL-1 HVLD system can be customized to meet a variety of project needs. This method offers a non-destructive, consistent and accurate method for leak detection. The technology does not contaminate the container being tested and is non-invasive.

About CS Analytical Laboratory

The world's only cGMP, FDA-registered contract laboratory exclusively designed and dedicated to container testing for the pharmaceutical, biotechnology, and medical device industries, the CS Analytical Team includes world-leading experts and thought-leaders on FDA and EU regulatory expectations and USP and EP primary package testing requirements inclusive of container closure integrity (CCI) testing (CCIT). Test services include CCI method development, validation, and analysis, USP/EP/JP physical and physicochemical testing, and Comprehensive and Complementary services for all common or unique primary packaging components and systems inclusive of glass, plastic, elastomeric, and more. CS Analytical is the single source to ensure a regulated industry product-package system meets strict, complex, and ever-changing regulatory requirements.

SOURCE CS Analytical