MicroCurrent HVLD Technology for All Parenteral And Biologic Products
Referenced in the new USP <1207> Chapter Guidance as a deterministic test method for container closure integrity testing.
PTI innovators have taken conventional HVLD technology and revolutionized the leak detection method to create HVLDMC – MicroCurrent HVLD, a non-destructive highly sensitive technology for container closure integrity for wide range of liquid filled parenteral products including extremely low conductivity sterile water for injection (WFI) and proteinaceous products with suspensions. The test method ensures product CCI by scanning a non-conductive container that is sealed with electrode probes to detect pinholes, micro-cracks, stopper/plunger leaks, non-visible leaks under crimping, and many other defects. When a defect is detected, the resulting resistance differential and change in current flow indicate a breach in the container as well as the approximate defect location.
Referenced in USP <1207>, PTI’s HVLDMC has proven to be a highly sensitive leak detection method for various types of liquid-filled packaging including, but not limited to pre-filled syringes, vials, cartridges and ampoules. The unique mode of HVLDMC utilizes about 50% less voltage and exposes the product and environment to less than 5% of the voltage when compared to conventional HVLD solutions. PTI’s E-Scan product line utilizes this revolutionary technology in a manner that is
non-destructive, non-invasive, requires no sample preparation and provides a high level of repeatability and accuracy.
Sealed non-conductive containers are scanned using a set of electrode probes. The package or container needs to have a minimum of 30 % liquid fill. In case of any defects like pinhole or cracks, there will be a resistance differential and change in current flow indicating a breach in the container and location of the breach.
Any breach in the sterile package systems can cause the growth of the environmental contaminants that can convert a life-saving product to a life-threatening microbial soup. The Microcurrent HVLD is a patent-pending unique High Voltage Leak Detection Technology that is highly effective across all parenteral products. This HVLD method can be easily migrated from offline to 100% inline testing applications at high production speeds. It is a highly effective online container closure testing method with minimal infrastructure modifications. This is an HVLD for prefilled syringes testing method that has joined the line of robust CCIT equipment from PTI.
The E-scan series is an innovative micro leak test equipment that can be used with a wide range of liquid-based products including low conductivity sterile water for injection and proteinaceous products with suspensions. The E-Scan Series also has the capability of quick changeover and can handle easy test parameter changes for different products and applications. The containers can also be of different types like glass, plastic or poly laminates. The E-scan 655 technology is a Microcurrent conductivity test exposing packages and products to lower voltage than other conductivity based solutions.
We, at CCIT, aim to achieve a high-level of CCI assurance across the entire range of parenteral products. We always ensure to use leading-edge technology for our systems and continuously innovate and improvise our process and products. We believe in giving the best packaging integrity for all pharmaceutical and biological products.
- Non-destructive, non-invasive, no sample preparation
- High level of repeatability and accuracy
- Effective across all parenteral products, including extremely low conductivity liquids (WFI)
- Low voltage exposure to the product and environment
- Listed in USP Chapter <1207> as the recommended method for parenteral liquid package inspection
- Robust method and approximate 3x Signal-Noise-Ratio for a wide range of product classes and package formats
- Simplifies the inspection and validation process
- Offline and 100% online inspection at high production speeds
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