Blogs

The pharmaceutical and medical device industries are witnessing a surge in the development and use of combination products. These products integrate a drug, biologic, or medical device into a single entity, offering improved patient convenience and therapeutic efficacy. However, ensuring the safety and efficacy of these products requires robust Container Closure Integrity testing (CCIT) strategies. This blog delves into the world of combination products, explores the challenges associated with their CCI testing, and introduces MicroCurrent High Voltage Leak Detection (HVLD) technology as a reliable solution.

The rise of combination products is driven by several factors:

• Enhanced treatment options: Combining drugs and devices allows for targeted delivery and improved therapeutic effects.
• Patient convenience: Pre-filled syringes, auto-injectors, and inhalers offer user-friendly administration methods.
• Reduced healthcare costs: Combination products can streamline treatment processes and potentially lower overall costs.

However, ensuring the integrity of the packaging in combination products presents unique challenges:

• Complex design: Integration of different components can introduce potential leak paths.
• Material compatibility: The packaging materials need to be compatible with both the drug and the device.
• Stringent regulations: Regulatory bodies require robust evidence of package integrity throughout the product lifecycle.

Container Closure Integrity Testing of Combination products using MicroCurrent HVLD Technology

PTI's MicroCurrent HVLD technology is a non-destructive and non-invasive Container Closure Integrity Test (CCIT) method that leverages unique voltage characteristics to inspect a wide variety of parenteral products, including complex combination products. This technology is applicable to pre-filled syringes, vials, cartridges, ampoules, BFS, bottles, and pouches. The MicroCurrent HVLD test method can accurately detect the presence and location of defects such as pinholes, micro-cracks, stopper/plunger leaks, non-visible leaks under crimping, and many others.

To ensure Container Closure Integrity, the method scans a non-conductive sealed container using electrode probes. Any defects in the package will cause a resistance differential and alter the current flow within the container. Unlike traditional HVLD technologies, MicroCurrent HVLD uses approximately 50% less voltage and exposes the product and environment to less than 5% of this reduced voltage. This lower exposure voltage not only minimizes the risk to the product but also significantly reduces ozone production during operation. As one of the most sensitive CCI technologies available, it is particularly suited for high-risk combination products.

Benefits Of Microcurrent HVLD Technology

• Non-destructive, non-invasive, no sample preparation
• High level of repeatability and accuracy
• Effective across all parenteral products, including extremely low conductivity liquids
• Low voltage exposure to the product and environment
• Listed in USP Chapter <1207> as recommended method for parenteral liquid package integrity testing .
• 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 automated online inspection