In the world of pharmaceutical packaging, where patient safety is non-negotiable, Container Closure Integrity Testing (CCIT) serves as a crucial safeguard. From sterile injectables to biologics and combination products, the integrity of a container-closure system can be the fine line between safety and risk. But as companies strive to optimize production efficiency, a recurring question emerges—how do we balance speed and sensitivity in package integrity testingpackage integrity testing, especially for high-risk applications?
Why Sensitivity Matters in High-Risk Applications
Imagine a life-saving biologic that loses sterility due to a microleak. The patient impact could be devastating. This is why sensitivity in CCIT isn't just a technical requirement—it’s a moral imperative.
High-risk products such as injectable biologics, ophthalmic solutions, or combination devices require maximum sensitivity to detect even the tiniest breaches in the container. These products are often sensitive to oxygen, moisture, or microbial ingress, and even a microscopic-defect can compromise their efficacy or safety. Traditional probabilistic methods like dye ingress or bubble emission simply lack the precision required for these applications. That's where deterministic technologies, especially High Voltage Leak Detection (HVLD), step in.
MicroCurrent High Voltage Leak Detection (HVLD) is a non-destructive method used in Container Closure Integrity Testing (CCIT), specifically designed to assess the integrity of parenteral packaging systems. This advanced testing technique is based on quantitative electrical conductivity measurements.
The principle of HVLDmc involves applying a low current signal across the package or container. In the presence of a leak, the electrical resistance of the package drops, leading to an increase in current—signaling a defect. MicroCurrent HVLD is particularly effective for liquid-filled, non-conductive containers and is applicable to a wide range of packaging formats, including:
- Pre-filled syringes
- Ampoules
- Drug product cartridges
- Liquid-filled vials
- Blow-Fill-Seal (BFS) containers
PTI’s MicroCurrent HVLD: Advancing Traditional HVLD Technology
PTI has redefined HVLD with the introduction of its MicroCurrent HVLD technology—a highly sensitive, non-invasive, and non-destructive CCIT method. This innovative approach extends the capabilities of conventional HVLD by using significantly lower voltages and currents, making it safer for delicate drug products and sensitive environments.
MicroCurrent HVLD is particularly suitable for testing liquid-filled containers, including challenging formulations such as low-conductivity sterile water for injection (WFI) and protein-rich drug suspensions.
PTI’s E-Scan HVLD system employs electrode probes to scan sealed, non-conductive containers. When a breach is present, the resulting variation in current flow identifies both the presence and approximate location of the defect. One of the key advantages of this technique is its ability to use approximately 50% less voltage, reducing product and environmental exposure to less than 5% of traditional HVLD voltage levels.
Moreover, the E-Scan HVLD system offers unmatched flexibility, seamlessly transitioning from offline laboratory testing to 100% inline automated inspection. It supports various packaging materials, including glass, plastic, and poly-laminate containers, making it an ideal solution for comprehensive parenteral package integrity testing.
Benefits of MicroCurrent HVLD:
- Deterministic, non-destructive, non-invasive
- High level of repeatability and accuracy
- Ideal package integrity solution for parenteral products
- Low voltage exposure to the product and environment
- Offline and 100% online inspection
In high-risk pharmaceutical applications, the choice between speed and sensitivity shouldn’t be a binary one. Instead, the goal should be to find a solution that optimizes both. Technologies like MicroCurrent HVLD offer a way forward—providing the precision required to detect critical defects, without sacrificing the throughput needed to meet production demands.