Pharmaceutical packaging serves as the first line of defense against contamination, preserving drug quality and ensuring patient safety. The primary objectives of pharmaceutical packaging include protection against environmental factors such as moisture, oxygen, and light; preservation of sterility and stability; communication of critical information like dosage and usage instructions; and convenience to enhance usability and compliance for patients and healthcare professionals. Primary packaging components like vials, ampoules, and pre-filled syringes are particularly susceptible to breaches in integrity, underscoring the need for robust testing methods.
Role of Container Closure Integrity in Pharmaceutical Package Inspection
Container Closure Integrity (CCI) ensures that a pharmaceutical package is sealed properly to prevent leakage, microbial ingress, and contamination. Regulatory authorities, including the FDA and EMA, mandate stringent CCIT testing protocols to validate the efficacy of packaging systems.
Traditional CCI testing methods include the bubble test, which involves a visual inspection for air bubbles indicating leaks and the dye Ingress test, which detects leakage by introducing dye into the packaging. While effective, these methods have limitations in sensitivity and are often destructive, resulting in the loss of valuable samples.
Pharmaceutical Package Inspection Using MicroCurrent HVLD
PTI's MicroCurrent HVLD technology is a unique High Voltage Leak Detection Technology for container closure integrity testing that is found to be highly effective across applications such as pre-filled syringes, vials, cartridges, ampoules, BFS, bottles and pouches. It is a non-destructive, non-invasive technology that utilizes about 50% less voltage and exposes the product and environment to less than 5% of the voltage when compared to conventional HVLD solutions. It is one of the most effective CCI technologies for all parenteral and biological products.
The technology employs a non-contact, non-invasive test method that does not necessitate sample preparation. PTI’s E-Scan technology is compatible with a variety of liquid-based products, including low conductivity sterile water for injection (WFI) and proteinaceous products with suspensions. To accommodate a wide range of products and applications, this technology includes a fast test cycle, simple operation, quick changeover, and easy recipe setup. In addition, the E-Scan MicroCurrent method can be migrated from laboratory to automated production line testing applications.
MicroCurrent HVLD is revolutionizing leak detection in pharmaceutical packaging by providing a non-destructive, highly sensitive, and efficient testing solution. As regulatory demands grow and the pharmaceutical industry continues to innovate, adopting advanced CCIT technologies like MicroCurrent HVLD is essential for ensuring drug safety and efficacy. Embracing this cutting-edge technology not only enhances product integrity but also strengthens patient trust in pharmaceutical products.