High-risk pharmaceutical products refer to medications and substances that, due to their nature or intended use, pose a higher level of risk to patients and the public. These products often include injectable drugs, biologics, vaccines, and other sensitive formulations that require stringent quality control measures to ensure patient safety and regulatory compliance.
The packaging of high-risk pharmaceutical products presents unique challenges due to the need for exceptional product protection, stability, and, most importantly, containment of the product to prevent contamination. As these products are often administered directly into the body, maintaining the integrity of the container closure system is critical to prevent microbial ingress, oxygen exposure, and other factors that could compromise the drug's efficacy and safety.
Container Closure Integrity (CCI) testing is a vital process within the pharmaceutical industry to verify that the packaging of a product effectively prevents any leakage or contamination. This testing is crucial in ensuring that the pharmaceutical product maintains its integrity throughout its shelf life, safeguarding patient safety and therapeutic efficacy.
MicroCurrent HVLD Technolgy for Testing Integrity of High-Risk Pharma
PTI's MicroCurrent HVLD technology represents a non-destructive and non-invasive approach to testing the container closure integrity (CCI) of various liquid-filled products, including pre-filled syringes, vials, cartridges, ampoules, blow-fill-seal (BFS) containers, bottles, and pouches. This method has proven to be highly effective in ensuring the integrity of container closures in diverse applications.
The technology employs electrode probes to scan sealed containers, aiming to detect any potential leaks. By analyzing changes in the current flow, both the existence of defects in the container and their approximate locations can be identified with precision. This makes the MicroCurrent HVLD technology particularly versatile, capable of detecting leaks in a wide range of liquid-filled products, even those with extremely low conductivity, such as sterile water for injection (WFI) and proteinaceous products with suspensions.
One notable advantage of MicroCurrent HVLD is its efficiency in terms of voltage usage. It utilizes approximately 50% less voltage compared to conventional HVLD solutions, contributing to a more energy-efficient and environmentally friendly testing process. Moreover, the reduced voltage exposure (less than 5% compared to traditional methods) minimizes potential risks to both the product and the testing environment.
Benefits of MicroCurrent HVLD:
- Deterministic, non-destructive, non-invasive, non-subjective
- High level of repeatability and accuracy
- Ideal package integrity solution for liquid filled parenteral products
- Low voltage exposure to the product and environment
- Offline and automated online inspection
- Referenced in USP 1207 guideline
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