In pharmaceutical packaging, ensuring the integrity of containers is paramount to maintaining product safety and efficacy. Various technologies and methods are employed for package integrity testing, with MicroCurrent High Voltage Leak Detection (HVLD) emerging as a reliable and efficient solution.
MicroCurrent HVLD technology is a non-destructive container closure integrity testing (CCIT) method designed to detect leaks in sealed pharmaceutical containers, such as vials, ampoules, and syringes. Unlike traditional methods like dye ingress testing or visual inspection, which may be destructive or less sensitive, MicroCurrent HVLD offers a high level of sensitivity without compromising the integrity of the package.
The technology operates by applying a high voltage potential across the container and monitoring the resulting electrical current. When a breach or defect is present in the container's seal, the electrical current will deviate from the baseline, indicating the presence of a leak. The sensitivity of MicroCurrent HVLD allows it to detect leaks as small as microns, ensuring that even minute defects are identified.
Role of MicroCurrent HVLD Technology in Pharmaceutical Package Integrity Testing
MicroCurrent HVLD technology plays a crucial role in pharmaceutical package integrity testing by offering enhanced sensitivity, allowing for the detection of even the smallest defects in packaging to mitigate the risk of product contamination or degradation. Its non-destructive testing capability ensures that tested products remain intact, facilitating their seamless progression through the manufacturing process. Additionally, the high throughput nature of MicroCurrent HVLD systems enables efficient testing of large volumes of pharmaceutical containers, making it scalable to meet high production demands. Furthermore, its compliance with regulatory standards ensures adherence to requirements for product quality and safety, while its cost-effectiveness, despite initial investment, leads to long-term economic benefits through the prevention of product loss and reduced need for retesting.
List of E-Scan Technologies offered by PTI
1. E-Scan 605: The E-Scan 605 is an entry-level solution ideal for basic container closure integrity (CCI) testing, providing rapid PASS/FAIL test results. Featuring single-channel operation and manual loading/unloading, it offers a compact footprint suitable for low- to medium-volume testing needs.
2. E-Scan 615: The E-Scan 615 is the ideal instrument for laboratory R&D QC testing and product quality monitoring of parenteral products. Testing takes literally seconds and provides operators with PASS/FAIL and supporting quantitative data
3. E-Scan 655: The E-Scan 655 is intended for in-depth analytical container closure integrity testing of parenteral products. Location defect identification is possible along with quantitative data and PASS/FAIL.
4. E-Scan RTX: Fully automated container closure integrity testing with robotic pick & place hangling. Ideal for automation it the laboratory and production line settings.
In summary, PTI's E-Scan series offers a range of MicroCurrent HVLD solutions catering to diverse pharmaceutical packaging needs, ensuring precise integrity testing while prioritizing efficiency, safety, and compliance with regulatory standards. These advanced technologies represent a pivotal step forward in safeguarding product quality and patient safety within the pharmaceutical industry.