Ensuring the integrity of container closures is a critical aspect of pharmaceutical and biotechnology industries. Maintaining the integrity of containers, such as vials, syringes, and cartridges, is essential to preserve the quality, efficacy, and safety of products throughout their entire lifecycle. Traditionally, blue dye testing has been a widely used method to detect leaks and potential breaches in container closures. However, with the ever-evolving landscape of technology and scientific advancements, it is essential to explore and embrace alternative methods that offer higher sensitivity, reliability, and efficiency.
In this blog, we will explore cutting-edge container closure integrity testing methods that go beyond the limitations of blue dye testing. While blue dye testing has served as a valuable tool for detecting gross leaks, it may not be sufficient to detect micro-leaks or hairline cracks that could lead to potential risks during storage, distribution, and administration of pharmaceutical products.
Non-destructive CCI testing methods offered by PTI:
1. Microcurrent HVLD Technology
High Voltage Leak Detection (HVLD) is a non-destructive and non-invasive container closure integrity test (CCIT) used to assess the closure integrity of parenteral product packaging, such as pre-filled syringes, vials, cartridges, ampoules, BFS, bottles, and pouches. By employing quantitative electrical conductivity measurements, this technique allows for non-destructive testing of packages.
The HVLD method involves passing micro-current signals through the sample packages. If there is a leak in the package, the electrical resistance of the sample decreases, leading to an increase in current flow. The newer MicroCurrent HVLD technology operates using approximately 50% less voltage and exposes the product and surrounding environment to less than 5% of the voltage compared to traditional HVLD solutions. This makes it a more efficient and safer option for evaluating packaging integrity in pharmaceutical and medical applications.
2. Vacuum Decay technology
Vacuum Decay has proven to be an exceptionally effective technology for detecting leak paths and ensuring the integrity of packages. One of its key advantages is the ability to provide quantitative, deterministic, and reliable test results without causing any damage to the containers being tested. The process involves placing the packages in a meticulously fitted evacuation test chamber connected to an external vacuum source. Throughout the testing, the vacuum levels are constantly monitored to detect any deviations from the predetermined target vacuum level. If a package has defects, air will escape, leading to a noticeable change in the chamber vacuum level. Conversely, non-defective packages will retain the air, ensuring the chamber vacuum level remains constant. The versatility of this method is remarkable as it can accommodate a wide range of packaging formats, including filled and sealed rigid, semi-rigid, and flexible packages made from both non-porous and porous materials.
3. Helium Leak Detection Technology
Helium leak testing is the method of locating leaks in various enclosed or sealed systems by using helium as a "tracer" gas and measuring the concentration of the gas as it escapes due to a leak. Helium is used as a tracer gas because it is non-toxic, non-flammable, and non-condensable, and its atmospheric concentration is less than 5 ppm. Helium, as the second-smallest molecule in the periodic table, can flow through practically any defect or openings. Furthermore, because it does not react with other compounds, helium is relatively safe to use. To find and measure the leak, a mass spectrometer leak detector (MSLD), also known as a helium leak detector, is used.
4. Volumetric Imaging Technology
The OptiPac One-Touch Tool-less technology is intended for non-destructive leak detection of blister packages. To identify leaks, the OptiPac uses volumetric imaging technology to measure the motion of a blister package under vacuum. With new blister package formats, the interface is practical and straightforward to set up, requiring no tooling changeover or extensive parameter modifications as seen with previous non-destructive blister package integrity testing systems. The system collects volumetric data from each cavity, responding to variable cavity shapes, sizes, and configurations of various blister pack forms.
In conclusion, as the pharmaceutical and biotechnology industries strive to ensure the highest standards of container closure integrity, it is evident that traditional blue dye testing alone may not be sufficient to detect all potential risks. Fortunately, cutting-edge container closure integrity (CCI) methods offer superior sensitivity, reliability, and efficiency, surpassing the limitations of blue dye testing.