When it comes to pharmaceuticals; container closure integrity is not just a quality control measure; it’s about patient safety. Gateway Analytical’s spotlight on Container Closure Integrity Testing (CCIT) underscores the significance of these tests in maintaining the sterility and efficacy of pharmaceutical products. Our innovative techniques and technologies stand at the vanguard of ensuring your packaging adheres to the strictest quality controls. Container closure systems are the first line of defense in protecting pharmaceutical products from external contamination and maintaining their sterility. A breach in this barrier can compromise product efficacy, leading to potentially severe consequences for patient health. CCIT, therefore, is an essential component of pharmaceutical quality assurance, ensuring that each container closure system is impervious to contaminants and maintains the product’s integrity throughout its shelf life.
At Gateway Analytical, we employ a suite of advanced CCIT methodologies, each designed to detect even the most subtle indications of container closure system failures. Our techniques, including vacuum decay, laser-based gas headspace analysis, and microcurrent high-voltage leak detection (HVLD), are at the forefront of CCIT technology. These non-destructive, deterministic methods provide quantitative data that is critical for making informed decisions about product safety and efficacy. Our vacuum decay method stands out for its sensitivity and reliability in detecting leaks. By creating a vacuum around the container system and monitoring for any decay in vacuum level, we can precisely identify leaks that could compromise product sterility. This method is particularly suited for a wide range of container formats, including vials, syringes, and flexible packaging. Laser-Based Gas Headspace Analysis: Precision in Every Measurement Laser-based gas headspace analysis is another cornerstone of our CCIT capabilities. This technique measures the concentration of gases like oxygen or carbon dioxide within the headspace of sealed containers, providing insight into the integrity of the seal. It’s an invaluable tool for ensuring the quality of products, especially those requiring stringent oxygen-sensitive environments.
Microcurrent HVLD: Cutting-Edge Leak Detection Our microcurrent HVLD technology offers a non-destructive approach to detecting leaks in liquid-filled containers. By applying a high-voltage, low-amperage current across the container, this method can pinpoint the location and presence of leaks with unparalleled accuracy. It’s an ideal solution for products stored in glass or semi-rigid containers.
Compliance with regulatory standards is a cornerstone of our CCIT services. Our methodologies are aligned with the stringent requirements of regulatory bodies, ensuring that your products not only meet but exceed the necessary safety and quality benchmarks. With our deep understanding of regulatory landscapes, including adherence to USP 1207, we provide peace of mind that your products are in full compliance.
In the critical pursuit of pharmaceutical quality and patient safety, CCIT plays an indispensable role. Gateway Analytical’s spotlight on CCIT showcases our commitment to advancing pharmaceutical safety through innovative testing solutions. Our cutting-edge techniques, coupled with a deep regulatory understanding, position us as your trusted partner in ensuring the highest quality standards for your packaging.
Explore how Gateway Analytical can support your journey to market. With over a decade of expertise in parenteral testing, we cover a broad range of services from process and formulation development, product-package validation, clinical & commercial manufacturing, to visual inspection, quality control, and release testing. Reach out to our experts at (724) 443-1900 or info@gatewayanalytical.com, or feel free to visit our contact page to connect with us!
