Container closure integrity (CCI) is a critical focus for regulatory agencies, demanding rigorous standards for ensuring the safety and efficacy of your injectable and parenteral products. Recent revisions to USP <1207>, EU GMP Annex 1, and the upcoming modifications to USP <382> highlight the importance of adopting deterministic CCI methods and validated testing solutions on your journey to market.
The Importance of Deterministic CCI Methods
Regulatory agencies now expect therapeutic developers and CMOs/CROs to implement deterministic CCI methods for new injectable and parenteral package systems. One such process, HVLD, is a non-destructive testing method that uses high voltage to detect leaks in pharmaceutical packaging. The technique works by applying a high voltage potential to the outside of a specialized container while the interior area is grounded. If there is a defect or leak, the high voltage will create an electrical current that can be detected, indicating a breach in the package integrity. These methods offer high sensitivity and accuracy, making them ideal for detecting even the smallest inconsistencies. By integrating these techniques, manufacturers can ensure their packaging systems meet the highest standards of leak tightness and safety.
Key Revisions in USP <1207> and USP <382>
The revisions to USP <1207> and the new USP <382>, effective December 2025, emphasize the need for validated CCI methods. These updates reflect the need for a comprehensive analytical approach to package system integrity, covering aspects such as:
Functional Testing: Testing protocols designed to ensure that packaging systems perform effectively under various conditions.
Functional Suitability: Testing protocols designed to assess the package’s ability to maintain its integrity throughout its lifecycle.
Maximum Allowable Leakage Limit (MALL): Testing protocols designed to help define acceptable leakage rates to ensure product safety.
Inherent Integrity: Testing protocols designed to evaluate the inherent robustness of the packaging system.
Adopting a Lifecycle Approach
Ensuring the integrity of your package and delivery systems remain a critical component of regulatory compliance. At Gateway Analytical, we emphasize our lifecycle approach that integrates integrity testing seamlessly across development, validation, and routine processes. This proactive strategy not only meets regulatory expectations but also safeguards product quality and patient safety at every stage. This involves:
Development: Selecting appropriate leak test methods and CCI methods during the product development phase.
Validation: Validating these methods to ensure they meet regulatory standards and are capable of detecting leaks accurately.
Routine Testing: Implementing these validated methods during product release and stability testing to ensure ongoing compliance.
Gateway Analytical is here to support your needs in achieving functional suitability and package/delivery system integrity. With our expertise and advanced analytical methods, we can help you navigate the complexities of CCI and ensure your products meet the highest standards of quality and safety. Contact us at (724) 443-1900 or info@gatewayanalytical.com, or visit our contact page to connect with us.
