Ensuring Integrity: The PTI Approach To Container Closure Integrity Testing

Maintaining Container Closure Integrity (CCI) is essential in pharmaceutical manufacturing to protect product sterility, ensure drug stability, and safeguard patient safety. Deterministic CCI testing methods, such as Vacuum Decay, MicroCurrent High Voltage Leak Detection (HVLD), and Helium Leak Detection, offer precise, science-based solutions for evaluating container systems. These approaches go beyond probabilistic methods, delivering accurate and repeatable results that meet stringent regulatory expectations. From early feasibility studies and parameter optimization to validation-ready protocols aligned with USP 1207 and global standards, deterministic testing provides confidence in compliance and quality.

Explore how advanced CCI strategies can help you mitigate risk, streamline processes, and maintain the highest standards for pharmaceutical packaging integrity.