What Pharma And Biopharma Should Know About Container Closure Integrity

By Martin Gabler and Christian Kolić

Ensuring patient safety with the production of flawless medication is of utmost importance to pharmaceutical and biopharmaceutical manufacturers. Injectable products, in particular, must be essentially free from viable microbial contamination, which could result from defects in the container closure system. Using appropriate Container Closure Integrity Testing (CCIT) methods can significantly lower the risk of such defects, therefore minimizing contamination.

Various regulatory bodies have established guidelines for proper CCIT. The testing techniques are categorized into probabilistic methods and deterministic methods. Key factors that influence the choice of CCIT technology for pharmaceutical companies include test duration, the size of detectable leaks, and the potential impact on the product. While numerous methods are suitable for laboratory evaluation or testing, only High Voltage Leak Detection (HVLD), Headspace Analysis (HSA), and vacuum and pressure decay are appropriate for commercial production. Explore these four methods in more detail as applied in pharmaceutical manufacturing.