In earlier times, container closure integrity testing was not regarded as an essential step in the process of manufacturing. The company developing drug product through such an intense process, use to consider container closure system only for packaging of the product. However, gradually it was realized that container closure integrity is a key factor that maintains product stability and sterility throughout its shelf life. Even a single failure in integrity of container closure system can directly impact patient’s health and safety. In fact, a compromised container closure system can act as a vehicle for microbial transmission and pose a significant risk to patient safety. Thereafter, high quality standards were set for packaging and closure of such containers by the regulatory bodies. Over the time, several stringent regulatory guidelines were put in place after learning about the consequences that could happen if the container closure system is defective. The history container closure integrity testing is mentioned below:
Probabilistic methods are considered conventional method as testing is performed through visual inspection. This eventually resulted in reduced usage of probabilistic methods, primarily because it does not produce reliable results. Other disadvantages are represented below:
Considering the challenges associated with the probabilistic methods, the pharmaceutical companies shifted towards deterministic testing methods. This has resulted in the change in the landscape of container closure integrity testing technology, which led to emergence of the new technologies, including headspace analysis and high voltage leak detection methods, with wide range of applications. These deterministic test methods are proven to overcome significant inefficiencies related to probabilistic methods. These deterministic methods can identify leaks with greater efficiency and yield quantifiable results. These methods have the ability to detect small holes. Further, advantages are mentioned below:
Despite the advantages of deterministic methods, these methods are not capable of generating efficient results for complex container systems. The testing for these container closure systems requires new approaches for the quality assurance. Therefore, companies are expected to invest more of their time and effort for further advancement of these methods that have the ability to test various type of container systems and provide greater sensitivity, reliability and accurate results.
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