Package integrity is defined as a package’s ability to prevent product loss, maintain product sterility, and in some cases, prevent oxygen ingress or maintain sub-atmosphere headspace pressures. As a result, container closure integrity testing is an important step in the preparation and transportation of many different products. Unlike other mass produced devices, blood filters, catheters, diagnostic probes, syringes, ventilator tubes and other items must meet strict requirements set by the Food and Drug Administration (FDA).
Last fall the United States Pharmacopeia (USP) released the proposed revisions to general chapter Sterile Product Packaging – Integrity Evaluation <1207> for public comment in the Pharmacopeial Forum. USP <1207> is designed to offer guidance on container closure integrity leak testing methods and qualification. While the document isn’t regulatory or prescriptive, the USP Package Integrity Expert Panel has considerably expanded the original, which was brief, outdated and filled with high level information. The proposed revision now provides more information on additional leak detection methods to help users identify which options might work best for them by dividing their choices into two sub-groups: deterministic and probabilistic. A few of the methods included in the chapter are non-destructive and can be used on product packages meant for distribution, factors representing a shift in industry tactics.
USP <1207> defines deterministic technology as a method that is less subject to error, particularly human error. Typically, this means that it uses leak testing equipment, requires less package preparation, and offers quantitative outcomes. One example of a deterministic method that is non-destructive would therefore be mass extraction, in which a sample is sealed into a closed chamber, creating a vacuum. Once the vacuum is established, leak detection equipment is used to monitor the amount of airflow required to maintain this state, with the amount of flow required to keep the vacuum steady equal to the amount of flow escaping from any leaks. The method requires that specific test parameters be set and monitored, but the leak detection method will report results quantitatively, can be applied to a wide variety of products, and requires little preparation to the object itself.
In contrast, probabilistic methods are highly subject to error, and include several traditional leak detection systems used by the pharmaceutical industry. Leak testing experts agree that these tests have their place when they are properly applied; however, the Panel agrees that probabilistic testing should not be used to establish the inherent integrity of a package.
These changes represent the potential for long-term savings, safety and more. The proposed revision opens up the way for achieving better product safety and protection for consumers by embracing newer and more updated technologies. The mass extraction method is a leak detection technology that ATC specializes in. Contact ATC for more information.