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The analytical services team has vast expertise and experience in extractables and leachables, particle analysis, container closure integrity, and performance and packaging/delivery systems among other methodologies. As a result of our understanding of materials and delivery systems and their compatibility with the drug product, we can assist our customers in designing studies and in navigating the challenging and evolving regulatory landscape.
West Services and Solutions, LLC, a subsidiary of West, manages and performs the tests described above.
Container closure integrity (CCI) has been a fundamental core requirement of containment and delivery solutions in the West product portfolio. Container closure systems (CCSs) must maintain both the sterility and stability of pharmaceutical products; very importantly they must be free of microbial contamination. Microbial ingress into a CCS will jeopardize product sterility.
Particles in an injectable drug product represent a huge risk not only to patient safety – but also to a drug company’s reputation and bottom line. Presence of visible or sub-visible particles has been one of the most common reasons for recalls. According to the FDA Recalls, Market Withdrawals, & Safety Alerts database, 23 of 59 (39%) recalls, market withdrawals, and safety alerts between 2018 and 2020 were due to particulate contamination1.
For vial containment and pre-filled syringe systems, it is essential to maintain drug sterility over shelf life. Ordinarily, such maintenance comprises prevention of ingress of oxygen, water, and microbes. To demonstrate this, it is essential to perform "container closure integrity testing” (CCIT), or leak testing.
Container closure integrity (CCI) has been a fundamental core requirement of containment and delivery solutions in the West product portfolio. Container closure systems (CCSs) must maintain both the sterility and stability of pharmaceutical products; very importantly they must be free of microbial contamination. Microbial ingress into a CCS will jeopardize product sterility.
Particles in an injectable drug product represent a huge risk not only to patient safety – but also to a drug company’s reputation and bottom line. Presence of visible or sub-visible particles has been one of the most common reasons for recalls. According to the FDA Recalls, Market Withdrawals, & Safety Alerts database, 23 of 59 (39%) recalls, market withdrawals, and safety alerts between 2018 and 2020 were due to particulate contamination1.
For vial containment and pre-filled syringe systems, it is essential to maintain drug sterility over shelf life. Ordinarily, such maintenance comprises prevention of ingress of oxygen, water, and microbes. To demonstrate this, it is essential to perform "container closure integrity testing” (CCIT), or leak testing.
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