WESTPAK Debuts Vacuum Decay Container Closure Integrity Testing

WESTPAK Inc. has added Vacuum Decay Container Closure Integrity Testing (CCIT) to its specialized package testing services. This capability is delivered through the Sepha Multi-Q CCIT system, developed and manufactured by Sepha Ltd.

Performed in accordance with ASTM F2338, the new service provides manufacturers with immediate access to a deterministic, non-destructive, and fully defensible leak-detection method—without the capital investment required to establish the capability in-house.

“At WESTPAK, our mission has always been to keep pace with the testing needs of the industries we serve. Vacuum Decay CCIT represents the gold standard in container closure integrity testing—deterministic, non-destructive, and fully aligned with today’s regulatory expectations,” WESTPAK President/CEO Nora Crivello stated. “We’re proud to give our clients direct access to this capability, backed by the expertise and independence they rely on us to provide.”

Meeting Deterministic Testing Demand

Regulatory pressure to move away from subjective, destructive methods such as dye ingress and water bath testing has accelerated in the pharmaceutical and medical device sectors. The U.S. Food and Drug Association, US Pharmacopeia, and international guidance documents increasingly call for manufacturers to justify and validate their CCI methodologies. Vacuum Decay answers that call with objective, quantitative results that are repeatable, audit-ready, and capable of detecting leaks down to one micron, depending on the product.

The Sepha Multi-Q CCIT system, operated by WESTPAK, supports a broad range of sterile container systems, including vials, ampoules, prefilled syringes, bottles, and flexible bags—making it well-suited for high-value biologics, sterile injectables, and limited or small-batch production runs where product preservation is paramount, according to the company.

Comprehensive Support Across the Product Lifecycle

Beyond the test itself, WESTPAK provides end-to-end CCIT support, including test method development, sensitivity studies, test method validation (TMV), and assistance in bridging legacy methods to modern deterministic technologies. Since WESTPAK operates as an independent, third-party laboratory, the data generated is unbiased and carries the credibility required for regulatory submissions and audits.

Companies engaging WESTPAK for CCIT can also take advantage of the laboratory’s broader testing capabilities—including package conditioning, transit simulation, ICH stability storage studies, and shock testing—making WESTPAK a single-source partner from development through commercial release.

Unlike in-house implementations or equipment-only solutions, WESTPAK combines the Sepha Multi-Q CCIT system with expert method development and independent validation support.

WESTPAK Inc. is an accredited, independent package testing laboratory with more than 40 years of experience supporting pharmaceutical, medical device, and life sciences companies. Headquartered in San Jose, Calif., WESTPAK offers various testing services—including distribution simulation, package integrity, stability, and container closure integrity testing—delivered with a collaborative, consultative approach and a commitment to fast, reliable turnaround.