An Industry-Leading Testing Lab Supporting Pharmaceutical and Medical Device Manufacturers with Deterministic CCIT as Regulatory Demands Rise
SAN JOSE, Calif., June 8, 2026 — WESTPAK, Inc., a trusted partner to the pharmaceutical and medical device industries for more than 40 years, today announced the addition of Vacuum Decay Container Closure Integrity Testing (CCIT) to its portfolio of specialized package testing services. This capability is delivered using the Sepha Multi-Q CCIT system, developed and manufactured by Sepha Ltd. Performed in accordance with ASTM F2338, the new service gives manufacturers immediate access to a deterministic, nondestructive, and fully defensible leak-detection method—without the capital investment required to establish the capability in-house.
Meeting the Demand for Deterministic Testing
Regulatory pressure to move away from subjective, destructive methods—such as dye ingress and water bath testing—has accelerated across the pharmaceutical and medical device sectors. The FDA, USP, 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 smallbatch production runs where product preservation is paramount.
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 bridging legacy methods to modern deterministic technologies. Because 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—developed and manufactured by Sepha Ltd—with expert method development and independent validation support.
Learn More
Learn more about WESTPAK’s Vacuum Decay Container Closure Integrity Testing (CCIT) at https://westpak.com/testing-services/reliability/container-closure-integrity-testingccit/
About WESTPAK
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, California, WESTPAK offers a comprehensive suite of 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. For more information, visit www.westpak.com.
# # #
Media Contact:
Lesia Ivzhenko | Marketing Manager
WESTPAK, Inc. | [email protected]
(415) 802-3479 | www.westpak.com
More information