WESTPAK has expanded its package testing portfolio with the introduction of Vacuum Decay Container Closure Integrity Testing (CCIT), strengthening its capabilities in non-destructive inspection and leak detection for pharmaceutical and medical device manufacturers.
The new service is delivered using the Sepha Multi-Q CCIT system and is performed in accordance with ASTM F2338 standards. The addition provides manufacturers with access to a deterministic, non-destructive leak detection method designed to support increasingly stringent regulatory requirements surrounding container closure integrity testing.
Container closure integrity testing plays a critical role in ensuring the sterility and safety of pharmaceutical and medical products. As regulatory agencies continue to encourage the adoption of deterministic and scientifically validated testing approaches, the demand for advanced inspection technologies has grown across the industry.
The Vacuum Decay CCIT method enables objective and repeatable leak detection while preserving product integrity during testing. The technology is capable of identifying leaks as small as one micron, depending on the application, making it suitable for high-value biologics, sterile injectables, and other sensitive pharmaceutical products.
“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. We’re proud to give our clients direct access to this capability, backed by the expertise and independence they rely on us to provide.” — Nora Crivello, President and CEO, WESTPAK
The newly introduced service supports a wide range of sterile container systems, including vials, ampoules, prefilled syringes, bottles, and flexible bags. By utilizing non-destructive testing principles, manufacturers can evaluate package integrity without compromising the product, an increasingly important requirement for limited production batches and high-value medical products.
Beyond testing services, WESTPAK also offers support for test method development, sensitivity studies, Test Method Validation (TMV), and the transition from legacy inspection methods to modern deterministic technologies. The company noted that operating as an independent third-party laboratory provides customers with unbiased data suitable for regulatory submissions and audit requirements.
The addition of Vacuum Decay CCIT further strengthens WESTPAK’s role in supporting quality assurance and package integrity verification throughout the product lifecycle. Manufacturers can also integrate CCIT services with WESTPAK’s broader testing capabilities, including package conditioning, transit simulation, stability storage studies, and shock testing.
As pharmaceutical and medical device industries continue to adopt advanced non-destructive testing methodologies, the introduction of Vacuum Decay CCIT reflects the growing emphasis on reliable, repeatable, and regulatory-compliant inspection solutions for critical packaging applications.
Reference: https://www.medicaldesignandoutsourcing.com/westpak-adds-vacuum-decay-ccit-testing-service/
