Leak-testing and packaging specialist Sepha has achieved micro leak detection down to 1µm with the development of a new high performance leak tester for CCIT (Container Closure Integrity Testing) applications.

Utilizing the vacuum decay test method, the new Multi-Q HD enables ultra-sensitive, non-destructive detection of defects in pharmaceutical containers. This enhanced testing functionality responds to demand Source: Sephafrom parenteral formats, which are experiencing unprecedented growth on the back of international COVID-19 vaccination programs.

Building on Sepha’s established Multi-Q leak testing platform, the Sepha Multi-Q HD is a standalone, lab-scale leak test system that can be used in combination with interchangeable attachments to fit the full range of parenteral container types available on the market. These include glass or plastic vials, ampoules, pre-filled syringes, bottles and blow fill seal containers. Its compact, bench-top design means it can be used in the lab during drug development or for in-process batch testing to verify the integrity of containers being manufactured on the production line.

Whilst the Multi-Q HD can be configured to perform a variety of non-destructive, deterministic tests, such as pressure decay, Sepha expects that it will primarily be used for applications that require a vacuum decay test. The Multi-Q HD allows manufacturers to test in accordance with the ASTM Standard Test Method F2338-09 for vacuum decay in line with U.S. Food and Drug Administration consensus and USP 1207 guidelines. This non-destructive and deterministic test method provides quick, reliable and repeatable results without any damage to the product or packaging.