Leak-testing and packaging specialist Sepha (Belfast) is launching a leak tester for container closure integrity testing (CCIT) applications that can detect leaks as small as 1 µm.
Known as the Multi-Q HD, the device supports the non-destructive detection of defects in pharmaceutical containers including parenteral packaging formats, which have experienced growth during the pandemic, thanks to mass-vaccination campaigns.
Even micro cracks and pinholes can negatively impact the shelf life and product efficacy of a range of pharmaceuticals. In terms of parenteral packaging, the Multi-Q HD supports a range of formats including glass or plastic vials, ampules, pre-filled syringes, bottles and blow-fill-seal containers.
Sepha Managing Director Paul Smith noted in a press release that the historic benchmark for CCIT had been 5 μm, but the industry has pushed to “raise the bar for increased integrity test sensitivity.” The trend has only accelerated during the pandemic.
The Multi-Q HD boasts a design that positions the sensor at the point of measurement to optimize response time and sensitivity.
The unit also supports testing in accordance with the ASTM Standard Test Method F2338-09 for vacuum decay, which is consistent with FDA and USP 1207 guidelines.