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Sepha unveils high performance leak tester for pharma packaging testing

By Pharmaceutical Processing Editor | June 17, 2021

SephaLeak-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.

Multi-Q HD

The Multi-Q HD from Sepha can detect micro cracks and pinholes in pharmaceutical packaging.

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