Pharmaceutical leak detection

Sepha, specialist in leak test solutions for the pharmaceutical packaging industry, has introduced new 3D leak detection technology for pharmaceutical blister packs. Aimed at pharmaceutical manufacturers, the new technology incorporates a 3D sensor to provide volumetric measurement to assess the integrity of a range of pharmaceutical solid dose and flexible barrier packaging.

The first application of the new technology will be released with Sepha’s latest model of non-destructive blister leak testers, the VisionScan 3D. This next generation machine will use the 3D technology in combination with differential pressure and vacuum to detect leaks in individual blister pockets as low as 5µm (pack and material dependent). The new technology can be applied to all foil types, matt or gloss, and different text patterns can be tested with one setting, making it ideal for production lines with multiple language variations. 

The VisionScan 3D and 3D technology have been developed for use within pharmaceutical packaging operations and in R&D environments. Philip Cooper, Sepha’s Head of Technology and New Product Development, comments: “We have been developing this technology for the past 12 months in response to customer demand for a non-destructive blister leak test solution that makes it easy to test different pack configurations with one setting. Validation and performance qualification processes can be time consuming, especially when different foil types are involved. Our 3D technology also allows for easy calibration and quick setup times to streamline the validation process”.

The VisionScan 3D is a non-destructive, deterministic leak detection device that uses the principle of vacuum deflection according to ASTM standard F3169-16. Compared with previous models (including the Blister Scan and VisionScan) this test principle has not changed. It is the new measurement technique, the 3D sensor that now creates the profile. The test area of the VisionScan 3D (297x210mm) is large enough to cover and simultaneously test all blisters produced in one index of a typical blister line platen plate. Once the blister packs are placed inside the test area, the pack locations are automatically identified, and the test can begin.

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