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Pharmaceutical Leak Testing Practices challenged by SEPHA
Date:5/4/2010

t the technical excellence associated with modern pharmaceutical manufacturing. The subjective nature of this test and variance in set-up across packaging lines can lead to validation issues. This results in needless destruction of good packs and an intensive reliance on the operator.” explains Sepha Product Manager, Phil Stevenson.

Sepha has developed fully validatable alternatives to the Methylene Blue Dye test. For sachets and pouches PakScan is a machine that tests multiple packs using load cells to measure the force generated by the packaging under vacuum. PakScan machines are designed to isolate this force, measuring peak force and rate of change to establish presence of both large and small holes down to 10 micron.

For blister packs, which require multiple load cells for a single pack constraining machine capacity, flexibility and ease of calibration, Sepha has developed Blisterscan. This utilises a single laser to move across the blister pockets measuring their deflection and enhancing these changes by altering the pressure levels during testing. This system allows multiple packs to be tested in a single test making the blue dye test methodology obsolete.

Along with the cost benefits BlisterScan and PakScan provide they also produce useful batch data that can be used by manufacturers to monitor their performance and improve their line efficiencies.

“The real cost of running the Blue Dye Test is seen only when the cost of disposing the waste (financial and environmental) and lost production is considered. For example one packaging line producing 14 tablet blisters running two 8 hour shifts would waste $4480 per day bas
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