White Paper

Eliminate Inspection Labor Costs On Your Blister Packaging Lines

Source: TASI Group: Bonfiglioli Engineering and Sepha

By Giuseppe Bonfiglioli

Production of tablets and capsules is carried out in cleanrooms and under stringent procedures as per GMP requirements. However the process also relies on machines and machine operators whereby misappropriate handling can result in a faulty blister pack containing micro leaks in the packaging thus allowing air and moisture to enter the blister and damage the product. What the Q&A department usually does to make sure blister packs are not leaking. This method is to perform a Methylene Blue Dye Test, which consists of placing a sample blister pack in the methylene blue dye for approx. 1 min after which a vacuum is applied to the container. As soon as the vacuum is released, should there be any hole in the blister pack the dye will replace the air that was sucked out under vacuum. The dye enters the blister and usually the tablet inside is stained with color.

The person performing the test has to check each individual blister manually to see which one contains a leak. This is the most commonly test performed on blister packs. It gives good results however it is messy and destructive and no data can be electronically documented.

Recently an innovative technological concept has been introduced to the pharmaceutical industry whereby Blister packs can be sample tested or even 100% tested for micro leaks. The process is clean, fast, precise and non-destructive.

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TASI Group: Bonfiglioli Engineering and Sepha