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Leak Detection Methods for Pharmaceutical Blister Packs

By Sepha

Detecting leaks in blister packaging has traditionally involved a destructive process, but non-destructive methods, which do not result in wasted products, have emerged as viable alternatives.

It’s clear that the time has come for a re-evaluation of current testing methods.

Leak testing is a fundamental part of ensuring product integrity. It is not only critical in terms of assessing product shelf-life and efficacy, but is also a Food and Drug Administration (FDA) regulatory requirement as specified in current good manufacturing practice (cGMP) 21 Code of Federal Regulations (CFR) 211.166 for finished pharmaceuticals.

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