Dye ingress and helium leak detection were tested on identical defective vials. Helium quantified leaks down to single-digit microns. Dye missed most of them entirely. For high-val...
pharmaceutical
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- Cell, gene, and some mRNA therapies are stored at −80°C or in liquid nitrogen. Elastomer closures contract at those temperatures and can lose seal. Helium leak testing at storage c...
- Prefilled syringes filled with viscous biologics are hard to leak-test. MicroCurrent HVLD detects pinholes, micro-cracks, and stopper/plunger leaks using about half the voltage of ...
- Dye ingress was the global standard for decades. It's now being rejected by regulators because it's probabilistic, operator-dependent, and destroys the sample. USP <1207>, AS...
