Cryogenic Ultra-Cold vial testing cell and gene therapy

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 conditions catches the failures that only appear in the cold chain — critical as Thai cold-chain capacity expands.

A vial that passes helium testing at 20°C with a leak rate of 1×10⁻⁹ mbar·L/s can fail at −80°C with a leak rate of 5×10⁻⁷ — three orders of magnitude worse, and now a sterility failure.

Cell and gene therapies and some mRNA products are stored at ultra-cold and cryogenic temperatures. Packaging that seals perfectly at room temperature can develop leaks when the elastomer closure contracts at −80°C or in liquid nitrogen. This study demonstrated helium leak testing of vials under cold and ultra-cold conditions — catching closure failures that only appear at storage temperature. Highly relevant as Thailand's biologics and vaccine cold-chain capacity grows. 

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