This webcast features: Eric Isberg, Vice President, Life Sciences, Savillex

Container integrity is critical when storing and shipping cell therapy products to ensure sterility. The security and durability of the container sealing region(s) should be weighed against usability of the container in clinical settings common to cell therapies. A study was performed to evaluate and quantitatively measure the associated leak rate for the container closure integrity of fluoropolymer bottles per USP <1207> Package Integrity Evaluation – Sterile Products using helium as the tracer. The study showed that bottles made from perfluoroalkoxy (PFA) fluoropolymer maintained integrity with as little as 17.5 in lb of closure torque, which is approximately hand tight.

Key takeaways include:

• Seal integrity must be weighed against usability in clinical settings
• A method for testing bottles for container closure integrity using USP <1207>
• Fluoropolymer bottles can have validatable closure integrity even when hand tightened

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