Vial Containment Systems For Gene Therapies: Container Closure Integrity

By Margaret A. Craig, Manager, Scientific Communications, Rui Li, Ph.D., Senior Scientist, R&D, Cryobiology, and T. Page McAndrew, Ph.D., Director, Scientific Communications

Maintenance of container closure integrity (CCI) at ultra-low temperature (approx. -80°C) is a necessity for a gene therapy vial containment system. Systems comprising Daikyo Crystal Zenith® cyclic olefin polymer vials and elastomer stoppers with a FluroTec™ barrier film were evaluated over time in a: (a) refrigerator at -80°C, and (b) dry ice container (-78°C). Excellent performance was observed, and no sample was breached.