How do I manage catastrophic failure of liquid nitrogen storage for human cells, tissues, and cellular and tissue‐based products?

Résumé fourni par la source

BACKGROUND: Human Cellular Therapy Laboratories (HCTL) use liquid nitrogen (LN2) tanks to preserve human cells, tissues, and cellular and tissue-based products (HCT/Ps). Continuous monitoring and proactive maintenance of LN2 tanks are critical to ensuring product potency and safety. Contingency planning is necessary to protect irreplaceable HCT/Ps should LN2 storage failure occur. Here we describe the management of 779 hematopoietic progenitor cell products (HPCs) and 7680 ampules from a failing tank in our HCTL. METHODS: A multidisciplinary working group, including HCTL technical staff, management, facilities, healthcare technology management (HTM), and leadership, was established to manage the at-risk HPCs. The group evaluated local resources and engaged geographic partners to support emergency storage relocation. The goal was to maintain temperature integrity, ensure safe transfer, and sustain uninterrupted operations. RESULTS: Over a 72-h period, 779 HPCs and 7680 ampules were relocated to on-site and off-site storage. Collaboration with a local partner provided LN2 dry shippers (DS), allowing transport of approximately 40 HPCs per trip to off-site storage. The operation was completed without loss of product integrity, and clinical operations proceeded uninterrupted. DISCUSSION: Frequent inspection and continuous monitoring of tanks are crucial for early detection of potential failures. Rescuing HPCs from a failing tank is challenging and carries risks to product integrity and staff safety. Careful contingency planning, including access to backup storage, LN2 DSs, and trained personnel, is essential for mitigating catastrophic tank failure.

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