Cleveland Clinic Foundation, cleveland, ohio cleveland, Ohio, United States
Background/Case Studies: Relocating liquid nitrogen (LN2) freezers containing cryopreserved hematopoietic progenitor cell (HPC) products presents significant challenges, as these irreplaceable products require ultra-low temperatures to maintain viability. Our hospital Cellular Therapy Laboratory (CTL) planned to transfer approximately 1,000 HPC products from three old LN2 freezers to a vapor-phase LN2 (VP LN2) freezer before permanent relocation to a remote cryogenic storage facility. A structured, well-planned approach was necessary to ensure the integrity of these valuable biological materials.
Study
Design/Methods: A multi-month planning process involved literature review,1 stakeholder engagement across operations, facility engineering, quality & safety, medical, legal, and financial teams, and consultation with the hospital Blood and Marrow Transplant (BMT) team. Three potential relocation strategies were evaluated: (1) internal transfer to existing VP LN2 freezers, (2) relocation of the existing LN2 freezers, or (3) external transfer to a qualified biorepository. The third option was selected.
Following this decision, a formal risk assessment, process validation plan, and logistics coordination were undertaken. BMT leadership was engaged to ensure institutional alignment and patient notification. A vendor was selected as the storage site, and a three-phase relocation plan was implemented: (1) temporary transfer of LN2 freezers to an on-site research biorepository, (2) transfer of cellular products to a new vendor-owned VP LN2 freezer, and (3) relocation of the filled VP LN2 freezer to the vendor biorepository. Inventory control was maintained via a validated freezer manifest, crosschecked against existing CTL records and translated into a de-identified, HIPAA-compliant format for the vendor.
The age of the LN2 freezers being moved was a significant concern, as their wheels were rusted and settled into the floor.
Results/Findings: The relocation was successfully executed with adherence to safety protocols and risk mitigation strategies, ensuring the preservation of all HPC products and safety of personnel handling the relocation.
Conclusions: Relocating LN2 freezers storing HPC products requires meticulous planning, regulatory compliance, and robust contingency strategies. Ensuring continuous temperature control, mechanical stability, and inventory security is critical. By implementing comprehensive risk assessments and mitigation strategies, institutions can safely transport and preserve these vital biological materials.
References
< !1. Reich-Slotky R. How do I transfer liquid nitrogen freezers to a new home safely? Transfusion. 2021;61(8):2234-39. doi:10.1111/trf.16550.
