Preventing Catastrophic Failure In Biobank Systems

Following the publication of a report investigating the devastating cryogenic freezer failure at the Karolinska Institutet (KI) in Sweden over Christmas 2023, storage facilities worldwide will be scrutinising their systems. We discover what went wrong and outline how Biovault protects against similar events.

THE “CHAIN OF SHORTCOMINGS” AT KI AND NEXT STEPS

An estimated 34,400 biobank samples were destroyed at KI between 22nd and 27th December 2023 when temperatures rose unnoticed in 16 cryogenic tanks. The samples represent decades of research material and years of research work.?

The investigation report, led by KI's head of security and published earlier this month, concluded that: "the accident did not occur due to a single event or source of error but a combination of several." Recommended measures focus on creating "a robust freezing infrastructure with a clear division of responsibilities." These include staff training and contingency planning. The report specified a "round-the-clock on-call service" for storage freezers and other business-critical elements.

ENSURING SYSTEM INTEGRITY AND RESILIENCE?

Like KI, Biovault stores and processes human samples for crucial medical research. However, we are also an NHS partner, meaning that any system failure could have immediate and terrible consequences for patients.??

In our experience, secure human tissue storage and processing depend upon:

• a committed team
• rigorous accreditation standards
• resilient power supplies
• complex continuous system monitoring
• a robust records system.?

5 KEY WAYS BIOVAULT PROTECTS AGAINST SYSTEM FAILURE

We adopt the best available security and safety measures in every area of our facility, beginning with a highly committed and experienced team. We have eliminated all single points of failure, making our highly regulated and active facility one our partners can trust.

1. A dependable team?Safe and successful human tissue processing demands a unique skill set. Our programme of regular peer and group assessments and relicensing regimen ensures optimum competence and enables team support.
2. A JACIE-accredited processing facility?JACIE represents the highest industry standards and is Europe's only official accreditation body in the haematopoietic stem cell transplantation (HSCT) and cellular therapy fields.?
3. 24/7 temperature monitoring?Remote monitoring, automated call-out systems, and 24-hour on-call staff mean samples are in the safest hands. Our independent call and email warnings are tested?quarterly and are made continuously until the issue is rectified.
4. Independent?nitrogen and power?supplies?Each freezer has its own supply independent of the main tank, which is checked daily to avoid supply problems or overfilling. An Uninterruptible Power Supply system, generator supply capability, and liquid gas backups mean we can guarantee continuity of service.
5. Cutting-edge quality management systems?The HTA and JACIE regularly audit our QMS, which is fully integrated into our bespoke LIMS (Laboratory Information Management System). Our QMS is backed up to several locations, all protected by our accredited supplier.?

CONTINGENCY SUPPORT FOR OTHERS

Biovault offers bespoke contingency planning and support, whether in a forward-facing manner or as an immediate corrective action to an incident affecting your programme.

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