Do you want to ensure optimal biobanking?
What can you do to protect your unique collection and minimize the risks, so you can be ready to act and recover when the unforeseen happens? Risk mitigation, redundancy and monitoring can help.
One of the worst nightmares a biobanker can face is the loss of samples that have been collected over many years due to disasters occurring. Earthquakes, flooding and other nature driven forces, human error or mechanical failures, have had devastating effects for several biobanks around the globe in the last decade.
During the construction or build up phase of the biobank, it is wise to invest time and resources in a thorough risk analysis, to build the infrastructure that can support operational continuity. An assessment of specific situations that are sometimes unique for a site (for instance earthquakes, lightning or hurricanes), helps to understand how to lower the risk. For example, biobanks are often located in the basement for cost reasons, but this needs a qualification of the risk for flooding.
Facilities should be qualified to address situations like flooding, backup power and emergency storage. In addition, instruments (refrigerators and freezers) should be performance qualified, to satisfy the appropriate regulatory agencies (IQ, OQ, PQ). Furthermore, a sample relocation plan should also be included in your business continuity plan or strategy document.
The aforementioned risks caused by nature have in many cases resulted in power failure, or freezers breaking down. These failures could also arise due to technical reasons, and that leads us to the second topic of redundancy.
Back up storage units that are already at the right temperature, have ample reserve of LN2, dry ice and generator fuel on site are critical. These measures sound obvious but surprises can still occur. One biobank shared that they had all the correct backups in place but didn’t have the required documents with the fuel provider. As a consequence when a hurricane hit and procedures needed to start, the biobank was not on the critical list to be resupplied. Continuous improvement of the cold storage solutions offered is in place to help assure stability and reliability of the range.
The statement “To further learn and improve, you need to measure” is also true for biobanks. Understanding at any time of the day the storage conditions of your samples being automatically notified with alarms for out-of-bounds conditions and technical problems can really help put your mind at ease.
Active and regular monitoring beyond only temperature, but also on relative humidity and/or CO2 concentration, supports to identify issues at an early stage, or even prevents them from happening altogether. Secure data logging and automatic audit trials support regulatory compliance, where in addition it can help the biobank to identify issues quickly and prevent real damage to highly valuable samples.
Everyone involved in life science research relies on human samples stored in biobanks. This is where science meets treatments and goes beyond just talking about vials or storage conditions. Collections represent a life’s work, potentially having enormous impact on patient treatments. With so much at stake, we can’t afford not to prepare for the unexpected.