Maintaining the availability and viability of biological materials and samples for research and development, as well as many other applications, requires standardization for producing, collecting, storing, manufacturing, and distributing these specimens.
Establishing best practices for biobanking is an important step in ensuring scientific assets are properly maintained and safeguarded. Recent events at life science organizations, in which valuable materials were damaged or destroyed due to operational oversight, highlight the importance of following best practices for biobanking. Some of these events were highly publicized due to their large scale operations and impact on consumers, but events like this happen far too frequently at organizations that store biological tissues, cells and samples, with many issues arising legally, financially and reputationally.
In most instances, the burden of managing and monitoring the equipment and facilities at biorepositories is delegated to facilities and operations teams, or in the case of an IVF clinic, the embryologists and other staff. These biobanks rarely have the bandwidth to facilitate their monitoring needs, which increases costs and overall time spent.
The size of the biobank is not always the most important factor. In every cryogenic storage facility, there must be established processes and procedures. These protocols, or best practices, must be homogenous to the overall biobank system, including equipment and facilities operations. It should not be a matter of why a tank or an alarm system failed, this is the reactive approach. It should be assumed that tanks and alarm systems will fail and in order to safeguard biobank storage and operations, the key is in establishing best practices and a proactive monitoring system design.
For a proper biobank storage system design, it must address several key aspects: facility and operations, equipment, emergency and catastrophe plans, inventory management, safety, monitoring, transportation, cold chain and shipping.
The International Society for Biological and Environmental Repositories provides a comprehensive overview of “Best Practices: Recommendations for Repositories”. Highlighted here are some of the most important as it relates to biobank monitoring.
For the optimal life of mechanical refrigeration equipment, repository ambient temperatures should be monitored and controlled following the manufacturers’ instructions for temperature and humidity. This is particularly critical for rooms containing multiple mechanical units.
Appropriate monitoring devices (e.g., oxygen and/or CO2 monitors), preferably with auditory and visual alarms, should be combined with a dedicated exhaust system and installed within areas where low oxygen level might develop or harmful gases might accumulate. This system provides a sufficient amount of recirculating air to replace the air volume of a room according to the local regulations. The extracted gases are vented to the outside of the building, according to regulations, and never to the interior areas of the building.
Repositories located in areas with high humidity (i.e., coastal regions) should employ a de-humidification system to ensure optimal operation of the equipment.
Repositories should be aware of the location of their building generators and confirm that they are on a backup power system.
Computer systems and electronic systems such as environmental monitoring systems, safety systems (e.g., oxygen sensors, ventilations systems), and controllers for liquid nitrogen freezers should be protected by an Uninterruptible Power System (UPS). UPSs used in repositories should be tested on an annual basis to ensure their proper backup capabilities.
Duplication of specimen collections and data in distinct locations (i.e., including different freezer units) is recommended to ensure preservation in case of a catastrophic event.
Notification of security and environmental monitoring systems should be verified on a routine basis. Where possible, emergencies should be simulated to ensure proper follow-through for the established emergency plan.
Freezer, refrigerator, and other cold storage units should be qualified prior to and periodically during use by performing temperature mapping to evaluate consistency of temperature. This temperature profile should be performed prior to its initial use so that warm and cold spots that could be problematic for material storage are identified.
Personnel should be trained on responding to alarms and procedures for recording alarm events and their resolution. Proficiency testing should also be included to determine that personnel know the proper manner by which to respond to alarms.
There are a variety of other relevant standards organizations that specify general requirements for biobanks and tissue, cell, or sample collection. These include the International Organization for Standardization (ISO), the Clinical & Laboratory Standards Institute (CLSI), and American Association of Blood Banks (AABB).
A biobank should consider and implement multiple quality standards to properly fit the type of services provided by that organization.