The storage of highly sensitive materials is an intrinsically important facet for Life Science industries. There are many variables and parameters that must be diligently controlled and monitored at almost every stage of a Life Science organization’s workflows, particularly when the storage of organic material is involved. Storage of these invaluable samples and assets, along with the proper functioning, maintenance and safeguarding of storage devices and equipment, are areas that require strict adherence to a multitude of local, state, federal, international, and in some cases, industry specific guidelines to prove compliance.
With myriad stringent regulations to adhere to, establishing proper SOPs that mitigate the risk of malfunctioning storage devices and equipment is a critical practice for Life Science organizations. In the event of a machine or equipment failure, precious samples, assets and time can be lost as the organization tries to respond to the unexpected, adverse event. Without having readily available, comprehensive SOPs in place, appropriate personnel might not be able to respond quickly and efficiently, increasing the potential for loss or future equipment failures.
There are many specific guidelines for the proper operation and maintenance of storage devices and equipment such as refrigerators, freezers, incubators, centrifuges, etc. GxP guidelines indicate that daily, or “date of use”, temperatures for all devices and equipment must be recorded and reported. Whether an organization is storing samples or assets for hours, days, weeks, months, or years, alerts are required for any deviations or anomalies involving out-of-range temperatures or other controlled conditions. There is also the necessity for a disaster recovery plan in the event of any equipment failure. This plan must be appropriately documented with corrective actions detailed for the proper personnel to respond in case of such an event.
Monitoring the plethora of parameters and conditions for storage devices and equipment can become cumbersome, particularly when an organization operates with error-prone, paper-based manual data entry. Even some digital monitoring devices that might already be implemented, such as data loggers, can carry costly complexities as it pertains to data acquisition, alerts, and reporting.
Industry leading Life Science organizations routinely refine and update the SOPs governing their storage areas and equipment. This ensures that the appropriate personnel are trained properly on storage equipment and device operation and maintenance, and that all necessary environmental considerations such as temperature, humidity, differential pressure, etc. are consistently controlled and documented, reporting on any deviations or anomalies. All equipment must be properly maintained and calibrated on a routine basis in accordance with standardized procedures that are well-documented and reported. This provides assurance that all equipment is functioning properly and the event of a machine malfunctioning will be far less likely. If a variable falls outside of pre-set parameters, alarms must be in place to alert staff members who can then respond in real-time to minimize risks and mitigate any potential loss of assets.
Another important variable to measure for storage areas and equipment, whether it’s for refrigerators, freezers, incubators, cryotanks, or larger storage areas, is temperature mapping. Temperature mapping is the process of measuring the variations in temperature that occur within a controlled system due to influences such as opening doors, proximity to fans, personnel movement, and quantity of products stored in a given location. GxP indicates that to ensure an optimal storage environment large refrigerators and freezers require adequate temperature mapping at multiple points in the unit. They will need to be maintained for predefined temperature ranges according to manufacturer specifications.
Raw data that demonstrates an adequate control of ambient conditions, such as temperature, humidity, ventilations, air pressure, and the overall proper functioning of laboratory equipment, should be available for immediate retrieval and analysis. Paper-based systems and data loggers allow for data to be recorded and analyzed, but in an often untraceable and retrospective manner. Without real-time data and notifications, systems like these will only inform an organization of problems and adverse effects on samples and equipment after they already occurred. Industry leading organizations require real-time monitoring systems that keep easily-accessible, historical records, particularly to aid in root cause analysis in the event of any deviation, and to identify trends through predictive analysis that indicate if equipment needs maintenance before it fails completely. Alarm notifications for equipment or environmental deviations allow for increased organizational awareness and appropriate response measures to be taken in the case of such an event.
Whether a valuable Life Science sample or asset must be stored for hours, days, weeks, years or decades, organizations that want to understand the benefits of implementing an autonomous, monitoring solution should look at the potential for increased productivity, improved data quality and acquisition, and reduced compliance risks. There is a wide-variety of monitoring solutions that can be used for storage areas and equipment, but most are pinpoint solutions and difficult to integrate, only capable of monitoring specific data outputs.
Simple, rudimentary sensors or data loggers on the market eventually encounter similar problems as time-consuming, manual data entry. The processes involved with these archaic systems are seldom superior to manual, paper-based tasks and are inadequate for proper review and reporting cycles. Monitoring systems that are robust and scalable are paramount for fast-growing companies. A cloud-based platform that is OEM agnostic and capable of monitoring both wired and wireless sensors will ensure that a company is well prepared for any potential problems. Autonomous, real-time monitoring closes gaps in procedures, increases the quality and traceability of an organization’s data, and mitigates common risks found in data loggers and paper-based monitoring practices.