Being well known for its anti-retroviral drug trials, it’s no surprise that the University of Kwazulu-Natal (UKZN) has been entrusted with the storage and distribution of COVID-19 vaccines in South Africa.
Unfavourable laboratory temperatures threaten the integrity of valuable research materials, which could be costly and time-consuming to fix. As South Africa’s Medical Research Council (MRC) races to immunise its population, it has become clear that remotely monitoring conditions in a facility is the most convenient and cost-effective way to protect assets.
In partnership with the Centre for the Aids Programme of Research in South Africa (CAPRISA), five UKZN research sites are playing an integral role in South Africa’s vaccine rollout. The vaccines must be stored in -20°C freezers as part of the preparation process, before being transferred into 2-8°C fridges prior to being administered. Local regulatory authorities require each facility to be monitored to prevent temperature deviations compromising the efficacy of the vaccines.
Replacing obsolete systems
Monitoring of operating temperatures in dry storage facilities, fridges and nitrogen freezers across UKZN sites was previously carried out manually. Since manually recorded data can only reflect the conditions at the time of reading and cannot immediately identify problems that arise between recording intervals, these protocols are impractical. Furthermore, temperature fluctuations occurring when a laboratory is unmanned could compromise valuable assets. In a worst-case scenario, research materials may deteriorate to the point where they cannot be used by the time storage temperature issues have been identified and addressed.
With nation-wide vaccine distribution being the only way out of the pandemic, losing assets to poor monitoring protocols is simply not an option. Therefore, UKZN and other CAPRISA partners, like the Aurum Institute in Johannesburg, engaged Omniflex to provide remote temperature and humidity monitoring solutions.
Learning the tools of the trade
Like the setup provided for Oxford University during its 2020 vaccine trials, plug-in sensors have been placed inside the UKZN fridges and freezers for continuous data recording. These sensors are networked to the cloud and send out SMS or email alerts in real-time in the event of abnormal temperature variation.
A crucial issue is compliance to FDA 21 CFR Part 11, which suggests any manual recordings could be manipulated. With remote temperature monitoring, data can be collected automatically, free from manipulation, and can capture any errors.
However, the monitoring system alone does not comply with the FDA regulations on Good Laboratory Practice and is integrated into the Standard Operating Procedures of the facility. To be fully compliant, UKZN required a centralised cloud-based system for admin staff to review the archived chronology of operating parameters. Omniflex was able to meet these requirements by installing its Data2Desktop system across the key sites storing vaccines for distribution.
Installed using GSM services, independent of local IT networks, Data2Desktop records a repository of all system data that can be accessed remotely through standard web browsers, with designated logins for auditing or post-event analysis. This repository can act as assurance to health officials that the Coronavirus vaccine is being stored and distribued correctly. Reporting and alerts are fully automated using emails and SMS to keep management informed 24/7/365.
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