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FEATURE
Temperature monitoring
for vaccine rollouts
Ian Loudon discusses how temperature and humidity monitoring is vital in the storage and
distribution of COVID-19 vaccines, where small fluctuations could compromise critical assets
IN A LABORATORY, unfavourable
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 CAPRISA, five
University of Kwazulu-Natal (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 administration.
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.
Visual inspections were required, with a
staff member recording data on a clip
board or spreadsheet. As 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 were 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 they cannot be used by the
time storage temperature issues have
been identified and addressed.
With nationwide 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 engaged Omniflex to
provide a remote temperature and
humidity monitoring solution.
Learning the tools of the trade
Like the set-up 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 then networked to the
cloud and send out SMS or email alerts
in real time in the event of abnormal
temperature variation, e.g. as a result of
a fridge seal rupturing. The relevant
personnel will be alerted to ensure
appropriate and efficient action is
taken.
This technology is more cost-effective
and efficient than manual equipment
monitoring, and it operates 24 hours a
day, 365 days a year. A crucial issue is
compliance with 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 capturing 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’s Data2Desktop
system met these requirements.
Installed across the key vaccine-storage
sites 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
distributed correctly. Reporting and
alerts are fully automated using emails
and SMS to keep management
informed 24/7/365.
Ian Loudon is international sales and
marketing manager at Omniflex
For more information:
www.omniflex.com
Tel: 01614 914144
With remote
temperature
monitoring,
data can be
collected
automatically,
free from
manipulation,
and capturing
any errors
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