John Masiye Ndaferankhande
Malawi Liverpool Wellcome Trust, Malawi
Scientific Tracks Abstracts: J AIDS Clin Res
Background & Aim: Cold chain management is integral in clinical trials. However, it is a challenge to maintain cold chain at
the quality levels required when administration of the pharmaceutical product takes place in the field. Here we describe the
temperature control as a major aspect of cold chain management as was the case in the TyVAC study.
Method: The study enrolled 28,000 participants randomized 1:1 to receive Vi-TCV (typhoid vaccine) and MenAfrivac
Meningococcal Group A Conjugate vaccine (MCV-A). The vials were stored at the research pharmacy and transferred daily to
vaccination field. Temperature records of field credos were analyzed from February 28, 2018 through to July 08, 2018. These
records were compared to the research pharmacy vaccine refrigerator temperature recordings from a beyond wireless remote
temperature monitoring system.
Result: The research pharmacy temperature ranged from 2.0 °C to 5.3 °C with a mean of 3.5 °C. The credo temperature ranged
from 4.2 °C to 12 °C with a mean of 5.6 °C.
Conclusion: Temperature recordings for both the pharmacy and the credo cubes were within range except on a single occasion
in which the credo temperature was 12 °C (the recommended temperature for cold chain is 2 °C to 8 °C). Cold chain can be well
managed at different sites as evidenced here provided staff involved in handling is well trained. Good cold chain management
ensures quality and gives confidence that pharmaceutical compounds were managed according to Good Pharmaceutical Practice.
John Masiye Ndaferankhande has completed his Honors degree in Pharmacy from the College of Medicine, University of Malawi. He is the Lead Pharmacist of Malawi Liverpool Wellcome Trust.
E-mail: jndaferankhande@gmail.com
Journal of AIDS & Clinical Research received 5264 citations as per Google Scholar report
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