Information

Monitoring of Vaccines and Pharmaceuticals

Regular and accurate temperature monitoring is essential to ensure that vaccines and pharmaceuticals are stored and transported safely.

Why Monitor vaccines temperature?

The World Health Organisation (WHO) recommendations on the storage of vaccines and maintenance of the 'cold chain', stipulate that vaccines should be transported and stored according to the manufacturers' recommended temperature range of +2 to +8°C until the point of administration. Heat speeds up the decline in potency of most vaccines and freezing may cause increased reactogenicity and loss of potency. Pharmaceutical distributors and manufacturers will not accept any vaccine for return once it has left their control, so vaccines may be wasted.

Failure to monitor and record temperatures accurately can mean that health professionals may be unaware of these potential effects on the vaccines, and of course their recipients. Problems can arise, for example, due to a faulty fridge, the door having been left ajar, the wrong temperature set, or even variations in temperature between the top and bottom of the fridge.

Why use a Data Logger?

The WHO recommendation is for the temperature of vaccine refrigerators to be continually monitored and for a record to be taken at least once per day and documented on a chart. Historically, a min/max thermometer would be used for this purpose. However, this is laborious and prone to human error, so a small data logger that sits next to the vaccines is an easier, more effective solution.

Tinytag data loggers record data which is then downloaded to a PC for analysis. The loggers can provide a comprehensive record of a fridge's temperature history in a clear and simple graph. Many data loggers feature indicators to show when the temperature reaches unacceptable levels. Our medical data logger for example has been designed to incorporate a red flashing LED, which is triggered if the temperature falls outside a user-defined temperate range. In this way it is immediately apparent to an observer if there is a problem.

Data loggers in the Tinytag range are suitable for use in medical freezers and cool boxes, as well as vaccine fridges.

Vaccine Monitoring Useful Tips
  • Data loggers should be positioned alongside the vaccines, preferably in the middle of a fridge where the temperature is most stable.
  • Ice build-up should be avoided because this reduces the effectiveness of the refrigerator.
  • During defrosting, an alternative refrigerator or an approved cool box (also monitored with a data logger) should be used to temporarily store the vaccines.
  • When packaging and transporting vaccines to outlying clinics, validated cool boxes and ice packs from a recognised medical company should be used.
  • Vaccines must be kept in the original packaging, wrapped in bubble wrap or other insulation material and placed in a cool box with cool packs as recommended by the manufacturers' instructions.
Calibration to Maintain Accuracy

The WHO recommends annual calibration checks. Gemini Data Loggers offers a calibration service where data loggers can be returned for a new battery and a traceable certificate of calibration.

References

World Health Organisation (2006) Temperature Sensitivity of Vaccines

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