Temperature monitoring is one of those essential requirements of many businesses and organisations, none more so than those in the highly regulated pharmaceutical chain. Luckily, temperature data logging is simple, yet its simplicity should not belie the huge savings in time in its ability to track temperatures in fridges, cold rooms or boxes and provide easy downloads in neat graphs and tables, helping formalise a procedure and provide physical evidence of pharmaceuticals being monitored.
The obligation of the practice manager (or anyone with responsibility for handling a drug) is to "have procedures in place to ensure correct working practices are being followed ... such as reviewing refrigerator temperature".1 Data logging directly addresses this issue.
Data loggers are small battery operated, inexpensive units which monitor the ambient temperature surrounding a vaccine or any other pharmaceutical product. Although a thermometer may already be used in a fridge for spot readings, data logging formalises the procedure by being able to record temperatures over a set period of time.
A data logger encourages good habits and highlights the importance of maintaining a stable temperature, pushing it to the forefront of a staff's mind at all times. The logger can be set to record at a suitable time interval, eg, hourly and then the information can be easily downloaded and documented when required.
Some loggers have an alarm, eg, a red flashing light, so that if, for example, a refrigerator's door is left open and temperature goes out of range, the alarm will be triggered, alerting the responsible person who can then download the data to see the fluctuations in temperature and to make a decision on what should happen to the pharmaceuticals or vaccines stored there.
When looking for the right data logger, it is important to look for a specialist logger for use in refrigerators, such as the Tinytag Medical, as this will maximise its potential and also meet the recommendations of the World Health Organization (WHO). For example, data loggers are best positioned in the middle of a shelf- in amongst the product being monitored, as this more closely reflects the temperatures they are exposed to.2
Ice build-up reduces the effectiveness of the vaccine.2 Temperatures in the refrigerator must be monitored and recorded at least once each working day.2 For no extra effort, using a data logger, this can be done more often, for instance every hour, and the data automatically documented on a chart for recording temperatures.
There may be a need to package and transport vaccines to outlying clinics, in which case a data logger can be packaged close to the packages of vaccines in order to keep a record of any fluctuations. 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. This prevents contact between the vaccine and the cool packs.2
Annual calibration checks of the data logger are recommended, so be sure to choose a supplier who will re-certify or advise on a replacement if necessary. Gemini Data Loggers, manufacturer of Tinytags, has an in-house calibration laboratory providing UKAS traceable certification.
Temperatures too high or too low or unduly fluctuating temperatures can jeopardise drugs. Automatic temperature monitoring, using Tinytag data loggers, helps meet regulations and provide the physical evidence of pharmaceuticals being monitored. For more information, email firstname.lastname@example.org
1. Rapid Response Alert (NPSA).
2. World Health Organization. Temperature Sensitivity of Vaccines. Available from: www.who.int/vaccines-documents/DocsPDF06/847.pdf
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