These items may not be stored within the recommended temperature range, which could affect their effectiveness and quality. For vaccines, heat can accelerate a decrease in potency. Frozen may result in increased reactogenicity and loss.
Health professionals might not be able to accurately monitor and record temperatures, which can lead to potential side effects on medicines and their recipients.
The UK regulations regarding temperature control must be adhered to by warehouses that store pharmaceutical products. These regulations require that medicines are “…consistently stored, transported, and handled under suitable conditions as required by the product specification or marketing authorization.” This could include monitoring and controlling both ambient and chilled storage.
European Good Distribution Practice (GDP).
Good Distribution Practice Guidelines2 came into operation in September 2013. GMP (Good Manufacturing Practice) and GDP (Good Distribution Practice Guidelines) are used to ensure quality assurance for medicines within the European Economic Area (EEA). The European Medicines Agency coordinates these activities and makes sure that the EEA follows the guidelines and principles.
GDP is a way to ensure that GMP-determined quality standards are maintained across the distribution network. This allows medicines to be distributed in their original form. Quality systems require, among other things, that storage conditions be observed at all times.
The Guidelines require that appropriate equipment and procedures be in place to monitor the environment in which medicinal products are stored. This includes factors like temperature and relative humidity. Monitoring equipment should be placed in the areas where there have been temperature fluctuations or extremes after an initial temperature mapping exercise. Even for small premises that are room temperature, it is important to consider potential hazards such as heaters and temperature monitors.
Alarms should be set up to notify of any deviation from predetermined conditions. Also, equipment used to control or monitor the environment in which medicinal products are stored must be calibrated at regular intervals.
The GDP also stipulates that transport temperatures must be maintained at the right temperature. It should be possible to show and investigate the conditions in which medicines were stored. If requested, it should also be possible to review the information to prove that correct storage conditions and temperature conditions have been met.
The World Health Organisation (WHO), has guidelines that will help you store your pharmaceutical warehousing properly. These should be given, checked, monitored, and recorded. It is recommended that pharmaceuticals be stored at ambient temperatures between 15-25°C in well-ventilated, dry premises.
WHO Guidelines also cover transportation, recommending that devices to monitor conditions such as temperature are used where appropriate.
The WHO recommends that temperature monitoring data be made available for review and that records should be kept. It recommends regular calibration of monitoring devices and temperature mapping, similar to the European GDP Guidelines.
Vaccines need to be stored in very specific conditions. The WHO recommends that vaccines be kept within the recommended temperature range of the manufacturer until they are ready for administration. This range is usually +2 to +8degC. However, temperature ranges can vary and be very specific for different vaccine types.
According to the WHO, “In all countries systems of temperature monitoring, refrigeration and record keeping are required in order to ensure that each vaccine vial is kept under appropriate conditions.”
Data loggers are used to monitoring the temperature and RH of pharmaceuticals
Tinytag data loggers are able to meet the requirements of European GDP and provide temperature and relative humidity monitoring for pharmaceuticals and sensitive medical equipment.
Tiny tags can measure temperature/RH changes and are precise. External probes and loggers are also available for monitoring areas that are difficult to reach or in fridges. Loggers can easily be moved to other locations or added units over time to create profiles across a site or expand the monitoring area.
Tinytag Explorer software presents the recorded results clearly and in detail, and allows data from different logging runs to be combined for comparison and analysis. The data is presented in tables and graphs that can be easily printed, copied, pasted, or exported to popular software programs.
Setup the system
This will involve two parts:
The temperature mapping of the storage area(s) will be the first step. This allows for the identification of risk areas, which will help to position ongoing temperature monitoring points (stage 2). For most climates, this will require both a winter study and a summer one. Second, you should map locations that are more or less likely to experience higher or lower temperatures, such as loading bays, close heaters, doors and windows, loading bays, north side of buildings (or the northern side in the southern hemisphere). Before the storage facility goes online, the mapping process will need to be repeated. Any significant changes made by analyzing the data will also require the repeating of the mapping exercise.
Two weeks is the best time to conduct a mapping study. This includes a weekend to accommodate differences in building use or HVAC system programming.
After identifying the hot and cold spots in the mapping, the next step will be to place permanent temperature logging at these risk areas. The number of monitoring points required for an installation will depend on the location of the facility, the size and layout of the facility, and the risk points that have been identified. Large warehouses might require as many as 100 monitoring points.
The right data logger
For initial warehouse temperature mapping, a lot of loggers may be required for a short time. A basic entry level logger, such as the Tinytag Transit 2 for example, is ideal for this. You can leave loggers to record in specific areas, then move them as needed. The recorded data can then be used to create an overall profile of the environmental conditions within a facility.
A standalone logger can be used to monitor small areas or facilities. They are reliable and durable and can be left running for extended periods of time if necessary.
A good system will include an alarm system and procedures to manage temperature excursions. If conditions are outside of the range, the Tinytags can provide alarm warnings. An audible alarm box is also available for certain models. The Tinytag View 2 logger has a digital display that includes an alarm icon.
The Tinytag Radio Data Logging System is well suited to stage two permanent monitoring of pharmaceutical warehouses. This system is perfect for large premises that have multiple monitoring points or require logging over time. Radio loggers automatically collect data and transmit it wirelessly via a receiver to be viewed on a computer, over a LAN, or remotely through the internet.
Radio loggers can record at height or in difficult to reach areas without the need to access them physically to download data. If required, a mains-powered option is also available. Logger quantities and their positions can easily be changed due to expansion of facilities/re-mapping following other changes. If conditions are not within the defined range of alarm warnings, the software will notify you. You can also send alarm warnings via SMS or email, which allows you to take corrective actions.
Regular calibration of temperature monitoring equipment is recommended by the WHO and European GDP guidelines. Gemini Data Loggers offers a calibration service for Tinytags with certificates traceable to national standards. You can order calibration at the time you place your order and return loggers for a standard fee.