Pharmaceuticals are sensitive products; their quality can be impaired, for instance as a result of incorrect storage temperatures or exposure to humidity. Therefore, in a professional pharmaceutical distribution chain, these environmental parameters must be monitored accurately and documented in a clear manner. Mini data loggers the size of a thumb provide indispensable support for this.
Correct storage of pharmaceuticals of all kinds is essential and guarantees that these products continue to be effective and retain the proper potency until the expiry date specified by the manufacturer. Strict regulations and government policies form the basis for the correct storage of pharmaceuticals; they are known as GDP (Good Distribution Practice). Therefore, compliance with the GDP regulations is essential and indeed existential for pharmaceutical companies, as inaccuracies or even gross violations thereof may result in significant damage to the company’s image as well as financial loss.
Temperature and humidity: the quality parameters
As an international pharmaceutical manufacturer who is active in various fields of medicine, e.g. pain management and cancer treatment, Italy-based company sigma-tau Pharma AG is especially bound to the effective country-specific regulations. For instance, within the scope of its quality assurance activities, this company’s subsidiary in Switzerland sought a suitable technical concept to help optimally monitor the critical environmental parameters, "temperature" and "relative humidity", in the distribution chain for pharmaceutical samples supplied to chemists and doctors, and to document them according to modern aspects. In practice, the sample packages to be distributed are stored in different locations, generally at room temperature – usually between 15 and 25 degrees Celsius. However, on the one hand the temperature in the storage location must not fall below or rise above this temperature range, whilst on the other hand the humidity must remain at a reasonable level.
Measurement technology stores data in miniature format
Whilst in the past, electronic recording systems were used to monitor the ambient temperature and humidity, these are no longer compliant with the current requirements of sigma-tau, in particular as the employees working within the distribution chain are now equipped with iPad computers. For this reason, both modern, wireless transmission technology and practice-oriented recording software are required.
When looking for new, compact data recording devices equipped with modern sensor, measured data recording and transmission technology, sigma-tau came across the MSR145WD wireless data loggers of Seuzach-based MSR Electronics GmbH. These small data recording devices record the crucial, calibrated parameters “temperature” and “relative humidity” in freely adjustable scanning intervals, ranging from seconds to hours, and store this measured data in an internal semiconductor memory.
The recording capacity of this memory is sufficient for monitoring taking place over several months (1 million recorded values). It is also possible to record the air pressure, light intensity and acceleration at the location. The mini logger, which is barely the size of a thumb, is powered by an internal battery that is charged automatically when configuring the logger via the USB connection and that is available with two different capacities, facilitating even long-term measurements over a number of months.
The temperature and humidity values can be read from the bright integrated display; however, the engineers of MSR have also integrated “Bluetooth Low Energy” (BLE) wireless short-range radio data transmission. This allows smartphones and tablets of all kinds to communicate with the MSR145WD via BLE and read out and display the measured values: Within a radius of approx. 10 m – the distance bridged by BLE radio technology – the temperature and humidity values of the storage location can be checked directly via a tablet or smartphone.
In addition, by using a BLE-enabled laptop, a special BLE receiver box, or a smartphone or tablet in the vicinity of the logger, all data can be uploaded and stored via the Internet connection to a protected MSR SmartCloud Service. The applications arising from this "MSR SmartCloud" range even further: Limit values previously defined while configuring the logger on the PC, for instance for the temperature, can also trigger alarm messages via the cloud. If required, the measured values from several MSR145WD data loggers can be read out and even shared with a team.
Generate Documentation and Reports
The data loggers permanently store all measured values in memory which can read out on a regulary basis for documentation purposes. Charting software is also available allowing, the storage conditions to be documented in a clear and unambiguous manner. Continuous monitoring with the aid of these small high-tech data loggers safeguards the quality of the medicines permanently and ensures that that storage conditions are documented in a manner that will stand up in court.
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