Monitoring the transport of medicines with BudgetLine Data Loggers
Strict regulations apply to the storage and transport of pharmaceutical products regarding the permitted environmental conditions. Reusable MSR BudgetLine data loggers record temperature and humidity values during storage and transport.
Pharmaceutical logistics basically includes all logistical processes of the pharmaceutical industry and downstream distributors. This ensures the availability of medicinal products and the active ingredients and ingredients required for the production of these medicinal products along the entire supply chain.
GDP Directive: Good Distribution Practice for Medicinal Products
Since the revision of the EU Directive on Good Distribution Practice (GDP) in this sector, temperature control during the transport of medicinal products has become a central issue. According to the directive, the same conditions must apply during transport as during storage. The new GDP guidelines therefore contain specific requirements for the transport of medicines. The main objective is to ensure that the quality or integrity of the medicinal product is not impaired during transport. Many medicinal products must be stored below 25 °C according to the information on the packaging. Medicinal products requiring refrigeration, on the other hand, must be transported and stored consistently between 2 and 8 °C. It should also be noted that - whether in the case of medicinal products requiring refrigeration or those not requiring refrigeration - the relative humidity in the transport area can increase with falling temperatures if it is not eliminated by technical means.
Monitoring and documenting data loggers
When transporting medicines, it is therefore particularly important to monitor and document the temperature and often also the humidity values, also in order to be able to find out, for example, the cause and the causer of environmental conditions that do not comply with the rules. This can be done in an uncomplicated way with the low-cost reusable data loggers from the "MSR BudgetLine" series. The credit-card-sized loggers are available with and without a display and, depending on the type, record the temperature or optionally also the relative humidity in adjustable time intervals starting from 1 min.
The memory capacity of the data loggers is 16'000 measured values per channel. A 6-point calibration certificate as well as configuration and evaluation software are included with the reusable MSR BudgetLine loggers. With the user-friendly configuration software, measurement parameters can be set and alarm thresholds can also be defined.
The recorded measurement data can be quickly transferred to a PC via USB connection. By stopping the logger, an automatic PDF report is generated, which can be directly saved or printed out for documentation purposes. The free TLog Explorer software is available for further data evaluation. The battery life of the reusable data loggers is approx. 1 year, the battery is replaceable.
The 21 CFR Part 11-compliant MSR BudgetLine data loggers are available in MSR's online shop, www.datenlogger.shop, and from MSR sales partners.
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