Laboratory Products

Thermal Mapping and Monitoring of Pharmaceutical Storage Facilities

Mar 27 2023

Author: Allan Javier on behalf of Xylem Japan

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Why this is required especially during the warmest period of the year

Summertime is fast approaching especially in most Asian Countries and it is no coincidence that most, if not all, Pharmaceutical or Healthcare companies are subjecting their storage facilities such as storage rooms and warehouses for a complete and thorough thermal mapping often based on predetermined temperature and humidity limits as main criteria.
The stability of healthcare products especially those heat-sensitive and thermolabile drugs are greatly impacted when they are stored in temperatures that are too high and too low and some drugs’ chemical stability is also compromised when temperature and humidity levels are not correctly maintained.
Summer months, especially in tropical countries where temperatures can increase to 40.0ºC, affects the efficiency of most storage facilities in maintaining the required temperature and %RH conditions. This hot season also contributes to a much faster temperature change when doors and loading docks of the storage rooms and warehouses are opened.
It is therefore sound and practical that thermal mapping activities are scheduled in this period when the worst possible scenario is considered and well accounted. The Xylem LAB Team is ready to provide the industry with a complete solution for this requirement with their expertise and experience, and with the right mapping and monitoring tools from Ebro.
It is of high significance in the healthcare industry that methods and procedures are done according to GMP and GDP provisions. Detailed and specific recommendations can be found in the WHO guidelines which is further discussed in other regulatory authorities like the USP and MHRA.
Xylem, in the Asia-Pacific and Germany, provide the total solution from the planning stage which covers the determination of the critical mapping points, documentations and drafting of the thermal mapping protocols, followed by implementation and the mapping executions up to evaluations and remediations.
Paramount to ensuring a high confidence level particularly with the data acquisition and results is using the correct tools. A fully compliant system such as the Ebro Cold Chain Loggers and the Winlog.Pro Software highly contributes to achieving our mapping and monitoring objectives.
Whether it’s the EBI 20 series which is Ebro’s most affordable, and yet the most popular cold chain logger in the world or the high-end high-precision EBI 3x0 USB loggers, these loggers deliver the required measurement accuracy needed to achieve your thermal mapping objectives.
One Logistics Company who uses hundreds of the EBI 20 Loggers for conducting thermal mapping of their warehouses, an EBI 300 for their fridges, freezers and chillers and an EBI 25 Continuous Monitoring System for their control and monitoring 24/7 is a good example of fulfilling GMP &GDP Compliance.
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