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Mappings

In the production, storage and distribution of medicines, guidelines relating to Good Manufacturing Practices (GMP) must be adhered to. To this end, you need to monitor important parameters such as temperature and relative humidity in rooms of pharmaceutical or other GMP-critical products. Need help? Count on Advipro. 

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Measurement equals knowledge

By performing temperature and/or relative humidity mappings, our experienced team demonstrates that the areas where products are processed and/or stored meet the required storage conditions. In fact, inadequate storage conditions can have a negative impact on the quality of a product, which should absolutely be avoided. Besides, thanks to the data collected, we can easily identify potential risks and have everything we need to support any improvement proposals

We do not only perform a temperature and relative humidity mapping in new spaces. When the use, layout or HVAC installation of an existing facility is changed, a mapping is also essential.  

Does a storage facility adjoin at least 1 exterior wall? In that case, both summer and winter mapping is needed. As a result, you know the effect of the seasons on your space and product, and potential risks can be identified. The mapping file provided proves the suitability of the space for the required use and is an essential piece of evidence for an audit

 

Sublime mapping requires the right know-how 

Our A-Team has acquired quite some expertise in mapping over the past few years, and in different types of spaces: 

  • Warehouses, depots & distribution centres 
  • Climate chambers & incubators 
  • Cold rooms, refrigerators & (mobile) refrigerated containers 
  • Freezers, freezer rooms & ultra-freezers (-80 °C) 
  • Heat furnaces & vacuum dryers 
  • Vaporized hydrogen peroxide (VHP) studies 
  • Autoclaves  
  • And more 

 

Good to know: depending on the space to be validated, we use specialised wireless data loggers or thermocouples. The equipment is always calibrated in the right temperature and humidity range and linked to validated software. We also have equipment that can be used in ATEX zones. Because we have that specialised equipment, a quick analysis is always possible.  

And what about safety? Another aspect that we, at Advipro, think is very important. That is why all our mapping experts have a VOL VCA certificate. As well as a certificate for an elevator/scissor lift to easily reach all the heights and corners in your warehouse. 

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  • Xenia Declercq
    “To get an accurate picture of the temperature and/or humidity distribution in the room, our experts install highly accurate data loggers. Through our extensive range of state-of-the-art test equipment, we validate warehouses, cold rooms and ULT freezers (-80 °C) as well as autoclaves and kill tanks in no time.”
    Xenia – Program Manager

Mapping of temperature & (relative) humidity - Advipro @ your service

  • Preparation of risk analyses & strategy definition 
  • Mapping air flows 
  • Preparation, execution & reporting of validation protocols followed by advice on corrective or preventive actions 
Datalogger Mappingen

Questions about temperature- and/or relative humidity-controlled environments?

Our experts are ready to offer you valuable guidance.