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IIR document

Measurement of temperature homogeneity in equipment for pharmaceuticals transport under controlled temperature.

Number: pap. n. 533

Author(s) : CAVALIER G., BOUDET N., BONED M.

Summary

The storage condition during the transportation of health products under controlled temperature is a major issue for all transporters and the manufacturers of temperature controlled vehicles. Indeed, with the evolution of the pharmaceutical regulations since Nov. 5, 2013, temperatures mappings were performed on refrigerated vehicles carrying temperature sensitive healthcare products. Currently, the existing standards (FD X 15-140, IEC 60068-3-X, ...) in the field of temperature characterization applies only to the fixed thermostatic chambers, and are not necessarily suited for refrigerated transport equipment. Additionally it has been proved that the test conditions while determining the temperature homogeneity in transport equipment, may have an impact on the outcome of the compliance. So it is probably necessary to harmonize practices in the specific standard. Following these facts, this article will first present the results obtained with mapping tests in the refrigerated trucks, highlighting the technical requirements and challenges that must be considered with the use of the existing standards. Secondly this article will outline a proposal for a testing protocol of temperature characterization for mobile pharmaceutical cabinets aiming to standardize testing methods.

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Pages: 9 p.

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Details

  • Original title: Measurement of temperature homogeneity in equipment for pharmaceuticals transport under controlled temperature.
  • Record ID : 30016033
  • Languages: English
  • Source: Proceedings of the 24th IIR International Congress of Refrigeration: Yokohama, Japan, August 16-22, 2015.
  • Publication date: 2015/08/16
  • DOI: http://dx.doi.org/10.18462/iir.icr.2015.0533

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