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Jan 16, 2017 20:54
7 yrs ago
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French term
cartographie en charge
French to English
Science
Medical: Instruments
sterilization
Source text is a list of steps used in monitoring the effectiveness of a medical-device sterilization process.
1 cartographie en charge sans injection d’oxyde d’éthylène avec l'intégration minimum de 42 enregistreurs autonomes de T°C et 18 enregistreurs d’humidité relative placés au cœur de la charge. [...] Cette cartographie en charge permet le réajustement des valeurs de pilotage du cycle, si besoin.
1 cartographie en charge sans injection d’oxyde d’éthylène avec l'intégration minimum de 42 enregistreurs autonomes de T°C et 18 enregistreurs d’humidité relative placés au cœur de la charge. [...] Cette cartographie en charge permet le réajustement des valeurs de pilotage du cycle, si besoin.
Discussion
http://www.vaisala.com/en/lifescience/blog/Lists/Posts/Post....
[...] According to best practice at least empty and full load mapping should be performed.
[...] If your system is expected (or known) to perform differently with different loads, then that would justify qualifying multiple loads.
http://www.gmp-compliance.org/eca_news_3695_7918.html
http://www.ellab.com/applications/pharma/eto-sterilization
When validating an EtO sterilization process, it is necessary to perform a mapping of the chamber and monitor temperature and relative humidity to evaluate the performance of EtO sterilization. Both empty and loaded chamber tests are required.
[...]
Depending on the size of the chamber, ISO standard 11135 provides a recommendation on the number of temperature and relative humidity sensors [...]. The location of the sensors must provide a useful representation of the behavior of the chamber throughout the cycle. The creation of a thermal map with an empty chamber provides the location of the most critical points to monitor during the process (ex. cold spot).