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Master Thesis

Mise en place d'une méthode de CCIT sur un produit injectable

Abstract : The integrity of pharmaceutical containers is a necessity to maintain product quality until the expiry date. A loss of integrity can have consequences on the physical, chemical and microbiological characteristics of the product. The Container Closure Integrity Test (CCIT) assesses the capacity of container closure systems to maintain a sterile barrier against potential contaminants. These tests, already well described in the USP, are tending to be used more and more in Europe. The theoretical approach based on USP 1207, followed by the practical approach of implementing this type of method demonstrate the importance of two parameters : the MALL and the LOD. The determination of these parameters and the validation of the CCIT method must be carried out according to a Quality Risk Management. Two types of methods can be chosen : the probabilistic or deterministic methods. However, there is not currently any CCIT method applicable to all types of products yet. The selection of the test method has to be made on a case-by-case basis. The implementation of a CCIT method involves different fields and parameters to be taken into consideration.
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Master Thesis
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Contributor : Frédérique Gambade <>
Submitted on : Wednesday, February 3, 2021 - 11:03:42 AM
Last modification on : Saturday, February 13, 2021 - 3:10:00 AM


Pharmacie_2020_El Harty.pdf
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  • HAL Id : dumas-03129931, version 1



Guillaume El Harty. Mise en place d'une méthode de CCIT sur un produit injectable. Sciences du Vivant [q-bio]. 2020. ⟨dumas-03129931⟩



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