Maîtrise de la contamination dans un secteur de remplissage aseptique

Abstract : The manufacture of injectable drugs imposes special requirements to minimize the risk of microbial and particulate contamination, The purpose of this PhD work is to present an approach for the investigation and the non-conformity analysis of a Media Fill Test (MFT). This corresponds to root cause research, the collection of decision-making elements and the action plan implementation in a continuous improvement process. For this, the principle of injectable preparations aseptic filling and an assessment of the contamination means of control in conventional clean rooms are presented. This study was carried out within an aseptic filling department of an enoxaparin solution production plant. It highlights the importance of monitoring both the particulate and microbiological environment and in-process controls for the manufacture of injectable drugs. In order to control the level of contamination, items such as adequate rooms, appropriate production equipment, designed to be easily cleaned and sterilized are required. The main risk of contamination in aseptic processes is the human intervention. That's why know-how, training and behavior of the staff involved must be supported by a carefully crafted formalized system and validated methodology at all stages of production.
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Master Thesis
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Clémence Cappelle. Maîtrise de la contamination dans un secteur de remplissage aseptique. Sciences pharmaceutiques. 2017. ⟨dumas-01927759⟩

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