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Master Thesis

La décontamination par voie aérienne des locaux dans l’industrie pharmaceutique : installation du Dry Fog®

Abstract : The pharmaceutical industry is a sector including research activities, manufacturing and marketing of medicines for human and veterinary uses. A production site may manufacture medicines in dry form (tablets, capsules, etc.), semi-solid form (cream, gel…) and liquid (syrup) or injectable form (ampoules, auto-injectable syringes, etc.). The manufacture of sterile drug requires specific production requirements to minimize the risk of microbial contamination, particulate and pyrogenic. Manufacturing must be done in a controlled atmosphere area to reduce contamination risks. Working in a clean room is a contamination control throughout the production cycle of a drug. Design, cleaning and disinfection are the criteria for obtaining a clean room. (BPF 2015, LD1 and glossary). We can also talk about clean area, which according to the ISO 14644 standard is defined as "a dedicated space in which the concentration of suspended particles in the air is contained and which is constructed and operated to minimize the introduction, production and retention of particles within the room, and in which other relevant parameters, such as temperature, humidity and pressure are controlled as required”. The term clean area therefore includes other features compared to controlled atmosphere area. A mean of optimization of the disinfection is the establishment of an aerial decontamination process. These processes are supervised by a regulatory context, in compliance with HSE rules. The pharmaceutical industries have the choice between two decontamination processes, one using hydrogen peroxide alone and the other in combination with acetic acid per.
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Master Thesis
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Submitted on : Wednesday, May 30, 2018 - 4:05:47 PM
Last modification on : Wednesday, July 4, 2018 - 1:15:15 AM
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  • HAL Id : dumas-01803631, version 1



Mickael Jaffar. La décontamination par voie aérienne des locaux dans l’industrie pharmaceutique : installation du Dry Fog®. Sciences pharmaceutiques. 2018. ⟨dumas-01803631⟩



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