Cleaning problems can have various consequences leading to contamination of drugs with a risk for the patients but also for the staff of the company. Further, contaminated equipment can cause ecological problems like environmental pollution, regulatory risks linked with a possible authorization withdrawal and economical problems like diminution of production, stock shortage, financial loss, but also a loss of image for the company. Three main factors should be taken into account in a contamination process: The source of contamination (e.g. previous Active Pharmaceutical Ingredient, API, in case of cross contamination), the vector (e.g. unclean apparatus) and the receptor (e.g. the final product). Numerous solutions exist to ensure the quality of a product and an absence of contamination: A validated cleaning method associated with trace monitoring, dedicated or disposable equipments associated with a good conception of plant, specific and well design equipment, adapted flow of equipment and staff.
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