Gaois

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  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #691231

    IATE #3650073
    próiseáil aiseipteach Reference "Cinneadh Cur Chun Feidhme (AE) 2024/2625 ón gCoimisiún lena leasaítear Cinneadh Cur Chun Feidhme (AE) 2021/1195 a mhéid a bhaineann le caighdeáin chomhchuibhithe maidir le próiseáil aiseipteach táirgí cúram sláinte agus staidéir ar fheidhmíocht chliniciúil ina n-úsáidtear eiseamail ó dhaoine"
    ga
    aseptic processing
    en
    Definition "process performed maintaining the sterility of a product that is assembled from components, each of which has been sterilised by steam, dry heat, ionizing radiation, gas or sterile filtration, and achieved by using conditions and facilities designed to prevent microbiological contaminants" Reference "COM-Terminology Coordination, based on: EMA. 'Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container' (17.3.2025). EMA/CHMP/CVMP/QWP/850374/2015"
    Comment Aseptic processing is not considered to be a sterilisation process