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영어

The objective of this presentation is to provide basic information necessary to produce sterile products by aseptic processing. Aseptic processing isprocess by which a sterile (aseptic) product is packaged in a sterile container in a way which maintains sterility. It is not only any technique but an integrated art through validations & risk assessment. It is included from establishing building and facility, process design, EM control, personnel training, disinfectant method, validation & qualification to CCM (closure and container monitoring method). It is important to make application of aseptic process practically after setting up each process through validation, for example AVP and autoclave PQ and so on. So this presentation will put emphasis on the nexus between the system & validation (risk assessment).