Aseptic processing, the technique used to ensure sterile drugs are packaged in sterile containers, is one of the most important steps in biopharmaceutical manufacturing, because of the risk that contamination poses to patient safety. Aseptic process simulation, also known as a media fill trial, estimates the contamination risk of an aseptic production process by using sterile culture media in place of the product constituents. Process simulations vary depending on the particulars of the process and the type of product to be filled, such as liquid or solid dosage forms.
The use of media fill trials for aseptic process simulations is not a new concept. The goal of a media fill is to demonstrate that the manufacturer can follow the routine aseptic production process using sterile media without contamination. However, drug manufacturers and regulatory bodies are not only concerned with the media fill results, but also with ensuring a quality approach to study design and proper risk analysis (FDA 2004). A successful media fill study should never be used to justify aseptic processing practices that pose unnecessary contamination risks.
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