Martin Muffler senior process engineer at CRB looks at risk mitigation in aseptic production with a view to future developments.
The European Pharmacopoeia’s definition is simple and comprehensible:
“The aim of production under aseptic conditions is to preserve the sterility of a preparation composed of sterilised components. This means that the raw materials necessary for production, including primary packaging, should be sterilised before aseptic further processing, provided that this is possible, and no contamination may occur during production.”