(Treffer aus pharmind, Nr. 10, Seite 1423 (2019))
The Use of Extractables Data for Risk Assessing Single-Use System Components / Mokuolu • Extractables Data · Mokuolu S · Watson-Marlow Fluid Technology Group, Falmouth, UK
Single-use technologies have become recognised as important for drug manufacturers who want to preserve space, increase their manufacturing flexibility and reduce costs. However, concerns about extractables and leachables can be a barrier to the implementation of single-use technologies at drug manufacturing facilities. One of the industry challenges is, there is no specific guidance in relation to polymeric processing equipment and how they are qualified. This paper presents a case study where common single-use components such as silicone tubing, silicone gaskets, nylon clamps and polypropylene connectors have been extracted using a mixture of aqueous and organic solutions at a worst-case process ...