Survey of cytotoxic contamination within a reconstitution unit

S. Nussbaumer1,2,3, M. Mattiuzzo1, L. Geiser3, F. Sadeghipour1, S. Fleury-Souverain1, P. Bonnabry1,2 1 Pharmacie des Hôpitaux Universitaire de Genève (HUG),
2 Section des sciences pharmaceutiques, Université de Genève, Université de Lausanne,
3 Swiss Centre for Applied Human Toxicology, Genève, Suisse

This work’s goal was to provide an overview on the state of cytotoxic contamination within a reconstitution unit so as to highlight critical contamination areas.

A surface sampling procedure combined with an LC-MS/MS method allowing for 10 cytotoxic substances (cytarabin, gemcitabin, methotrexate, phosphate etoposide, ifosfamide, cyclophosphamide, irinotecan, doxorubicin, epirubicin and vincristine) to be determined simultaneously was used. Its quantitative performances were clearly defined in terms of productivity and accuracy according to the compound and the surface tested (Anal. Bioanal. Chem. 398 (2010) 3033-3042; Anal. Bioanal. Chem. in press, DOI 10.1007/s00216-011-5157-2).

About 100 samplings were made in the production area and in the cytotoxics logistics management area. The most heavily contaminated locations were inside the isolators. In the logistics room, only a few traces of cytotoxic substances were detected.

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