Measurement of chemical cross contamination in the preparation of injectable cytotoxics

J. Ramseyer , F. Sadeghipour, P. Bonnabry Pharmacie des Hôpitaux Universitaires de Genève, Section des sciences pharmaceutiques, Université de Genève, Université de Lausanne, Genève, Suisse

Objective

Evaluation of the propagation of chemical contamination in the preparation of injectable cytotoxics. The dissemination of chemical contamination of the flask surfaces (= external contamination), on and in the final bags and the transmission of the content of the flask to be sampled (= internal contamination) are assessed.

Methods

The contaminations were simulated by a tracer - quinine dihydrochloride – and quantified by fluorimetry. External contamination resulted from soaking bottles of WFI in a 0.25 M quinine solution (contamination: 7 mg/bottle). Internal contamination was estimated by handling of bottles of quinine to be reconstituted (final quantity: 198 mg/bottle). The content of the bottles was transferred into a bag using a needle. Cross contamination: a series of two successive preparations, the first with a bottle contaminated by quinine, the second without quinine. Accumulation of contamination: a series of ten successive preparations with quinine. The entities analysed were outside of the bags, their content (for external contamination only) and the surface of different pairs of gloves.

Results

External contamination: no phenomenon of permeation of the contamination inside the bags but the presence of quinine on the bags of the final preparations without quinine (38 µg ± 21, n=10). The accumulation phenomenon does not appear on the bags or in their content, but on the gloves used for the preparation (193 µg). Internal contamination: absence of quinine on the surface of the final bags and a small quantity of tracer found on the gloves (26 µg ± 31, n=10). There was no accumulation on the bags but on the gloves used for the preparation (112 µg).

Conclusion

There is chemical cross contamination in the preparation of injectable cytotoxics without permeation into the bags. The accumulation of contamination on the gloves used for the preparation evidences the necessity of more effective decontamination procedures. The quantities measured remain low, suggesting an absence of risk for the personnel in the majority of cases.

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