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Technology (including: robots for production, Incompatibilities, drug production and analytics, CRS)
Cytotoxic surface contamination in a robotic system compared with manual preparation
  1. B. Gandré,
  2. I. Krämer
  1. 1University Medical Center of the Johannes Gutenberg University Mainz, Pharmacy, Mainz, Germany

Abstract

Background The preparation of cytotoxic drugs involves an occupational risk of contamination by aerosolised drug or contact contamination. To work with a robot could be an option to reduce risk to the operator, assuming that automation causes less contamination than manual preparation on a workbench.

Purpose To compare the surface contamination with cytotoxic drugs during automated preparation and manual preparation.

Materials and methods The contamination level of 5 predetermined areas in the CytoCare cabinet was investigated with swab tests by a known method (Schierl R et al). Samples were analysed by gas chromatography-mass spectrometry or inverse voltammetry after UV digestion. In the first series, 15 bags of 5-FU and 15 bags of platinum-containing cytotoxic drugs were prepared over two consecutive days. All surfaces were swabbed before (directly after the cleaning procedure) and after the preparation process. A second series was prepared and in addition the outer surface of each bag was swabbed. In parallel, the surface contamination during the manual preparation was studied. 15 bags of 5-FU and 15 bags of platinum-containing cytotoxic drugs were prepared over two consecutive days. 4 particular areas of the laminar air flow, the gloves of the technician and all bags prepared were swabbed by the same method.

Results Contamination with cytotoxics was observed in the working area of the CytoCare and on the outer surface of several automatically compounded products. The contamination levels were similar or higher in the robot to those in the manual preparation process.

Conclusions The cleaning procedure of the CytoCare turned out to be insufficient and must be improved. Further investigations are necessary to identify the origin(s) of the contamination and reduce them.

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