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Cytotoxic Surface Contamination in a Robotic System in Comparison to Manual Compounding


B.Gandre, I Kramer

University Medical Center of the Johannes Gutenberg University Mainz, Pharmacy, Mainz, Germany

Introduction: The preparation of cytotoxic drugs involves the occupational risk of the contamination by aerosolized drug product or contact contamination. Some of these drugs are known to be carcinogenic, mutagenic or teratogenic in humans, therefore, the operator exposure should be kept as low as possible. To work with a robot could be an option to reduce the operator’s risk, however, some previous works showed that the contamination with the cytotoxic drugs during automated preparation could be similar or higher than that during the manual preparation. The main goal of this study was to compare the surface contamination with cytotoxic drug substances during automated preparation and during the manual preparation process.

Material and method: The contamination level of 5 predetermined areas with a possible high risk of contamination inside the APOTECA™ cabinet was investigated with swab tests, according to a known method. In the first series, 15 bags of 5-FU and 15 bags of platinium containing cytotoxic containing drugs were prepared during two consecutive days. All surfaces were swabbed before and after the preparation process and in addition the outer surface of each bag was swabbed. A second identical series was prepared. In parallel, the surface contamination during the manual preparation was studied. 15 bags of 5-FU and 15 bags of platinium containing cytotoxic containing drugs were prepared during two consecutive days. 4 predetermined areas of the laminar air flow, the gloves of the technician and all bags prepared were swabbed by the same method. 5-FU suspect samples were analyzed by gas chromatography-mass spectrometry and platinum suspect samples were analyzed by inverse voltammetry after UV-digestion.

Result and discussion: Cytotoxic contamination was observed in the working area of the APOTECA™ and on the outer surface of several products automatically but the contamination levels were comparable or lower during robotic preparation than during manual preparation.

Conclusion: The key parameters to reduce a cytotoxic surface contamination with an automated robotic system for chemotherapy compounding are the adjustments of the robotic arm. In addition, a good and reliable cleaning method needs to be regularly performed in order to remove thoroughly the potential surface contamination.

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This entry was posted on December 4, 2012 by .

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