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Residual contamination during semi-automated compounding of paclitaxel and gemcitabine

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European Statement

Production and Compounding

Author(s)

Schoening Tilman, May Cornelia , Hoppe-Tichy Torsten

Why was it done?

Results of the wipe tests should be used to adapt the existing cleaning protocols in a way that residual contamination with cytotoxic drugs on parts of the robot, gloves and infusions bags are either reduced or avoided.

What was done?

At Heidelberg University Hospital the semi-automated device “Smartcompounder Chemo” (Smartcompounders, Enschede, NL) has been operated since 2019. We conducted three sets of wipe tests at three consecutive dates to identify contamination on parts of the robot, bags and gloves for selected drugs happening during the preparation process depending upon changes in cleaning protocols.

How was it done?

Wipe tests had been provided by Institute for Energy- and Environment Technics (IUTA, Duisburg, Germany) and analysed according to the published standards. Before and after a preparation run of gemcitabine as well as paclitaxel there had been performed two wipe tests sets of potentially exposed surfaces: Gloves after loading and unloading of the device, robot head, syringe holder, vial adapters, bag adapters, infusion bags and vials. After evaluation of the results of the first wipe test set, we adapted cleaning agent and techniques and a second set was performed.

What has been achieved?

Both wipe test sets did not show any positive results for paclitaxel. For gemcitabine residual contamination was shown on gloves after loading and unloading, syringe holder and robot head before and after preparation run, vial adapter before and after preparation and bag adapter after preparation run. The second wipe test set after adaptation of cleaning procedures showed considerably smaller numbers of positive tests and smaller amounts of gemcitabine contamination as well.

What next?

Results demonstrate that contamination patterns associated with automated preparation of cytotoxic drugs are related to the design of the device and effective cleaning procedures of the robot parts and the vials can result in lower contamination values of surfaces. Therefor it is vital to analyze the effectiveness of cleaning protocols when working with these devices and to adapt them if necessary. We were also able to demonstrate, that the final container was not relevantly affected by residual contamination during automated preparation process of Smartcompounder Chemo meaning a positive impact on staff safety.

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