Semiautomated aseptic preparation of patient-individual antineoplastic intravenous solutions: first experiences in a German hospital pharmacy.

OBJECTIVES

In 2013, the PharmaHelp device was introduced to daily patient care at the University Hospital of Heidelberg in order to improve process and staff safety and health. It is a semiautomated device located in a safety workbench for aseptic preparation with weight-and-visual-supported process check as well as radio-frequency identification of bags and vials.

METHODS

After qualification and a training period, several high-admixture-volume drugs were chosen stepwise to be prepared by the device. During a reporting period of 6 months, the number of processed production runs and produced bags were assessed as well as the productivity per hour of the device based on the processed admixing volume and time consumption for manual preprocessing and postprocessing steps.

RESULTS

Weight conformity tests of 246 processed bags in 11 admixing-volume ranges showed 99.19% with a deviation of <5%. Validation of the automated preparation process with 40 media fills showed no microbiological growth. Daily patient care production in the first 6 months led to a nearly similar weight accuracy and an average productivity of 22.5 preparations per running hour of the device at an average admixing volume of 39.6 mL, excluding manual preprocessing and postprocessing tasks. Time consumption for all manual steps was about 76 min per run.

CONCLUSIONS

The automated admixing process of the device showed remarkable effectivity and a satisfying accuracy, but the manual preprocessing and postprocessing steps are time consuming, which is associated with the local environment, and has to be reorganised.