3PC-007 Accuracy and sterility performance of a new pharmacy robot-closed system transfer device combination

<h3>Background and Importance</h3> Oncology pharmacists must provide sterile and accurate preparations, while limiting exposure to hazardous drugs. Robotic compounding may provide a partial solution for short-staffed pharmacies. One new automation solution is designed to work together with a closed system transfer device (CSTD) to maintain drug sterility and prevent hazardous drug release, while streamlining CSTD implementation for administration according to USP &lt;800&gt;. Accuracy and sterility must be verified when integrating the robot into production. Incidence of incorrect drug concentration with manual production can reach 88%,¹ while reported robot failure rates range from 0.9–18.7%.² <h3>Aim and Objectives</h3> The aim was to determine cytotoxic drug dilution accuracy and verify sterility using an automated compounder combined with a CSTD. <h3>Material and Methods</h3> Tests were performed at Remedix Care, a preparation centre with ISO/IEC 17025:2017 accreditation. Dose accuracy was determined for 522 preparations of carboplatin, endoxan, 5-fluorouracil, gemcitabine, oxaliplatin, and paclitaxel. Injected volumes ranged from 7 to 83 ml. The robot self-checks accuracy by mass increase of IV bags. Deviation of actual vs. expected concentrations was determined. Media fill tests were performed on 210 infusion bags over 4 days. A range of typical manipulations to the bags were performed using the robot with CSTD. The bags were incubated at 25–30 °C for 14 days. Growth promotion tests (GPT) were performed by injecting 10 microorganism species into a sample of bags and repeating incubation. <h3>Results</h3> Ninety-seven percent of preparations met the strict criterion of &lt;5% deviation. Mean deviation for all preparations was ±1.6%. None of the 210 infusion bags showed any growth in the media fill test, while all GPT controls exhibited growth. <h3>Conclusion and Relevance</h3> The new robot + CSTD combination system was found to maintain sterility in prepared infusion bags and to reliably produce doses of the correct concentration. Comparison to other studies is difficult, due to variation in drugs prepared, acceptance criteria, and variable inclusion of a CSTD. The new combination device represents a new paradigm for safe and accurate cytotoxic preparation. Future studies will evaluate whether it can reduce cytotoxic contamination of the environment. <h3>References and/or Acknowledgements</h3> Hedlund N, <i>et al. BMJ Open</i> 2017;<b>7</b>:e015912. doi:10.1136/bmjopen-2017-015912 Yang C, Ni X, Zhang L, Peng L. <i>Medicine</i> 2023;<b>102</b>:19(e33476) <h3>Conflict of Interest</h3> Corporate sponsored research or other substantive relationships: KM, OS, and NH declare no conflict of interest. IT and EASS are employed by Simplivia Healthcare, Ltd., a CSTD manufacturer.