3PC-002 Evaluation study of a paediatric non-hazardous robotic compounding system: is it safe and dose accurate?

<h3>Background and Importance</h3> Robotic-compounding-systems (RCS) ensure parental medications through fully automated system controlled by a software. To reduce the working area’s contaminations and medication errors during paediatric manipulations, a new RCS was located into our Hospital Pharmacy’s centralised intravenous additive service (CIVAS) in 2021. APOTECAped can compound standard-dose/personalised paediatric medications into appropriate final containers; all equipment used is carried out into the clean room through a barcode-system. It guarantees an aseptic process thanks to HEPA filters and a controlled environment. <h3>Aim and Objectives</h3> With this work we evaluated APOTECAped’s productivity (total compounding time, dose accuracy) and drugs’ sterility. <h3>Material and Methods</h3> APOTECAped’s productivity was evaluated in a production batch of 10 Pantoprazole 4 mg/ml 10 ml and 10 Cefotaxime 50 mg/ml 20 ml syringes (data collected from APOTECAped’s final reports); dose accuracy was analysed through gravimetric and volumetric controls. Bacteria and fungi’s contamination was tested by the Hospital’s Hygiene Department at time 0 and after 7 days from preparation (one syringe of each drug each time) after inoculation into TSB broth solutions and incubation for 7 days. Endotoxins’ quantification was done by the hospital pharmacist using a chromogenic kinetik LAL-test method. The Endotoxines-Limit (EL) was 4,17 EU/mg for Pantoprazole (data based on the maximum dose administered to a paediatric patient) and 0,05 UE/mg for Cefotaxime (data from European Pharmacopoeia). We calculated the maximum dilution volume (MDV) to avoid interferences during test; for our analysis we used MDV/2 (1:800 for pantoprazole, 1:125 for cefotaxime). <h3>Results</h3> Pantoprazole syringes were prepared using 40 mg lyophilised powder and 10 ml of NaCl 0,9% solution; mean of dose error was – 3,87%, total time to make the production batch was 57 minutes (approximately 5 minutes/syringe). Cefotaxime syringes were prepared using 1000 mg lyophilised powder, 4 ml of sterile-injectable-water (reconstitution) and 16 ml of NaCl 0,9% (dilution); mean of dose error was −2,12%, total time to make the production batch was 88 minutes (approximately 8 minutes/syringe). Microbiological tests demonstrated the absence of bacteria and fungi’s growth, LAL-test that the endotoxins’ quantification was under the EL. <h3>Conclusion and Relevance</h3> APOTECAped guaranteed dose accuracy and drug sterility during the compounding. Even if the total robotic preparation time was longer than manual, RCS could reduce human errors and increase drug safety. <h3>References and/or Acknowledgements</h3> <h3>Conflict of Interest</h3> No conflict of interest