3PC-002 Evaluation study of a paediatric non-hazardous robotic compounding system: is it safe and dose accurate?
Year: 2025
Type: conference-paper
Abstract: Background and Importance 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. Aim and Objectives With this work we evaluated APOTECAped’s productivity (total compounding time, dose accuracy) and drugs’ sterility. Material and Methods 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). Results 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. Conclusion and Relevance 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. References and/or Acknowledgements Conflict of Interest No conflict of interest
Authors: N Monti Guarnieri, E Andresciani, R Pallotto, V Rosini, AMF Garzone, A Simonini, C Polidori, I Bartolucci, A Pompilio
Language: English
Subfield: Pharmacology
Domain: Life Sciences
Open Access status: gold
OpenAlex ID: W4408376000