Evaluation of Kiro Oncology® robot performances to make bags, syringes and elastomeric pumps of chemotherapy drugs

7 October 2016

M. Jobard1, M-L. Brandely-Piat1, A. Hurgon2, L. Escalup2, F. Chast1 1 Service de Pharmacie Clinique, Groupe des Hôpitaux Universitaires Paris Centre,
site Hôtel-Dieu, 1 place du Parvis Notre Dame, 75004 Paris, France
2 Service de Pharmacie, Institut Curie, 26 rue d’Ulm, 75005 Paris, France

Kiro Oncology® (Kiro Robotics), a robot for the preparation of intravenous chemotherapy drugs, was installed in our hospital pharmacy due to a stronger activity. The robot prepares bags, syringes and elastomeric pumps of anticancer drugs. The aim was to evaluate the performances of the robot to make these 3 types of preparations.

Preparations were made with the following materials: NaCl 0.9% 100 mL Freeflex® bags; 1, 3, 10, 20 et 60 mL BD Plastipak® syringes and 240 mL (5 mL/h) Baxter® Elastomeric Pumps. Six volumes of preparations were tested to evaluate the minimum and maximum volumes and the various syringe references: 0.6; 1; 5; 10; 20 and 48 mL for the bags and 0.25; 1; 5; 11.7; 25 and 48 mL for the syringes. Two placebo solutions (aqueous and foaming) packaged in 5, 20 or 100 mL vials were used. Only one volume was assessed for elastomeric pumps: 120 mL extracted from 100 mL vials of aqueous placebo. All preparations were checked using gravimetric controls. Accuracy was determined for each preparation. Repeatability (RP) was defined for each volume with 6 repetitions performed the same day. Intermediate precision (IP) was determined for each volume with 3 repetitions performed on 3 different days.

A total of 48 bags, 48 syringes and 8 elastomeric pumps were made with the aqueous solution and 48 bags and 48 syringes with the foaming solution. For bags and syringes, the precision (RP and IP) was validated from 1 mL (CV<5%) with the two placebo solutions. The filling accuracy was within the limit of ± 10% from 1 mL to 5 mL and of ± 3% from 10 mL to 48 mL. The performances were not satisfactory for the volumes of 0.25 mL (syringe preparations) and of 0.6 ml (bag preparations): the coefficients of variation (CV) (RP and IP) were higher than 5%; accuracy was outside the range [90; 110%]. For elastomeric pumps, the CV of RP and IP were <1% and accuracy was within the limit of ± 1%.

The precision and accuracy of the robot Kiro Oncology® are validated to make bags, syringes and elastomeric pumps for volumes higher than 1 mL with aqueous and foaming solutions. This assessment will have to be supplemented with an analysis with viscous solutions.

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