Qualification of a chemotherapy-compounding robot

Abstract

KIRO® Oncology (Kiro Grifols, Spain) is a robotic system for automated compounding of sterile injectable drugs including intravenous cytotoxic treatments. The present article describes the qualification procedure applied prior to production phases. Peristaltic pumps which ensure the reconstitution of drugs were tested with water and NaCl 0.9%. The performance of the robot (accuracy and precision) to prepare bags, syringes and elastomeric pumps was evaluated with three placebo solutions (aqueous, foaming and viscous) using gravimetric controls. Microbiological controls were also performed. The pumps met the requirements set for volumes ranging from 5 to 100 mL. A total of 274 preparations was compounded. For the bags, the filling accuracy was within the limit of ±10% from 1 to 48 mL with aqueous solution, from 0.6 to 48 mL with foaming solution and from 5 to 48 mL with viscous solution. For all syringes and elastomeric pumps, it was within the limit of ±10%. The precision was validated for all preparations, except for bags and syringes prepared with 0.6 and 0.25 mL, respectively. The samples of surfaces and air complied with ISO 5 class environment. Among the 24 gloves tests performed, two presented microbiological growth. All Media fill tests were validated. The qualification procedure led us to exclude injections of any active principle volume strictly lower than 1 mL. The microbiological contamination of operators' gloves remains a critical point. Our operators will be made aware of the issue during the training period.

Evaluation of the efficacy of a self-cleaning automated compounding system for the decontamination of cytotoxic drugs

“…KIRO® Oncology is an automated system designed for the compounding of intravenous (IV) treatments, including cytotoxics and biologicals. 24 , 25 The compounding area comprises two robotic arms able to perform separate tasks simultaneously ( Figure 1(a) ) and cameras for the identification of vials, IV bags, and supplies by comparing images and barcodes with those stored in the system database. Gravimetric controls are performed at each step of the compounding process and final products are released based on their accuracy to the prescribed dose (final containers: infusion bags, capped syringes, cassettes or elastomeric pumps, Figure 1(b) ).…”

Safe handling of hazardous drugs

“…Each healthcare facility will need to assess the need for such devices in their environment. 20 – 24 …”

“…Each healthcare facility will need to assess the need for such devices in their environment. [20][21][22][23][24] It is strongly recommended that all mixing and preparation of administration sets with a hazardous drug be performed in one centralized area in a specially designated class II type B BSC 21 that: (a) is exhausted through a HEPA filter to the outside atmosphere in a manner that prevents recirculation into any inside area; (b) has exhaust and ventilation systems that remain in operation for a sufficient period of time to ensure that no contaminants escape from the BSC into the workplace; and (c) is equipped with a continuous monitoring device to permit confirmation of adequate airflow and cabinet performance.…”

Evaluation of external contamination on the vial surfaces of some hazardous drugs that commonly used in Chinese hospitals and comparison between environmental contamination generated during robotic compounding by IV: Dispensing robot vs. manual compounding in biological safety cabinet

“…18,19 Most recently, the robot-assisted compounding systems have been introduced to pharmacies based on the advantages of robotic compounding over manual compounding, such as safety improvement of healthcare worker and patient, enhancement of workflow efficiency, and complete accountability of the compounding process. 20 Inspired by the findings that compounding HDs with intelligent robotic systems (such as APOTECAchemo, ARCT, CytoCare, KIRO etc) could dramatically reduce environmental contamination, [21][22][23][24][25][26] several leading Chinese hospitals have implemented the robotic systems for preparing HDs to further improve their working environment. However, there is no report investigating the environmental contamination generated with such robot-assisted systems in China.…”