Media-fill simulation tests in manual and robotic aseptic preparation of injection solutions in syringes

Abstract

Extensive media-fill tests simulating manual and automated preparation of ready-to-use cytotoxic injection solutions revealed the same level of sterility for both procedures. The results of supplemental environmental controls confirmed that the aseptic procedures are well controlled. As there was no difference in the microbial contamination rates of the media preparations depending on the extent of cleaning and disinfection of the robot, the results were used to adapt the respective standard operating procedures.

Simulation program of a cytotoxic compounding robot for monoclonal antibodies and anti-infectious sterile drug preparation

“…This method was already used by Krämer et al. 38 to qualify the APOTECAchemo® robotic system. Similar to our findings, this method allowed them to adapt standard operating procedures.…”

“…This contamination could be transferred to septum of vials or bags when handled by operators and confirms the need to respect good practices related to the frequency of gloves' disinfection and changes. This method was already used by Kra¨mer et al 38 to qualify the APOTECAchemo Õ robotic system. Similar to our findings, this method allowed them to adapt standard operating procedures.…”

“…KIRO Õ Oncology robot is the only robot available on the market providing a self-cleaning system. To assess its effectiveness towards microbiological contamination, microbiological environmental monitoring was achieved simultaneously to MFT as previously purposed by Kra¨mer et al 38 for cleaning validation of their APOTECAchemo robot.…”

Qualification of a chemotherapy-compounding robot

“…These are comparable results with those obtained by the APOTHECAchemo Õ robot which had also been set up under a laminar air-flow hood. 9 Before starting the compounding of products intended for patients, the efficiency of the recognition system of vials containing antineoplastic drugs should be assessed.…”

Microbiological validation of a robot for the sterile compounding of injectable non-hazardous medications in a hospital environment

“…1 The implementation of robotic devices for the intravenous (IV) medication compounding has been proposed to be powerful tools in accomplishing the aseptic processing due to the high repeatability of operations and movements that avoids contacts between critical components and ensures error prevention. 2 Nevertheless, although the presence of IV compounding robots in hospitals has led to a significant revolution in clinical practice, their use has mainly occurred in the preparation of IV anticancer drugs as a result of high toxicity and low therapeutic index of certain chemotherapeutic drugs. [3][4][5][6][7] Indeed, manual compounding is still the most common practice for the preparation of nonhazardous (n-Hz) IV medications such as antibiotics, anti-emetics, diuretics, cortisones and so on.…”