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Qualification of a chemotherapy-compounding robot.

Marion Jobard1, Marie-Laure Brandely-Piat1, François Chast1

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Journal of Oncology Pharmacy Practice : Official Publication of the International Society of Oncology Pharmacy Practitioners
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PubMed
Summary

The KIRO robotic system for automated compounding of sterile injectable drugs, including cytotoxic treatments, was qualified for production. The system demonstrated acceptable accuracy and precision, with specific exclusions for low-volume injections and identified operator glove contamination as a critical point.

Keywords:
Automated compoundingchemotherapy preparationsqualificationrobot

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Area of Science:

  • Oncology
  • Pharmaceutical Compounding
  • Robotics

Background:

  • Automated compounding systems are crucial for preparing sterile injectable drugs, especially cytotoxic treatments.
  • Ensuring the accuracy, precision, and sterility of automated compounding is essential before clinical implementation.

Purpose of the Study:

  • To describe the qualification procedure for the KIRO robotic system prior to production phases.
  • To evaluate the performance of the robotic system in preparing sterile injectable drugs.

Main Methods:

  • Qualification of peristaltic pumps using water and NaCl 0.9%.
  • Gravimetric and microbiological controls to assess robot performance (accuracy, precision) with placebo solutions.
  • Environmental monitoring (surfaces, air) and operator glove testing.

Main Results:

  • Peristaltic pumps met volume requirements (5-100 mL).
  • Filling accuracy within ±10% for various solutions and preparations, with precision validated except for specific low volumes.
  • Environmental and media fill tests complied with ISO 5 standards; however, two operator glove tests showed microbial growth.

Conclusions:

  • The KIRO system's qualification procedure excluded active principle volumes below 1 mL.
  • Operator microbiological contamination via gloves is a critical concern requiring enhanced training.