Qualification of a chemotherapy-compounding robot.

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.