Background Our pharmacy has recently installed and GMP qualified an automated robot (APOTECAchemo) for cytotoxic compounding. Within a year the robot will be upscaled to produce 34,000 units per year. A majority of the units will be stock held for more than 24 h, which makes greater demands on the documentation of the aseptic process.
Purpose To describe the setup of the initial performance qualification of the robot with media fill and continuous particle counts.
Materials and methods Media fills with growth media were used to simulate the compounding processes in order to evaluate sterility of the products. Critical factors were taken into account: Personnel (number and time shift), type and size of final container, number of needle picks in the final containers and different compounding processes with liquid drugs and powder drugs.
Planned interventions were made several times during the media fill to simulate ‘worst case’ scenarios that could happen in a normal working day. The waste bin was changed, the door into the production area was opened twice to simulate cleaning after a spill and picking up a fallen vial. Media fills were performed at least eight hours a day, three days in a row. 108 units were produced and incubated for 14 days at 32.5 ± 2.5 ºC. Particle counts in the robot production zone were monitored continuously during media fills.
The acceptance criteria of the media fill were <1 contaminated unit and the acceptance criteria of the particle level was in accordance with EN ISO 14644–1.
Results After incubation, the units were inspected visually for microbial growth. None of the products were contaminated and none of the particle counts measured during the media fill exceeded the acceptance criteria.
Conclusions With media fill and continuous particle monitoring, we assessed our technique, evaluated the aseptic preparation on the robot and qualified the operators. We demonstrated that the environmental control is adequate to meet the requirements necessary to produce cytotoxic units for stock hold.
No conflict of interest.
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