Background In March 2016, one of our hospital pharmacies started using a robotic solution for chemotherapy compounding. This solution was placed in a production room with an EU-GMP class D classification. During an audit related to the start-up, our governing body requested to see results to determine if the robotic solution could uphold the EU-GMP classification for its respective areas, and sustain the same level of microbiological cleanliness as manual production done in an isolator. We performed extended environmental monitoring of the robotic solution for the first 6 months of production, and compared the results with routine samples from manual production.
Purpose To show that the robotic solution can sustain the same level of microbiological cleanliness as manual productions in an isolator during chemotherapy compounding, in a EU-GMP class D classified production room.
Material and methods The extended environmental monitoring for the first 6 months of compounding consisted of: daily monitoring with 5 settle plates, 3 were placed in the production area (require EU-GMP class A), 1 in the carousel area and 1 in the loading area (both require EU-GMP class B); weekly monitoring consisted of all swab and contact samples (see figure). Air samples were performed twice. The number of colony forming units (CFU) were determined after incubation for 7 days at 20–25°C and then for 5 days at 30–35°C. 25 separate media fill procedures, 250 media fill preparations in total, were also performed. All environmental samples for the robotic solution were sampled during preparations, and during routine activity in the production room. There were 3445 preparations compounded in the robotic solution during this period.
Results Some of the environmental samples were outside the limits of their respective EU-GMP class, but less frequent and lower averages of CFU than for manual production in the isolators. The media fill preparations had no deviations.
Figure Sample locations and results.
Conclusion Our environmental monitoring showed that it is possible for the robotic solution to obtain at least the same level of microbiological cleanliness as manual production in an isolator in an EU-GMP class D classified production room.
References and/or acknowledgements The technicians and pharmacist involved in the daily production and sampling.
No conflict of interest
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