Background The traditional process of preparing ready-to-use antibiotics imposes the following challenges: 1) Limited capacity leading to shortage problems, 2) Monotonous repetitive work, 3) High-risk human involvement in large-scale aseptic processing. To address these issues, two collaborating Danish hospital pharmacies have automated the process by introducing cleanroom robots. But is automation the key to success?
Purpose To evaluate the implementation of cleanroom robots in preparing ready-to-use antibiotics.
Materials and methods In 2007, the hospital pharmacies from the Capital Region of Denmark and Odense University Hospital decided to automate the process of preparing ready-to-use antibiotics. Technology was used to maximise compliance with GMP. All qualification and validation tests were completed by the first product release in June 2011.
Results The authors discovered that:
1) Production capacity increased from 150 products per hour to 350 products per hour with equivalent man-hours
2) The monotonous repetitive work was reduced to a minimum
3) Compliance with GMP was optimised by:
▶ Excluding human interference in class A
▶ Using dedicated cleanroom robots
▶ Qualifying robot movement and UDF (unidirectional airflow)
▶ Manufacturing machine parts in polished 316 stainless steel
▶ Using vision and image processing for continuous process monitoring
▶ Fitting probes for particle count
But this was achieved at the cost of:
▶ a large financial investment (∼1 million €)
▶ a significant delivery time on equipment (∼2 years)
▶ a high demand for qualification and validation (time consuming)
▶ restricted handling of different materials (eg, vials)
Conclusions The use of cleanroom robots in preparing ready-to-use antibiotics has proven to be clever GMP. Automation requires initial investments and time, but automating the process has increased production capacity and facilitates a healthy work environment. Concurrently, automation made it possible to optimise compliance with GMP on several critical aspects of large-scale aseptic processing.
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