Robot for aseptic compounding of cytotoxics
9 October 2011A. Hurgon, A. Chassin, C Giard, L. Escalup Institut Curie, service Pharmacie,
Process to integrate an automated system in a cytotoxic preparation unit
With the aim of ensuring automation and securing reconstitution of cytotoxics, the Curie Institute initiated validation and integration of an automated system within its unit. The ultimate goal was to turn this automated system into a validated, secure tool in accordance with Best Preparation Practices, answering both to our needs (productivity, taking over series of doses, securing preparation and diversifying procedures) and installation within an isolator.
Working in partnership with the Medical Dispensing System Company over two years (2009-2010), we jointly developed technical upgrades to the Pharmahelp® prototype and conducted operational qualifications (safety, accuracy, autonomy, productivity, adaptation to products and computerised management) on the machine. In parallel with this, the design of a custom isolator mobilised a team of technicians, ergonomists and pharmacists.
In September 2010, installation of the automated system in its environment led to the performance qualification phases focusing on:
- accuracy of sampling,
- safety of gravimetric testing and correlation with analytical tests,
- parameterising products and reliability of inspection by camera,
- absence of microbiological contamination by media fill test and implementation of environmental microbiological checks,
- quality of computerised management of malfunctions and its impact on productivity.
To make the automated system productive, our thinking evolved gradually towards optimal management of the stages in the process, defining the technician/pharmacist team set-up and how they were to interact. Training of referral technicians over a one-week period paved the way for the automated system being taken over with full autonomy. Planning series, management of malfunctions and release by gravimetric test were all conducted by the referral pharmacist.
By the end of December 2010, transfer of part of our production to automated mode commenced by series of two pilot molecules (5FU for the solution form and cyclophosphamide for the powder form). Then came a ramp-up with the integration of three new molecules leading to gradually improved productivity.
Routine use showed the stability of the automated system’s performances. Malfunctions related in the great majority of cases to the limits of the control software. Rarer mechanical failures also impacted our productivity.
Management of malfunctions in real time and in parallel with production required the manufacturer to interact closely and remain available. Fine tuning to achieve optimal operation was achieved over time.
Obviously, this automated system is not the ideal tool. The low level of the tool’s autonomy, operation with needle/air inlet and it being impossible to produce syringes were the main weaknesses of this first generation. However, integration of the automated system proved to be a success since automated production in addition to our manual production has now proved itself to be indispensable especially in a difficult context where there are not enough technicians and musculoskeletal incidents are common occurrences.