Implementation of the DIANA® automaton for the preparation of dose banded chemotherapy in an isolator
6 October 2017E. Goiffon , J. Bayle, R. Chevrier UPCO Centre Jean Perrin, Clermont-Ferrand, France
Faced with the repetitive gestures involved in the production of dose banded chemotherapy and associated musculoskeletal disorders, the DIANA® preparation aid was acquired. A preliminary validation protocol was perfomed before use it for the dose banded preparation of 2 molecules.
- Weigh accuracy check of 36 samples.
- Compliance analysis of 10 chemotherapies prepared with the automaton by an analytical control method (UV / RAMAN spectrometer) (± 10% of the target concentration).
- Process qualification by carrying out 3 media-fill tests for each dose-banded molecule.
- Performing 2 sterility tests per molecule by mimicking a preparation with water injection in sodium chloride infusion: a microbiological analysis was carried out to evaluate the sterility of the preparations, one after manufacture and one after a storage period of 28 days at fridge.
- Environmental contamination evaluation with 9 fluorescein tests.
- Isolator qualification after opening an entrance door and installing the automaton.
- Taken volumes’ precisions are in accordance with the data of the supplier (mean 0.84%).
- Concentrations of chemotherapies infusions are correct (mean error of 2.6% of the target concentration).
- None of the media-fill products prepared shows turbidity after incubation period, allowing us to validate the manufacturing process.
- No microbiological contamination found during sterility tests.
- During each fluorescein tests, only the compress with which the connectors were wiped are contaminated.
- After qualification, the isolator complies with the requirements of Class A.
These tests validated the use of DIANA® for dose banded chemotherapy preparations.