Implementation of the DIANA® automaton for the preparation of dose banded chemotherapy in an isolator

E. Goiffon , J. Bayle, R. Chevrier UPCO Centre Jean Perrin, Clermont-Ferrand, France

Introduction

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.

Methods

  1. Weigh accuracy check of 36 samples.
  2. Compliance analysis of 10 chemotherapies prepared with the automaton by an analytical control method (UV / RAMAN spectrometer) (± 10% of the target concentration).
  3. Process qualification by carrying out 3 media-fill tests for each dose-banded molecule.
  4. 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.
  5. Environmental contamination evaluation with 9 fluorescein tests.
  6. Isolator qualification after opening an entrance door and installing the automaton.

Results

  1. Taken volumes’ precisions are in accordance with the data of the supplier (mean 0.84%).
  2. Concentrations of chemotherapies infusions are correct (mean error of 2.6% of the target concentration).
  3. None of the media-fill products prepared shows turbidity after incubation period, allowing us to validate the manufacturing process.
  4. No microbiological contamination found during sterility tests.
  5. During each fluorescein tests, only the compress with which the connectors were wiped are contaminated.
  6. After qualification, the isolator complies with the requirements of Class A.

Conclusion

These tests validated the use of DIANA® for dose banded chemotherapy preparations.

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