The conception of a laboratory suited to the chemotherapies analysis in hospital pharmacy

Nicolas Guichard1,2, Pascal Bonnabry1,2 et Sandrine Fleury-Souverain1 1. Pharmacy, Geneva University Hospitals, Geneva, Switzerland
2. School of Pharmacy, Geneva University, Lausanne University, Geneva, Switzerland

Objective

Anticancer drugs are important candidates for pharmaceutical analysis, for the purpose of quality control, stability studies or trace determination in environment. Given the wide range of physico-chemical properties and the high toxicity of anticancer drugs, the development of analytical methods for their quantification and identification can be difficult. In addition, the implementation of the analysis of these highly toxic drugs can not be detrimental to the safety of the analyst and the environment.

Method & results

* Analytical aspects

Two techniques were chosen for their analytical complementarity :

  • Capillary electrophoresis coupled to UV detection allows the quantification of high concentration formulations with very low volumes (of the order of nL) with limited waste (a few mL) ;
  • LC-MS/MS for the analysis of non-UV visible compounds as well as all anticancer drugs in trace amounts.

* Protection aspects

As the production of chemotherapies, confinement is a key point in securing the analytic process. Thus, a dedicated analysis laboratory equipped with an autonomous ventilation and an airlock was created in order to maintain a depression of at leat 30 Pa inside the laboratory. In addition, specific equipment has been installed to secure each step of the analysis :

  • Sample preparation :
    • A horizontal laminar flow weighing hood equipped with a HEPA filter in order to limit the risk related to projections of reference powders
    • A type II BSC with HEPA and activated carbon filters and a sample preparation automation to limit the risk of sample dilution
  • Analysis :
    • A laboratory fume hood to confine the LC-MS/MS equipment that can generate nebulisates
  • Waste treatment : sealed bins and secured flow.

Discussion-conclusion

The laboratory created allows the development of analytical methods for quality control of formulations produced by the chemotherapy production unit but also the development of stability studies or analysis of trace compounds by LC-MS/MS ensuring analyst security and protection of the working environment.

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