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Technology (including: robots for production, Incompatibilities, drug production and analytics, CRS)
Chemical contamination during the preparation of cytotoxics: a multi-site simulation study
  1. M. Mattiuzzo,
  2. S. Nussbaumer,
  3. F. Sadeghipour,
  4. S. Fleury-Souverain,
  5. P. Bonnabry
  1. 1Geneva University Hospitals, Pharmacy, Geneva, Switzerland

Abstract

Background Although an effort is always made to reduce contamination, traces of cytotoxic drugs can be found in the environment. External surfaces of vials can be a source of contamination, but the operators themselves also contribute to this problem during manipulation.

Purpose To quantify the chemical contamination generated by a large panel of operators during a standard preparation process, using a non-toxic tracer in a multi-site simulation.

Materials and methods Preparation was simulated voluntarily by operators in Swiss hospital pharmacies. Each operator had to reconstitute 3 vials of quinine diHCl powder (200 mg) with 5 mL of water and dilute them in 3 saline solution infusion bags (50 mL). A standard procedure was used, using only one 10 and one 20 mL syringe, 2 needles and 15 gauze compresses, creating a worst-case scenario. Contamination on vials, bags, gloves and compresses was analysed by a validated fluorimetric method (λex=345 nm, λem=448 nm, LOD (limit of detection) =0.3 ng/mL or 15 nL and LOQ (limit of quantification) =1 ng/mL or 50 nL at pH 3.0).

Results Sixty-two operators in 24 hospitals (1 to 5 per hospital) participated in the study. 95% of operators contaminated at least one object. Mean total contamination was 78 µL (0 to 596 µL). Compresses were the most contaminated items (mean 72 µL, 0 to 592 µL). Contamination also occurred on gloves (0.2 µL, 0 to 59 µL), bags (0.7 µL, 0 to 24 µL), quinine vials (0.2 µL, 0 to 16 µL) and water vials (0.02 µL, 0 to 0.8 µL).

Conclusions A simple validation protocol for chemical contamination, using a non-toxic tracer, enables the ability of operators to avoid spillage to be checked. It demonstrated wide variability between operators in a multi-site survey. Such a simulation tool is of the utmost importance in the context of the operator's initial and continuing training and qualification.

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