Study of particle contamination in activity areas dedicated to the automated preparation of doses to administer (APDA)

4 October 2023

I. Bari, E .Gayet, J.-N. Maurer
Centre Hospitalier de Verdun Saint-Mihiel, Verdun, France

Background and aims
In our establishment, two studies on automated preparation of doses to administer (APDA) revealed a potential risk of chemical exposure of staff to drugs by the inhalation and cutaneous routes, and a production of particles during activity. This current study has two objectives: to compare the particulate concentrations obtained in the APDA areas with those obtained in the main pharmacy room, where no drugs are repackaged, and to assess the effectiveness of the collective protection systems used for APDA (a suction system connected to our automatic dispensers and an extractor hood for the repackaging activity).

We carried out a particle count, in accordance with standard ISO 14644-1, using a discrete particle counter considering particles with a size greater than or equal to 1 µm. Samples were collected in 3 rooms: the work areas dedicated to APDA - the production room (PR) and the deconditioning room (DR) - and the overall storage and dispensing room considered to be the reference room (RR). For the APDA rooms, measurements were taken with and without the extraction systems. The sampling points were evenly distributed in each room and their number corresponded to the square root of the floor area.
Particulate concentrations, given as the number of suspended particles per m3, were compared using statistical tests.

The 305 samples showed a significantly higher average particulate activity concentration in the reference room compared with the APDA rooms (α = 0.05): RR = 371,093 vs PR = 133,620 (p = 3.38E-8) vs DR = 25,807 (p = 2.42E-9). Mean particulate concentrations in APDA rooms were significantly higher when the exhaust systems were inactive (α = 0.05): PR = 288,484 vs 133,620 (p = 1.26E-5) and DR = 124,641 vs 25,807 (p = 2E-5).

From a quantitative point of view, exposure to particles is no greater in the APDA areas than in the reference room with no deconditioning activity. The suction systems used for the APDA are effective in terms of personnel protection, as they significantly reduce dust in the working environment. This work is part of a risk management approach and has served as a communication tool to raise awareness among pharmacy staff of the need to comply with protective measures. It is also of interest to other establishments that are implementing or are planning to implement a APDA.

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