Multicenter Study on Incubation Conditions for Environmental Monitoring and Aseptic Process Simulation.

Abstract

Microbiological environmental monitoring and aseptic process simulation confirm that pharmaceutical cleanrooms are in an appropriate hygienic condition for manufacturing of sterile drug products. Guidance documents from different health authorities or expert groups differ regarding recommendation of the applied incubation time and incubation temperature, leading to variable manufacturers practices. Some recent publications have demonstrated that laboratory studies are not relevant to determine the best incubation regime and that in situ manufacturing site studies should be used. To solve any possible bias coming from laboratory studies or single-site in situ studies, we conducted a multicenter study at four manufacturing sites with a significant amount of real environmental monitoring samples collected directly from the environment in pharmaceutical production during manufacturing operations with four solid and liquid nutrient media. These samples were then incubated under four different conditions suggested in the guidance documents. We believe that the results of our multicenter study confirming recent other single-site in situ studies could be the basis of the strategy to determine the best incubation regime for both viable environmental monitoring and aseptic process simulation in any manufacturing facility.