Different time points are defined, where selected batches are tested for a range of HPHCs in the aerosol, physical and chemical characteristics, sensory property of the product, and visual inspection.
For quantitative data, all values measured are then aggregated together to build a regression model for the time evolution and the confidence limit for every parameter followed in the course of the aging study. The confidence level is then compared to a pre-established specification to define the shelf life of the product.
Product robustness under various climatic conditions
Our smoke-free products will be used in different regions; therefore, we need data to demonstrate that the products performance will be maintained in various climatic conditions.
To do that, we have a climatic smoking machine, enabling testing the products under defined humidity and temperatures. We use the temperature and humidity ranges covering the WHO climatic zones defined in ICH guidelines (Q1), also used for aging studies.
The results published by Poget et al. (2021) indicate that, regardless of the considered climatic conditions, the HPHC levels investigated in our Tobacco Heating System (THS) 2.2 aerosol were reduced by at least 90%, on average, when compared with the levels measured in 3R4F cigarette mainstream smoke. This confirmed the robustness in performance for THS 2.2 to deliver reduced levels of HPHCs under extreme climatic conditions.