(542g) H2O2 Decontamination for Sterile Manufactruing: Impact of Sorption By Polymers on the Duration of Aeration

Hydrogen peroxide decontamination is the key technology to sterilize isolators or clean rooms to produce injectables. Typically, injectables are manufactured batch-wise, where decontamination serves as the change-over operation between batches. Decontamination is known to be time-intensive, especially the aeration part to reduce the residual H₂O₂ to a target concentration (e.g., 1 ppm, or even lower). Decontamination is becoming relevant, along with the market growth of biopharmaceuticals/vaccines that are usually provided as injectables, and also with the trend of small lot-size production and frequent change-overs.

We analyzed the impact of H₂O₂ sorption by polymers on the duration of aeration. Five polymers, which are typically used as materials/parts in sterile isolators, were investigated: chlorosulfonated polyethylene, silicone, polyethylene, polyoxymethylene, and polyvinyl chloride. For assessing different polymers, we defined the storage capacity and diffusion coefficients of H₂O₂ in the polymer as the indicators. Experiments were conducted to assess the abovementioned five polymers, and also to develop models to estimate the required duration of aeration, given the target H₂O₂ concentration. We extended the model calculation to map-out the duration, given the properties of the polymers. In the simulated setup, polyoxymethylene and silicone showed the tendency to require long duration for aeration. The result suggests that the application of these polymers in the isolator requires attention. Also, the target H₂O₂ concentration affected the superiority of the polymers largely, which is another practical finding from the analysis. This result suggests the benefit of integrating product information into the design of isolators, in order to achieve a rapid cycle of decontamination and aeration.