Impact of HO Sorption by Polymers on the Duration of Aeration in Pharmaceutical Decontamination.

As part of manufacturing a sterile drug product, we quantified the impact of HO sorption by polymers on the duration of aeration in pharmaceutical decontamination. Five polymers, which are typically used as materials/parts in sterile isolators, were investigated: polyethylene, polyvinyl chloride, Silicone, polyoxymethylene (POM), and chlorosulfonated polyethylene. Experiments were performed to estimate the storage capacity and diffusion coefficients of HO in the polymer. Considering these key properties of sorption/desorption, mathematical models were developed to simulate the duration of aeration to achieve the target HO concentration, which is the indicator to minimize. The models were used to create a map-out of the duration given the properties of the polymers, including the five polymers. In the simulated setup, POM and Silicone were found to require prolonged aeration. Thus, when using these polymers in the isolator, the size/amount should be carefully investigated. Another practical finding was that the superiority of the polymers changed depending on the target HO concentration. This result motivates an early incorporation of the product information in the isolator design, to achieve a rapid decontamination/aeration cycle.