Impact of H2O2 Sorption by Polymers on the Duration of Aeration in Pharmaceutical Decontamination

As part of manufacturing a sterile drug product, we quantified the impact of H2O2 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 H2O2 in the polymer. Considering these key properties of sorption/desorption, mathematical models were developed to simulate the duration of aeration to achieve the target H2O2 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 H(2)O(2 )concentration. This result motivates an early incorporation of the product information in the isolator design, to achieve a rapid decontamination/aeration cycle. (C) 2020 American Pharmacists Association (R). Published by Elsevier Inc. All rights reserved.