Investigation of oxidation potential in a vaporized hydrogen peroxide-decontaminated production isolator

Vaporized Hydrogen Peroxide (VHP) sterilization is widely used in aseptic pharmaceutical manufacturing due to its microbial decontamination effectiveness. However, residual VHP inside isolators can lead to oxidative degradation of sensitive formulations, posing a risk to drug product quality. Ensuring formulation stability in vaccines is critical to maintain safety, efficacy, and regulatory compliance. At GSK, residual VHP absorption in formulations is assessed using an empirical model based on factors such as exposure time, residual VHP concentration, container format, and fill volume. However, this model does not account for all sources of VHP uptake, such as absorption by silicone tubing and its subsequent release into the product path. This thesis investigates hydrogen peroxide uptake during the filling process by analyzing its diffusion, adsorption, and oxidative effects on biologics and excipients. Experimental work involved exposing various packaging components (glass vials, syringes, silicone tubing) to controlled VHP levels, followed by quantitative H₂O₂ measurements using the Amplex Red Method. The study explores how tubing geometry (wall thickness, and surface area) and material properties affect H₂O₂ retention and release. It also examines the role of vial siliconization, VHP concentration, exposure time, and filling volume in influencing peroxide uptake. Results show that tubing materials and dimensions significantly affect peroxide absorption, and that different components contribute variably to residual peroxide in the drug path. Conclusions from this study contribute to the optimization of VHP sterilization protocols by establishing strategies for minimizing residual hydrogen peroxide exposure while maintaining sterility standards.