In aseptic filling, hydrogen peroxide vapour (VHP) is a proven means of decontamination - but it does harbour risks. New research shows that VHP can remain in filling tubes and later be released into products, jeopardising the quality of sensitive biopharmaceuticals.
In a recent study, researchers from Fribourg, Muttenz and Basel systematically investigated for the first time how material properties such as wall thickness, density and hardness influence VHP uptake and release. To this end, they established a model insulator on a laboratory scale and confirmed their results in a GMP-compliant filling line.
What do these findings mean for manufacturers and operators and what approaches exist to protect the integrity of their products?