Gaseous Plasma as a New Barrier System Inactivation of Geobacillus stearothermophilus Endospores, Validation Routine and Self-Decontamination Capabilities - Part 1

Transferring material from the outside world into an aseptic filling isolator is regularly a challenge. Usually, a form of transfer lock brings required material, such as syringe containers ("tubs"), into the aseptic area. Different transfer lock configurations exist, ranging from simple alcohol spraying and volatile hydrogen peroxide (VHP) to full e-beam in-line sterilizers. This article presents a new barrier system based upon gaseous plasma decontamination. Plasma, as an ionized gas, is found to be capable of inactivating a number of sporulated forms of microorganisms, from polymers to stainless steel. The presented system operates in vacuum and only decontaminates the outer surface of syringe tubs. The plasma itself does not penetrate into the tub. The focus of this publication is to present the operating principles and develop and establish a validation routine on the basis of standard commercial biological indicators.