29-Aug-2012

Isolator decontamination with nitrogen dioxide

Abstract

The majority of isolators are decontaminated using hydrogen peroxide vapour technologies, but limitations in process control, aeration efficiency, and product compatibility have led to research into new decontamination methods. DNA in mammalian cells is degraded via single-strand breaks upon exposure to nitrogen dioxide, which is now being developed as a sterilant.

Testing has been carried out using an NO2 generator connected to a fully loaded three-glove Transfer Isolator

New decontamination technology based on NO2 gas promises many benefits. James Rickloff, David Opie and Evan Goulet look at the specific advantages for decontaminating isolators used in aseptic manufacture.

Isolators are an important part of any life science company’s manufacturing and QC processes. These sealed areas are used both to produce and test pharmacopeial products in a decontaminated, “germ-free” environment.

Sterilant generators were developed in the late 1980s to provide for a more effective and validated decontamination process to control microbiological contamination in these aseptic processing areas. The majority of isolators in use today are decontaminated using hydrogen peroxide (H2O2) vapour technologies. However, limitations in process control, aeration efficiency, and product compatibility, especially with protein-based drugs, have led to research into new decontamination methods.

Nitrogen dioxide (NO2) has been thoroughly studied over the past decades, not as a sterilant, but rather as a common component of air pollution. This body of knowledge has contributed to the development of NO2 as a sterilant. Prior research has shown that DNA in mammalian cells is degraded via single-strand breaks upon exposure to NO2 gas.1,2

. . .

This is a small extract of the full article which is available ONLY to subscribers. Subscribers sign-in (top right) to read the article.

Or

Subscribe now to Cleanroom Technology

Email this story