Published on 9th September 2010
CONTAMINATION CONTROL - Sterilization | Redefining Decontamination Safety: Hydrogen peroxide vapor offers advantages over other processes
By Martin Orlowski
The inherent safety of hydrogen peroxide vapor decontamination allows operators to execute and monitor the process from outside while operations continue.
Although widely expected for a long time, the classification of formaldehyde as a carcinogen by the World Health Organization means that the United States is now likely to follow other parts of the world by issuing a ban on the use of the chemical. Such an action will result in the need to revise decontamination protocols across many industry sectors as modifications are made. Fortunately, a proven alternative in the form of hydrogen peroxide vapor already exists and provides an opportunity to redefine the health and safety risks associated with large-scale decontaminations in various production environments.
The use of hydrogen peroxide vapor within the pharmaceutical industry is not new. Its use has dominated aseptic isolator sterilization for over 15 years, and one does not need to look far to see why. The technology is beautifully simple, but an advanced element of control means that more than just a hot plate is required. Regardless of the target application, a liquid form of hydrogen peroxide solution is flash evaporated in a controlled manner and the vapor evenly distributed.
The process continues until the right conditions are achieved; this state is maintained for a predetermined period of time. The final phase catalyzes the vapor into harmless byproducts—water vapor and oxygen—to return the system to its original, yet sterile, condition. This residue-free characteristic has added to the technology’s success, as have its ease of validation and material compatibility, over both the long and short terms.
Since its conception, the technology has evolved from a focus on small, contained systems such as isolators and chambers to greater spaces such as rooms, suites, and even entire buildings. However, such scaling up comes with its own unique set of challenges, resulting from the shift away from dealing with systems specifically designed for hydrogen peroxide vapor decontamination. Issues of validation, health, and safety are among those needing to be addressed.
To read the full version of this article, click here...