Past mistakes and misstatements have adversely influenced industry decontamination practices with vapor phase hydrogen peroxide, and this article endeavors to clarify the process.

The introduction of isolation technol ogy in the pharmaceutical industry by the French firm La Calhene in the 1980s required a means for the reli able microbial econtamination of the isolator interior. This was initially per formed using a mist of peracetic acid/water; however, this was considered un desirable for a variety of reasons, with objections over its use primarily aimed at the resultant corrosion of surfaces, wet surfaces, and lengthy aeration times. In the late 1980s, AMSCO (now Steris) of fered the first widely available lternative with their VHP-1000 generator, which delivered vapor phase hydrogen peroxide (VHP). With the introduction of the VHP-1000, this technology and its derivatives became the dominant means for isolator decontamination.

Initially, the performance expectations for the decontamination process varied according to the end user’s protocol re quirements. The process target (decon tamination or sterilization) and the means to establish them (the biological indicator [BI] population to use and the selection of cycle duration) varied widely. Firms with near identical systems and practices con sidered them differently.

A shift in perspective is essential to suc ceed in the changing landscape. The exist ing log reduction requirements are poorly suited to the emerging perspectives of de contamination using a vapor treatment.

Increasing usage of vaporized hydrogen peroxide has resulted in numerous publi cations describing applications of various types, from small pass-through chambers to entire suites of rooms. Unfortunately, past mistakes and misstatements have been incorporated which have adversely influenced industry practices. This doc ument endeavors to clarify the process relying on the core science underlying it. Many of the problematic statements regarding vapor decontamination are provided in this paper followed by the scientific reality.