VHP bio-decontamination: an ally for Annex 1 compliance

The new version of Annex 1 focuses on risk management by requiring manufacturers to have a clear strategy to prevent contamination of final products.

VHP bio-decontamination is an excellent ally to help sterile drug manufacturers meet several Annex 1 requirements such as RABS gloves or other inaccessible surfaces sterilisation.

VHP technology, using hydrogen peroxide in vapour form (Vapour-Phase Hydrogen Peroxide), enables the rapid and effective elimination of a broad spectrum of micro-organisms, offering the same microbial load reduction levels as sterilisation (6 Log) and a perfectly uniform gas diffusion to reach even the most difficult places.

Bioreset®, the patented line of V-PHP generators, is particularly suitable for the decontamination of cleanrooms, isolators and RABS and fulfils the requirements of Annex 1.

Find out more by reading the article (courtesy translation in English available here) published in the September issue (No. 8) of NCF – Notiziario Chimico Farmaceutico magazine.