Manufacturing & Sterility

VHP

Vaporized Hydrogen Peroxide

What a definition is not

A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.

Vaporized (or vapor-phase) hydrogen peroxide is a low-temperature sporicidal agent used to bio-decontaminate enclosed spaces such as isolators, RABS, transfer hatches, and cleanrooms. It achieves surface sterilization/decontamination without the heat or moisture that would damage sensitive equipment and materials.

A VHP cycle typically runs conditioning, gassing, dwell, and aeration phases; the aeration phase is critical because residual peroxide must be brought below levels that could affect product or operators before the space is used. Cycle efficacy is demonstrated with biological indicators of a resistant spore species.

VHP is the workhorse for isolator decontamination in aseptic filling, enabling the high assurance of grade A conditions inside a sealed enclosure. Load configuration, surface materials, and enclosure geometry all affect distribution and must be represented in the validation.

KEY POINTS
  • Low-temperature sporicidal decontamination of enclosed spaces.
  • Phases: conditioning → gassing → dwell → aeration.
  • Aeration must reduce peroxide residuals before use.
  • Efficacy proven with resistant-spore biological indicators.
REGULATORY BASIS

EU GMP Annex 1 (2022) bio-decontamination of isolators/RABS; ISO 22441 (2022) low-temperature vaporized hydrogen peroxide sterilization.

Frequently asked questions

What does VHP stand for?

VHP stands for Vaporized Hydrogen Peroxide.

What is VHP?

Vaporized (or vapor-phase) hydrogen peroxide is a low-temperature sporicidal agent used to bio-decontaminate enclosed spaces such as isolators, RABS, transfer hatches, and cleanrooms. It achieves surface sterilization/decontamination without the heat or moisture that would damage sensitive equipment and materials.

Which regulations cover VHP?

EU GMP Annex 1 (2022) bio-decontamination of isolators/RABS; ISO 22441 (2022) low-temperature vaporized hydrogen peroxide sterilization.