How the VH₂O₂ sterilization process works
The VH₂O₂ process is based on the controlled vaporization of liquid hydrogen peroxide, transformed into vapor through a dedicated vaporized hydrogen peroxide generator and evenly distributed inside the chamber or environment to be treated.
A typical cycle includes three main phases:
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Conditioning: preparation of the environment and creation of optimal conditions for VH₂O₂ diffusion.
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Injection and diffusion: introduction of H₂O₂ vapor and its homogeneous distribution over the surfaces to be treated.
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Exposure and aeration: contact time for the oxidizing action, followed by the removal of hydrogen peroxide down to safe levels.
This process ensures high antimicrobial efficacy without leaving toxic residues, while protecting sensitive materials and complex geometries.
Why choose VH₂O₂ sterilization
Sterilization with vaporized hydrogen peroxide offers numerous strategic advantages:
• Low-temperature process, ideal for heat-sensitive materials
• Rapid cycle times compared to traditional technologies
• No toxic residues and fast aeration
• High efficacy even on complex geometries
• Compatibility with isolators, RABS, classified environments and process chambers
HyPerPure®: De Lama’s superior technology compared to traditional VH₂O₂
Although effective, VH₂O₂ technology presents intrinsic limitations such as reduced penetration capability, risk of condensation, and lack of suitability for the terminal sterilization of complex products.
To overcome these limitations, De Lama developed HyPerPure®, an exclusive process based on the use of hydrogen peroxide under deep vacuum conditions, bringing low-temperature sterilization performance to an entirely new level.
The main advantages of HyPerPure® include:
• Superior penetration, even inside narrow cavities, long tubes, prefilled syringes, Tyvek® blisters, porous materials and complex geometries.
The HyPerPure® process can easily penetrate at least 3 layers of Tyvek® (or medical paper).
• Total elimination of condensation risk, ensuring stable, repeatable and fully validatable cycles, thanks to the combination of an advanced process, extensive experience, and the exclusive vaporized hydrogen peroxide generator HyPerGeneSys®, an internationally patented De Lama innovation.
• True sterilization, with the ability to achieve LOG 6 to LOG 12 levels, typical of the most rigorous sterilization processes.
• Significant reduction in cycle times and increased production efficiency.
• Extended compatibility with sensitive materials and packaging not treatable with traditional VH₂O₂.
• Environmentally friendly process, leaving no residues and requiring very low energy consumption.
• Major ecological and economic advantages, with savings of:
– 70% energy reduction
– 70% CO₂ emissions reduction
– 100% water savings
• Applicable even to non heat-sensitive products.
Thanks to the ecological and economic benefits above, many pharmaceutical and medical companies are now adopting HyPerPure® as a replacement for saturated steam autoclaves.
• Possibility of combined units with two processes: saturated steam + HyPerPure® hydrogen peroxide.
Many companies, seeking greater flexibility and broader sterilization validation using HyPerPure®, are investing in combined systems capable of managing both processes.
This represents a major innovation and another exclusive De Lama solution.
• No capacity limits.
De Lama can manufacture HyPerPure® systems from 100 liters, ideal for small productions or research laboratories, up to very large units (90 m³) capable of supporting mass production of medical devices and replacing EtO (Ethylene Oxide) sterilization capacity—with an extremely faster process (average 5 hours vs 72 hours), safer, ecological, and fully internalizable within the production site.
This feature reduces both operating costs and the time-to-market typically associated with external sterilization centers.
Thanks to these characteristics, HyPerPure® is today considered the most advanced low-temperature sterilization technology in the world, adopted by leading pharmaceutical and medical device companies globally.
Industrial applications
VH₂O₂ technology – and even more so HyPerPure® – is used in numerous sectors:
• Pharmaceutical: sterilization of components, packaging, chambers, isolators and critical surfaces
• Medical devices: treatment of heat-sensitive materials and complex geometries
• Biotechnology: high-sterility processes in controlled environments
• Cosmetics: decontamination of containers and production systems
• Food industry (in containment): targeted treatments in high-hygiene sensitive areas
De Lama’s experience in hydrogen peroxide
For over 75 years, De Lama has been developing advanced technologies for sterilization and decontamination, combining innovation, safety and maximum reliability.
After 20 years of research, De Lama launched in 2015 the world’s first HyPerPure® vaporized hydrogen peroxide sterilizer, becoming a pioneer of this technology and continuously evolving it over the years, thanks also to close collaboration with leading pharmaceutical and medical device companies that adopted it.
This deep know-how has been further strengthened by De Lama’s internal laboratories, where thousands of sterilization tests, material compatibility studies and packaging validations have been performed on a vast range of products from both the pharmaceutical and medical device sectors.
