HyPerPure®: advanced vaporized hydrogen peroxide sterilization for pharma and medical devices
Low-temperature sterilization has become one of the most important areas of innovation for the pharmaceutical industry and for medical device manufacturers. The driver is twofold: a growing share of heat-sensitive products that cannot tolerate the heat of steam, and the regulatory and environmental pressure that is steadily narrowing the role of ethylene oxide (EtO). In this context, vaporized hydrogen peroxide sterilization (vH₂O₂) has established itself as a reference technology for materials sensitive to heat and moisture.
De Lama, founded in 1949 and with more than 77 years of experience in the design and construction of sterilization systems, raised this principle to a new level with HyPerPure®, an internationally patented process that uses vaporized hydrogen peroxide under deep vacuum. Launched in 2015 as the world’s first deep-vacuum vH₂O₂ sterilizer after two decades of research, HyPerPure® today represents one of the most advanced cold-sterilization technologies on the market. In this article we look at what vaporized hydrogen peroxide sterilization is, how the process works, why the industry is seeking alternatives to EtO and steam, and what sets HyPerPure® apart from conventional vH₂O₂ solutions.
What is Vaporized Hydrogen Peroxide (vH₂O₂) Sterilization?
Vaporized hydrogen peroxide sterilization is a low-temperature process that uses hydrogen peroxide (H₂O₂) in vapor form as the sterilizing agent. Liquid hydrogen peroxide is converted into vapor by a dedicated generator, then distributed uniformly across the surfaces to be treated. As a strong oxidizer, hydrogen peroxide irreversibly damages cell membranes, proteins and genetic material, inactivating bacteria, spores, viruses and fungi.
The main advantage of vH₂O₂ is that it typically operates below 60 °C, a thermal window that allows the treatment of materials that saturated steam would damage. At the end of the cycle the peroxide decomposes into water and oxygen, two non-toxic by-products, which makes this one of the cleanest sterilization options from an environmental standpoint.
A vaporized hydrogen peroxide sterilization process generally unfolds in four phases: conditioning (preparation of the environment and creation of the optimal temperature and vacuum conditions for effective diffusion), injection and diffusion (introduction of the vapor and its homogeneous distribution across all surfaces), exposure (contact of the sterilant with the load for the time needed to reach the required sterility assurance level, or SAL), and aeration (removal of residual peroxide until concentrations are safe for operators and compatible with product residue limits).
The technology is now fully standardized: the international reference is ISO 22441:2022, which defines requirements for the development, validation and routine control of vH₂O₂ sterilization for medical devices. Validation relies on biological indicators with Geobacillus stearothermophilus, an organism recognized for its high resistance to vH₂O₂, together with independent monitoring that detects any deviation in process parameters.
Is VHP considered a sterilization process?
Yes. When properly developed and validated, vaporized hydrogen peroxide (also referred to as VHP) is a true sterilization process, not merely surface decontamination. The distinction matters: simple vaporization at near-atmospheric conditions acts mainly on visible surfaces, which is more accurately described as decontamination. A deep-vacuum process such as HyPerPure® instead achieves the high sterility assurance levels, from LOG 6 to LOG 12, typical of the most rigorous methods, and is recognized by international standards such as ISO 22441:2022 and the general framework ISO 14937. This is what qualifies it for the terminal sterilization of finished, packaged products.
Why the industry is moving beyond traditional sterilization methods
For decades the industry has relied on two dominant methods: steam (moist heat) for heat-stable products and EtO for heat-sensitive ones. Both retain a central role, but both carry intrinsic limits that are pushing a growing number of manufacturers to evaluate low-temperature technologies such as vH₂O₂.
Limitations of steam sterilization for heat-sensitive products
Steam sterilization remains the benchmark for efficacy, cost and process robustness, governed by standards such as ISO 17665. Its very principle, however, defines its limit: it works through moist heat at 121 °C to 134 °C. This makes it unsuitable for any material that deforms, degrades or loses function above a given thermal threshold. Polymers, electronics, optics, adhesives and many composite materials cannot withstand steam cycles, and the presence of moisture rules out moisture-sensitive products. These are precisely the categories growing fastest, from electronic medical devices to single-use plastics and complex biotech products.
The growing need for alternatives to EtO sterilization
On the EtO side, the issue is primarily one of health and environment. Ethylene oxide is classified as a carcinogen, emission standards for commercial sterilization facilities have tightened, and the FDA has actively facilitated the adoption of vH₂O₂, recognizing it in January 2024 as an Established Category A method. That recognition, alongside ISO 22441:2022, has reduced the regulatory burden for manufacturers adopting vH₂O₂, simplifying 510(k) submissions. EtO remains indispensable for many devices and the regulatory picture continues to evolve, but the combination of health risk, compliance cost and supply continuity has made validated alternatives strategic.
De Lama brings a distinctive perspective here. It has produced ethylene oxide sterilizers since the 1950s, in vacuum execution and in sizes from roughly 100 liters to tens of thousands of liters, and still does today. This firsthand knowledge of EtO, of its strengths and its constraints, is exactly what allows the company to guide customers through an informed transition to vH₂O₂ where materials and process requirements allow.
HyPerPure®: De Lama’s proprietary approach to vH₂O₂ sterilization
HyPerPure® is the vaporized hydrogen peroxide process developed and patented by De Lama, launched in 2015 as the world’s first deep-vacuum vH₂O₂ sterilizer. It builds on two historical roots: the company’s long experience in vH₂O₂ decontamination with HyPerDekont® technology, and the deep know-how in vacuum management acquired since the 1950s through its vacuum dryers, still in the catalogue today.
Conventional vH₂O₂ technologies, while effective, share intrinsic limits: reduced penetration capability, the risk of peroxide condensation on surfaces, and a not always complete suitability for the terminal sterilization of complex products. HyPerPure® was created specifically to overcome these limits, acting on the critical point of every vaporized peroxide process: the conditions in which the vapor reaches the surfaces to be treated.
Deep vacuum technology and zero-air process
The defining feature of HyPerPure® is the use of hydrogen peroxide under deep vacuum and in zero-air conditions. By removing air from the chamber before injection, the vapor diffuses without obstacles and reaches even the most difficult geometries uniformly. This is a fundamentally different approach from vH₂O₂ systems operating near atmospheric pressure, where residual air hampers penetration and favors condensation.
This operating condition, combined with the exclusive vaporized hydrogen peroxide generator HyPerGeneSys® (an internationally patented De Lama innovation that also ionizes the vapor to improve sterilization efficacy), allows the total elimination of condensation risk and delivers stable, repeatable and fully validatable cycles, an essential requirement for terminal sterilization in regulated sectors.
Enhanced penetration, repeatability and cycle performance
Deep vacuum gives HyPerPure® superior penetration into areas that conventional vH₂O₂ technologies struggle to treat: narrow cavities, long tubes, prefilled syringes, porous materials and complex geometries. The process has been proven by De Lama, including in official presentations, to penetrate at least 4 layers of Tyvek® or medical paper, a decisive capability for terminal sterilization, where the product must be treated already inside its sterile barrier packaging.
The elimination of condensation is the key to repeatability: stable, predictable cycles mean processes that can be validated in compliance with ISO 22441:2022 and that suit GMP contexts. At the same time, the technology delivers a significant reduction in cycle times and an increase in production efficiency compared with traditional low-temperature methods.
Key Benefits of HyPerPure® for Pharma and Medical Devices
The benefits of HyPerPure® translate into concrete advantages for pharmaceutical and medical device manufacturers, on the technical, economic and sustainability fronts alike.
Sterilization of complex and thermolabile products
HyPerPure® operates between 25 °C and 45 °C, an especially gentle window that widens the range of thermolabile products that can be treated. Because the process penetrates multilayer sterile barriers and complex geometries, finished products can be sterilized within their own packaging, covering plastics, electronic devices, drug-delivery systems, diagnostic components and complex biotech products that neither steam nor, increasingly, EtO can serve.
Sustainability and reduced environmental impact
As a low-temperature process, vH₂O₂ avoids the thermal energy waste of hot methods such as saturated steam, and the peroxide leaves no toxic residues, decomposing into water and oxygen. According to De Lama’s internal data, the HyPerPure® process can deliver up to 70% energy savings, 70% lower CO₂ emissions and 100% water savings compared with conventional approaches. This positions HyPerPure® as a green alternative, complementary and in many cases substitutive, to EtO, gamma rays, E-beam and X-ray sterilization, and, where materials allow, to steam itself.
Process reliability and scalability from small to large chambers
HyPerPure® carries no practical size limit: De Lama builds systems from roughly 100 liters for laboratories and small production up to very large chambers for industrial-scale manufacturing. Every configuration is designed for validatable processes in compliance with ISO 22441:2022 and GMP requirements, with full traceability in line with 21 CFR Part 11, and can be integrated with isolators, RABS and controlled environments supporting Grade A operations.
Applications of HyPerPure® Technology
Vaporized hydrogen peroxide sterilization is used across sectors where the guarantee of sterility is subject to stringent regulatory requirements.
Pharmaceutical manufacturing
In pharma, vH₂O₂ is used to sterilize components, materials and equipment that cannot be steam-treated, and to bio-decontaminate isolators, cleanrooms and transfer systems. The ability to operate at low temperature and to leave non-toxic residues makes it particularly well suited to aseptic processing and to the critical production areas addressed by the new Annex 1.
Medical devices
For device makers, HyPerPure® is one of the strongest alternatives to EtO for heat-sensitive and single-use products such as catheters, syringes and prostheses. Beyond the FDA recognition that has simplified market access, the technology offers a major operational advantage: the ability to internalize sterilization within the manufacturing site, removing the need for external sterilization centers and reducing both cost and time-to-market.
Laboratory and research environments
Its low-temperature operation and non-toxic residues make HyPerPure® well suited to laboratories and research centers handling sensitive instruments and materials, as well as to adjacent fields such as nuclear medicine and radiopharmacy, the nutraceutical industry and cosmetics.
Why Choose HyPerPure® Over Conventional vH₂O₂ Systems?
Conventional vaporized hydrogen peroxide systems typically act by aspersion on visible surfaces, at near-atmospheric conditions, with the limits in penetration and condensation described above. HyPerPure®, operating under deep vacuum and zero air, moves the technology from surface decontamination to true terminal sterilization.
How long does VHP sterilization take?
Cycle time depends on the load, the packaging and the target SAL, but vH₂O₂ cycles are generally completed in a matter of hours, and peer-reviewed reviews note that some applications can run in under an hour. This is far faster than EtO, which can require many hours or even days once long aeration times are included. The speed of the process, together with the absence of toxic residues, is one of the main reasons manufacturers adopt the technology.
Safety, efficiency and validation advantages
Because hydrogen peroxide decomposes into water and oxygen, HyPerPure® avoids the toxic residues and the prolonged aeration of EtO, a gas that is also critical to manage and store. Combined with stable, condensation-free cycles, this delivers processes that are safe for operators, energy-efficient, and straightforward to validate to ISO 22441:2022 within a GMP framework.
A technology trusted by leading pharma and medical device companies
Since its launch in 2015, HyPerPure® has been installed across Europe, the United States, Asia and the Middle East, with cycles validated to support the differing regulatory requirements of each market. The technology has been developed in close collaboration with leading pharmaceutical and medical device companies that adopted it early, and De Lama’s role in the field has been recognized by industry observers, including its 2025 award as a top sterilization company in Europe.
Conclusion
Vaporized hydrogen peroxide sterilization is no longer a niche method: it is a mature, standardized and fast-growing technology, supported by a regulatory landscape that increasingly values low-temperature alternatives. For manufacturers that need to sterilize heat-sensitive products with repeatable, validatable and sustainable processes, HyPerPure® offers a concrete path forward. To explore De Lama’s solutions in more detail, see the full range of sterilizers or the dedicated medical devices section.
