HyPerPure® hydrogen peroxide + saturated steam sterilizer COMBO 2 in 1

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Sterilization is a physical or chemical process aimed at eliminating or inactivating living microorganisms, including bacteria, spores, viruses, molds and fungi, present on materials, surfaces or products.

The final result is a state of sterility, in which the probability of survival of a microorganism is lower than one in one million (logarithmic reduction of 10⁶ or higher) in every point of the target.

In the industrial sector, sterilization is a fundamental step to ensure product safety, regulatory compliance and the protection of the patient or the end consumer. It is an essential process in the pharmaceutical, medical, cosmetic, food and scientific research fields.

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Purpose and Importance of the Sterilization Process

The main goal of sterilization is to prevent any form of biological contamination, ensuring that treated products can be used in completely safe conditions.
In industrial applications, the process must be not only effective but also repeatable, controllable, and fully traceable, in accordance with GMP (Good Manufacturing Practices) and international standards such as ISO 17665, ISO 11135, ISO 14937, and 21 CFR Part 11.

A proper sterilization process:

• guarantees protection of the patient or end user;

• ensures product integrity and quality;

• reduces the risk of non-compliance or product recalls;

• safeguards the company’s reputation and reliability.

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Types of Industrial Sterilization

Depending on the nature of the product, its thermal resistance, and production context, sterilization can be performed using different technologies, each with its own principles and applications:

• Steam sterilization: uses pressurized steam at high temperature (121–134 °C) for a defined time. It is the most widely used and reliable method for metallic instruments, glass, rubber, and materials compatible with heat and humidity.

• Dry-heat sterilization: employs hot, dry air at temperatures between 160 °C and 180 °C, ideal for materials that cannot tolerate humidity, such as powders or oils.

• Superheated-water or air/steam mixture sterilization: hybrid systems that allow homogeneous treatment of complex or thermo-sensitive products.

• Hydrogen Peroxide (H₂O₂) Sterilization:
  a low-temperature technology ideal for plastic materials and heat-sensitive devices.
  Vaporized hydrogen peroxide acts as a powerful oxidizing agent, ensuring high microbiological efficacy without leaving toxic residues.
  Today, thanks to its significant advantages in energy savings (over 70%), CO₂ emission reduction (over 70%), and complete water savings (100%) compared with saturated-steam sterilization, vaporized hydrogen peroxide technology is increasingly being adopted even for non-heat-sensitive materials.
  Another major field of application is the terminal sterilization of packaging for medical and pharmaceutical products.

• Ethylene oxide (EtO) sterilization: a chemical method used for complex or assembled devices that cannot withstand heat. EtO penetrates deeply into materials and neutralizes even the most resistant spores.

• Plasma and emerging technologies: innovative solutions designed for specific applications requiring maximum compatibility with sensitive materials.

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The Phases of the Sterilization Process

An industrial sterilization cycle is composed of several phases, each monitored and controlled through automated systems:

1. Load preparation – cleaning, drying, and placement of materials or devices to be treated.

2. Initial condition setting – air removal and adjustment of vacuum, temperature, or humidity parameters.

3. Sterilization phase – application of the selected sterilizing agent (steam, heat, H₂O₂, EtO, etc.) for a defined time.

4. Removal or neutralization of the agent – degassing, aeration, or decomposition of any residual chemicals.

5. Drying and cooling – to ensure product integrity and stability.

6. Verification and batch release – monitoring of parameters, validation, and recording of process data to ensure complete traceability.

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Sterilization and Quality: An Inseparable Link

Sterilization is not just a technical procedure; it is an integral part of the company’s quality system.
Every sterilization system must ensure repeatability, validation, and long-term reliability, supported by advanced control software, precision sensors, and electronic data recording.
For this reason, De Lama’s sterilization systems are designed to guarantee maximum efficiency, full regulatory compliance, and continuous monitoring of all critical process parameters.

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Innovation and Sustainability

In recent years, technological progress has enabled the development of more sustainable and energy-efficient sterilization systems.
De Lama has introduced patented solutions such as the HyPerPure® technology, which uses hydrogen peroxide under deep vacuum and zero air, achieving the most advanced cold-sterilization process on the market — a safe, ecological alternative to traditional EtO or gamma-ray methods.

These innovations allow to:

• reduce energy consumption by up to 70%;

• eliminate the use of process water;

• avoid toxic or carcinogenic substances;

• achieve a LOG 12 microbiological reduction;

• preserve the integrity of even the most delicate materials.

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Conclusion

Sterilization is a cornerstone process in modern industrial production.
Through a combination of experience, research, and innovation, De Lama S.p.A. stands today as one of the world’s leading manufacturers of sterilization systems for the pharmaceutical, medical, and biotechnological industries.
Each system is custom-designed, ensuring high performance, safety, sustainability, and full compliance with the most rigorous international standards.[/read]

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Sterilization with vaporized hydrogen peroxide (VH₂O₂) is today one of the most effective and widely used technologies to ensure complete microbial inactivation in pharmaceutical, medical, biotechnological applications and in all high-hygiene sectors. Thanks to its effectiveness, low thermal impact and rapid cycle times, VH₂O₂ is an ideal solution for surfaces, instruments and heat-sensitive equipment, as well as for chambers, isolators and controlled environments.

De Lama, with its long-standing experience in the development of sterilization and decontamination systems using H₂O₂, offers technologies designed to ensure high performance, stable processes and total control of critical parameters. In particular, HyPerPure® deep-vacuum Hydrogen Peroxide sterilization, protected by international patent, represents today the golden standard of the industry.

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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:

1. Conditioning: preparation of the environment and creation of optimal conditions for VH₂O₂ diffusion.

2. Injection and diffusion: introduction of H₂O₂ vapor and its homogeneous distribution over the surfaces to be treated.

3. 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.

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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

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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.

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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

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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.

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Saturated steam sterilization is one of the most reliable, validated, and widely adopted methods for achieving complete microbial inactivation across a broad range of materials, components, devices, and products used in high-hygiene environments. By combining controlled temperature, pressure, and moisture, saturated steam penetrates uniformly into even complex or porous loads, ensuring consistent, repeatable, and internationally compliant sterilization results.
This makes it the reference thermal sterilization method for the pharmaceutical, biotechnology, medical device, healthcare, and laboratory sectors.

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How the Steam Sterilization Process Works

The process is performed inside an autoclave, where saturated steam — steam in equilibrium with its liquid phase — is generated to deliver highly efficient heat transfer. This is essential for the rapid and reliable inactivation of microorganisms, including resistant bacterial spores.

A standard saturated steam sterilization cycle includes:

• Air removal via vacuum pulses or gravity displacement to ensure deep steam penetration.

• Injection of saturated steam that raises chamber temperature and pressure to defined cycle parameters.

• Sterilization exposure (holding time), during which the load is maintained at target conditions to achieve the required lethality.

• Exhaust, cooling, and drying, returning items to ambient conditions in a sterile state.

This combination of temperature, moisture, pressure, and exposure time is what makes saturated steam sterilization highly effective and globally recognized as a gold standard for thermal sterilization.

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Typical Sterilization Temperatures

Saturated steam sterilization operates at internationally standardized temperatures, selected based on material compatibility and microbiological risk:

• 121 °C (1.1 bar overpressure) – the standard sterilization cycle for most autoclavable instruments, components, and laboratory materials.

• 134 °C (2.1 bar overpressure) – fast, high-performance cycles used for surgical instruments and high-risk medical devices requiring superior sterilization assurance.

These temperature levels deliver sufficient lethality to eliminate spore-forming microorganisms, which are considered the most resistant biological forms.

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LOG Reduction, SAL, and Sterilization Assurance

Defining the required level of microbial safety is essential for designing and validating a steam sterilization process.

• The Sterility Assurance Level (SAL) expresses the probability that a sterilized unit remains contaminated. For medical and pharmaceutical applications, the accepted benchmark is SAL = 10⁻⁶, meaning a maximum probability of 1 viable microorganism per 1,000,000 sterilized items.

• Log-reduction quantifies how much the microbial population is reduced. A 6-log reduction corresponds to a reduction by a factor of 10⁶.

Although related, SAL and log-reduction are not equivalent:
log-reduction measures microbial kill; SAL expresses the probability of survival.

Regulations such as UNI EN 556 define a process as “sterile” only if it achieves SAL 10⁻⁶.

To reach this level, steam sterilization cycles must be thoroughly validated, demonstrating that the combination of temperature, exposure time, pressure, and humidity consistently achieves the required microbial reduction. Many industries adopt overkill validation strategies, applying more stringent cycles to ensure robust sterility even in the presence of variability in load configuration or bioburden.

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Applications of Saturated Steam Sterilization

Steam sterilization is used wherever high microbial safety is required. Typical applications include:

• Reusable medical devices (surgical instruments, endoscopy components, diagnostic tools).

• Equipment, components, and accessories used in pharmaceutical production.

• Glassware, containers, and laboratory instruments.

• Textiles, wraps, and porous materials compatible with high temperatures.

• Culture media, broth, and laboratory solutions.

• Heat-resistant components for the cosmetic and nutraceutical industry.

Because it is compatible with many robust materials, saturated steam sterilization is among the most versatile processes used in regulated settings.

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Industries and Markets Using Steam Sterilization

Thanks to its high lethality, environmental safety, and lack of chemical residues, saturated steam sterilization is widely used in:

• Pharmaceutical manufacturing

• Medical device production

• Hospitals, clinics, and CSSDs (Central Sterile Services Departments)

• Biotechnology and research laboratories

• Cosmetic industry

• Food and nutraceutical production facilities

Its popularity is driven by its high microbiological performance, process repeatability, cost-effectiveness, and full alignment with GMP, GLP, ISO, and global regulatory requirements.

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