Integration with isolator through Magnetodoor® magnetic driven door

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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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Pharmaceutical washing: advanced processes and Cleaning Validation according to the latest regulations

Pharmaceutical washing represents a critical phase within the production processes of the pharmaceutical, medical device and biotechnology industries. An effective washing system does not only aim to remove visible residues, but must ensure the repeatable and validated removal of chemical, microbiological and particulate contaminants, in full compliance with GMP regulations and the latest Cleaning Validation guidelines.

De Lama designs and manufactures high-performance industrial and pharmaceutical washing systems, capable of meeting the most stringent requirements in terms of efficacy, repeatability, traceability and regulatory compliance.

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The strategic role of washing in pharmaceutical processes

In the modern pharmaceutical context, washing is no longer a simple preliminary step before sterilization, but a critical and independent process that directly impacts:

• final product quality

• patient safety

• regulatory compliance

• reduction of cross-contamination risk

Components such as machine parts, tools, process accessories, containers, trays, carts, aseptic line components and transfer systems must be washed using repeatable, validatable and fully documented processes.

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How the pharmaceutical washing process works

The pharmaceutical washing process is based on a controlled combination of mechanical, chemical and thermal action and time, optimized according to:

• the type of contaminant

• the material to be treated

• the geometry of the components

A typical washing cycle includes:

1. Pre-washing
   Removal of gross residues and preparation of surfaces.

2. Detergent washing
   Chemical and mechanical action aimed at removing product residues, APIs, excipients, oils, greases and organic contaminants.

3. Intermediate rinses
   Complete removal of detergent residues.

4. Final rinse
   Performed with qualified water (PW, HPW or WFI), depending on the application.

5. Drying
   Controlled and repeatable, to prevent recontamination and ensure immediate availability of components for subsequent process steps.

De Lama washing systems ensure precise control of all critical process parameters, including pressure, flow rate, temperature, time and detergent concentration.

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Washing and the new Cleaning Validation

Recent regulatory developments have further strengthened the role of Cleaning Validation, which today requires a scientific, risk-based and highly repeatable approach.

A pharmaceutical washing system must enable:

• clear definition of critical process parameters

• cycle repeatability under all operating conditions

• complete data traceability

• integration with site quality and validation systems

De Lama solutions are designed to facilitate Cleaning Validation, thanks to highly repeatable cycles, advanced software, rigorous control of critical parameters and documentation compliant with GMP requirements.

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Advantages of De Lama washing systems

De Lama pharmaceutical washing systems offer numerous operational and regulatory advantages:

• high contaminant removal efficiency

• maximum process repeatability

• reduced risk of cross-contamination

• full support for Cleaning Validation

• compatibility with delicate materials and complex geometries

• integration with subsequent sterilization or decontamination processes

Each system is custom-designed, based on the specific requirements of the customer, the production process and the application.

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Applications of pharmaceutical washing

De Lama washing systems are used in a wide range of applications:

• pharmaceutical and biotechnology industries, including both solid oral dosage and sterile and aseptic production

• medical devices

• research and development laboratories

They can be used to treat process components, production accessories, line parts, containers, tools and carts.

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De Lama’s experience in industrial and pharmaceutical washing

For over 75 years, De Lama has been developing advanced technologies for washing, sterilization and decontamination for the most highly regulated industries. Field-proven experience, combined with continuous investment in research and development, allows De Lama to deliver reliable, validated solutions ready to meet the challenges of the new Cleaning Validation requirements.

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Decontamination is a physical or chemical process designed to reduce or eliminate microbial or particulate contamination present on materials, surfaces, or environments.
It is an essential phase in all high-criticality industrial contexts — such as pharmaceutical, medical, biotechnological, cosmetic, and research fields — where cleanliness and contamination control are indispensable to ensure product quality and process safety.

During the decontamination process, specific agents (such as vaporized hydrogen peroxide – H₂O₂) are used to reduce the microbial load, while maintaining material integrity and ensuring full compatibility with controlled environments (clean-rooms, isolators, transfer chambers).

[read more] 

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Difference between Sterilization and Decontamination

Although the two terms are often used interchangeably, sterilization and decontamination represent different processes with distinct objectives and microbiological efficacy levels.

Aspect	Sterilization	Decontamination
Objective	Eliminate microorganisms and achieve a sterile condition where the probability of survival of a microorganism at any point on the target is less than one in a million (SAL ≤ 10-6 and therefore a logarithmic reduction of 10⁶ or greater).	Significantly reduce or eliminate biological contaminants present on surfaces, materials, or environments.
Microbial Reduction Level	From LOG6 to LOG 12 or higher.	Variable (LOG 3 – LOG 6) depending on process and application.
Typical Application	Instruments, components, or products that must be sterile (pharmaceuticals, implantable devices, final sterile packaging).	Environments, isolators, surfaces, materials, or equipment that must be “clean” before entering a sterile area.
Common Agents & Technologies	Saturated steam, dry heat, deep-vacuum H2O2, ethylene oxide (EtO), plasma.	Vaporized hydrogen peroxide (H2O2), ozone, UV light, HEPA-filtered air, combined processes.
Purpose	Ensure total sterility and complete process traceability.	Prevent cross-contamination and maintain production environment quality.

In summary:

• Sterilization is a process, bringing materials to a completely sterile state with a probabilistic microbial reduction of LOG6 or more, in every point (SAL

• Decontamination is a preventive or intermediate process, ensuring materials and environments are suitable for subsequent sterilization or clean-area handling.

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De Lama Decontamination Technologies

De Lama S.p.A. offers two main vaporized hydrogen peroxide (H₂O₂) decontamination technologies, developed to ensure maximum microbiological efficiency, short cycle times, and full cGMP compliance.

Pass-Box with Air Degassing
An ideal solution for the safe transfer of materials between areas with different cleanliness classifications.
During the decontamination cycle, vaporized H₂O₂ is evenly distributed inside the chamber to reduce the microbial load.
The final degassing phase is performed through controlled aeration with HEPA-filtered air, which completely removes any chemical residues, ensuring safety, ease of use, and optimized cycle times.

Pass-Box with Degassing by Vacuum
An advanced technology that employs vacuum exclusively during the degassing phase to accelerate the removal of residual hydrogen peroxide, particularly from porous materials.
This system allows for faster, more uniform, and more complete degassing, while maintaining material integrity and ensuring compliance with the most stringent process validation requirements.

An additional advantage is that degassing is performed using a vacuum pump rather than airflow: this means the system does not need to be connected to the facility’s HVAC system, eliminating any risk of interference or alteration of its calibration.
For this reason, it represents an ideal solution for existing facilities, where it can be installed without the need to reconfigure or rebalance HVAC systems — a particularly valuable benefit in larger chambers where the airflows required for degassing would otherwise be significant.

It is particularly suitable for pharmaceutical, medical, and biotechnological applications, where productivity, repeatability, and process validation are key operational requirements.

Combined Washing + Decontamination + Sterilization Systems
De Lama also designs integrated systems that combine multiple phases into a single automated unit, reducing process time, energy consumption, and space requirements in sterile areas.
These combined solutions represent the most efficient approach for modern production lines, where automation, traceability, and sustainability are essential.

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Phases of the Decontamination Process

1. Material preparation – identification, cleaning, and loading of items.

2. Controlled transfer – loading materials into the chamber or pass-box while maintaining area segregation.

3. Decontamination cycle – injection of vaporized H₂O₂ and maintenance of the defined parameters (concentration, time, temperature).

4. Degassing / final aeration – removal of residual agents and verification of environmental safety.

5. Verification and release – process validation, data recording, and complete digital traceability.

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Advantages of De Lama Decontamination Systems

• Proven microbiological efficacy, with reductions up to LOG 6.

• Compatibility with thermosensitive and porous materials.

• Short cycle times and high process repeatability.

• No toxic residues thanks to air or vacuum-assisted degassing.

• Custom design, easily integrable into isolators and clean-rooms.

• Full compliance with GMP, ISO 14644, Annex 1, and 21 CFR Part 11.

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Industrial Applications

De Lama decontamination technologies are used in a wide range of industries:

• Pharmaceutical: for material transfer into sterile areas, filling lines, and production environments.

• Medical: for packaging, surgical instruments, plastic and metallic components.

• Biotechnological and research: for isolators, laboratories, and critical surfaces.

• Cosmetic and nutraceutical: for containers, bottles, and production lines.

• Archives and cultural heritage: for removing biological contaminants from sensitive objects and materials.

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Conclusion

Decontamination is a critical stage in modern industrial processes, essential for ensuring safety, quality, and production continuity.
With its extensive experience and vaporized hydrogen peroxide technologies, De Lama S.p.A. stands today as one of the leading international manufacturers of industrial decontamination systems, fully integrable into the most advanced pharmaceutical and medical production processes.

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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.

[read more]

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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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Steam air mixture sterilization is a modern and highly efficient technology used to sterilize liquids, closed or open containers, and components that are sensitive to internal pressure changes. By combining high temperature steam with compressed air, the process ensures uniform and controlled heat and pressure distribution, providing sterilization levels that meet pharmaceutical, cosmetic, nutraceutical, and food industry standards.

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How the process works

Steam air mixture sterilization is performed inside an autoclave through a controlled sequence of phases:

• Generation of high pressure, high temperature steam through an internal boiler,

• Introduction of compressed air to balance the external pressure with the internal pressure of sealed containers, preventing deformation or rupture,

• Mixing of steam and air to achieve uniform heat and pressure distribution across the load,

• Sterilization phase where temperature and pressure are maintained for the required exposure time to ensure microbial inactivation,

• Cooling and drying, maintaining pressure balance to protect container integrity until the cycle is completed.

This configuration allows effective sterilization of liquids in sealed containers or products sensitive to internal pressure, which cannot be safely treated using standard saturated steam cycles.

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Key advantages

Steam air mixture sterilization provides several important benefits:

• High microbial efficacy, ensuring the inactivation of bacteria, viruses, fungi, and spores,

• Full compatibility with liquids and sealed containers, making it suitable for syringes, vials, bottles, and injectable products,

• Uniform heat and pressure distribution, ideal for loads with complex geometries or sensitive components,

• Versatility, widely used for final sterilization of pharmaceutical, cosmetic, medical, and nutraceutical products,

• Regulatory compliance, supporting validation requirements in GMP controlled environments.

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Typical applications

• Liquid pharmaceutical products in vials, syringes, ampoules, and closed bottles,

• Heat and pressure sensitive cosmetic and nutraceutical formulations,

• Equipment and components used in sterile pharmaceutical manufacturing,

• Sterile packaging for medical devices and diagnostic kits,

• Biotechnology and research laboratories requiring sterilization of liquid filled containers.

This process is particularly effective for materials that must maintain both sterility and structural integrity during and after sterilization.

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Why choose steam air mixture sterilization

Steam air mixture sterilization is the ideal solution when saturated steam cannot be used, especially for liquids in sealed containers or products that cannot tolerate pressure differentials.
The controlled balance between steam and compressed air minimizes the risk of container deformation or breakage, while providing a highly repeatable, validatable, and safe sterilization process that meets strict regulatory requirements.

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Superheated water sterilization is one of the most advanced and reliable technologies for sterilizing liquids, solutions, and products contained in sealed containers such as vials, bottles, prefilled syringes, ampoules, or any packaging that cannot be treated with traditional saturated steam cycles. The process uses water heated above 100 °C under controlled pressure, ensuring uniform heat distribution and complete protection of container integrity.
This method is widely adopted in the pharmaceutical, cosmetic, food, and nutraceutical industries, as well as in all production environments requiring validated and repeatable sterilization cycles.

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How superheated water sterilization works

The process takes place inside an autoclave and relies on a water circulation or water spray system operating under overpressure conditions, allowing the water to reach high temperatures without boiling.

A typical cycle includes:

• Filling or recirculation of process water, partially or fully covering the products,

• Pressurized water heating, through heat exchangers or thermal generators, until the programmed sterilization temperature is reached,

• Sterilization hold phase, during which temperature and pressure remain constant for the time needed to achieve microbial inactivation,

• Controlled cooling, with gradual temperature reduction while maintaining pressure to protect container integrity,

• Optional chilled water integration or heat exchanger cooling to rapidly reduce product temperature without causing thermal stress.

Water is continuously circulated or sprayed over the load, ensuring highly uniform heat transfer and exceptionally repeatable cycles, regardless of container shape, size, or geometry.

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Key advantages of superheated water sterilization

This technology provides numerous strategic benefits for regulated industries:

• Total protection of sealed containers, minimizing the risk of deformation or breakage,

• Uniform thermal distribution, ideal for complex loads or critical packaging geometries,

• High microbiological efficacy, ensuring the elimination of bacteria, viruses, fungi, and spores,

• Fast and controlled cooling, essential for heat sensitive products,

• Compatibility with liquids, suspensions, emulsions, and packaged products,

• Suitable for glass, plastic, multilayer, and composite containers,

• No harmful thermal shock, thanks to constant control of internal and external pressure,

• Regulatory compliance, with full validation capability according to GMP, GLP, ISO, and pharmaceutical guidelines.

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Typical applications

Superheated water sterilization is particularly suitable for:

• Glass or plastic vials and bottles containing liquids or solutions,

• Prefilled syringes and cartridges,

• Sealed bottles and containers,

• Nutraceutical liquids, syrups, and specialized formulations,

• Heat sensitive products requiring gentle but highly effective sterilization,

• Cosmetic and dermo pharmaceutical products in closed packaging,

• Liquid or semi liquid food products in sealed containers.

This process is ideal whenever a high sterility level is required without compromising the mechanical or thermal stability of the packaging.

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Why choose superheated water sterilization

Superheated water sterilization is a technologically advanced solution for applications that require:

• Sterilizing liquid products in sealed containers,

• Maintaining full container integrity,

• Ensuring constant and uniform heat transfer,

• Achieving validated, repeatable, and fully documentable cycles,

• Treating materials sensitive to pressure differences or incompatible with saturated steam.

Precise control of temperature and pressure makes this process a strategic choice for industries with strict regulatory requirements, where quality, safety, and process reliability are essential.

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De Lama’s superior technology

De Lama’s superheated water sterilizers integrate advanced engineering solutions that deliver significantly higher performance than conventional systems. The process chamber is equipped with three water spray ramps, positioned at the top and on both sides, ensuring complete coverage of the load and exceptionally uniform thermal distribution. This design surpasses systems that rely solely on top water showers and provides greater cycle homogeneity and enhanced heat transfer efficiency.
The solution is further optimized by a high efficiency water recirculation system, engineered to minimize consumption, improve thermal efficiency, and reduce environmental impact while maintaining maximum reliability and repeatability.
For installations with space constraints or limited architectural depth, De Lama also offers vertically sliding doors, an exclusive option designed to optimize space without compromising safety, ergonomics, or cycle performance.
Thanks to these features, De Lama’s technology ranks among the most advanced in the field of superheated water sterilization, ensuring uniform process performance, energy efficiency, flexible installation, and a level of customization that is unmatched in the industry.

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