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.
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.
The Phases of the Sterilization Process
An industrial sterilization cycle is composed of several phases, each monitored and controlled through automated systems:
Load preparation – cleaning, drying, and placement of materials or devices to be treated.
Initial condition setting – air removal and adjustment of vacuum, temperature, or humidity parameters.
Sterilization phase – application of the selected sterilizing agent (steam, heat, H₂O₂, EtO, etc.) for a defined time.
Removal or neutralization of the agent – degassing, aeration, or decomposition of any residual chemicals.
Drying and cooling – to ensure product integrity and stability.
Verification and batch release – monitoring of parameters, validation, and recording of process data to ensure complete traceability.
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.
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.
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]
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).
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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.
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.
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.
Phases of the Decontamination Process
Material preparation – identification, cleaning, and loading of items.
Controlled transfer – loading materials into the chamber or pass-box while maintaining area segregation.
Decontamination cycle – injection of vaporized H₂O₂ and maintenance of the defined parameters (concentration, time, temperature).
Degassing / final aeration – removal of residual agents and verification of environmental safety.
Verification and release – process validation, data recording, and complete digital traceability.
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.
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.
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.
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.
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.
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.
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.
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.
De Lama’s technological evolution finally brings to the market a 2-in-1 combination of HyPerDekont® vaporized hydrogen peroxide (VH2O2) decontamination and a saturated steam sterilization process.
This allows both technologies to be operated in a single machine, with maximum flexibility. Specifically, it allows pharmaceutical companies and medical device manufacturers to manage different processes with De Lama’s advanced HyPerDekont® vH202 decontamination technology and saturated steam sterilization..
The HyPerDekont® H202 decontamination technology
De Lama has been on the market for over 20 years with vH202 HyPerDekont® decontamination and is universally recognized as a pioneer and leader in hydrogen peroxide (H202) process, also evolved in 2015 with the release on the market of the exclusive HyPerPure® vH202 sterilization process.
The HyPerDekont® and HyPerPure® technology, today evolved, refined and absolutely reliable, is present in the most important pharmaceutical companies and manufacturers of medical devices with systems ranging from150 liters up to 85 square meters.
This new frontier of cold sterilization is also the real alternative to EtO (Ethylene Oxide) and Gamma Rays and the greenest solution to reach Carbon Zero target also as an alternative to classic steam sterilization.
One of the ingredients that makes the process with HyPerDekont® and HyPerPure® so special and highly performing is De Lama’s proprietary peroxide generator called HyPerGeneSys®covered by aninternational patent
It is a special H202 generator that is able to operate in a high vacuum and in addition operates by acting with an electromagnetic field capable of ionizing the peroxide molecules in order to increase their lethal effect on microorganisms, and in this sense making the process even faster and more effective.
DESIGN & CONSTRUCTION FEATURES
Capacity: from 150 lts. up to 85 cubic meters (other sizes available on request)
