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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:
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guarantees protection of the patient or end user;
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ensures product integrity and quality;
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reduces the risk of non-compliance or product recalls;
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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:
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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.
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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.
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Superheated-water or air/steam mixture sterilization: hybrid systems that allow homogeneous treatment of complex or thermo-sensitive products.
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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.
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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.
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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:
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Load preparation – cleaning, drying, and placement of materials or devices to be treated.
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Initial condition setting – air removal and adjustment of vacuum, temperature, or humidity parameters.
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Sterilization phase – application of the selected sterilizing agent (steam, heat, H₂O₂, EtO, etc.) for a defined time.
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Removal or neutralization of the agent – degassing, aeration, or decomposition of any residual chemicals.
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Drying and cooling – to ensure product integrity and stability.
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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:
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reduce energy consumption by up to 70%;
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eliminate the use of process water;
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avoid toxic or carcinogenic substances;
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achieve a LOG 12 microbiological reduction;
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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]
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Depyrogenation is a process adopted for the removal of
pyrogens, especially
bacterial endotoxins, from pharmaceutical equipment and products. It is essential for ensuring the safety of injectable drugs and sterile medical devices. [read more]The most common method is
dry heat depyrogenation, using temperatures above 250°C to destroy endotoxins. This process is distinct from sterilization, targeting harmful non-living contaminants. Depyrogenation is validated through
endotoxin challenge tests to ensure effectiveness. Used in aseptic manufacturing, especially for
vaccines,
IV fluids, and
ophthalmics. Regulated under
GMP and closely monitored by agencies like the FDA and EMA. Modern systems offer
automated control,
real-time monitoring, and seamless integration. Proper handling post-process prevents recontamination and ensures patient safety. Depyrogenation is a critical step in producing
safe, high-purity pharmaceuticals.[/read]" ["parent"]=> int(0) ["count"]=> int(4) ["filter"]=> string(3) "raw" ["term_order"]=> string(1) "0" } [2]=> object(WP_Term)#20841 (11) { ["term_id"]=> int(975) ["name"]=> string(7) "WASHING" ["slug"]=> string(7) "washing" ["term_group"]=> int(0) ["term_taxonomy_id"]=> int(975) ["taxonomy"]=> string(7) "process" ["description"]=> string(12082) "
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.
[read more]
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:
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.
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:
A typical washing cycle includes:
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Pre-washing
Removal of gross residues and preparation of surfaces.
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Detergent washing
Chemical and mechanical action aimed at removing product residues, APIs, excipients, oils, greases and organic contaminants.
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Intermediate rinses
Complete removal of detergent residues.
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Final rinse
Performed with qualified water (PW, HPW or WFI), depending on the application.
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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.
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:
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clear definition of critical process parameters
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cycle repeatability under all operating conditions
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complete data traceability
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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.
Advantages of De Lama washing systems
De Lama pharmaceutical washing systems offer numerous operational and regulatory advantages:
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high contaminant removal efficiency
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maximum process repeatability
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reduced risk of cross-contamination
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full support for Cleaning Validation
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compatibility with delicate materials and complex geometries
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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.
Applications of pharmaceutical washing
De Lama washing systems are used in a wide range of applications:
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pharmaceutical and biotechnology industries, including both solid oral dosage and sterile and aseptic production
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medical devices
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research and development laboratories
They can be used to treat process components, production accessories, line parts, containers, tools and carts.
[read more]
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]
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:
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Sterilization is a process, bringing materials to a completely sterile state with a probabilistic microbial reduction of LOG6 or more, in every point (SAL
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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
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Material preparation – identification, cleaning, and loading of items.
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Controlled transfer – loading materials into the chamber or pass-box while maintaining area segregation.
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Decontamination cycle – injection of vaporized H₂O₂ and maintenance of the defined parameters (concentration, time, temperature).
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Degassing / final aeration – removal of residual agents and verification of environmental safety.
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Verification and release – process validation, data recording, and complete digital traceability.
Advantages of De Lama Decontamination Systems
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Proven microbiological efficacy, with reductions up to LOG 6.
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Compatibility with thermosensitive and porous materials.
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Short cycle times and high process repeatability.
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No toxic residues thanks to air or vacuum-assisted degassing.
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Custom design, easily integrable into isolators and clean-rooms.
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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:
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Pharmaceutical: for material transfer into sterile areas, filling lines, and production environments.
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Medical: for packaging, surgical instruments, plastic and metallic components.
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Biotechnological and research: for isolators, laboratories, and critical surfaces.
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Cosmetic and nutraceutical: for containers, bottles, and production lines.
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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.
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