STERILIZATION

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:

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.

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.