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Sterilizers

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Application sectors

Laboratories & Research Centers

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Processes

LOW TEMPERATURE & HIGH PRECISION TREATMENTS

COMBINED PROCESSES

Sterilization: advanced technologies, processes and De Lama solutions

Sterilization is a fundamental process in the pharmaceutical, medical, biotechnological and cosmetic sectors, aimed at reducing the microbial load to a level that ensures a validated state of sterility, with a probability of survival of a viable microorganism lower than one in one million (SAL 10⁻⁶ or higher), on surfaces, equipment, tools and production materials.

In regulated environments, sterilization is a critical and fully validatable process, essential to ensure patient safety, product quality and compliance with GMP regulations and international guidelines.

De Lama is one of the world’s leading references in industrial and pharmaceutical sterilization technologies, with more than 77 years of experience, an outstanding technical know-how, and a well-established presence among the major international pharmaceutical and medical device companies.

What sterilization is and why it is essential

Unlike cleaning or disinfection, sterilization is a process designed to achieve a defined Sterility Assurance Level (SAL), reducing the probability of microbial survival in a controlled and validated manner, in accordance with regulatory requirements.

A properly designed and validated sterilization process allows to:

ensure patient safety
preserve product quality and integrity
guarantee GMP regulatory compliance
reduce the risk of contamination and cross-contamination

De Lama sterilization technologies

De Lama offers a complete range of industrial and pharmaceutical sterilizers, designed to cover all major sterilization technologies required by modern regulated industries, ensuring maximum process flexibility, repeatability and validatability.

Vaporized hydrogen peroxide sterilization (VH₂O₂) – HyPerPure® technology

Vaporized hydrogen peroxide (VH₂O₂) sterilization at De Lama is implemented through the exclusive HyPerPure® technology, a patented process based on the use of hydrogen peroxide under deep vacuum conditions.

HyPerPure® represents today the gold standard in low-temperature sterilization, thanks to:

superior penetration, even into narrow cavities, long tubes and complex packaging
complete elimination of condensation, ensuring stable and highly repeatable cycles
fully validatable sterility levels, up to LOG 6–LOG 12
compatibility with heat-sensitive materials and Tyvek® packaging
environmentally friendly process, with no toxic residues and reduced energy consumption

This technology is adopted by leading international pharmaceutical and medical device companies for critical applications and high-complexity processes.

Saturated steam sterilization

Saturated steam sterilization is a well-established technology for the sterilization of porous and non-porous loads, metal components and large volumes.

De Lama steam sterilizers ensure:

precise control of temperature, pressure and time
high reliability and cycle repeatability
full compliance with GMP requirements

Air–steam mixture sterilization

Air–steam mixture sterilization is designed for applications requiring accurate internal pressure control, such as deformable containers, prefilled syringes, vials and sensitive packaging.

This technology allows:

pressure balancing during the cycle
protection of container integrity
uniform sterilization of complex loads

Dry heat sterilization (DHS – Dry Heat Sterilizers / Ovens)

Dry heat sterilization (DHS), also known as dry heat ovens, is used for the sterilization and depyrogenation of materials resistant to high temperatures, such as glassware, metals and specific components.

De Lama DHS systems provide:

high and uniform temperatures
effective endotoxin destruction
fully validatable cycles

Superheated water sterilization

Superheated water sterilization is suitable for products and containers requiring uniform heat transfer and precise process control, ensuring protection of both the product and the packaging.

Ethylene oxide sterilization (EtO)

Ethylene oxide (EtO) sterilization is used for products highly sensitive to heat and humidity, particularly in the medical device sector.

De Lama designs EtO systems featuring:

maximum operational safety
strict control of aeration phases
compliance with environmental and safety regulations

Combined solutions (steam + HyPerPure®)

To provide maximum flexibility and optimized investment, De Lama develops combined systems capable of managing multiple sterilization technologies within the same unit, such as:

saturated steam + HyPerPure®

These solutions allow manufacturers to expand process validation, adapt to different product types and manage current and future production needs with a single system.

De Lama’s competitive advantages in sterilization

De Lama stands out in the industrial and pharmaceutical sterilization market thanks to:

over 77 years of experience in sterilization, washing and decontamination technologies
extensive technical know-how, supported by in-house laboratories and thousands of validation tests
full customization in terms of shape, dimensions, layout and process
strong presence among leading international pharmaceutical and medical device groups
complete GMP validation support, with advanced software and full data traceability
scalable solutions, from laboratory scale to full industrial production

Why choose De Lama sterilizers

Choosing De Lama sterilizers means relying on reliable, validated and fully customized technologies, designed to meet the most complex requirements of modern manufacturing processes, ensuring safety, regulatory compliance and operational continuity.