Passbox for decontamination with vaporized hydrogen peroxide under vacuum with HyPerDekont® technology

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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).

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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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