DHS - Dry Heat Ovens For Sterilization And Depyrogenation Class

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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:

• 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.

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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.

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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.

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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.

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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.

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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]

" ["parent"]=> int(0) ["count"]=> int(16) ["filter"]=> string(3) "raw" ["term_order"]=> string(1) "0" } [1]=> object(WP_Term)#20819 (11) { ["term_id"]=> int(963) ["name"]=> string(14) "DEPYROGENATION" ["slug"]=> string(14) "depyrogenation" ["term_group"]=> int(0) ["term_taxonomy_id"]=> int(963) ["taxonomy"]=> string(7) "process" ["description"]=> string(1441) "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)#21030 (11) { ["term_id"]=> int(997) ["name"]=> string(23) "Dry heat depyrogenation" ["slug"]=> string(23) "dry-heat-depyrogenation" ["term_group"]=> int(0) ["term_taxonomy_id"]=> int(997) ["taxonomy"]=> string(7) "process" ["description"]=> string(7526) "La depirogenazione è un processo adottato per la rimozione dei pirogeni, in particolare delle endotossine batteriche, da apparecchiature e prodotti farmaceutici e dispositivi medici. È essenziale per garantire la sicurezza dei farmaci iniettabili e dei dispositivi medici sterili. Il metodo più comune è la depirogenazione a calore secco, che utilizza temperature superiori a 250 °C per distruggere le endotossine. Questo processo è diverso dalla sterilizzazione, poiché mira a contaminanti non viventi nocivi. La depirogenazione è convalidata tramite test di provocazione con endotossine per garantirne l'efficacia. [Leggi di piu]  Utilizzata nella produzione asettica, in particolare per vaccini, fluidi endovenosi e prodotti oftalmici. Regolamentata secondo le GMP e attentamente monitorata da agenzie come FDA ed EMA. I sistemi moderni offrono controllo automatizzato, monitoraggio in tempo reale e perfetta integrazione. Una corretta gestione post-processo previene la ricontaminazione e garantisce la sicurezza del paziente. La depirogenazione è una fase fondamentale nella produzione di farmaci sicuri e ad elevata purezza.

Cosa sono esattamente i pirogeni?

I pirogeni sono sostanze che causano un aumento della temperatura corporea, cioè febbre. Il termine deriva dal greco: pyro- (fuoco) e -geno (generatore), quindi "generatori di calore".

Tipi di pirogeni

1. Pirogeni esogeni: provengono dall'esterno dell'organismo, soprattutto da:

   • Batteri, ad esempio i lipopolisaccaridi (LPS) della parete dei batteri Gram-negativi.

   • Virus, funghi o altre tossine microbiche.

2. Pirogeni endogeni: prodotti dal corpo in risposta ai pirogeni esogeni, tra cui:

   • Citochine infiammatorie, come:

     • Interleuchina-1 (IL-1)

     • Interleuchina-6 (IL-6)

     • Fattore di necrosi tumorale alfa (TNF-α) Questi agiscono sull'ipotalamo, regolando il "termostato" del corpo e innalzando la temperatura corporea.

Importanza

• Clinica: La presenza di pirogeni, soprattutto nei prodotti iniettabili (come farmaci o soluzioni endovenose), può causare febbre o reazioni avverse nei pazienti. Per questo si fanno test di controllo (come il test LAL con amebociti di Limulus).

• Biologica: La febbre è una risposta difensiva dell’organismo per contrastare infezioni, rallentando la replicazione dei patogeni e stimolando il sistema immunitario.

Perchè non è sufficiente la semplice sterilizzazione per eliminare i pirogeni?

1. I pirogeni non sono organismi viventi

• La sterilizzazione (ad esempio con calore, radiazioni o filtri) serve a uccidere o rimuovere microrganismi come batteri, virus e funghi.

• I pirogeni, però, sono sostanze chimiche (come i lipopolisaccaridi batterici), non viventi, quindi non “muoiono” con la sterilizzazione.

2. I pirogeni sono molto resistenti

• I lipopolisaccaridi (LPS) dei batteri Gram-negativi, che sono i pirogeni più comuni, resistono al calore: anche a temperature di sterilizzazione standard (121 °C per 15–20 minuti), possono restare attivi.

• Sono anche stabili chimicamente e non si degradano facilmente.

3. I pirogeni possono restare anche dopo l’eliminazione dei batteri

• Anche se si uccidono tutti i batteri, i residui delle loro pareti cellulari, contenenti pirogeni, possono rimanere attaccati a superfici o presenti nelle soluzioni.

Come si eliminano i pirogeni allora?

Ci sono tecniche specifiche chiamate depirigenazione, come:

• Calore secco ad alte temperature (es. 250 °C per almeno 30 minuti)

• Filtrazione speciale (per soluzioni termolabili)

• Lavaggi e processi chimici (es. con acido forte)[/Leggi di meno]

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