Technical Articles

In pharmaceutical and medical device manufacturing, it is not enough for an autoclave to complete its cycle without alarms. Manufacturers are required to demonstrate, through documented and reproducible evidence, that the process consistently delivers the intended sterilization conditions across the defined load configurations. This is the purpose of autoclave validation: a structured path that starts [...]

In pharmaceutical and medical device manufacturing, cleaning is not a preliminary afterthought but a critical, validated process step, directly linked to patient safety and regulatory compliance. A washer-disinfector combines automated washing with thermal disinfection in a single controlled cycle, removing product residues, active ingredients, particulates and microbial contamination from equipment, components and reusable devices. Unlike [...]

Dry heat sterilization is one of the most established and reliable methods for reducing microbial contamination, and it remains indispensable wherever steam cannot be used. Unlike the autoclave, it does not rely on moisture: it works with hot, dry air at high temperature, inactivating microorganisms through the oxidation of their cellular components. It is the [...]

Low-temperature sterilization has become one of the most important areas of innovation for the pharmaceutical industry and for medical device manufacturers. The driver is twofold: a growing share of heat-sensitive products that cannot tolerate the heat of steam, and the regulatory and environmental pressure that is steadily narrowing the role of ethylene oxide (EtO). In [...]

Trovate qui sotto il testo dell’intervista a Marco Bianchi di De Lama, pubblicata su BioMedNews, magazine del Distretto Biomedicale di Mirandola, il principale distretto italiano per i produttori di dispositivi medici. Con una storia che affonda le radici in oltre 77 anni di eccellenza italiana, De Lama S.p.A. si conferma oggi come il punto di [...]

Understanding how an autoclave works comes down to four fundamental elements: the sterilizing agent, temperature, pressure and exposure time. This balance is the basis of most industrial sterilization in the pharmaceutical, medical, biotechnology and laboratory sectors. In this article we look at what an autoclave is, what it does, how its mechanism works step by [...]

Ensuring the complete absence of microorganisms on instruments, materials and products is a critical requirement across many industries: pharmaceutical, biomedical, medical devices, cosmetic and food. The sterilization process is the procedure that makes this possible, and it represents one of the cornerstones of public health and product quality worldwide. In this article we look at [...]

For decades, sterilization has represented one of the main operational limitations in aseptic processes. A necessary step, but inherently slow, often organized in batch mode, and therefore unable to keep up with the pace of modern high-speed filling lines. With ZeroStop® Sterilization Station, De Lama introduces a solution set to completely redefine this scenario. This [...]

📄 New Paper by De Lama! 🚀 MYTHS vs REALITY Can HyPerPure® Vaporized Hydrogen Peroxide sterilization be the real alternative to Saturated Steam? 👉 The answer is YES. And now we prove it. VH₂O₂ works at low temperature, and it is not only the best solution for thermosensitive products, but in most cases also when [...]

A new important paper available to be downloaded in PDF. Learn why De Lama HyPerPure®, a patented technology, is today chosen by the most important pharmaceutical and medical device companies worldwide and can be truly considered the Gold Standard in Vaporized Hydrogen Peroxide Sterilization The technology is supported by dozens of validated references and covers [...]

🔬 A NEW PAPER is available today! De Lama is revolutionizing the aseptic process with the innovative Magnetodoor® and the concept of direct integration with the isolator. ✅ Full Annex 1 compliance ✅ Elimination of cross-contamination risks during transfers ✅ True Class A aseptic environment With Magnetodoor®, sterilizers (including exclusive #HyPerPure® VH₂O₂ sterilization), decontamination units, [...]