We define a true Class 100 dry heat sterilizer and depyrogenation oven as a system capable of maintaining Class 100 conditions throughout the entire temperature cycle, from heat-up to cool-down, not only at room temperature or during the sterilization/depyrogenation phase.
All Nicos dry heat ovens meet or exceed the latest cGMP requirements:
The entire framework of the dry heat oven is constructed in tubular 304 stainless steel.The chamber and doors of the standard oven are polished to a surface roughness average of Ra 20 µm.Excellent heat distribution is achieved through the heating jacket applied to the chamber bottom, with temperature deviation inside the chamber not exceeding ±3–4°C.
The HEPA filters installed in the recirculation wall feature a gasketless vacuum sealing system, eliminating particle shedding and reducing filter gasket maintenance requirements.
The HEPA filters used in the Nicos dry heat sterilizer are pre-cured and tested using specially designed equipment custom-engineered by Nicos. Designed according to Nicos specifications, these filters are uniquely engineered to guarantee Class 100 conditions throughout the entire cycle, rather than only at room temperature.
HEPA filters on the recirculation wall have a gasketlees vacuum sealing system which eliminates particle shedding and filters’ gasket maintenance. The HEPA filters installed the recirculation wall of the ICOS Dry heat sterilizer are “precured” and tested with specially designed equipment custom manufactured by ICOS. They are specially designed as per ICOS specification, and are the only ones worldwide which can guarantee Class 100 conditions during the entire cycle and not only at room temperature.
The doors of the Nicos dry heat sterilizer oven are sealed with a patented system designed to improve the bond between the seal profile and the sealing surface, ensuring maximum reliability during operation. In the event of a leak caused by seal wear, whether inward or outward, the vacuum system draws any contamination away from the loaded chamber, preventing compromise of the sterile environment.
This sealing technology also significantly extends the lifespan of the door gaskets, increasing their durability by three to four times thanks to the absence of mechanical stress. Additionally, the system allows the chamber of the dry heat oven to maintain constant pressure, which in turn ensures stable and uniform temperature conditions throughout the sterilization cycle.
The recirculation air inside the dry heat sterilizer is distributed uniformly across the chamber through an air inlet wall equipped with fixed perforations. On the outlet wall, the perforations gradually increase in size from top to bottom, ensuring constant air velocity throughout the chamber.
Once the unit is built, no further adjustment of the airflow is required, as the system is engineered for permanent balance and consistency. Unlike other designs, Nicos dry heat sterilizers do not use deflectors that require frequent manual adjustment or bending, eliminating a common maintenance burden and ensuring long‑term operational stability.
All standard Nicos equipment is supplied with 21 CFR Part 11–compliant control systems, ensuring full regulatory conformity for data integrity and electronic records management in pharmaceutical and high‑compliance environments.
Dry heat sterilization offers several intrinsic advantages that make it a preferred solution in applications where high temperatures, absence of moisture, and material compatibility are essential. Unlike moist heat or autoclave‑based processes, dry heat relies solely on hot air to achieve sterilization, eliminating the presence of steam and preventing corrosion, oxidation, or material degradation. This makes dry heat sterilization particularly suitable for heat‑resistant equipment, depyrogenation cycles, glassware, metal instruments, powders, and materials that cannot tolerate moisture.
When compared to autoclave and moist heat sterilization, dry heat provides a series of operational and performance benefits. Moist heat sterilization—typical of autoclaves—relies on pressurized steam to transfer heat rapidly, making it highly efficient for general-purpose sterilization but less suitable for moisture‑sensitive materials. Autoclaves also require strict control of steam quality, condensate management, and gasket integrity, whereas dry heat sterilizers eliminate these variables entirely.
Furthermore, dry heat sterilization ensures complete depyrogenation, a result that moist heat sterilization cannot achieve due to the presence of water vapor. Although dry heat cycles typically require higher temperatures and longer exposure times, they offer unmatched stability, no risk of corrosion, and superior compatibility with materials that would be damaged by steam. For industries requiring absolute dryness, pyrogen removal, and long‑term material preservation, dry heat sterilization remains the most reliable and contamination‑resistant method available.
Services provided out of the Norwood New Jersey facility
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Nicos Group, Inc.
80 Oak Street
Norwood NJ 07648 - USA
Fax 201 768 9504
info@nicosgroup.com
Nicomac Europe Srl
Via Curiel, 12 20060 Liscate
Milano – Italy
Ph. +39 02 9542041
Fax +39 02 95420444
