Kolmi Hopen, a manufacturer of single-use medical equipment, has developed ISO AIR sterile masks sterilized using ethylene oxide (EO) gas. It is the first company to employ this sterilization method for masks dedicated to controlled environments.
Sterilization is a process aimed at eliminating viable microorganisms from a product, ensuring a reduction in microbial load.
Typically, masks and other disposable protective equipment are sterilized using gamma irradiation, which is the most commonly employed method.
Ethylene oxide gas has also demonstrated its effectiveness over time. But its use for masks dedicated to controlled environments is a novel application. This is what Kolmi Hopen, a leading manufacturer of medical masks, managed to do.
Ethylene Oxide Sterilization vs. Irradiation (Beta, Gamma)
The ISO AIR Sterile Masks they develop undergo a sterilization process using ethylene oxide (EO). According to the company, this technology offers several notable technical features and benefits.
One key advantage is the masks’ maintained filtration performance. Even after sterilization, the masks consistently demonstrate high levels of Bacterial Filtration Efficiency (BFE), Particle Filtration Efficiency (PFE), and Viral Filtration Efficiency (VFE), exceeding 99%. In comparison, gamma irradiation may lead to up to a 15% decrease in filtration capacity due to material degradation.
The ISO AIR Sterile Masks also maintain their organoleptic properties. Ethylene oxide sterilization does not cause any discoloration or unpleasant odors, ensuring a favorable and comfortable wearing experience for users.
These masks also offer technical specifications. They achieve over 99% BFE, PFE, and VFE, as verified by independent laboratory Nelson. The ethylene oxide sterilization process used on these masks ensures a Sterility Assurance Level of 10-6, providing a high level of sterility. Designed for use in controlled environments, such as ISO 3 Class A or higher environments, these masks pass the rigorous Helmke Drum Test requirements, meeting the standards outlined in IEST-RP-CC003.4.
Additionally, the ISO AIR Sterile Masks are easy to wear and provide enhanced comfort. The transverse elastic bands facilitate easy donning, while the masks offer excellent breathability with a Delta P measurement of less than 29 PA/cm2. To minimize particulate contamination and reduce the risk of wearer irritation, the masks incorporate Softex technology.
Manufactured in ISO 9001 and 13485 certified facilities, and within ISO 8 cleanroom environments, these masks adhere to stringent manufacturing standards. They comply with the sterilization protocols outlined in ISO 11135:2014, ensuring the proper sterilization and control of healthcare products using ethylene oxide.
The Growing Market for Cleanrooms
In France, the cleanroom surface area has increased by 33,327 square meters since 2016, accompanied by the addition of 10,332 operator positions. This trend is expected to continue as the medical and pharmaceutical industries experience significant growth, driven by revised French innovation strategies focused on reshoring and investments in these sectors. Consequently, the number of cleanrooms and the demand for sterile equipment will inevitably rise (France 2030 Plan: reshoring and increased drug production capacity).
Simultaneously, stricter regulations push manufacturers to elevate their production standards and rely more on controlled environments. This was the motivation behind the launch of the ISO AIR non-sterile mask range in late 2022, catering to the increasing needs of industries equipped with cleanrooms, including micro and nano-electronics.
Similar demands may arise from upcoming projects such as the Automotive Cells Company (ACC), the first gigafactory for electric vehicle batteries in France, established in Pas-de-Calais, and the semiconductor factory announced by STMicroelectronics and GlobalFoundries in Isère.
Content provided by Kolmi Hopen