By Sean Fenske, Editor-in-Chief
While the pandemic put a pause on the controversy surrounding EtO sterilization and any action taking place by the EPA or FDA, the matter is far from resolved. In fact, a number of medical device manufacturers have used the additional time to explore other sterilization options for products still in development. As such, there’s perhaps never been more uncertainty over medical device sterilization or what process to use.
Providing a solution of its own, De Lama has developed its HyPerPure® technology, which leverages hydrogen peroxide, but has coupled it with a unique process and equipment to enable it to be used for a broader spectrum of products. This low-temperature sterilization process can be used for a number of medical devices that were not previously able to be treated with hydrogen peroxide.
To fully explain this technology, Marco Bianchi, marketing and sales manager, and Guido Rovera, marketing & sales director, of De Lama spa, took time to explain the benefits of their system, how it differs from traditional hydrogen peroxide sterilization methods, and how it compares to EtO.
Sean Fenske: Can you please explain why it’s important for companies to explore medical device sterilization alternatives outside of ethylene oxide (EtO)?
Marco Bianchi: Our company has been producing EtO sterilizers for more than 50 years; this equipment is still available in the De Lama catalog and continues to be delivered today. This technology, however, has always proved challenging to handle—the media is toxic, carcinogenic, and explosive. These problems make it expensive and difficult to manage. In addition, international regulations have gotten more and more restrictive. As a result, FDA recently promoted the development of alternative sterilization methods.
Considering the shortcomings of EtO, the FDA’s call to action, and urging from customers, De Lama took on the challenge to develop an alternative sterilization method. Our HyPerPure® technology represents the success of those efforts.
Fenske: What is HyPerPure® with vapor phase hydrogen peroxide and how does it differ from other hydrogen sterilization technology?
Guido Rovera: Traditionally, hydrogen peroxide technology is associated with superficial sterilization, for which a better name would be “decontamination.” With traditional hydrogen peroxide technology, media is vaporized, and as a sterilizing agent, ensures its action by aspersion on only the visible surface of the product. With a simple vaporization, it is not possible to penetrate complex product geometries or Tyvek® packaging, where normally medical devices and prostheses are positioned before sterilization with EtO or gamma rays.
De Lama’s HyPerPure® technology differs from “traditional” hydrogen peroxide decontamination, because it works under deep vacuum and zero-air condition. With this method, hydrogen peroxide is able to reach all internal surfaces, just as what occurs with EtO. For example, we can penetrate and sterilize the internal part of long, ultra-thin catheters, something that is absolutely impossible with traditional hydrogen peroxide techniques. We are also able to penetrate Tyvek® packaging and we ensure a complete sterilization (12-log) of all products contained inside the packaging.
In a way, we reproduce what happens with traditional saturated steam sterilization, where air in the chamber is totally replaced by steam in a saturated state.
Additionally, De Lama’s HyPerPure® generator performs ionization of vaporized H202, improving the sterilization efficacy.
The extended firsthand experience of De Lama in the production of saturated steam sterilizers, EtO sterilizers, and vacuum dryers during the last 70 years drove the De Lama Technical Department through the development of this new technology. This gave us a big advantage in the study and development of this kind of process.