The proposed technology is able to sterilize bulk or pre-packaged items in blisters, through the indirect action of a non-thermal plasma. The invention claims to be an alternative to other existing methods of sterilization, e.g. using ethylene oxide (EtO).
Main advantages:
Patent Status
GRANTED
Priority Number
102018000006094
Priority Date
07/06/2018
License
INTERNATIONAL
Market
The global revenue from sterilization services market stands at US$ 3.4 Bn in 2022 with the global market expected to reach a valuation of approximately US$ 7.1 Bn by the end of 2033 as regards heat sensitive devices.
Problem
The current post-pandemic situation has increasingly highlighted the need for sterile devices. Disposable medical devices are proposed as the most effective and safest solution in avoiding or containing the spread of infections. This type of device, being made of plastic material, needs to be sterilized with low temperature methods. Sterilization must also take place for objects previously packaged in the appropriate containment blisters. The sterilization processes suitable for this type of product must therefore be able to reach the inside of the container blisters without significantly increasing their temperature.
Current technology limitations
The method most used nowadays for the sterilization of disposable medical devices is based on Ethylene Oxide gas (EtO) as it is effective and economical. On the other hand, EtO is classified as a flammable, explosive, toxic, mutagenic and carcinogenic gas. These reasons have led to a strong limitation in the construction of new plants based on EtO, and to a virtual ban on its use. This ban will be implemented once alternative sterilization technologies are available on the market. A second sterilization process used in the medical field for heat-sensitive devices is that achieved by irradiation. This method is typically effective but expensive. The radiation used can also be carcinogenic for workers in the sector and can also modify the chemical-physical properties of the treated samples. Other methodologies such as hydrogen peroxide are typically confined to small sterilization volumes.
It is therefore necessary to invest in new technologies to find valid, economic, sustainable and less harmful to health solutions, thus avoiding limiting the development of this sector which is so strategic in the daily life of the population. The plasma technology developed by us aims to replace EtO in sterilization processes, using the reactive species produced by an electric discharge generated in air at atmospheric pressure. This process promises to be backwards compatible, cost-effective and more environmentally friendly than current solutions on the market.
Killer Application
Our technology and solutions
The process object of the patent is able to sterilize bulk objects or pre-packed in blisters, through the indirect action of a non-thermal plasma. The air present in the environment or synthetic air stored in cylinders is pumped, through a possible humidity reducer, inside the reactor. An electrical discharge is generated in it capable of producing reactive oxygen and nitrogen species (ROS and RNS) and charged particles. This effluent is introduced into a vacuum chamber inside which the object to be sterilized is placed. The vacuum is previously created in this chamber and the ROS and RNS are subsequently pumped. This procedure allows the active species to be able to penetrate even inside the classic blisters used in the medical field, as they are equipped with a semi-porous membrane. After a certain time spent in the vacuum chamber, the chamber is emptied and the effluent can either be reused for a new cycle, or, previously purified, released into the atmosphere.
Advantages
The main advantage lies in the backwards compatibility of the plasma process with respect to that of EtO, the most commonly used method for sterilizing disposable medical devices. In this way, the changes to be made to the entire production, packaging, treatment and shipping chain of sterilized objects will be minimized. The use of activated air makes it possible to reduce costs, guaranteeing a lower environmental impact and a drastic reduction in the risks associated with the health of operators and end users.
Roadmap
We have been collaborating with the company ADM srl to build a first pilot plant. The project started one year ago. This ‘real life’ plant includes a sterilization chamber of 20 m3 and an electric generator for the formation of the discharge of about 15 kW. The prototype is under construction and will be ready after the summer.
TRL
Team
