MX2011009710A - Process for sterilizing gauzes by ozonification. - Google Patents

Abstract

The present invention refers to a process for sterilizing gauzes by ozonification. This process basically consists in: a) loading the gauzes into the sterilization chamber (autoclave) and vacuuming the chamber, b) ozonifying the gauzes by ozone injection up to a pressure of from about 1.4 Kg/cm2, at a flow of from about 19 l/min for a period of 3.5 h to 5 h, c) aerating the gauzes by introducing the filtrated air to the chamber and by storing the same in a closed environment. The product obtained by the sterilization process is highly recommended for medical usage.

Description

PROCESS OF STERILIZATION OF GASES THROUGH OZONIFICATION Field of the invention The present invention pertains to the technical field of sterilization processes of surgical products; more particularly it belongs to the technical field of gauze sterilization for medical use; and more particularly, it belongs to the technical field of gauze sterilization processes by ozonation.

State of the art The use of gauze is necessary within the hospital service for the handling of the different procedures, hence the importance of the elaboration of these in the sterilization centers. The gauze is a very lightly woven fabric of lightweight and transparent cotton that is used to make bandages and compresses. These help in the cleaning of wounds, in the prevention of contamination of wounds, and help in the healing process.

This type of products may be subject to infection or contamination by microorganisms, viruses, and other pathogens, and therefore, to be handled or used, they require hygienic and sanitary conditions, otherwise they may cause serious damage when used under normal conditions. unhealthy Generally, the process of sterilization of this type of products. Here, the user washes hands, cuts the gauze into pieces or segments desired, bends it in such a way as to cover or hide the lint, and then wraps the gauze in creped paper, labels the paper and sterilizes in an autoclave by pressure steam at 180 ° C. However, this type of process is highly energy consuming since large quantities of it are required to raise the temperature to 180 ° C and maintain them for the duration of the sterilization. Additionally, the product of the sterilization is soaked by the water vapor to which it was exposed and therefore a drying time has to be applied.

More recently, ozone has been used as a way to sterilize hospital surgical tools. The biocide properties of ozone are known: the ozone gas is actually a strong oxidant and in contact with the cells produces a rupture of the cell membrane, breaking them and consequently exerts a similar oxidation and devastating action within the cytoplasm, causing that the target organism dies. For this reason, the toxicity of ozone is well known, both by contact (weak toxicity) and by inhalation (serious toxicity), due to the fact that ozone does not discriminate between "good" and "bad" organisms.

There are a variable number of sterilization processes, for a wide variety of products, that use the biocidal properties of ozone. For example, US 5334622 provides a sterilization system wherein the water is heated above the boiling point at ambient pressure to produce steam for injection to the ozone-producing gas produced by an ozone generator. The steam is heated to 120 ° C. Thus, the vapor / ozone mixture used for the sterilization supposedly has a temperature close to 100 ° C. However, since the decomposition of ozone is potentially increased with the temperature in the range of 20 to 300 ° C, the injection of water vapor at a temperature of about 120 ° C leads to decomposition of premature ozone. Furthermore, carrying out the sterilization at a high temperature and close to 100 ° C will require a period of substantial cooling of the sterilized materials, thereby making the sterilization a long and inefficient process.

Another example is that provided by the patent application WO2003039607. Said application provides a method for sterilization with ozone at a relative humidity above at least 95% and at a sterilization temperature of about 25-40 ° C. This temperature is selected to maximize the half-life of the ozone during sterilization. Although the results obtained by this process are excellent, the sterilization cycle is very long because cycles of up to 4.5 hours are used to guarantee complete sterilization.

Due to this problem, there is a continuous need for new gauze sterilization processes for hospital use. In this sense, the present invention provides a new sterilization process for this type of products. This process is based on the use of ozone as a sterilization agent.

Specification of the invention An object of the present invention is to provide a method for gauze sterilization based on the use of ozone.

The preferred sterilization method according to the invention includes the steps of: a) load the gauze into the sterilization chamber (autoclave), seal the sterilization chamber, and evacuate the chamber by vacuum, maintain the atmosphere in the sterilization chamber at a treatment temperature in the range of 20 to 30 ° C. b) Ozonification by injection of ozone up to a pressure of 1.4 Kg / cm2, at a flow of 19 Its / min during a period of 3.5-5 hours. c) Aeration by means of filtered air entering the chamber and by storage in a closed environment.

Best method of carrying out the invention The sterilization process is carried out using an autoclave and an ozone generator.

The process consists of the following stages: 1) Preconditioning At this stage the gauzes to be sterilized are placed inside the autoclave and the lid is sealed. Subsequently, an initial evacuation of the autoclave is made by vacuuming by means of a pump at -0.4 bar.

Ozonification This stage begins with the injection of ozone by the ozone generator. The ozone is supplied directly from the ozone generator losing the vacuum and they keep working in this way. The ozone generator reaches a power of 3.5 Amperes. The pressure generated by the ozone in the autoclave will reach a pressure of 1.4 Kg./cm2. The ozone flow in the autoclave will be 19 Its / min. The temperature of the autoclave is maintained in the range of 20 to 30 ° C, with slight variations through the flow of ozone. The product is kept under these conditions for a period of 3.5 to 5 hours. Final evacuation of the autoclave and air injection when the process ends. The ozone generated in the autoclave is eliminated by forced air flow to the outside 3) Aeration This procedure takes place after each ozonation cycle and is generally carried out in 2 stages: The first takes place in the same equipment, through the entry of filtered air into the chamber; and the second by storage in closed environments at room temperature of 12 to 24 hours, the ozonated material is kept in quarantine 4) Validation The validation requires the control and optimization of a series of variables such as ozone power, ozone pressure generated in the autoclave, ozone quantity or flow, exposure time, etc. Since this process depends on many variables, the criterion to ensure its quality requires the introduction of the concept of "validation of the ozonation process". The validation of the process consists of a documented program, which provides the assurance that all the sterilized units meet sterility specifications, for which it will be necessary to send samples of the product to a laboratory authorized by the Ministry of Health after each cycle carried out. , in order to guarantee its use.

It is intended that the above described embodiment of the present invention be taken as an illustrative example and in no way limiting the scope thereof. It is considered that all those alterations, modifications and variations of the invention made by a person skilled in the art are within the scope of the invention.

Claims (1)

CLAIMS A gauze sterilization process, characterized in that it comprises the following steps: i) loading the gauzes into the sterilization chamber of the autoclave and evacuating the chamber by vacuum, ii) injecting the chamber of the autoclave until pressure reaches a pressure of 1.4 Kg / cm2 and a flow of 19 Its / min over a period of 3.5-5 hours, iii) removing ozone to the outside by forced air flow, iv) aerating the sterilized material by entering filtered air into the chamber and through storage in a closed environment, and v) validate the sterilization of the material through microbiological tests. The product obtained by the process of claim

1.