Sterilization is a validated process used in the preparation of sterile medical or pharmaceutical devices or cosmetics to free the product, equipment, excipients and packaging from living microorganisms and their spores. Sterilization quality defines the Sterility Assurance Level (SLA) as the degree of assurance with which the process ensures the sterility of all units in a batch - the probability of having a non-sterile unit in a batch. A sterile medical device (MD) according to GOST EN 556-1-2011 is considered to be a medical device with y (US) 10-6, i.e. One non-sterile medical device is acceptable from a batch of 1 million medical devices.

Radiation sterilization method (RS) - sterilization by irradiating the product with ionizing radiation. The bactericidal effect of ionizing radiation is used. This method can be used for sterilization of medical devices, medicinal and cosmetic herbal raw materials, herbal medicines, herbal medicines, excipients and packaging. It is permitted by the General Pharmacopoeial Article GPM.1.1.0016.15 “Sterilization Section 4. Radiation method of sterilization”, and GOST R 52249-2009 “Appendix 1 pp. 98-103 for medicines”. It is carried out as a validated process in accordance with GOST 11137-1-2011.

Sterilization practice has established that only radiation sterilization can provide a UOS of 10-6. For comparison, the thermobaric method provides UOS 10-2-10-3, the method of gas sterilization with ethylene oxide UOS 10-4 -10-5 (with a limited scope for sterilization of medical devices). Thus, radiation sterilization is the most reliable and effective method. In addition, it is the most common, most versatile in relation to medical devices, drugs and cosmetics and provides high performance.

Advantages of radiation sterilization compared to other methods:

• higher degree of inactivation of microorganisms;
• processing of products in final transport packaging (products remain sterile for a longer period);
• possibility of processing products from thermolabile materials;
• safety of the process and processed products;
• sterilization of products is carried out when they are already placed in sealed packaging, which ensures long periods of maintaining sterility;
• packages with products irradiated by an electron beam do not contain carcinogenic substances, as with gas sterilization;
• products can be used immediately after irradiation;
• When irradiated, products heat up slightly and do not get wet;
• safety of products and the sterilization process.

Reliability and guarantees of working with the INEX Group of Companies are supported by current legislation - the manufacturer is responsible for the quality of medical devices and medicines in the “Sterile” category, subjected to radiation sterilization.