Sterilization of medical devices
Sterilization is a critical safety measure for medical devices, aimed at eliminating all forms of microorganisms, including spores.
History of Sterilization
Closely linked to the development of medicine and microbiology
- 19th century: With the discovery of microorganisms (Pasteur, Koch), the need for instrument disinfection arises.
- Hot air and boiling water – the first sterilization methods.
- 1870s: Joseph Lister introduces antisepsis; autoclaving (saturated steam sterilization) later becomes widespread.
- 20th century: Advances in chemistry and physics lead to gas, radiation, and other sterilization methods for medical (including single-use) devices.
Modern Sterilization Methods
Today, the most common methods for sterilizing medical devices are:
1. Ethylene Oxide (EtO) Gas Sterilization
Mechanism: Ethylene oxide is a highly reactive gas that destroys microorganisms’ DNA and proteins
Advantages:
Effective at low temperatures (30–60°C)
Suitable for heat-sensitive materials (plastics, polymers, nonwovens)
Deep penetration into packaging and complex structures
Disadvantages:
Gas toxicity requires strict ventilation and control
Long sterilization cycle (up to several days, including aeration)
Requires expensive equipment and special protective measures
Applications:
Widely used for industrial sterilization of single-use medical devices (syringes, catheters, surgical apparel, etc.)
2. Radiation Sterilization
Types of Radiation:
Gamma radiation (Cobalt-60)
Electron beams
X-ray radiation
Advantages:
High effectiveness
Fast process
Capability to sterilize in tightly sealed packaging
Disadvantages:
Requires specialized shielded facilities and radiation sources
High cost
Not all materials are radiation-resistant (possible polymer degradation)
Applications: Sterilization of large batches of certain products, including medical kits, PVC devices, and laboratory equipment.
Development of Sterilization Methods
This is a continuous improvement of technologies in line with safety, environmental, and efficiency requirements. In the modern medical industry, ethylene oxide gas sterilization and radiation sterilization remain the leading methods for processing heat-sensitive, complex, or pre-packaged products. The choice of method depends on material characteristics, product type, and regulatory standards (ISO 11135, ISO 11137).
We were among the first companies to implement, in addition to radiation sterilization, our own ethylene oxide gas sterilization process.
Despite several drawbacks — such as structural degradation of polymer materials under gamma irradiation, which negatively affects the strength of fabrics and materials, aesthetic appearance, and may produce an unpleasant odor—radiation sterilization remains necessary for certain products.
(Note: The translation maintains technical accuracy, corporate emphasis, and regulatory references while preserving the original structure and intent.)
