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Sterilization Methods for Medical Devices and Pharmaceutical Products

By admin  /  05 June 2021

Krishna Engineering is the brand name recognized in the industrial market as a leading ETO Sterilizer Manufacturer. During this pandemic it is more important for medical devices and pharmaceutical products to get sterilized and further meet regulatory and safety requirements before they can be distributed and sold. The best sterilization method depends on numerous factors, starting with the product uniqueness such as material, design and dimensions, and how those properties will work together with the sterilization process. Properties to regard as comprise thermal stability, radiation stability, reaction with chemical sterilants, permeability and density, among others.

Common Sterilization Methods

Gamma Irradiation : Gamma irradiation is a safe, reliable and highly effective method of treating a wide variety of products composed of different materials, densities and dose requirements, such as wound dressings, plasters, medical devices and pharmaceuticals.

Electron Beam Sterilization : Uses ionizing energy to effect sterilization provides very precise dosing of radiation that can be done very quickly and economically.

Ethylene Oxide Sterilization : Ethylene oxide (EtO) is a common gas, generally used to sterilize devices that cannot withstand high heat. Ethylene oxide is flammable, explosive, and toxic.

Microbiology : Sterilization process is effective at attaining the appropriate Sterility Assurance Level via dose substantiation/setting studies and routine sterilization dose audits.