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Sterilisation is an important method that manufacturers widely use to keep medical devices safe for patient use. It is a considered a ‘cold’ sterilization technique and offers high compatibility with most materials used in the manufacturing & packaging of medical devices, such as plastics, polymers, metals and glass. For many medical devices, EO sterilisation may be the only method that effectively sterilizes without damaging the device during the sterilisation process.

Sterilisation is a crucial process in the pharmaceutical industry to ensure the safety and efficacy of drugs and medical devices. Ethylene oxide (EO) sterilisation is one of the most widely used methods for sterilising pharmaceutical products. In this article, we will discuss the basics of EO sterilisation, its advantages and disadvantages, and its applications in the pharmaceutical industry.

Sterilization is the process of eliminating or reducing the number of microorganisms. It is a critical step in the manufacturing and packaging of medical devices and pharmaceuticals to ensure safe for use for patients. EO sterilization is a commonly used method of sterilization in the medical and pharmaceutical industries.

At Medistri, we believe in delivering the highest quality services to our customers. In the sterilisation process of medical devices using ethylene oxide (EO), it is important to carefully consider several variables to ensure that the process is effective.

Medistri, a leading provider of contract sterilization & laboratory services for healthcare companies, is excited to announce the arrival of its fifth sterilization line this week. The new chamber will be used primarily for the sterilization of pharmaceutical & medical devices coming from multiple countries. It will be fully operational and ready to use by the beginning of 2023.

Sterility testing is required to ensure viable contaminating microorganisms are not evident in a product. This testing is conducted by direct inoculation or membrane filtration methods and is performed in a cleanroom environment.

Steam sterilisation works by placing products in a steam autoclave and exposing the products to pressurised steam at high temperatures in order to destroy viable microorganisms.  This allows for the creation of saturated steam which will immediately induce condensation on the surface of the product to sterilise.

It is critical when evaluating packaging materials that the risks from sterilisation methods are assessed. Different types of sterilisation methods impact materials and products in different ways.Medistri’s team has gathered more than a decade of experience working with the world’s most innovative healthcare companies and helping them scale globally.

Steam sterilisation technology exposes your products with saturated steam under pressure. Steam enhances the ability of heat to kill microorganisms by reducing the time and temperature required to denature or coagulate proteins in the microorganisms.

Prior to beginning routine ethylene oxide sterilisation, a product with a sterile claim needs to complete a validation process to ensure the Sterility Assurance Level claimed is met according to ISO 11135.

An Ethylene Oxide (EO) Sterilization Validation is designed to assist the manufacturer in the development of a sterilization process that delivers the appropriate sterility assurance level and ensures repeatability for each product type developed.