Introduction to EO Sterilisation Validation
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.
EO Sterilisation Load Variables
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 to Welcome it's Fifth Sterilization Line
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 for Medical Devices
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.
Introduction to Steam Sterilisation
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.
EO Sterilisation & Packaging
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.
Contract Steam Sterilization Services
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.
Ethylene Oxide (EO) Sterilization Validation
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.
Medistri drives sharp increase in sterilisation of medical devices with integrated electronics during Research & Development phases.
Medistri’s Switzerland Plant in Domdidier is optimised to help innovative companies scale faster and remove friction to their development cycles. And many of the Medical Devices most complex and innovative products contain electromechanical parts.
