As Ankalaps, we make validated sterilization as outsourched for you. Sterilization process of your products;
EN ISO 11135-1: 2007 Sterilization of healthy products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.
ISO 14937: 2009 Sterilization of health products - General requirements for the characterization of a sterilizing agent and development, validation and routine control of the sterilization process for medical devices.
Standards. There is no reporting without verification of the sterilization process. Sterilization validation study is required for your products. In the validated sterilization process, product sterilization safety is guaranteed by our company.