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  1. 6 Απρ 2016 · Book PDF Available. STERILISATION AND DISINFECTION. April 2016. Authors: Moshtaq Talip Al-mohanna. University of Al-Qadisiyah. Figures (1) Abstract and Figures. Disinfection and...

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      Book PDF Available. STERILISATION AND DISINFECTION. April...

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  2. A new e-book has been published: Sterilization: Practical Approaches offers practical approaches to sterility testing, Gamma Irradiation for single use disposables, sterilization using EtO...

  3. This document provides guidance on testing for sterility of substances, preparations, and articles according to the European Pharmacopoeia. It describes the precautions that must be taken to avoid microbial contamination during testing.

  4. The purpose of sterilization is to provide sterile products, material and medical equipment. All goods which have been sterilized must have a sterility assurance.

  5. Sterility testing. Sterility can be defined as the freedom from the presence of viable microorganisms. However, the conditions that guarantee absolute sterility are usually too harsh for active ingredients, and the definition of sterility for a medicinal product must be defined in functional terms.

  6. Sterile devices are free of viable microorganisms. Regulatory requirements for medical devices include particular requirements for devices supplied or intended to be used in a sterile state.

  7. A sterile medical device is one that is free of viable microorganisms. International standards that specify requirements for validation and routine control of sterilization processes, require, when it is necessary to supply a sterile medical device, that adventitious microbiological contamination of a medical device prior to