Before electron beam (E-Beam) | X-Ray irradiation can be used as a method of sterilization, a validation process must be done to establish the sterility assurance level. This process then sets the sterility standard for future testing of a product. The validation process guidelines on health care products per ISO 11137 have three sections: Requirements for development, validation, and routine control of a drug product. Establishing the sterilization dose. Guidance on dosimetric aspects. What follows is an overview of the standards established by industry regulations for E-Beam | X-Ray irradiation. Read more >
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