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Sterile Process Validation

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Therapeutic products sold as “sterile” are often produced by means of a terminal sterilization process.  This is particularly true of medical devices and various international standards exist to substantiate the chosen sterilization process, be it by Ethylene Oxide, Gamma Irradiation, Autoclaving or other novel process.  Our consultants have extensive experience in helping clients to achieve successful validations of such processes in accordance with international standards that will be acceptable to regulatory authorities.