Sterilization validation for medical compresses at IRASM multipurpose irradiation facility

In Romania, IRASM Radiation Processing Center is the unique supplier of radiation sterilization services—industrial scale (ISO 9001:2000 and ISO 13485:2003 certified). Its Laboratory of Microbiological Testing is the sole third party competent laboratory (GLPractice License, ISO 17025 certification in progress) for pharmaceutics and medical devices as well.We here refer to medical compresses as a distinct category of sterile products, made from different kind of hydrophilic materials (cotton, non-woven, polyurethane foam) with or without an impregnated ointment base (paraffin, plant extracts). These products are included in the class of medical devices, but for the sterilization validation, from microbiological point of view, there are important differences in testing method compared to the common medical devices (syringes, catheters, etc).In this paper, we present some results and practical solutions chosen to perform a sterilization validation, compliant with ISO 11137: 2006.