ISO 13408-7 Aseptic Handling of Health Care Products - Alternative Treatments for Medical Devices and Combination Products

Material Testing

ISO 13408-7 Aseptic Handling of Health Care Products - Alternative Treatments for Medical Devices and Combination Products

ISO 13408-7 specifies requirements and provides guidance on alternative approaches to process simulations for the qualification of aseptic processing of medical devices and combination products that cannot be terminally sterilized and for which the process simulation approach according to ISO 13408-1 cannot be applied.

ISO 13408-7 Aseptic Handling of Health Care Products - Alternative Treatments for Medical Devices and Combination Products

ISO 13408-7 describes how risk assessment can be used during the development of an aseptic process to design a process simulation study for medical devices and combination products where direct media substitution during aseptic processing is not possible. it does not simulate the actual aseptic process.

Terms and definitions, for the purposes of this document, the terms and definitions given in ISO 13408-1 apply. Exogenous contamination, the introduction of exogenous material during the manufacturing process, the focus of exogenous contamination in this part of ISO 13408 is biological agents bacteria, mold, yeast. Process simulation simulates the manufacturing process or parts of the process to demonstrate the capacity of the aseptic process to prevent biological contamination.

EUROLAB assists manufacturers with ISO 13408-7 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.

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