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For medical devices and health care products that must be sterilised before use, the appropriate sterilisation cycle parameters must be determined through a sterilisation validation process.
Medical device sterilisation validations are one of the most important aspects of medical device testing because an improper sterilisation procedure could lead to severe patient consequences or even patient death. Since all products have unique designs, material densities, and packaging configurations, sterilisation conditions that are sufficient and appropriate for one device may prove inadequate for another. Thus, all sterilisation processes must be validated based on the device.
The typical sterilisation validations performed at Riverside include both Gamma irradiation and ETO validations for single use products.
Various ISO standards describe the procedures for sterilisation cycle validations based on the type of sterilisation to be used. Generally, the procedure involves inoculation of a device or product with bacterial spores prior to performing a sterilisation cycle. The device or product is then tested for sterility to determine whether the required Sterility Assurance Level (SAL) is achieved.
Performed by dosing a representative sample of devices with a verification dose, and then testing those devices for sterility.
For this testing, Riverside works with one of our partners that doses the devices with radiation, after which the microbiological analysis begins. These procedures are performed according to the ISO 11137 standards.
• BI Population Verification
• BI Sterility Testing
• Sterilisation Validations
• Radiation Sterilization (gamma and e-beam support testing)
• Ethylene Oxide (support testing)