Product Adoption for Ethylene Oxide Sterilization

Click here to view this TechTip as a PDF Introduction Medical device manufacturers are constantly developing new products or improving the design, packaging and/or load configurations of their current products. Adoption of a new product into a device family or changes to an existing load configuration requires an impact assessment to the currently-validated sterilization process.…

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2x Processing for Ethylene Oxide Sterilization

Click here to view this TechTip as a PDF When validating an ethylene oxide process, it is advantageous for both the Customer and the sterilization facility to qualify a 2X process. A 2X process is the ability to subject the validated routine load configuration through two complete sterilization cycles. Why would 2X processing be necessary?…

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Significant Figures

Significant figures are numbers that carry a contribution to a measurement and are useful as a rough method to round a final calculation. For more complex systems such as the uncertainty of a dosimetry system, or estimating the bioburden of a product, more accurate methods should be used

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X-ray Plant Design

The layout of the plant and manufacturing process is designed to fulfill international standards, including the quality management system standard for medical devices ISO 13485, ISO 11137: Sterilization of Healthcare Products – Radiation, cGMP and Food and Drug Administration guidelines.

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