10993-12 Sample Preparation and Reference Materials

Mike Hendershot

Senior Project Development Advisor NAMSA

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Overview What is Extraction? Sample Preparation Extraction Process – Important Considerations

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What is Extraction?

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Extraction is a process that exposes a test article to an extraction vehicle to evaluate the test article for potential,

chemical leachables

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Sample Preparation- Preparation of the device for the extraction process

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Typically two options Surface area – preferred Weight – used if surface area cannot be determined

accurately

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To select the correct method, you must consider what to include in

the preparation Portions with direct patient contact Portions with indirect patient contact

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Based on the device, select the appropriate method/ratio

<0.5 mm thick = 6 cm2/ml >0.5 mm thick = 3 cm2/ml Irregularly shaped objects = 0.2 gram/ml Irregularly shaped/low density = 0.1 gram/ml Elastomeric = 1.25 cm2/ml

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Extraction Process – Important

Considerations

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When extract vehicle is poured, device must be covered

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Agitation is required

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Extract collected after extraction should not be filtered or

centrifuged without justification

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pH of collected extract should not be adjusted without justification

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To view the complete series about 10993-12 Sample Preparation and Reference Materials Visit NAMSA Seminars

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