SteriPro® Labs
sterilization, sterilize, sterilisation, medical device sterilization, contract sterilization

Endotoxin / LAL

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Residual

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Residual Testing

When a product is sterilized with ethylene oxide (EO), some of the gas may be absorbed by the product and/or its packaging and retained after sterilization. There may also be traces of EO bi-products present after sterilization. The extent of degassing and aeration used during the sterilization process will have a significant effect in reducing these residue levels.

Why you need it

Residual testing is your assurance that your product is safe to market

Determining the levels of EO and its by-products is a requirement for many medical devices. The International Standard (ISO) 10993-7 describes the categorization of products, methods of residual testing and allowable limits of residues.

SteriPro® Laboratories provide:

The Simulated Use Method extracts residues over a set time based on the maximum time thedevice would be exposed to a patient, and the route by which any dose would be administered.

The Exhaustive Extraction Method extracts residues by heating the product in a sealed systemand testing the vapour above it, or by repeated aqueous extraction of the samples.

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