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Download Flyer
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Contract EtO Sterilisation
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Send your products to our laboratory at Kortrijk, Belgium (20km from Lille, France) for contract sterilisation. Customers benefit from the advantages of EtO sterilisation without having to invest in the necessary equipment. Each of the customer’s loads is sterilised separately from any other loads, in our ISO 13485 certified laboratory.
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More information about contract sterilisation
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Bioburden Test (AN6210)
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This test determines the number of organisms that are on a device after cleaning and wrapping, but before the sterilisation process. The results of the test determine how effective the sterilisation process will be.
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Sterilisation Validation (AN6200)
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A process validation is required for any manufacturer of a sterile medical device as microorganisms may be present. Gas sterilisation validation must confirm to ISO11135/EN550 standard. Andersen provide complete validation support covering installation, operational and performance qualification. On completion we will provide a dossier suitable for CE, FDA, or other registrations.
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Gas Residual Test (AN6215)
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Performed post-sterilisation with a gas chromatograph, this analysis measures devices and packaging for levels of retained EtO and its bi-products after the sterilisation process. The bi-products that can remain are called Ethylene Chlorohydrin (ECH) and Ethylene Glycol (EG). The International Standards Organisation has set a maximum level for these residuals. This is determined by the length of time that a patient is likely to be exposed to the sterilised device.
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Aging Studies (AN6220)
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There are two purposes for the Aging Studies:
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1. To verify the shelf life of manufactured products. Prior to sterilisation the quantity of microorganisms on these products must first be established.
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2. To analyse the effectivenss of cleaning agents on killing bacteria
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Hot and humid chambers are used to accelerate the testing process.
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