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SGS’ Life Science Services supports its partners in the medical device industry with a broad range of services.
SGS performs hygienic qualification of the production facilities, microbiological tests on the products before and after sterilization, and control of the sterile product with regard to possible
toxic residues from the sterilization process (endotoxins, ethylene oxide). SGS’ Life Science Services also conducts implantation tests for testing the safety of medical devices. |
SERVICES INCLUDE
- Determination of bioburden before sterilization
- Method development and validation
- Sterility testing according to USP and EP of products and biological indicators
- Test for endotoxins
- Test for ethylene oxide residue according to
DIN EN ISO 10993-7
- Hygiene monitoring for the qualification and control of production zones
- Implantation test (muscular, peritoneal, ocular, intraosseous)
- Cytoxicity testing
- Biocompatibility according to EN ISO 10993
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SGS INSTITUT FRESENIUS Berllin GmbH & Co. KG
Tegelerweg 33
D - 10589 Berlin
t +49 30 34607-500
f+49 30 34607-600
de.qualitycontrol sgs.com
SGS INSTITUT FRESENIUS GmbH
Im Maisel 14
D - 65232 Taunusstein
t +49 6128 744-377
f +49 6128 744-700
de.qualitycontrolsgs.com
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