focus on seriate laboratory, italy
18 avril 2019
It has been one year since we completed the expansion of our laboratory in Seriate, Italy by adding a new sterility testing suite and upgrading the testing areas.
The Seriate lab supports our E-beam and gamma sterilization facilities by testing to ISO11137, with routine bioburden, endotoxin and environmental testing.
The laboratory also supports our ethylene oxide processing in Italy with biological indicator testing, and EO and ECH residual testing on medical devices, intravenous devices and pharmaceutical containers and primary packaging.
The laboratory performs validation of test methods for medical devices and pharmaceutical containers according to ISO 10933-7 Annex A and Annex B requirements and ICH Q2 (R1) - Validation of analytical procedures: text and methodology.
Additionally, the laboratory performs extraction and analysis of EO and ECH residuals for pediatric-use medical devices, where the specified limits are very low.
These tests can support our Customers in validating the degassing processes and demonstrating compliance of their products to these limits.
Contact us today to learn more about our laboratory testing services.
À propos de STERIS
STERIS est l'un des principaux fournisseurs mondiaux de produits et services destinés aux soins des patients, avec un accent particulier sur la prévention des infections.
NOUS AIDONS NOS CLIENTS À CRÉER UN MONDE PLUS SAIN ET PLUS SÛR en fournissant des produits et services innovants dans le domaine des soins de santé et des sciences de la vie à travers le monde.
Pour plus d'informations, rendez-vous sur www.steris.com.
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