April 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.
