Screening Workflow for Extractables Testing of Medical Devices Using the UNIFI Scientific Information System

Library Number:
APNT135084779
Part Number:
720007255EN
Author(s):
Baiba Cabovska
Source:
Waters
Content Type:
Application Notes
Content Subtype:
Technical Notes
Related Products:
 

The UNIFI Scientific Information System provides analysts with a well-established workflow for extractable screening analysis of medical devices, supporting standards such as ISO 10993-18. The UNIFI workflow starts with the scientific library for targeted screening, followed by statistical analysis for the determination of markers or relevant compounds. The Discovery tool automatically utilizes information-rich raw data for elemental compositions, followed by a structural database search and fragmentation assignments. This integrated workflow reduces the amount of time required for extractables screening analysis with structural elucidation.


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