Lucideon’s VALIDATA service provides quantitative, on-going, third party cleanliness validation ensuring your products are safe and providing peace of mind.
We understand the difficulty in determining “how clean is clean”, and defining and justifying your acceptable limits to the regulatory authorities. This is why we developed the Lucideon “Cleanliness Index” using our VALIDATA service. VALIDATA provides a condensed, quantifiable parameter so you can see and compare your product cleanliness either during process development, or batch-to-batch.
You’ll benefit from quantified product and process cleanliness- independent or relative to a previous result, as well as access to our troubleshooting expertise to help pinpoint and solve cleanliness issues. The service can be performed on specifically designed test coupons or the product itself.
How It Works
VALIDATA quantifies residual contamination using advanced surface analysis techniques, to detect what has not been removed by your cleaning processes. This is then compared to what is expected to be there and, by the application of a proprietary combinatorial algorithm, expresses the result as a single “Cleanliness Index” parameter in the form of a “% clean” figure.
Our techniques include:
- White Light Interferometry (3DP)
- Optical Microscopy
- X-ray Photoelectron Spectroscopy (XPS)
- Scanning Electron Microscopy (SEM)
- Energy-Dispersive X-ray Spectroscopy (EDX)
- Dynamic Secondary Ion Spectroscopy (DSIMS)
- Time of Flight Secondary Ion Spectroscopy (ToFSIMS)
- Atomic Force Microscopy (AFM).
With Lucideon’s VALIDATA service you receive quantitative imaging, elemental/molecular detection and surface structure modelling to detect what cannot be seen by eye to ensure your products are clean and safe.
Surface contamination investigation
Application of Lucideon's cleaning validation procedure - Validata
Lucideon has worked with Greatbatch Medical to help them gain FDA approval.