Automatic documentation:

Reproducible single particle analysis. All of the raw data (images, image analysis results and Raman spectra), as well as all of the user settings are documented and saved along with the results file. All of the generated data conform with the 21 CFR Part 11 required for operation, in compliance with xGMP guidelines.

The spectra are interpreted and attributed to known contamination sources by querying the database. The integrated spectrum editing tool allows the user to automatically eliminate background and fluorescence using algorithms specifically developed for this application. This ensures that all of the spectra are analyzed and interpreted in the same manner. The particles are identified by matching the peak positions and peak areas with those of known compounds in the database.

The overall system – from sample preparation and image analysis to Raman spectroscopy – is ready for user-specific IQ/OQ/PQ validation and includes all of the necessary documentation. The results conform to the relevant standards (ISO 16232, etc.) and ensure operation in compliance with cGMP guidelines.