Umetrics PAT Suite is a unique offering that includes unlimited use of all Umetrics software from the off-line products MODDE and SIMCA-P+ all the way to our top of the line on-line software SIMCA-4000 and SIMCA-Batch On-Line.
The four levels of PAT, as defined by Professor Svante Wold, require different multivariate tools. During pilot projects and full scale operation work we have found that different stages in the total process will be done at the different PAT levels and that there is a need for a PAT suite as a combination of the individual tools.
Umetrics PAT Suite is offered as an unlimited use license within a company or specific site, for a competitive price.
Successful PAT applications with Umetrics
Process analytical technologies can be applied in many different areas. Some successful applications using Umetrics’ multivariate technology software include:
| • |
Fermentation batch analysis |
| • |
Failure mode analysis of past batches - off-line fault classification |
| • |
Real-time analysis and monitoring |
| • |
Tablet production and final QC (Quality Control) measurements: |
| |
- |
Both real-time and off-line granulation analysis and monitoring |
| |
- |
Both real-time and off-line coating monitoring |
| |
- |
Dissolution and other final QC measurement predictions as related to dryer performance |
| • |
Raw materials: |
| |
- |
Analysis of raw material batch to batch variation |
| |
- |
Analysis of combined variation – ie: overall conformance of all the raw materials combined with each other |
| |
- |
Excipient variability – choosing between two vendors of a common excipient |
| • |
Scale up from lab bench scale to full scale production |
| • |
Sensor calibration |
|
|

Four Levels of PAT
1.
Off-line chemical analysis in labs to large extent substituted by at-line analysis – spectroscopy, fast chromatography, images, and sensor arrays. Multivariate calibration used to convert PAT data to traditional space (e.g., concentrations, disintegration rate).
2.
The at-line PAT data are used directly without conversion back to the traditional space – MVI (Multivariate Identification), MSPC (Multivariate Statistical Process Control).
3.
On-line PAT: Data are measured also during the batch evolution of each production step – on-line MSPC, BSPC (Batch Statistical Process Control).
4.
Over-all on-line PAT: Putting data from all steps and raw materials together for a total view of the process. Involves 1–3.
|