Process Understanding is closely related to Quality by Design. A high level of process understanding is nowadays mandatory for effective first-time-right implementation and successful filing of new processes. Health agencies increasingly demand information and insight in performance of your process in order to assess the quality risk adequately. For process understanding applications, extensive calibration and modelling is often not desired. InProcess-LSP offers smart, fit for purpose modelling approaches which effectively extract the desired information from your process.
Process Understanding areas for which PAT can be applied effectively:
- Process Development: activities like Design of Experiments, Upscaling and Validation
- Tech Transfer: by evaluating real time “process signatures” from PAT data, without the need for laborious sampling and corresponding analytical workload
- Troubleshooting: identification of possible causes for poor process performance
In these areas PAT provides in-depth understanding of your process and reduces the overall cycle time and required resources.
Typical for Process Understanding Applications is the temporary nature of the application. InProcess-LSP offers the unique possibility for you to make use of PAT equipment and expertise on a temporary basis, in those cases where major long term investments are difficult to justify.