How to obtain process control data
There are multiple reasons to make use of PAT. One of the most common drivers for applying PAT is efficiency. For many processes required intermediate process control data is obtained by sampling and offline analysis in a QC lab.
Sampling and offline analysis impacts the process
This approach requires access to the process sample stream in a representative way, which often requires stopping of the process as well.
Besides the possible impact of stopping a process and sampling itself (with additional risk for contamination and/or sterility), the offline analysis takes time before the process can continue.
Timeconsuming and unreliable
In addition, offline analysis requires manpower to sample, analyze, and evaluate before actual feedback to the process.
In some cases, an offline sampling approach is based on extensive modeling during process development in order to translate the intermediate in-process data into feed-forward information for the process. For this approach extensive knowledge of the process, and relation to process variables are mandatory.
Although this approach can be effective, setting up a reliable model to translate limited in-process data into reliable feed-forward information can take significant development time (up to years!), while the mentioned drawbacks of sampling and offline analysis still exist.
Use PAT to study critical process parameters
During process development, scale-up and transfer PAT is a very attractive approach to study critical process parameters and their impact on product quality.
Typical for the design of experiment-based development activities, involving large numbers of samples and process variations, PAT will provide an effective way of gaining knowledge.
PAT is extremely helpful
Since highly dense data from the process is obtained continuously and instantly PAT can be extremely helpful to understand your process characteristics either in development, scale-up, transfer or manufacturing.
High costs due to the absence of appropriate particle size monitoring solutions
Reducing the risk of failure by Process Control
Complex processes will consequently show higher risks of failure for end-product quality. A PAT tool capable of monitoring critical process parameters will significantly lower the risk of failure by providing possibilities to detect any anomaly in real time at an early stage, or to adjust process settings automatically to assure the right product quality.
In addition, PAT data of multiple production batches will form a valuable database for continuous improvement and evaluation of process performance.
Opportunities by PAT
Although most business cases and arguments to make use of PAT are related to efficiency wins and lowering of risks,
PAT provides specifically for complex processes and products a unique way to improve the precision of the manufacturing process.
While for several products, specifications are based on the current performance of the production process, PAT may offer new possibilities to produce at significantly tighter specification limits, which may correspond to better-performing products or other competitive advantages.
- reduce production cycling time
- prevent rejection of batches
- enable real-time release
- increase automation and control
- improve energy and material use
- facilitate continuous processing
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.