Out of control processes in pharma manufacturing are not something to take lightly. If your production runs are seeing frequent deviations, leading to expensive batch losses or frequent rework, it’s time to take a look at ways to correct any process deviations in a more expedient manner. Uncorrected deviations or processes that vary from approved process parameters can lead to costly and dangerous mistakes.
Being able to monitor processes in real time and take corrective action immediately means more confidence in your production processes, and in your operations team, along with more consistent product quality.
You don’t want to wait until you have regulatory warnings or face fines before taking steps to avoid risking a patient’s health and safeguarding your processes and company’s reputation.
One of the most effective ways to ensure your processes stay within their approved critical quality attributes is with real-time process monitoring. To be effective, that means having reliable real-time data analytics tools running throughout your production runs that give your operators the information they need in time to make the right corrections.
It’s not enough to hope that training and operator experience will do the trick, or that your team will be able to handle the most common types of process deviations quickly. You need a more reliable and quantifiable method that ensures patients' health, and your compliance with FDA and regulatory guidelines.
Multivariate monitoring in real-time
Using advanced data analytics models in real time gives your team and your company more confidence in your process performance. A real-time analytics tool such as SIMCA®-online allows your production floor staff to know when a process is performing optimally or to see immediately when a deviation occurs. This early warning allows them to take the necessary steps right away to correct any issues that might cause a batch to be rendered unusable or to stop contamination of a downstream process.
Ultimately, that will mean an improvement in your overall production quality, reduction in process deviations and fewer ruined batches. You will even be able to predict when a process might start deviating from acceptable conditions.
Why a multivariate data analytics tool?
A real-time multivariate analytics solution utilizes regression models to summarize all of the individual data points from various operations into multivariate models that can be monitored in real time. This becomes very efficient in the control room because instead of looking at a large number of individual parameters or signals, your operators have a small set of summary parameters that let them monitor all the variables at the same time. This makes it easier to notice changes in the process as they happen.
Using multivariate analytics application for real-time monitoring turns all the process data you are collecting into a benefit for operations. Being able to monitor processes in real time and take corrective action immediately will help minimize your operational costs while improving efficiency. That means more confidence in your production processes, and in your operations team, along with more consistent product quality.
What can SIMCA-online do?
SIMCA-online is the real-time data analytics tool from Sartorius that lets you use data from all your processes in a proactive way. With SIMCA-online you can:
Monitor in real time. You can create an ideal model of your process and then compare your actual data for the process to the model in real time. This works for both batch processes and continuous processes.
Predict with confidence. The multivariate analysis model provides a basis for predicting quality parameters over time using regression analysis. Using this tool, you can predict the final critical quality attributes with a high degree of confidence.
Control at a glance. SIMCA-online improves your overall understanding of process and equipment because you are getting real time data and updates about what is happening in the process right now. Plus, with real-time drill downs you can pinpoint issues and detect problems with equipment as they happen.
SIMCA-online gives you:
- remote monitoring
- multivariate predictive monitoring
- fault detection
- root cause analysis (whenever a fault is detected)
- automatic corrective recommendation (available now with Control Advisor in SIMCA-online)
A real-time view of multivariate data using SIMCA-online lets production operators easily see how each batch in a process is doing.
Predicting the future
Effective process monitoring using data analytics doesn't have to stop at monitoring what’s happening right now. The right data analytics tools can also help predict the future for a process given the parameters of the current production state.
A great feature inside SIMCA-online is the module called Control Advisor. Control Advisor is a supervisory type of control tool that advises you how you should run your process to avoid problems before they arise and to get optimal final results.
Control Advisor can be used in both continuous processes and batch type processes. Control Advisor uses existing measurements of the process (up till current time point), future known set points and the multivariate model to propose “smart” adjustments to critical process parameters.
Find out more about how real-time data analytics can be used to predict the future in this article: How to predict the future and optimize your production process.
See how it works
To find out more about how SIMCA®-online can help with real-time monitoring and predictive optimization, sign up for a free demo.