Process analytical technology

Making products with consistent quality is an unending challenge for pharmaceutical manufacturers. What is the most effective way to ensure product quality? The current belief at the US FDA is that rigorous testing does not ensure the best quality. Quality is something that has to be built-in to your manufacturing process.

Process Analytical Technologies have been defined by the US FDA as a mechanism to design, analyze and control pharmaceutical manufacturing processes through the timely measurement of Critical Process Parameters (CPP) which affect Critical Quality Attributes (CQA) during processing. PAT is not a product or service. It is a working principle or a framework for operating, depending on you implement it. We can help you with this.

What can we do for you?

• Select the right analyzer for your measurement problem.
• Select the most efficient calibration method.
• Design and construct the PAT installation.
• Identification of acceptable operating ranges for CPPs and estimation of the Design Space of your process by applying Design of Experiments tools and advanced Multivariate Data Analysis tools.
• Implementing process control strategies, like Multivariate Batch Process Monitoring.