Companies have partnered to offer integrated software solutions for advanced control and monitoring of pharma processes
Siemens AG and Perceptive Engineering have announced a partnership offering the integration of Perceptive’s PharmaMV and Siemens Simatic Sipat software products. The agreement provides a versatile solution for advanced process control (APC) and optimisation applications (process analytical technology, PAT) in both continuous and batch pharmaceutical manufacturing.
The interest to have APC integrated into a PAT platform is growing significantly within the life sciences industry. The goal of this collaboration is to offer the pharmaceutical industry the integrated combination of technologies that have — independently from each other — established a proven track record in the past decade.
Integrated PAT data management system, like Siemens’ Sipat, have been adopted by the regulated industries. Siemens’ software solution offers a 21CFR11 compliant PAT platform to monitor the end product quality in real-time while it’s been produced.
Advanced Process Control (APC) using Perceptive Engineering’s software products is well established in different industries, achieving control solutions on batch and continuous processes. Its pharmaceutical version, called PharmaMV, features specific functionalities to comply with the requirements in a regulated environment.
The integrated approach of both software solutions provides a complete platform, for structured data collection, real-time CQA calculation and multivariate modelling and monitoring, which is then combined with automated multivariable feedback directly into the process control layer to simultaneously maintain all CQA’s within the desired design space.
The combined platform has now been deployed with major pharmaceutical partners, and at key innovation centres around the world.
Simatic Sipat is a scalable and modular software solution that enables companies to extend their PAT-based quality control strategies on a step-by-step basis within the scope of a Quality-by-Design (QbD) approach.
"With Sipat as integrated PAT platform, product development and production processes can be monitored, controlled and optimized by measuring and calculating the Critical to Quality Attributes (CQA) of end products in real-time," said Siemens.
The continuous monitoring of product quality can prevent deviations from specifications and therefore reduce production costs. It also allows for real-time release testing so that final quality inspections can be reduced or eliminated.
Headquartered in northwest UK, Perceptive Engineering specialises in the deployment of model-based advanced process control (APC), especially within the pharmaceutical sector.
Perceptive's PharmaMV platform provides modular tools to design, deploy and maintain advanced applications within a regulated environment.
The platform includes software tools to ease the transition from development into manufacturing, reducing the time to transfer knowledge and technology into commercial value.
APC solutions are already available for a wide range of pharmaceutical process units, for both small and large molecules, batch and continuous processes, all now conforming to an Industry 4.0 design.