An integrated PAT Data Management
system like Siemens' Sipat has been increasingly adopted by the regulated industries, offering a 21CFR11 compliant PAT platform to monitor the end product quality in real-time while it's been produced. This is based on the structured collection of data from spectral PAT analyzers combined with traditional process data and raw data information from e.g. a LIMS application.
Advanced Process Control (APC)
with Perceptive Engineering's PerceptiveAPCTM has been established in different industries, realising APC often based on process data only. Its pharmaceutical version, called PharmaMV, has been enriched with 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.
This combined platform has now been deployed
with major Pharmaceutical partners, and at key innovation centres around the world. Perceptive Engineering, based in the UK, Singapore and Ireland can provide complimentary application support for Sipat and APC solutions worldwide.
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) based 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.