The US Food & Drug Administration (FDA) recognized that the introduction of efficient production procedures in the pharmaceutical industry was hampered in the past by legal obstacles. To simplify and accelerate the development and introduction of products, therefore, it drew up a specification for process analytical technology (PAT) and adopted this in its final version in September 2004.
PAT is a system with which product development and production processes can be designed, analyzed and controlled on the basis of real-time measurements of critical quality and performance attributes in such as way that the achievement of the quality required for the end product can be guaranteed. According to this system, the production takes place in a strictly controlled process that is oriented toward producing products of perfect quality.
The real-time tracking of the parameters relevant for product quality also aids better understanding and management of the overall process as well as avoiding or considerably reducing the scope of final inspections. The preparation of samples for quality control at the end of the process (which can sometimes be extremely time-consuming) or for follow-up checks can thus be omitted.
With SIMATIC SIPAT, Siemens has a powerful software platform for PAT implementation in product development and production processes (for details, see Chapter "Industry Applications", Section "Process Analytical Technology").
To accompany this, Siemens offers the Premium Service SIMATIC SIPAT Consulting particularly for customers from the pharmaceutical industry and related industries. This provides additional consultation services as well as experimental investigations for the PAT integration, providing valuable support in the development, pilot project and production phases:
- Project management
- Evaluation of suitable production processes
- Evaluation of suitable analytical processes
- Process optimization
- Risk analysis
- Design of Experiment
- Multivariate data analysis
- Personnel training