Process analytical technology for the pharmaceutical and life science industries
The direct path to the perfect batch: Our PAT software SIPAT ensures optimum process performance and integrated quality in the pharmaceutical industry. The PAT software SIPAT is fully compliant with the FDA initiative "Pharmaceutical Manufacturing in the 21st Century” that fosters implementing process analytical technology (PAT).
The goal of process analytical technology is to spark a new approach to production and a critical review of all processes that directly or indirectly influence product quality. With the PAT software SIPAT, we support you in each phase of your process analytical technology implementation by using our knowledge of the technological, organizational and validation-specific aspects of process analytical technology. This is our QBD methodology. For example, during process evaluation we search for levers that will allow the systematic improvement of quality control. Based on the information gathered in that step, we develop a process analytical technology strategy for you that will bring you closer to your goals for process quality, product quality and real-time product release. We then work with you to implement a custom process analytical technology solution based on our proven PAT software SIPAT.
The result is a thoroughly optimized QbD implementation for a production process that delivers perfect quality – batch after batch – and is always flexible. The PAT software SIPAT allows production expansion, new products and new challenges.
Process analytical technology: Background
The Food & Drug Administration (FDA) recognized that significant regulatory barriers inhibited pharmaceutical manufacturers from adopting state-of-the art manufacturing practices within their industry. As a result, the FDA issued its final-form PAT guidance in September 2004.
Business Benefits of SIPAT
Implementing process analytical technology with the PAT software SIPAT, you can achieve better process insight, real-time product release, manufacturing performance improvement, quality consistency improvement, and regulatory compliancy using online quality control.
What is SIPAT?
SIPAT is Siemens’ PAT software solution that supports QbD implementation. The PAT software features functions such as data collection, data mining, real-time prediction of quality parameters, 21CFR11-ready, version management, online visualization, as well as reporting and analysis of historical data.
Utilize our process analytical technology solution based on SIPAT, the high-performance PAT software. Benefit from features such as data collection, data mining, monitoring and control, and reporting-overview complying with legal regulations and 21CFR11.